The Eu2P programme offers various training opportunities in pharmacovigilance and pharmacoepidemiology, including short courses, certificates, masters, and PhD programmes. The training is delivered through an online platform and is offered by a partnership between universities, pharmaceutical companies, and regulatory agencies. Courses cover topics such as basics of epidemiology and statistics, clinical research methods, pharmacovigilance regulations, risk identification and communication, and assessing the public health impact of medicines. The training is designed to improve professional competencies for healthcare professionals, students, and industry professionals.
The document discusses Quality by Design (QbD) principles for pharmaceutical product development. It defines key QbD concepts like quality target product profile, critical quality attributes, critical material attributes, critical process parameters, risk assessment, design space, and control strategy. It provides examples of applying these concepts for developing different dosage forms like tablets, capsules, solutions, and creams. The document aims to guide systematic development of pharmaceutical products using a QbD approach with a focus on understanding and controlling critical factors influencing quality.
This document provides guidelines for antibiotic treatment of common infections in general practice. It lists respiratory infections, ear, nose and throat infections, and gastrointestinal and genitourinary infections. For each condition, it summarizes the management, common pathogens, and first-choice and alternative antibiotic treatments. The guidelines aim to promote prudent antibiotic use and recommend first choosing effective first-line antibiotics, reserving broad-spectrum antibiotics only for indicated conditions.
This document provides an overview of essential drugs and the World Health Organization's (WHO) model list of essential medicines. It discusses the history and definition of essential drugs, as well as the criteria and guidelines for establishing a national essential drugs program. Key points include:
- The concept of essential drugs was developed in 1975 to improve access to necessary medicines in developing countries. The first WHO model list was published in 1977.
- Essential drugs are those that satisfy the health care needs of most of the population and are available at all times. Selection is based on disease prevalence, treatment resources, and financial constraints.
- Establishing a national essential drugs program requires designating a drug authority, developing treatment guidelines and form
Clinical pharmacy services-Thao's presentationHA VO THI
This document discusses the roles and responsibilities of a clinical oncology pharmacy specialist. It describes clinical activities such as rounding with the medical team, counseling patients, reviewing chemotherapy orders, and developing treatment protocols. It also covers administrative duties like reporting medication errors and participating in hospital committees. The specialist also teaches students, residents, and other healthcare professionals. References are provided for clinical guidelines, drug information resources, and pharmacy meetings.
This document provides guidelines for the non-clinical and clinical evaluation of biosimilar monoclonal antibodies. It recommends a step-wise approach to non-clinical and clinical development to establish comparability between a biosimilar and reference product. For non-clinical studies, it recommends initial in vitro studies followed by a determination of need for in vivo studies. For clinical studies, it recommends initial pharmacokinetic studies followed by pharmacodynamic and comparative efficacy and safety trials. It also addresses extrapolation of indications and post-approval pharmacovigilance requirements. The goal is to demonstrate similar safety and efficacy while ensuring the safety and efficacy established for the reference product is maintained.
This document outlines key concepts in pharmacoepidemiology study designs. It discusses the scientific method and different types of epidemiologic study designs including descriptive studies, analytical studies, case reports, case series, ecological studies, cross-sectional studies, case-control studies, and cohort studies. It emphasizes that randomized controlled trials provide the strongest evidence while case reports and ecological studies provide the weakest evidence.
This document discusses clinical studies and trials for traditional medicines and natural products. It provides an overview of the different phases of clinical drug development, including Phase I trials which test safety in small groups, Phase II trials which assess efficacy and side effects in larger patient groups, and Phase III trials which demonstrate safety and efficacy in large patient populations. The goal of clinical trials is to determine appropriate dosages and identify potential risks before drugs can be approved for medical use.
This document outlines the course curriculum for the first two semesters of the M.Pharm Pharmacology program. The first semester covers advanced pharmacology topics like drugs acting on the nervous system and cardiovascular system. It also covers pharmacokinetics, pharmacodynamics, and drug metabolism. Practical courses apply the concepts from theory. The second semester focuses on clinical pharmacology, toxicology, preclinical evaluation, and clinical research methodology. It examines drug therapy for various disorders and special patient populations. Overall, the curriculum provides in-depth training in pharmacology principles, preclinical and clinical evaluation, and research methodology.
The document discusses Quality by Design (QbD) principles for pharmaceutical product development. It defines key QbD concepts like quality target product profile, critical quality attributes, critical material attributes, critical process parameters, risk assessment, design space, and control strategy. It provides examples of applying these concepts for developing different dosage forms like tablets, capsules, solutions, and creams. The document aims to guide systematic development of pharmaceutical products using a QbD approach with a focus on understanding and controlling critical factors influencing quality.
This document provides guidelines for antibiotic treatment of common infections in general practice. It lists respiratory infections, ear, nose and throat infections, and gastrointestinal and genitourinary infections. For each condition, it summarizes the management, common pathogens, and first-choice and alternative antibiotic treatments. The guidelines aim to promote prudent antibiotic use and recommend first choosing effective first-line antibiotics, reserving broad-spectrum antibiotics only for indicated conditions.
This document provides an overview of essential drugs and the World Health Organization's (WHO) model list of essential medicines. It discusses the history and definition of essential drugs, as well as the criteria and guidelines for establishing a national essential drugs program. Key points include:
- The concept of essential drugs was developed in 1975 to improve access to necessary medicines in developing countries. The first WHO model list was published in 1977.
- Essential drugs are those that satisfy the health care needs of most of the population and are available at all times. Selection is based on disease prevalence, treatment resources, and financial constraints.
- Establishing a national essential drugs program requires designating a drug authority, developing treatment guidelines and form
Clinical pharmacy services-Thao's presentationHA VO THI
This document discusses the roles and responsibilities of a clinical oncology pharmacy specialist. It describes clinical activities such as rounding with the medical team, counseling patients, reviewing chemotherapy orders, and developing treatment protocols. It also covers administrative duties like reporting medication errors and participating in hospital committees. The specialist also teaches students, residents, and other healthcare professionals. References are provided for clinical guidelines, drug information resources, and pharmacy meetings.
This document provides guidelines for the non-clinical and clinical evaluation of biosimilar monoclonal antibodies. It recommends a step-wise approach to non-clinical and clinical development to establish comparability between a biosimilar and reference product. For non-clinical studies, it recommends initial in vitro studies followed by a determination of need for in vivo studies. For clinical studies, it recommends initial pharmacokinetic studies followed by pharmacodynamic and comparative efficacy and safety trials. It also addresses extrapolation of indications and post-approval pharmacovigilance requirements. The goal is to demonstrate similar safety and efficacy while ensuring the safety and efficacy established for the reference product is maintained.
This document outlines key concepts in pharmacoepidemiology study designs. It discusses the scientific method and different types of epidemiologic study designs including descriptive studies, analytical studies, case reports, case series, ecological studies, cross-sectional studies, case-control studies, and cohort studies. It emphasizes that randomized controlled trials provide the strongest evidence while case reports and ecological studies provide the weakest evidence.
This document discusses clinical studies and trials for traditional medicines and natural products. It provides an overview of the different phases of clinical drug development, including Phase I trials which test safety in small groups, Phase II trials which assess efficacy and side effects in larger patient groups, and Phase III trials which demonstrate safety and efficacy in large patient populations. The goal of clinical trials is to determine appropriate dosages and identify potential risks before drugs can be approved for medical use.
This document outlines the course curriculum for the first two semesters of the M.Pharm Pharmacology program. The first semester covers advanced pharmacology topics like drugs acting on the nervous system and cardiovascular system. It also covers pharmacokinetics, pharmacodynamics, and drug metabolism. Practical courses apply the concepts from theory. The second semester focuses on clinical pharmacology, toxicology, preclinical evaluation, and clinical research methodology. It examines drug therapy for various disorders and special patient populations. Overall, the curriculum provides in-depth training in pharmacology principles, preclinical and clinical evaluation, and research methodology.
This document outlines topics related to pharmaceutical formulations, drug delivery systems, dosage forms, compounding, manufacturing, and clinical pharmacy practice. It discusses pre-formulation characteristics, formulation systems, pharmaceutical calculations, dispensing, manufacturing specialties like radiopharmaceuticals, facilities, conventional and non-conventional drug carrier systems, aseptic processing, preformulation studies, types of dosage forms, drug delivery systems, routes of administration, pharmaceutical ingredients, pharmacy compounding, compounding and dispensing. It also discusses good manufacturing practices, personnel, quality assurance, contamination control, stability, validation, health promotion, essential medicines, counseling, pharmacoeconomics, pharmacovigilance, hospital pharmacy, community pharmacy, forensic pharmacy,
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
The document discusses the process of clinical drug design and development. It begins by defining drugs and their targets in the body. It then outlines the various phases of clinical trials that drugs must undergo to test their safety and efficacy before regulatory approval. These phases progress from small healthy volunteer groups to large patient populations. The document also discusses approaches to drug design like computer-aided design and targeting specific sites in the body. Quality by design principles are highlighted as important to developing products that meet clinical needs. In total, the clinical drug design process involves methodical testing from early targets to final approved treatments.
This clinical trial protocol summarizes a phase 2 double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of TJ301 for the treatment of active ulcerative colitis. The trial will enroll 90 patients to receive either 600mg of TJ301 biweekly, 300mg of TJ301 biweekly, or placebo biweekly for 12 weeks. The primary endpoint is clinical and endoscopic remission at week 12. Secondary endpoints include safety assessments, pharmacokinetic measures, and changes in disease activity scores from baseline to week 12. The protocol outlines the study design, patient selection criteria, treatments, assessments, data management, and statistical analysis plan.
This document outlines the course syllabus for Clinical Pharmacy and Therapeutics at the University of Zambia School of Medicine. The 120-hour course aims to provide students with the ability to integrate pharmaceutical sciences, social sciences, and pharmacotherapeutic aspects of various diseases in order to make sound therapeutic decisions. It covers topics such as clinical pharmacy processes, prescribing, pharmacokinetics, drug interactions, adverse drug reactions, specific disease states, required clinical skills for pharmacists, and therapeutics for body systems including gastrointestinal, cardiovascular, respiratory, and central nervous systems. Assessment includes tests, assignments, laboratory reports, and course competencies focus on pharmacy practice services, responding to ailments, delivering pharmaceutical care, and effective
This document discusses the opportunities and future for pharmacists. It begins by explaining that pharmacy is an attractive career option that provides many job opportunities due to advances in technology and the pharmaceutical industry. It then outlines various job roles for pharmacists in industries, hospitals, retail, academics, and research. It also describes the skills and qualifications needed for different pharmacy careers including diploma, bachelor's, Pharm.D, master's and doctorate degrees. Overall, the document presents the wide range of career paths available to pharmacists across different settings.
The document outlines the phases of clinical trials. Phase I trials involve small studies with healthy volunteers to determine safety and dosage. Phase II trials enroll more participants and aim to determine efficacy. Phase III trials are large randomized controlled trials to confirm efficacy and monitor adverse effects. Phase IV trials take place after marketing approval to further monitor long-term safety in broad patient populations. The document provides details on objectives, methods, and goals of each phase of clinical trials.
03 investigational use drugs update from guidelinesSohani Ali
1. Research drugs are pharmaceutical entities not approved for general use but being evaluated for safety and efficacy in clinical trials. They require specialized labeling, informed consent processes, and regulatory approval and oversight.
2. Clinical trials involving human subjects must be reviewed and approved by institutional review boards to ensure risks are justified and subjects provide informed consent. Trials are also subject to regulations and reporting requirements by health authorities.
3. Proper documentation, storage, dispensing, monitoring and informed consent procedures are required when using research drugs in clinical trials to protect safety of trial subjects and integrity of trial data. Regular reporting to sponsors and regulatory authorities is also needed.
The document discusses the history and development of clinical pharmacy in India. It notes that clinical pharmacy began emerging in India in the 1980s and 1990s in response to issues with drug misuse and safety. Several key developments followed, including revisions to pharmacy education regulations and the establishment of early master's programs in pharmacy practice. Today, clinical pharmacy practice has expanded further, with pharmacists taking on roles like providing drug information, managing medication therapy, and counseling patients in both hospital and community settings.
The protocol summarizes a study to assess the effectiveness of oral sulfonylurea medication for patients with type-2 diabetes who have not previously received drug therapy. The study will use an open label, active control design to evaluate the safety and efficacy of glimepiride treatment. Any adverse events will be reported according to guidelines. The protocol outlines the study objectives, design, selection criteria for participants, treatment plan, and procedures for data collection and management in keeping with regulatory standards.
The document discusses the various phases of clinical drug trials. Phase 3 trials involve large patient populations of 500-3000 people across multiple sites to confirm the drug's safety, effectiveness, and appropriate dosage. Phase 4 trials occur after marketing approval and involve post-marketing surveillance and pharmacovigilance to monitor long-term safety and effectiveness in an even larger population under regular medical practice. The overall goal of clinical trials is to generate necessary data to allow regulatory approval and safe medical use of new drugs.
Clinical pharmacology studies the effects and uses of drugs in humans, including their therapeutic effects, safety, and how the body processes them. It aims to ensure rational and optimal drug use by evaluating drugs' efficacy, safety, appropriate dosage, and monitoring treatment outcomes. Choosing drugs based on clinical needs, costs, and minimizing use is important to avoid issues like delayed treatment, unnecessary side effects, and developing antimicrobial resistance. Selecting a limited set of well-understood "P-drugs" can help providers give more effective care while reducing complications.
Drug utilization studies aim to evaluate prescribing and usage of medications in a systematic way. They describe patterns of drug use, identify irrational use, help improve drug use, and provide quality control of the drug use process. Data on drug use comes from various sources like large databases, regulatory agencies, suppliers, and practice and community settings. Conducting drug utilization studies involves 11 steps - from identifying drugs/therapeutic areas to study, to designing the study, collecting and evaluating data, providing feedback, and continually reassessing the program.
The document discusses the types of medication orders, the six rights of administering medication, routes of medication administration, important considerations when administering medication including dosage calculations and identifying the patient, common abbreviations used, and the importance of proper documentation. It emphasizes that nurses must understand pharmacology and drug administration fundamentals to safely administer medications.
This document outlines a Phase III clinical trial protocol to compare the efficacy and safety of a novel calcium channel blocker drug called Cardex to the drug Nifedipine in treating patients with stage 1 hypertension. The proposed randomized controlled trial would involve 600 patients across 15 centers in India. Patients would be randomly assigned to receive either Cardex or Nifedipine and their blood pressure and platelet aggregation would be measured at regular intervals over 18 months to assess the comparative efficacy, safety and pharmacokinetics of the two drugs. The protocol provides details on the study objectives, design, procedures, statistical analysis and ethical approval process.
This document discusses the phases of clinical trials. It begins by defining a clinical trial and explaining their importance. It then outlines the typical phases:
Phase I trials involve small groups of healthy volunteers and focus on safety, tolerability and pharmacokinetics. Phase II trials enroll larger numbers of patients to study efficacy and further evaluate safety. Phase III trials involve thousands of patients and aim to confirm efficacy and further monitor safety. Phase IV trials occur after marketing approval to further monitor long-term safety and efficacy.
The document provides details on the objectives, features, sample sizes, and information gained from each phase of trials. It discusses microdosing studies, pharmacogenomics studies, and post-marketing surveillance. In summary
The document discusses guidelines for clinical trial protocols according to various regulatory agencies. It provides definitions of a protocol, describes common components of protocols such as objectives, study design, and safety assessments. It also outlines regulatory requirements for bioequivalence studies from agencies like FDA, EMA, and CDSCO regarding issues like study design, sample size, acceptance criteria, product handling and more. Requirements for conducting fed and fasting studies are also covered.
The document outlines the courses for Semester VII. It includes 10 theory courses and their corresponding practical courses. The courses cover subjects like Pharmaceutical Chemistry, Pharmaceutics, Pharmacology, Pharmacognosy, and Pharmaceutical Analysis. For each course, it provides information on the number of lecture and practical periods per week, as well as the evaluation scheme which includes components like class attendance, teacher assessment, sessional marks and end semester examination. The document also provides book recommendations for each course.
Tacy wrote about her family, providing the names of her mother, father, grandmother, sisters, and brothers. She explained that her nana works for the government, her mom works at a brewery, and her dad works at a vaping solutions company. Tacy also included the ages of her family members, with her stating she is 8 years old and her little sister being the youngest at 5 months old.
This document contains comments on proposed regulations regarding business and financial disclosures. It discusses several key points:
1) Sunset provisions should be included to evaluate new disclosure requirements based on complexity and impact. A staff review would help ensure changes are implementable without undue delay.
2) Disclosure thresholds may need updating as some are outdated. Materiality definitions do not require changes.
3) Principles-based and prescriptive approaches both have advantages and disadvantages for registrants and investors. Balancing the two could help preserve benefits while addressing concerns.
This document outlines topics related to pharmaceutical formulations, drug delivery systems, dosage forms, compounding, manufacturing, and clinical pharmacy practice. It discusses pre-formulation characteristics, formulation systems, pharmaceutical calculations, dispensing, manufacturing specialties like radiopharmaceuticals, facilities, conventional and non-conventional drug carrier systems, aseptic processing, preformulation studies, types of dosage forms, drug delivery systems, routes of administration, pharmaceutical ingredients, pharmacy compounding, compounding and dispensing. It also discusses good manufacturing practices, personnel, quality assurance, contamination control, stability, validation, health promotion, essential medicines, counseling, pharmacoeconomics, pharmacovigilance, hospital pharmacy, community pharmacy, forensic pharmacy,
Preparation of Clinical Trial Protocol of India.Aakashdeep Raval
The document provides information on clinical trial protocols in India. It discusses the purpose of clinical trials and phases of clinical trials from Phase 0 to Phase 4. It explains that the clinical trial protocol is a document that states the background, objectives, design, methodology and statistical considerations of a clinical trial. The protocol describes inclusion/exclusion criteria, assessments of efficacy and safety, data management, quality control and other key elements to ensure proper conduct of the clinical trial. An effective clinical trial protocol provides all the necessary details to guide researchers in safely and ethically evaluating a medical treatment.
The document discusses the process of clinical drug design and development. It begins by defining drugs and their targets in the body. It then outlines the various phases of clinical trials that drugs must undergo to test their safety and efficacy before regulatory approval. These phases progress from small healthy volunteer groups to large patient populations. The document also discusses approaches to drug design like computer-aided design and targeting specific sites in the body. Quality by design principles are highlighted as important to developing products that meet clinical needs. In total, the clinical drug design process involves methodical testing from early targets to final approved treatments.
This clinical trial protocol summarizes a phase 2 double-blind randomized placebo-controlled trial to evaluate the safety and efficacy of TJ301 for the treatment of active ulcerative colitis. The trial will enroll 90 patients to receive either 600mg of TJ301 biweekly, 300mg of TJ301 biweekly, or placebo biweekly for 12 weeks. The primary endpoint is clinical and endoscopic remission at week 12. Secondary endpoints include safety assessments, pharmacokinetic measures, and changes in disease activity scores from baseline to week 12. The protocol outlines the study design, patient selection criteria, treatments, assessments, data management, and statistical analysis plan.
This document outlines the course syllabus for Clinical Pharmacy and Therapeutics at the University of Zambia School of Medicine. The 120-hour course aims to provide students with the ability to integrate pharmaceutical sciences, social sciences, and pharmacotherapeutic aspects of various diseases in order to make sound therapeutic decisions. It covers topics such as clinical pharmacy processes, prescribing, pharmacokinetics, drug interactions, adverse drug reactions, specific disease states, required clinical skills for pharmacists, and therapeutics for body systems including gastrointestinal, cardiovascular, respiratory, and central nervous systems. Assessment includes tests, assignments, laboratory reports, and course competencies focus on pharmacy practice services, responding to ailments, delivering pharmaceutical care, and effective
This document discusses the opportunities and future for pharmacists. It begins by explaining that pharmacy is an attractive career option that provides many job opportunities due to advances in technology and the pharmaceutical industry. It then outlines various job roles for pharmacists in industries, hospitals, retail, academics, and research. It also describes the skills and qualifications needed for different pharmacy careers including diploma, bachelor's, Pharm.D, master's and doctorate degrees. Overall, the document presents the wide range of career paths available to pharmacists across different settings.
The document outlines the phases of clinical trials. Phase I trials involve small studies with healthy volunteers to determine safety and dosage. Phase II trials enroll more participants and aim to determine efficacy. Phase III trials are large randomized controlled trials to confirm efficacy and monitor adverse effects. Phase IV trials take place after marketing approval to further monitor long-term safety in broad patient populations. The document provides details on objectives, methods, and goals of each phase of clinical trials.
03 investigational use drugs update from guidelinesSohani Ali
1. Research drugs are pharmaceutical entities not approved for general use but being evaluated for safety and efficacy in clinical trials. They require specialized labeling, informed consent processes, and regulatory approval and oversight.
2. Clinical trials involving human subjects must be reviewed and approved by institutional review boards to ensure risks are justified and subjects provide informed consent. Trials are also subject to regulations and reporting requirements by health authorities.
3. Proper documentation, storage, dispensing, monitoring and informed consent procedures are required when using research drugs in clinical trials to protect safety of trial subjects and integrity of trial data. Regular reporting to sponsors and regulatory authorities is also needed.
The document discusses the history and development of clinical pharmacy in India. It notes that clinical pharmacy began emerging in India in the 1980s and 1990s in response to issues with drug misuse and safety. Several key developments followed, including revisions to pharmacy education regulations and the establishment of early master's programs in pharmacy practice. Today, clinical pharmacy practice has expanded further, with pharmacists taking on roles like providing drug information, managing medication therapy, and counseling patients in both hospital and community settings.
The protocol summarizes a study to assess the effectiveness of oral sulfonylurea medication for patients with type-2 diabetes who have not previously received drug therapy. The study will use an open label, active control design to evaluate the safety and efficacy of glimepiride treatment. Any adverse events will be reported according to guidelines. The protocol outlines the study objectives, design, selection criteria for participants, treatment plan, and procedures for data collection and management in keeping with regulatory standards.
The document discusses the various phases of clinical drug trials. Phase 3 trials involve large patient populations of 500-3000 people across multiple sites to confirm the drug's safety, effectiveness, and appropriate dosage. Phase 4 trials occur after marketing approval and involve post-marketing surveillance and pharmacovigilance to monitor long-term safety and effectiveness in an even larger population under regular medical practice. The overall goal of clinical trials is to generate necessary data to allow regulatory approval and safe medical use of new drugs.
Clinical pharmacology studies the effects and uses of drugs in humans, including their therapeutic effects, safety, and how the body processes them. It aims to ensure rational and optimal drug use by evaluating drugs' efficacy, safety, appropriate dosage, and monitoring treatment outcomes. Choosing drugs based on clinical needs, costs, and minimizing use is important to avoid issues like delayed treatment, unnecessary side effects, and developing antimicrobial resistance. Selecting a limited set of well-understood "P-drugs" can help providers give more effective care while reducing complications.
Drug utilization studies aim to evaluate prescribing and usage of medications in a systematic way. They describe patterns of drug use, identify irrational use, help improve drug use, and provide quality control of the drug use process. Data on drug use comes from various sources like large databases, regulatory agencies, suppliers, and practice and community settings. Conducting drug utilization studies involves 11 steps - from identifying drugs/therapeutic areas to study, to designing the study, collecting and evaluating data, providing feedback, and continually reassessing the program.
The document discusses the types of medication orders, the six rights of administering medication, routes of medication administration, important considerations when administering medication including dosage calculations and identifying the patient, common abbreviations used, and the importance of proper documentation. It emphasizes that nurses must understand pharmacology and drug administration fundamentals to safely administer medications.
This document outlines a Phase III clinical trial protocol to compare the efficacy and safety of a novel calcium channel blocker drug called Cardex to the drug Nifedipine in treating patients with stage 1 hypertension. The proposed randomized controlled trial would involve 600 patients across 15 centers in India. Patients would be randomly assigned to receive either Cardex or Nifedipine and their blood pressure and platelet aggregation would be measured at regular intervals over 18 months to assess the comparative efficacy, safety and pharmacokinetics of the two drugs. The protocol provides details on the study objectives, design, procedures, statistical analysis and ethical approval process.
This document discusses the phases of clinical trials. It begins by defining a clinical trial and explaining their importance. It then outlines the typical phases:
Phase I trials involve small groups of healthy volunteers and focus on safety, tolerability and pharmacokinetics. Phase II trials enroll larger numbers of patients to study efficacy and further evaluate safety. Phase III trials involve thousands of patients and aim to confirm efficacy and further monitor safety. Phase IV trials occur after marketing approval to further monitor long-term safety and efficacy.
The document provides details on the objectives, features, sample sizes, and information gained from each phase of trials. It discusses microdosing studies, pharmacogenomics studies, and post-marketing surveillance. In summary
The document discusses guidelines for clinical trial protocols according to various regulatory agencies. It provides definitions of a protocol, describes common components of protocols such as objectives, study design, and safety assessments. It also outlines regulatory requirements for bioequivalence studies from agencies like FDA, EMA, and CDSCO regarding issues like study design, sample size, acceptance criteria, product handling and more. Requirements for conducting fed and fasting studies are also covered.
The document outlines the courses for Semester VII. It includes 10 theory courses and their corresponding practical courses. The courses cover subjects like Pharmaceutical Chemistry, Pharmaceutics, Pharmacology, Pharmacognosy, and Pharmaceutical Analysis. For each course, it provides information on the number of lecture and practical periods per week, as well as the evaluation scheme which includes components like class attendance, teacher assessment, sessional marks and end semester examination. The document also provides book recommendations for each course.
Tacy wrote about her family, providing the names of her mother, father, grandmother, sisters, and brothers. She explained that her nana works for the government, her mom works at a brewery, and her dad works at a vaping solutions company. Tacy also included the ages of her family members, with her stating she is 8 years old and her little sister being the youngest at 5 months old.
This document contains comments on proposed regulations regarding business and financial disclosures. It discusses several key points:
1) Sunset provisions should be included to evaluate new disclosure requirements based on complexity and impact. A staff review would help ensure changes are implementable without undue delay.
2) Disclosure thresholds may need updating as some are outdated. Materiality definitions do not require changes.
3) Principles-based and prescriptive approaches both have advantages and disadvantages for registrants and investors. Balancing the two could help preserve benefits while addressing concerns.
This document contains comments on disclosure requirements for businesses and finances as required by regulations. Several comments discuss balancing the costs and benefits of required disclosures for both registrants and investors. There is discussion around tailoring requirements based on materiality and industry to reduce unnecessary costs while still providing useful information to sophisticated investors. Comments also address potential relocations of certain required disclosures to improve flow and readability.
The document summarizes the disclosure requirements for various items in Schedule 14A, which is used for proxy statements. It discusses the requirements for items 1 through 7, covering information like the date, time and place of shareholder meetings, procedures for revoking proxies, disclosure of interested parties in matters being voted on, security ownership of management and others, and requirements regarding identifying directors and board committee composition and responsibilities. The document is an educational summary of the key disclosure rules for public companies in filing proxy materials with the SEC.
This document contains comments on proposed changes to SEC regulations regarding financial statement disclosures required for business acquisitions and other transactions. It discusses proposed modifications to significance tests used to determine disclosure requirements for acquired businesses, equity method investments, and collateralized securities. The commenter recommends replacing existing tests with simpler tests based on revenue and fair value to improve the reliability and understandability of disclosures for average investors. The commenter also provides feedback on changing requirements for pro forma financial statements, consolidated financial statements of guarantors, and scaled disclosures for smaller reporting companies.
SEC compliance and disclosure- Annual Report to the Shareholders, the case of GEArthur Mboue
This document discusses the requirements and process for preparing and distributing a company's annual report to shareholders. It covers SEC rules requiring companies to prepare an annual report and distribute it to shareholders. It outlines the roles and responsibilities of management, directors, advisors and counsel in preparing the report. It also describes the typical format and contents of an annual report, including financial statements, letter to shareholders, business descriptions, and other information. Finally, it discusses delivery requirements for annual reports to the SEC and stock exchanges.
International financial institutes in crisisArthur Mboue
- Jim Kim was reappointed for another term as World Bank Group President despite calls from employees to fire him for his management style, including firing talented employees and intimidating staff.
- Dominique Strauss-Kahn resigned as IMF Managing Director in 2011 after being arrested for sexual assault. There are questions about whether he favored countries with legalized sex work in loan approvals.
- Christine Lagarde was found guilty of negligence by a French court for improperly handling an arbitration case while serving as French Finance Minister, raising integrity questions about favoring political friends over her actual employers.
World bank group governance is here to stayArthur Mboue
1. The World Bank group governance structure was adapted from corporate governance models to suit the "social bank" context. This structure guides policy decisions for the World Bank group leadership and its various institutions.
2. The board of governors acts ceremonially and delegates authority to the board of executive directors for day-to-day supervision. The executive directors represent member countries, either individually or in constituencies of multiple countries.
3. Voting power disparities between countries led to the constituency system to reduce differences, but questions remain about incentives for executive directors to represent all countries in their constituencies equally versus their own. Consensus decision-making further shifts control away from votes.
Laws related to voice reform at the world bank groupArthur Mboue
1. The document discusses reforms to voting rights and power at the World Bank Group. It outlines changes in the percentage of voting power held by developed and developing countries for various divisions of the World Bank like IBRD, IDA, IFC, and MIGA.
2. Trends in the top eight shareholder countries' voting power from 2009-2016 are shown. The US and China have seen increases while European countries have experienced decreases.
3. The reforms and changes in voting power allocation aim to address complaints from World Bank employees and member countries about the President's management style and lack of representation in decision making.
This short document features photos from various photographers and suggests that the viewer may be inspired to create their own presentation on SlideShare. It includes photos from mikelo, EverJean, Mick Cam, fred_v, and _Lev_ without any other text.
This short document promotes creating presentations using Haiku Deck, a tool for making slideshows. It encourages the reader to get started making their own Haiku Deck presentation and sharing it on SlideShare. In just one sentence, it pitches the idea of using Haiku Deck to easily create engaging slideshow presentations.
The document discusses the benefits of exercise for mental health. Regular physical activity can help reduce anxiety and depression and improve mood and cognitive function. Exercise causes chemical changes in the brain that may help protect against mental illness and improve symptoms.
Accountable Director and Officer proxy statement questionnaireArthur Mboue
This document is a questionnaire for a company's directors and officers regarding their independence and any related party disclosures required by securities regulations. It requests personal information, details on family/business relationships with the company, current and prior employment history, details of compensation and equity ownership in the company, and asks if the respondent has been involved in certain legal or financial proceedings. The goal is to obtain full disclosure on these topics for the company's proxy statements and regulatory filings.
This document is about Aaron's mom. It provides biographical details about her, such as that she studied to be a vet in college, taught Aaron about animal anatomy, and was born in Bolivia. It also lists some of her favorites, including Jigglypuff from Pokemon, the ponyta, and Pikachu. Her favorite food is empanadas and her favorite number is 18 because that's how old she was when Aaron was born. The document concludes with a brief section about her jobs, including previously working at a restaurant in San Antonio and currently babysitting in Washington D.C.
The document discusses the use of interim executives to address organizational challenges and capability gaps. It notes that interim executives can be brought in to immediately fill gaps ("traditional interims") or address specific issues for a defined period as subject matter experts ("strategic interims"). Hiring interim executives provides a flexible, cost-effective way to access key skills. It highlights examples of how interim executives have helped organizations improve performance, accelerate projects, and implement changes.
This document provides instructions for making a fruit smoothie. It lists the necessary tools like a blender or masher, cups, fruit, sugar, lemon juice, and ice. The directions explain that you first cut up fruit, add it to a blender along with ice, and blend it. Then you pour the smoothie into a cup to enjoy the cold, fruity drink. Optional decorations like umbrellas or jeweled wine glasses are also mentioned. The author is a third grade student who chose this topic because she is knowledgeable about smoothies.
The document provides guidelines for a competency-based postgraduate training program for an MD in Pharmacology. It outlines three key areas of competency that students should acquire: 1) acquisition of knowledge regarding concepts, principles, and processes of pharmacology and therapeutics; 2) skills in teaching undergraduate students; and 3) abilities to conduct research from planning through publication. The guidelines describe specific learning objectives and competencies in cognitive, affective, and psychomotor domains that students are expected to gain in the areas of knowledge, teaching, and research over the course of the training program.
This document outlines courses for the first two semesters of a Hospital Pharmacy program. Semester I includes courses in modern analytical techniques, pharmacotherapeutics, hospital and community pharmacy, manufacturing pharmacy, and a practical. Semester II includes courses in quality use of medicines, additional pharmacotherapeutics, pharmaceutical formulation and control, pharmacoepidemiology, economics, and another practical. It then provides more detailed descriptions of the objectives and content of courses in analytical techniques, pharmacotherapeutics I, and hospital and community pharmacy.
The document describes the Master of Science in Regulatory Science program offered by the University of Maryland School of Pharmacy. The two-year program can be completed part-time and exclusively online, with five courses taken over five semesters. The science-driven program focuses on drug development and regulation, and teaches skills like developing global drug strategies and differentiating regulatory requirements. Graduates will be prepared for regulatory careers in government agencies like the FDA or in the pharmaceutical industry. The program is complemented by the University's Center of Excellence in Regulatory Science and Innovation, funded by the FDA to support new regulatory assessment tools.
Clinical trials research and administrationBII Noida
Clinical trials are research studies that test new drugs and treatments on people. This 12-month course provides students with a theoretical and practical understanding of how to design, conduct, analyze, and interpret clinical trials. Students will learn about clinical trial methodology, regulations, and ethics. The course aims to equip students with the skills needed for careers related to clinical research such as clinical research coordinator, associate, investigator, and manager. There is high demand for professionals in the growing field of clinical research in India and abroad.
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to improve decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters between individuals.
Pharmacometrics is the science of using mathematical and statistical methods to characterize and predict the pharmacokinetic and pharmacodynamic behavior of drugs. It aims to quantify uncertainty in drug behavior to aid decision making in drug development and pharmacotherapy. Pharmacometric models integrate pharmacokinetic and pharmacodynamic models to describe the relationship between drug concentration, effect, and patient characteristics. Population pharmacometric modeling is useful for characterizing variability in these parameters.
- Whilst the realization of the CTD took many years, there is now a common format for the submission of Marketing Authorizations Applications across the three ICH regions - Europe, Japan and the USA.
- This should facilitate pharmaceutical companies to make simultaneous filings in the ICH regions as it will eliminate the extensive work previously required to convert, for example, a US dossier to an EU dossier and vice versa.
This document outlines the course syllabus for PMY 5430 Professional Pharmacy Practice at the University of Zambia School of Medicine. The course aims to develop competencies and skills for effective pharmacy practice in various specialties. Over 120 hours, students will learn about communication, leadership, ethics and various areas of pharmacy practice including hospital, ambulatory care, and specialty areas like pediatrics and infectious diseases. Assessment includes tests, assignments, laboratory reports, and developing competencies in pharmacy practice skills and responding to patient ailments. The syllabus provides reading materials and outlines the course content to be delivered over 15 topics covering key aspects of professional pharmacy practice.
this presentation mainly based on the regulatory aspects of packaging and gives all significance about packaging regulations,help in pharma or biotechnology .
This document provides guidelines for students, preceptors, and lecturers involved in the Master of Clinical Pharmacy program at the University of Zambia. It details expectations for all parties and outlines the clinical pharmacy specialties covered in the program, including nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, and others. The program involves 12 months of coursework followed by an 18-month experiential and research component. Students must complete a clinical pharmacy research project during the program. The document is intended to guide implementation of the competency-based clinical specialty training under the MClinPharm program.
This document provides guidelines for students, preceptors, and lecturers involved in the Master of Clinical Pharmacy program at the University of Zambia. It details expectations for all parties and outlines the program's curriculum, which includes 12 months of coursework followed by 18 months of experiential training and a research project. The program aims to equip students with clinical skills across several pharmacy specialties, including nuclear pharmacy, nutrition support pharmacy, oncology pharmacy, and others. Students must complete rotations in their selected specialties under the supervision of preceptors to gain practical experience.
This document contains course information from Dr. L.T.M. Muungo on various pharmaceutical topics:
1. The document outlines several courses on formulation systems, pharmaceutical calculations, dispensing, manufacturing, compounding, clinical pharmacy practice, and other related topics.
2. Many of the courses discuss dosage forms, drug delivery systems, pharmaceutical ingredients, sterile and non-sterile processing, and other areas of pharmaceutics.
3. The document also provides information on clinical pharmacy year attachments, case studies, health systems, rational drug use, and research processes including proposal writing, data collection, analysis, and publication.
Biosimilars
A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). (A medicine whose active substance is made by a living organism.)
Biologicals
Biological medicines contain active substances from a biological source, such as living cells or organisms and are often produced by cutting-edge technology.
Biological medicinal product
Biological Medicinal Products, also known as biologics or biologicals, are medicinal products that are manufactured using biotechnology processes and derived from living organisms or their products. They can include vaccines, blood products, gene therapies, monoclonal antibodies, recombinant proteins, and other complex biological substances.
Biological Investigational Medicinal Product
Refer to biological products that are being investigated in clinical trials or research studies to evaluate their safety, efficacy, or pharmacokinetic properties. These products have not yet received marketing authorization and are still in the experimental phase.
In the European Union, A biological substance is referred as the active ingredient in biological products.
A "biological substance" is defined as "a substance that is produced by or extracted from a biological source
That requires a combination of physico-chemical-biological testing, along with the production process and its control, for its characterization and the determination of its quality.“
Examples: Immunologic medicines
Medicines derived from human blood and plasma
Medicines developed by means of recombinant DNA technology
Hybridoma and mAb methods
Advanced therapy medicinal products
The requirements of the EU centralized procedure.
The approval standards for biotechnology products are the same as for chemically synthesized medicines.
Both types of products must be safe and effective and have appropriate quality.
MAA for a biotechnology product must meet the standard dossier submission requirements
MAA must generally comply with the CTD format, including with respect to
Module I (administrative information, including labelling)
Module 2 (various summaries)
Module 3 (chemical, pharmaceutical, and biological information)
Module 4 (nonclinical reports)
Module 5 (clinical study reports)
The EU has approved the highest number of biosimilars worldwide, and consequently has the most extensive experience of their use and safety.
EMA has issued scientific guidelines to help developers conform to the strict regulatory requirements for approving biosimilars.
The guidelines have evolved to keep pace with rapid advances in biotechnology and analytical sciences, and they take on board increasing experience of clinical use.
All medicines produced using biotechnology and those for specific indications must be approved in the EU through EMA
Some biosimilars may be approved at national level, such as some low-molecular weight heparins derived from porcine intestinal mucosa.
This New Drug Approval Process
The new drug approval process is a complex and rigorous process that pharmaceutical companies must go through in order to bring a new drug to market. The process is designed to ensure that new drugs are safe and effective for their intended use.
The new drug approval process typically takes several years to complete and involves the steps mentioned in presentation
This document provides an overview of the MPharm program at King's College London. It discusses the program's emphasis on integrated teaching and research-informed learning. Students receive extensive clinical placements and are expected to achieve high standards, including international projects and graduate skills. The course aims to produce pharmacists who can apply scientific principles to optimize medication use for patients. It covers topics like the cardiovascular and renal systems through lectures, tutorials and simulations. Assessments include clinical exams and integrated papers. Placements increase in responsibility from first to final year, covering community and hospital settings. The program emphasizes developing problem-solving, consultation, and care delivery skills to work with complex patients.
This document provides an overview of the scope of pharmacology. It discusses the history and evolution of pharmacology from materia medica and early pharmacy to its modern academic, industrial and research applications. Key areas of pharmacology discussed include drug development process, clinical pharmacology, special domains like pharmacovigilance, pharmacoeconomics and emerging areas like pharmacogenomics. The document outlines the past, present and future scope of pharmacology and how it aims to advance human health through rational and safe use of medicines.
This document outlines a curriculum for a Master of Science in Veterinary Pharmacy program in Zambia. The two-year program has three routes: an alternative route focusing on technology, a second alternative route, and a main route. The main route results in a Master of Science in Veterinary Pharmacy degree after coursework in areas like toxicology, pharmacotherapy, and a research project. The goal is to train specialists who can provide expert pharmaceutical services and education regarding animal healthcare.
Regular review and monitoring of product information for medicines is important, to support awareness of relevant updates/changes which may affect prescribing, dispensing, administration or monitoring practices.
This document summarizes a part-time postgraduate course in Medical Device Quality Assurance and Regulatory Affairs. The course consists of eight modules over one to four years, covering topics like medical device regulations, risk management, clinical evaluation, and quality systems. It is intended to enhance professionals' credentials for strategic regulatory and quality roles. The course is delivered by experts in industry and notified bodies. Students complete a research project and can earn a Postgraduate Certificate, Diploma or MSc.
This document discusses the principles of conducting drug trials in cardiology. It covers types of clinical trials like randomized controlled trials (RCTs), phases of drug trials from Phase I to Phase IV, objectives of trials, trial design considerations like blinding and use of steering committees, and challenges conducting trials in India like regulatory hurdles and lack of qualified investigators. The overall goal of drug trials is to evaluate new treatments for safety and efficacy.
3. Discover the Eu2P programme
Choose the Eu2P online
and on-the-job training
Make the most of a training
designed by the Eu2P public-private partnership
Find the Eu2P course
that fits your real needs
Gain rapid and accurate expertise
through the Eu2P short courses
Improve your professional competencies
through the Eu2P academic Certificate diploma
Strengthen your profile
through the Eu2P Master of Science
Deepen your knowledge
through the Eu2P PhD degree
Apply on-line
for a Eu2P training programme
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The Eu2P training offer
Eu2P offers courses in pharmacovigilance and
pharmacoepidemiology provided and updated
by a strong partnership of seven universities,
fifteen pharmaceutical companies,
the French and the European Medicines Agencies.
Eu2P offers academic courses recognized by private and
regulatory experts:
Short courses
Short courses of 30 minutes to 2 hours on hot topics
or focused on your needs, available over one month or more
25 stand-alone certificates
A standard module that runs over 3 months
and leads to an academic Certificate
Master programme
A postgraduate curriculum in one or two years associated to
a research project that leads to a Master of Science degree
PhD programme
A thesis in three years associated to a postgraduate curriculum
that leads to a PhD degree
8.
9. 9
Eu2P provides flexible and modular courses
through its web-based platform.
Each trainee is identified and is granted access rights
to the e-Learning platform tools and resources
in order to interact with trainees and trainers.
By choosing Eu2P, you can learn anytime,
anywhere, anypace!
Eu2P is designed:
For healthcare
professionals
For graduate and postgraduate students
in Health and Life Sciences
For non-specialists
professionals
For companies, regulatory agencies and
academic institutions
13. 13
The Eu2P training partnership
The Eu2P training partnership is composed of
seven universities, two regulatory agencies and
fifteen pharmaceutical companies.
The University of Bordeaux is the academic coordinating institution
for the whole Eu2P programme.
17. Course domains
D1 - Basics for pharmacovigilance
and pharmacoepidemiology
D2 - Benefit assessment
of medicines
D3 - Medicines pharmacovigilance
and regulatory aspects
D4 - Medicines risk
identification and quantification
D5 - Medicines benefit-risk
assessment
D6 - Medicines
and public health
D7 - Medicines
risk communication
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Eu2P Domain 1
Basics for pharmacovigilance
and pharmacoepidemiology
Directed by the University of Bordeaux
Course objectives
Introductory level modules
íí To make the trainees familiar and able to understand the main epidemiological
and statistical principles, concepts and tools used in pharmacovigilance and
pharmacoepidemiology practices and research
íí To train on the main health indices used to describe mortality and morbidity
of the population
íí To learn the principles used to design and appraise observational studies
íí To master basics concepts on how to communicate written and oral scientific
results
19. 19
Academic course offer in Domain 1 Offered as
1. Basics in epidemiology
-- Descriptive epidemiology (person, place and time)
-- Observational studies in pharmacoepidemiology
-- Biases in pharmacoepidemiology studies
-- Causality criteria, evidence level and critical reading
Certificate
or
Master module
2. Basics in statistics
-- Introduction to statistics and probability
-- Estimates
-- Statistical testing
-- Introduction to multivariable linear regression
Certificate
or
Master module
3. Valorisation and critical appraisal in research
-- Critical reading of scientific literature:
clinical trials and observational studies
-- Principles of the redaction of scientific papers
and reports
-- Principles of scientific posters and oral communication
-- Introduction to scientific watch: principles and
techniques
-- Presentation of the main institutions in Health Sciences
-- Principles for research funding
Certificate
or
Master module
Introductory level
TOPICSTOPICSTOPICS
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Eu2P Domain 2
Benefit assessment
of medicines
Directed by the Autonomous University of Barcelona
Course objectives
Introductory level module
íí To understand the need of benefit assessment of medicines in order to fulfil
patients’ needs
íí To develop a general knowledge of the clinical, pharmacological and
epidemiological principles underlying medicines prescribing and use
íí To review and become familiar with the clinical, pharmacological and
epidemiological basis of medicines effects evaluation
íí To understand the clinical, pharmacological and epidemiological principles
of the evaluation of medicines efficacy and effectiveness
Intermediate and advanced level modules
íí To know the scientific principles underlying the decision making process
of prescribing
íí To know the methods used in epidemiological studies and in randomized
clinical trials to assess the efficacy and effectiveness of medicines
íí To be aware of the limitations of scientific evidence in the benefit assessment
of medicines
íí To discuss and analyse the need to solve therapeutic uncertainties through
clinical research
21. 21
Academic course offer in Domain 2 Offered as
1. Basics in clinical pharmacology
-- Clinical pharmacology: aims and uses in the therapeutics
-- Clinical pharmacology and epidemiological evaluation
of medicine effects
-- The randomized clinical trials (RCT) as a method
for assess the efficacy of medicines
-- Basics for RCT appraisal:
extrapolation of RCTs results to clinical practice
Certificate
or
Master module
2. Clinical and pharmacological principles
-- Patients’ therapeutic needs, medicines and society
-- Patients, physicians, information and prescribing
-- Clinical and pharmacological basis of therapeutics
-- Variability in medicines response
-- Therapeutics and medicines prescribing of medicines
for selected health problems
Certificate
or
Master module
or
PhD module
3. Methods in clinical research, pharmacoepidemiology
and in the assessment of the efficacy of medicines
-- Scientific methods and causality
-- Statistical and methodological issues for the design
and analysis of clinical trials
-- Ethical issues in the development of clinical research
and clinical trials
-- Systematic review and meta-analysis of randomised
clinical trials
-- Other methods for the evaluation of the effectiveness
of medicines and therapeutic interventions
Certificate
or
Master module
or
PhD module
4. Critical appraisal of clinical trials:
evidence-based medicine and its uncertainties
-- Randomised clinical trials limitations
-- Evidence-based medicine and its limitations
-- Critical appraisal of randomised clinical trials limitations
-- Critical appraisal of a meta-analysis of randomised
clinical trials
-- From therapeutic uncertainty to a research protocol
Certificate
or
Master module
or
PhD module
Introductory level Intermediate level Advanced level
TOPICSTOPICSTOPICSTOPICS
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Eu2P Domain 3
Medicines pharmacovigilance
and regulatory aspects
Directed by the University of Hertfordshire
Course objectives
Introductory level module
íí To enable trainees to develop an understanding of the principles of
pharmacovigilance from the development of the science to its place in pre and
post-authorisation environment and the roles of various stakeholders within
pharmacovigilance
Intermediate level modules
íí To develop an understanding of European, USA, Japanese and major local
and worldwide regulations and guidelines concerning pharmacovigilance.
Emphasis is placed on the problems of interpretation of pharmacovigilance
regulations both pre- and post-authorisation
íí To enable participants (specialists) to develop an understanding of the
requirements of Pharmaceutical Industry of the operational aspects of
pharmacovigilance as it relates to the preparation of documents legally
required by regulatory bodies.
Focus is on the adverse event reporting process within Industry, placed within
the context of regulatory requirements and best practice
23. 23
Academic course offer in Domain 3 Offered as
1. Principles of pharmacovigilance
-- Introduction to Pharmacovigilance principles
-- Safety evaluation during a products lifecycle
-- Labelling and risk management
Certificate
or
Master module
2. Pharmacovigilance regulations
-- Pharmacovigilance regulations: concept
-- The working Pharmacovigilance regulations
-- Other related Pharmacovigilance regulations and
guidelines
-- Pharmacovigilance regulations
Certificate
or
Master module
or
PhD module
3. Pharmacovigilance regulatory processes
-- Case reporting
-- Periodic reporting
-- Product Labelling and Risk Management Plans
-- Contractual arrangements
Certificate
or
Master module
or
PhD module
Introductory level Intermediate level
TOPICSTOPICSTOPICS
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Eu2P Domain 4
Medicines risk identification
and quantification
Directed by the Erasmus Medical Center of Rotterdam
Course objectives
Intermediate and advanced level modules
íí To enhance knowledge about and make the trainees capable of identifying and
quantifying risks of medicines and to interpret publications and study results
25. 25
Academic course offer in Domain 4 Offered as
1. Principles of identifying and recognizing
adverse events and safety signals
-- Definition of adverse drug reactions - type of ADRs
-- Detection and recognition of adverse events
in clinical trials
-- Adverse event coding principles and differences
-- Spontaneous reporting databases
-- Principles of signal detection on electronic health care
databases
-- Risk management plans
Certificate
or
Master module
or
PhD module
2. Substantiation and quantification of risks
-- Introduction: from case based reasoning to population
based reasoning, examples: Augmentin, H1N1
vaccination, Yellow fever vaccine
-- Theory of causality: causality from different perspectives,
validity & causal diagrams, plausibility & substantiation
-- Designing a study: study designs, basic epidemiological
measures, data sources, workflow to quantify risks, case
and exposure identification, codes of conduct, writing a
protocol
-- Data analysis: SAS, raw data to metrics, elementary and
advanced analysis, controlling confounding, Bayesian
methods, sensitivity analysis, meta-analysis
-- Communication of results: communication with
academia, regulators, pharmaceutical industry, writing
a pharmacoepidemiological paper
Certificate
or
Master module
or
PhD module
3. Identifying susceptibility for adverse drug reactions
-- Introduction, risk factors and effect modification
-- Variability in drug response and principles
of pharmacogenetics/pharmacogenomics
-- Assessment of pharmacogenetic influence through
candidate genes and genome-wide association studies
(GWAS)
-- Ongoing initiatives and biological interpretation
-- Successes and failures in pharmacogenetic studies
Certificate
or
Master module
or
PhD module
Intermediate level Advanced level
TOPICSTOPICSTOPICS
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Eu2P Domain 5
Medicines benefit-risk
assessment
Directed by the University of Utrecht
Course objectives
Introductory level module
íí To obtain overview/basic insight into benefit-risk assessment methods
(including pharmacoeconomics), the process of decision making on medicines
Intermediate and advanced level modules
íí To obtain detailed insight into benefit-risk assessment methods
(including pharmacoeconomics), the process of decision making on medicines
by different stakeholders
íí To be able to apply benefit-risk assessment methods in daily practice
27. 27
Academic course offer in Domain 5 Offered as
1. Introduction to benefit-risk assessment and
pharmacoeconomics in decision making
-- Introduction
-- Benefits
-- Risk/Harms
-- Principles and methods of comparative benefit-risk
assessment
-- Principles of Pharmacoeconomics
Certificate
or
Master module
2. Principles of pharmacoeconomics
and valuation of health states
-- Introduction
-- Costs
-- Effects
-- Pharmacoeconomic analysis
-- How to perform a good pharmacoeconomic evaluation
Certificate
or
Master module
or
PhD module
3. Fundamentals of quantitative benefit-risk
assessment methods in decision making
on medicines
-- Introduction to benefit-risk analysis methods
-- Benefit/Risk assessment during life cycle of medicines
-- Measures based on statistics/simulation
-- Health outcomes models
Certificate
or
Master module
or
PhD module
4. Advanced quantitative benefit-risk assessment
methods in decision making on medicines
-- Multi-criteria decision analysis
-- Conjoint analysis
-- Personalized benefit-risk assessment
Certificate
or
Master module
or
PhD module
Introductory level Intermediate level Advanced level
TOPICSTOPICSTOPICSTOPICS
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Eu2P Domain 6
Medicines
and public health
Directed by the Autonomous University of Barcelona
Course objectives
Introductory level module
íí To provide basic knowledge of the evaluation of the effects of medicines
from an epidemiological point of view
íí To understand the limits of the available information on efficacy and risks
associated with medicines
íí To understand the differences between experimental studies and the actual
use of medicines in clinical settings
íí To know how is it possible to study the effects of medicines from a public
health point of view
Intermediate level modules
íí To provide intermediate and advanced knowledge of the effects of medicines
from a public health point of view
íí To develop theoretical and practical knowledge of the quantitative analysis
of medicines utilisation
íí To develop theoretical and practical knowledge of the qualitative analysis
of medicines utilisation
Advanced level module
íí To know how to study the health and economical impact of side effects
of medicines for the community
29. 29
Academic course offer in Domain 6 Offered as
1. Basics in pharmacoepidemiology
-- Patients, medicines and prescribing in society.
Life cycle of medicines
-- The knowledge-building process of the effects and
adverse effects of medicines during their development
and clinical use
-- Overview of studies to detect and to evaluate the risk
associated with therapeutic interventions
Scope, uses and limitations
-- The need to monitor the medicines prescribing process
-- Introduction to the study of the use of medicines
in clinical practice
Certificate
or
Master module
2. Drug utilisation studies:
introduction and quantitative methods
-- Measurement of drug use
-- Overview of drug utilisation studies DUS
-- Quantitative measures of drug utilisation
-- Design of quantitative DUS
-- How to read papers on quantitative DUS
Certificate
or
Master module
or
PhD module
3. Drug utilisation studies: qualitative methods
-- Sources of data and standards to compare with
-- Methods to identify how medicines are used
in the community (1) - prescription vs indication
and indication vs prescription
-- Methods to identify how medicines are used
in the community (2) - cohort and case-controls studies
as a source of drug utilisation data
-- Design of qualitative DUS:
Objectives, methods and discussion of proposals
-- How to read papers on qualitative DUS
Limitations of DUS
Certificate
or
Master module
or
PhD module
Introductory level Intermediate level
TOPICSTOPICSTOPICS
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Academic course offer in Domain 6 Offered as
4. The public health impact of adverse drug reactions
-- Data generalization: from particular cases to population
impact-1, the interpretation of the results of clinical trials
and meta-analyses from the public health point
of view
-- Data generalization: from particular cases to population
impact-2, examples of the value of observational studies
and meta-analyses of observational studies in the
evaluation of the public health impact of medicines use
-- Public health impact - Case: Hormone replacement
therapy
-- Public health impact beyond case-control studies
-- The importance of the denominator: Case-population
studies, the future of pharmacovigilance
Certificate
or
Master module
or
PhD module
Advanced level
TOPICS
31.
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Eu2P Domain 7
Medicines
risk communication
Directed by the University of Bordeaux and the University of Verona
Course objectives
Introductory level modules
íí To know the basic principles of medicines risk communication, its tools and
its place in mitigating risks linked to the use of medicines
Intermediate and advanced level modules
íí To get a clear understanding of the stakes and stakeholders’ involvement
in medicines risk communication and their determinants
íí To have an accurate view of the way medicines risk communication works
in the real life
33. 33
Academic course offer in Domain 7 Offered as
1. Basics in communication
-- Which knowledge and skills are useful
for communication?
-- Concrete examples of communication:
what do we retain?
-- Why communicate?
Nature and importance of communication
Personal and social dimension of communication
-- Face to face between doctor and patient
How to find the right word?
Certificate
or
Master module
2. Information and communication about
benefit-risk of medicines. Basic principles.
-- Principal actors in communication on medicines risk,
of traditional and new forms of communication, of routes
of communication and their evolution through time
-- Basis of risk communication process
-- Regulatory responsibilities and requirements concerning
medicines risk communication
-- Communication of actual and alleged risks associated
to medicines: three different scenarios
Certificate
or
Master module
or
PhD module
3. Key roles and stakeholders in medicines risk
communication: duties and challenges
-- Historical perspective : evolution of concept of
risk communication, social impact of drug risk
communication
-- Risk perception: actual vs perceived and factors
influencing perception, population vs individual risk
perception
-- Concept of uncertainty: how to deal with this in risk
communication
-- Nature and importance of communication of risk of
medicines: accessibility of data, conflict of interest
and independent information
-- Regulatory agencies’ strategies to address
the challenges of risk communication
Certificate
or
Master module
or
PhD module
Introductory level Intermediate level
TOPICSTOPICSTOPICS
34. 34
Academic course offer in Domain 7 Offered as
4. Case studies in medicines risk communication
-- Hepatitis B vaccine in France, pandemic influenza
vaccines, HRT and cancer: what can we learn? What
could have been done?
-- Communication aspects based on drug withdrawals:
e.g. rofecoxib, rosiglitazone, benfluorex, what can we
learn? What could have been done?
-- How to measure the effectiveness of risk
communication?
Certificate
or
Master module
or
PhD module
Advanced level
TOPICS
37. 37
The Eu2P short courses
programme organisation
Get a Certificate of Training Achievement
The Eu2P short course is a training designed for professionals who want to get
an up-to-date, quick and solid knowledge. This programme leads to Awards in
pharmacovigilance and pharmacoepidemiology jointly acknowledged by the
European Universities working together as Eu2P partners.
Get a valuable Certificate for job market
A recognised quality for audit inspections
Eu2P programme ensures and controls up-to-date knowledge, expertise and
qualification of medicines related collaborators from individuals to large teams.
Designed for experts by experts
The Eu2P Short Courses are built and recognised by all the 24 academic,
regulatory and industrial Eu2P partners so that they are grounded in real job
market and today's practices.
Eu2P programme is being noticed and recognized worldwide as an excellent
means to get medicines related jobs.
Choose a flexible online programme
Awarded for e-learning quality, Eu2P online courses can be attended from home
or work. The average course workload is less than 2 hours. The learning activities
can be followed according to your wish. You can start a learning activity then stop
and start another one, then come back later to the one you have firstly opened.
The Certificate is awarded after a final assessment.
38. 38
Enjoy affordable prices
Eu2P short courses are affordable - typically 500€ per course for a monthly
registration per person.
Buy short courses package to save money:
Students & Professionals Companies
1 short course
500 €
5 short courses
1,500 €
10 short courses
2,000 €
Custom package
Quote on request
Eu2P welcomes worldwide pharmaceutical companies into its short course
programme and provides quotes tailored to their needs in terms of content,
duration and number of collaborators.
Find detailled
informations on this offer
in the Eu2P short courses leaflet
41. 41
The Eu2P Certificate
programme organisation
Get a European academic Certificate
The Eu2P Certificates leads to academic Awards in pharmacovigilance and
pharmacoepidemiology jointly delivered by the European Universities working
together as Eu2P partners.
Standard and extended Eu2P certificates learning achievements are recognized as
respectively 3 and 6 ECTS credits.
Get a valuable Certificate for job market
Graded expertise level
You can choose between introductive, intermediate or advanced Certificate
courses level fitting your background and needs!
A recognised quality for audit inspections
Eu2P programme ensures and controls up-to-date knowledge, expertise and
qualification of medicines related collaborators from individuals to large teams.
Designed for experts by experts
The Eu2P Short Courses are built and recognised by all the 24 academic,
regulatory and industrial Eu2P partners so that they are grounded in real job
market and today's practices.
Eu2P programme is being noticed and recognized worldwide as an excellent
means to get medicines related jobs.
Choose a flexible online programme
Awarded for e-learning quality, Eu2P online courses are followed at home and
on job premises at your convenience. The average course workload is one day a
week over a 3 or 6 months period (depending on the course weight).
The Certificate diploma is awarded after a final assessment session.
42. 42
Enjoy affordable prices
Tuition fees are ajusted to student or professional status.
Savings on regular fees can be offered under eligibility conditions.
Students Professionals Companies
1,500 € 3,000 € Quote on request
Get savings
Partners' saving
Each Eu2P partner benefits from a special price on Eu2P tuition fees for their
students or employees!
Savings for Certificate fees
Student in a Eu2P University - 50%
Employee in a Eu2P agency, company or affiliate - 30%
Reward programme
Gain up-to 20% of savings when studying with Eu2P!
Eu2P gives you reward points each time you register to a Eu2P Certificate:
one point amounts to one euro. You can redeem these points and get savings on
next course tuition fees!
Apply on-line
Calendar
On-line application sessions are organised
throughout the year according to
the certificates calendar:
íí A first certificate session runs from October to December
íí A second certificate session runs from January to April
íí A third certificate session runs from April to June
Check regularly on
www.eu2p.org
43. 43
Admission criteria
The application procedure and the selection
process are the same for all candidates,
regardless of whether you come from Eu2P
partners or not, from European or third countries.
To be eligible, you must:
íí be fluent in English
íí be familiar with computer use and have Internet access
íí submit a complete on-line application, together with all supporting
documentation required (diplomas, certificates, letter of motivation...)
Pre-requisites depend on the chosen module: please refer to each Certificate
description page on www.eu2p.org.
More info about
application P61
47. 47
The Eu2P Master
programme organisation
Get a European Master of Science degree
120 ECTS credits over 2 years
The Eu2P Master is an academic post-graduate training in pharmacovigilance
and pharmacoepidemiology that leads to a MSc degree jointly awarded by the
European Universities working together as Eu2P partners.
The Eu2P Master includes for each academic year:
íí 30 ECTS credits through the validation of theoretical content
íí 30 ECTS credits through the validation of a research project
Each Master trainee must conduct a research project in parallel to the theoretical
training along the academic year. This research project can be achieved within
an academic, regulatory or private body.
Your curriculum specialization
In second year, choose a Master specialization among:
íí Benefit assessment of medicines
íí Medicines risk identification and quantification
íí Medicines benefit-risk assessment
íí Medicines and public health
íí Medicines risk communication
or select "à la carte" modules to match specific needs
Get a valuable Master degree for job market
The Eu2P Short Courses are built and recognised by all the 24 academic,
regulatory and industrial Eu2P partners. Eu2P courses are grounded in real job
market and today's practices and research projects can be performed in public or
private environments.
Eu2P programme is being noticed and recognized worldwide as an excellent
means to get medicines related jobs.
48. 48
Choose a flexible online programme
Awarded for e-learning quality, Eu2P online courses are followed at home and on
job premises at your convenience.
Master Year 1 or 2 curriculum can be performed on a full or part time basis to suit
your time availability.
The Master can be entered directly into the 2nd
year for postgraduate trainees.
Get savings and grants
Master annual tuition fees
Students Professionals
7,000 € per year 12,000 € per year
Partners' saving
Each Eu2P partner benefits from a special price on Eu2P tuition fees for their
employees!
Savings for Master year fees
Employee in a Eu2P agency, company or affiliate - 20%
Reward programme
Gain up-to 20% of savings when studying with Eu2P!
Eu2P gives you reward points each time you register to a Eu2P Master
programme: one point amounts to one euro. You can redeem these points and get
savings on next course tuition fees!
Master grants
Eu2P offers a limited number of grants to Master selected applicants to cover
partial Master tuition fees.
Eu2P grants are awarded by the Eu2P consortium and private organizations on the
appraisal of the applicant's status regarding:
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íí Academic performance
íí Professional ambition and environment
íí Personal situation
íí Any special and financial circumstances that may affect training performance
Apply on-line
Calendar
The first and second Master years run from the end of September to early July
for theoretical training and research project.
On-line application runs each year from January to June through www.eu2p.org
Admission criteria
The application procedure and the selection
process are the same for all candidates,
regardless of whether you come from Eu2P
partners or not, from European or third countries.
To be eligible, you must:
íí be fluent in English
íí be familiar with computer use and have Internet access
íí submit a complete on-line application, together with all supporting
documentation required (diplomas, certificates, letter of motivation...)
If you apply to the full Master (entry in Year 1), you must:
íí have at least a Bachelor degree or an equivalent certified level in Health or
Life sciences
If you apply to Master Year 2, you must:
íí hold a Master Year 1 level or an equivalent certified level in Health or Life
sciences including credits in basic pharmacology, epidemiology and statistics
or
íí be employed, have a graduate level in Health or Life sciences and 3
years of relevant professional experience in Pharmacovigilance and
Pharmacoepidemiology
More info about
application P61
50. 50
Master Year 1 curriculum
The Master Year 1 trainee must validate the theoretical and the practical trainings
to progress to the second year programme of the Master in Pharmacovigilance
and Pharmacoepidemiology.
Theoretical courses (30 ECTS credits)
Basics in
epidemiology
Basics in
statistics
Valorisation and critical
appraisal in research
Basics in clinical
pharmacology
Principles of
pharmacovigilance
Basics in
pharmaco-
epidemiology
Basics in medicines
risk communication
Analysis and synthesis
of health data
Each course module is appraised through continuous and/or final assessment.
The Master Year 1 trainee must at least obtain the "pass" grade in each module to
validate the theoretical training part of the Master first year programme.
Project research (30 ECTS credits)
Each Master trainee must conduct a research project in parallel to the theoretical
training along the academic year. This research project can be achieved within an
academic, regulatory or private body.
Note: If you are employed, you can perform the research project on your employer's premises.
This research project is assessed through three separate assessments:
íí the overall research project conduct
íí the research project written report
íí the oral defence of the research project report
The Master Year 1 trainee must at least obtain the overall "pass" grade for the
research project to validate the practical training part of the Master first year
programme.
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Master Year 2 curriculum
The Master Year 2 trainee must successfully complete the theoretical and the
practical trainings to be awarded the Eu2P Master in Pharmacovigilance and
Pharmacoepidemiology.
Theoretical courses (30 ECTS credits)
TRACK D2
TRACK D4
TRACK D5
TRACK D6
TRACK D7
Clinical
pharmaco-
logical
principles
Pharmaco-
vigilance
regulations
Principle of
identifying and
recognising
adverse events
and safety
signals
Introduction
to benefit-risk
assessment
and pharmaco-
economics
in decision
making
Drug utlization
studies :
introduction
and
quantitative
methods
Information
and
communication
about
benefit-risk
of medicines.
Basics
principles
Methods
in clinical
research, PE
and in the
assessment
of efficacy of
medicines
Pharmaco-
vigilance
regulations
processes
Substantiation
and
quantification
of risks (1)
Principles of
pharmaco-
economics and
valuation of
health states
Drug utilization
studies :
qualitative
methods
Key roles and
stakeholders in
medicine risk
communication
duties and
challenges
Critical
appraisal of
clinical trials:
evidence-
basedmedicine
and its
uncertainties
Substantiation
and
quantification
of risks (2)
Fundamentals
of quantitative
benefit-risk
assessment
methods
in decision
making on
medicines
The public
health impact
of adverse
drug reactions
Case studies in
medicines risk
communication
Identifying
susceptibility
for adverse
drug reactions
Advanced
quantitative
benefit-risk
assessment
methods
in decision
making on
medicines
Each course module is appraised through continuous and/or final assessment.
The master Year 2 trainee must at least obtain the "pass" grade in each module,
whether their course modules are mandatory or complementary.
Each square counts for 3 ECTS credits
Mandatory course modules Course modules for specialisation
52. 52
For this second year of Master, two teaching scenarios are proposed to trainee:
“Specialised Master” vs “A la carte Master”.
Specialised Master
ää All black modules row is mandatory
ää One specialisation track column is chosen among:
¯¯ TRACK D2 = “Domain 2 - Benefit assessment of medicines”
¯¯ TRACK D4 = “Domain 4 - Medicines risk identification and quantification”
¯¯ TRACK D5 = “Domain 5 - Medicines benefit-risk assessment”
¯¯ TRACK D6 = “Domain 6 - Medicines and public health”
¯¯ TRACK D7 = “Domain 7 - Medicines risk communication”
ää Complementary modules have to be selected among remaining modules to
overall validate 30 ECTS credits
"A la carte" Master
ää This track is composed of four modules of your choice among the Master
specialisations (blue modules)
ää All black modules row is mandatory
ää Complementary modules have to be selected among remaining modules to
overall validate 30 ECTS credits
Project research (30 ECTS credits)
Each Master trainee must conduct a research project in parallel to the theoretical
training along the academic year. This research project can be achieved within an
academic, regulatory or private body.
Note: If you are employed, you can perform the research project on your employer's premises.
This research project is assessed through three separate assessments:
íí the research project supervisor evaluation
íí the research project written report
íí the oral defence of the research project report
The Master Year 2 trainee must at least obtain the overall "pass" grade for the
research project to validate the practical training part of the Master second year
programme.
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The Eu2P PhD
programme organisation
Get a valuable academic PhD degree
180 ECTS credits over 3 years
The Eu2P PhD programme is an academic doctorate curriculum in
pharmacovigilance and pharmacoepidemiology. It leads to a PhD degree awarded
by one of the Eu2P Academic Partners under the authority of the relevant
National Ministry of Higher Education or ad hoc authority.
The whole Eu2P PhD curriculum covers 3 consecutive years, for a total of 180
ECTS credits, including:
íí 120 credits gained progressively by researching and writing a thesis
íí 60 credits for secondary PhD portfolio activities carried out at any given
moment during the research period.
Yearly overview of the PhD curriculum
Type of activity
ECTS credits
(number/year)
Total of ECTS
(credits/year)
Thesis
research
Bibliographic knowledge 10
40
Advanced research training 30
Portfolio
activities
Eu2P workshop 4
20
Eu2P local and distant learning 6
Seminars & workshops
participation
10
Your curriculum specialization
PhD students are driven by a supervising team related to one of the Eu2P
Academic partners for their thesis, but also to carry out their advanced project
research, portfolio activities or simply to meet them and benefit from their
knowledge. All these activities are detailed in their personal Doctoral Study Plan.
56. 56
Get a valuable post-graduate degree for job market
The Eu2P PhD programme is built and recognised by all the 24 academic,
regulatory and industrial Eu2P partners. Eu2P courses are grounded in real job
market and today's practices and research projects can be performed in public or
private environments.
Eu2P programme is being noticed and recognised world-wide as an excellent
means to get medicines-related jobs and improve regulatory sciences.
Choose a flexible online programme
The Eu2P PhD is open to applicants who hold a post-graduate diploma (e.g.
Master of Science), from both EU and non-EU countries, without limitation in
terms of age and nationality. Applicants may belong to Universities who are not
part of the Eu2P PhD network.
Full-time doctoral study
PhD curriculum should be carried out on a full-time basis for 3 consecutive years
with a sufficient funding.
Half-time doctoral study
PhD curriculum may be carried out in parallel to a professional occupation with
a sufficient funding: in such case, the PhD curriculum may be followed and
research carried out on a half-time basis. Trainees must ensure that they shall
be able to complete their research work and defend their PhD thesis within an
absolute maximum of 5 years beginning with the date of initial registration
in the doctoral programme.
Get savings and grants
PhD annual tuition fees
Students Professionals
4,500 € per year 6,000 € per year
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Partners' saving
Each Eu2P partner benefits from a special price on Eu2P tuition fees for their
employees!
Savings for PhD year fees
Employee in a Eu2P agency, company or affiliate - 20%
PhD grants
Eu2P offers a limited number of grants to PhD selected applicants to cover partial
PhD tuition fees.
Eu2P grants are awarded by the Eu2P consortium and private organizations on the
appraisal of the applicant's status regarding:
íí Academic performance
íí Professional ambition and environment
íí Personal situation
íí Any special and financial circumstances that may affect training performance
Apply on-line
On-line application runs each year
through www.eu2p.org
Admission criteria
The Eu2P PhD is open to applicants from both EU and non-EU countries, without
limitation in terms of age and nationality.
Applicants may also belong to Universities who are not part of the Eu2P PhD
network.
To be eligible, you must:
íí satisfy the entrance requirements for admission to the doctoral programme
(3rd
cycle within the European Higher Education and Research Area)
íí have solid background in Pharmacovigilance and Pharmacoepidemiology
documented on the basis of your transcripts and your Master of Science
degree in Pharmacovigilance and Pharmacoepidemiology
More info about
application P61
58. 58
Doctoral study plan
The definition of the PhD topic is carried out in the Doctoral Study Plan in several
stages by updating the research project for which the student has been selected
and subject to remarks and suggestions along the whole duration of the thesis.
The Doctoral Study Plan is consequently subject to supervision and validation by
the Eu2P degree-awarding institution through the Eu2P Doctoral Board members
and the approval of their related local doctoral school.
Supervision of the doctoral study plan
The Eu2P Doctoral Board sets the standards that the doctoral student must
achieve and approves for each student, an academic plan and a project
programme involving mobility called "Doctoral Study Plan".
For this purpose, the Doctoral Board appoints during the first induction month
a PhD supervisor in line with the student Research project synopsis. The PhD
supervisor must belong to a Eu2P Academic Partner and hold an accreditation or
an equivalent level to supervise doctoral thesis such as full professor.
In the first three months of the programme, the PhD supervisor oversees
the student's progress, strengths or weaknesses, and guides him/her to the
preparation of the Doctoral Study Plan that is submitted to the Doctoral Board at
the end of the first trimester.
The PhD supervisor in particular helps the student in the adoption of the most
appropriate methodology to carry out his/her research successfully and guides
him/her in the necessary research and drafting of a final thesis. There must be at
least two meetings a year gathering the PhD student and the supervisor. Video-
conferencing facilities may be used for meetings. The doctoral student may also
benefit from other forms of peer monitoring in hosting academic and research
centres.
Setting up and annual validation of the doctoral study plan
A Doctoral Study Plan must be established for each selected Eu2P PhD Student.
Eu2P members explicitly invite innovative project proposals which are prepared
to strike out into new fields. Within the programme, public and private Eu2P
members can provide expert supervision and academic accompaniment in a wide
variety of fields and their interconnections.
The Doctoral Study Plan drawn up during the first term of the PhD curriculum
between the PhD student and his/her supervisor, must detail:
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íí The thesis research project supervision such as appointment rules, names
and roles of the supervisor
íí The thesis research project conduct locations, the description and scientific
justification of the mobility within the Hosting academic and research centres
íí The research activities main lines and expected results
íí The programmed portfolio activities
The final validation of the initial Doctoral Study Plan is the last mandatory step
needed before the student can actually finalise his/her registration with the
awarding Eu2P Academic Partner.
The Doctoral Study Plan must be yearly updated and validated together with the
PhD student and supervisor. Each annual update must be sent to the Eu2P Central
Office to be recorded and available for consultation by the Doctoral Board and each
related doctoral school of Eu2P Academic Partners.
Doctoral study location and mobility
The Eu2P PhD student is advised to make the most of the Eu2P consortium
possibilities and build a close research network among the Eu2P partners. Each
PhD student is based primarily at one Eu2P Home academic institution depending
on his/her PhD supervisor.
The student is strongly encouraged to work at least 6 months of the programme
at another public or private Hosting Institution.
The Eu2P PhD student has the opportunity to perform the thesis research project
in the premises of:
íí A Eu2P Academic Partner
íí An Higher Education Institution which it is not a Eu2P partner
or
íí A non-Higher Education Institution, which may or may not be a Eu2P partner
In all cases, the Eu2P PhD student must be supervised by the PhD supervisor
appointed by the Doctoral Board, belonging to a Eu2P Academic Partner and full or
associate professors.
When the student is conducting research in another location than the supervisor
institution, a local tutor is appointed by the supervisor. In any case, the tutor must
be full or associate professors or equivalent with full authority to graduate PhD
i.e. must have an academic accreditation to supervise research.
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Mobility to a public or private institution must be justified in the Doctoral Study
Plan.
For PhD students currently pursuing in parallel their work at one of the Eu2P
Associated Partner's premises, the mobility requirement may be adapted in the
Doctoral Study Plan, upon specific agreement granted by the Eu2P Doctoral Board.
PhD portfolio activities
Doctoral Activities
In order to enhance the students' employability and to improve their written/oral
communication skills, the Doctoral Board has added portfolio activities so that the
future Ph. Doctors are also fully operational as global academics. The academic
plan of doctoral students comprises the carrying out of portfolio activities.
All the activities below are strongly recommended to the Eu2P doctoral students,
but only 60 ECTS credits worth of activities are validated for their degree; this can
be done at any stage during the whole duration of the Doctorate.
Doctoral Activities
ECTS credits
(number)
Producing an article for publication in a recognized journal 10
Producing a review for publication in a recognized journal 10
Participating or organising a conference, symposium... 3
Teaching experience at higher-education level 3
Completing Eu2P training courses and summer school From 3 to 6
Completion of Eu2P training courses
The PhD student must justify the follow up and completion of the theoretical
training along their project research work for at least a total amount of 20 ECTS
credits along the three years of PhD registration.
Students may either follow modules chosen from the Eu2P web-based training
offer among the seven domains or follow local face-to-face Eu2P Academic
partner courses during the annual Summer schools.
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The Eu2p process to apply
for a training programme
Application
The on-line process
Eu2P registration tool enables you to apply on-line to any Eu2P training.
The Eu2P application process must be fully completed on-line.
You are asked to upload all the needed documents within this on-line application.
To apply for Eu2P programme, you have to:
Choose one training programme to apply for
Login to your "My Eu2P" account, or create one if needed
Provide required application data
Pay for application fees: 25 €
The paper process
The Eu2P application process must be fully completed on-line.
Nevertheless, if you can not upload needed documents, please print your on-line
application fully completed and send it by postal mail with the copy of all needed
documents to the following address:
Eu2P Central Office
Université de Bordeaux
146 rue Léo Saignat - Case 36
33076 Bordeaux cedex
FRANCE
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Selection
Once your on-line application file is complete, it is sent to the respective Domain
Board.
The Board ranks Eu2P applicants for each of the training:
íí Eligible list: you are eligible for immediate registration.
íí Waiting list: you could be eligible, provided that some "Eligible list" applications
are cancelled.
íí Non-eligible list: your application data are not approved for registration.
You will be warned about your application status by the Eu2P
Central Office by e-mail.
Registration
Once you are informed about your selection status by e-mail, you are invited to
confirm your registration as follows.
íí You are eligible: you need to confirm your registration before a deadline and to
pay for tuition fees to validate your registration
íí You are on waiting list: you need to confirm your position on the waiting list
If you are non-eligible, you can contact the Eu2P Central Office for further
explanations.