Spontaneous reporting involves unsolicited communication about suspected adverse drug reactions (ADRs) to regulatory authorities from healthcare professionals or consumers. Passive surveillance relies on voluntary ADR reporting by health professionals, while active surveillance uses organized monitoring systems. The Pharmacovigilance Programme of India (PvPI) currently uses spontaneous reporting to collect drug safety data. Reporting forms collect patient information, reaction details, suspected medications, and reporter information to submit individual case safety reports (ICSRs) on suspected ADRs. Both healthcare professionals and consumers can report ADRs to the National Coordination Centre (NCC) to help ensure public health and drug safety.
Post-marketing surveillance (PMS) monitors drug and medical device safety after market release using approaches like spontaneous reporting databases, prescription monitoring, and health records. PMS identifies potential safety issues through data review and helps detect rare or long-term adverse effects not seen in pre-market clinical trials which have limited patient populations and durations. PMS provides additional safety and efficacy information on marketed products and allows monitoring of special patient groups. Common PMS methods include spontaneous reporting, observational studies, randomized trials, and active surveillance networks.
Adverse drug reaction monitoring and reportingTHUSHARA MOHAN
This document discusses types of adverse drug reactions and factors influencing them. It describes types A-E reactions, which include augmented, bizarre, chemical, delayed and end of treatment reactions. Polypharmacy, age, drug characteristics, gender, race and genetic factors can influence susceptibility. Detection methods include pre-marketing studies, post-marketing surveillance, underreporting and communicating reactions. Healthcare professionals should monitor high-risk patients and gather information to assess causality between drugs and adverse events. Underreporting is common due to various barriers but can be addressed through improved reporting systems and education.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) assessment of individual reports and pooled data, and 3) interpretation of signals based on the available data. Initiatives have been taken to widen reporting bases to include pharmacists and nurses. Special focus has been given to reporting reactions related to HIV drugs, pediatric drugs, and herbal products to improve surveillance in underreported areas.
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) data assessment of individual cases and pooled data, and 3) data interpretation to generate safety signals. Countries have different reporting forms, like the Yellow Card used in the UK since 1964. Factors like educational campaigns and inclusion of reporting options in prescription pads have helped increase reporting rates in the UK. India's Pharmacovigilance Programme similarly encourages voluntary reporting of all suspected adverse reactions via established adverse drug monitoring centers.
Spontaneous reporting involves unsolicited communication about suspected adverse drug reactions (ADRs) to regulatory authorities from healthcare professionals or consumers. Passive surveillance relies on voluntary ADR reporting by health professionals, while active surveillance uses organized monitoring systems. The Pharmacovigilance Programme of India (PvPI) currently uses spontaneous reporting to collect drug safety data. Reporting forms collect patient information, reaction details, suspected medications, and reporter information to submit individual case safety reports (ICSRs) on suspected ADRs. Both healthcare professionals and consumers can report ADRs to the National Coordination Centre (NCC) to help ensure public health and drug safety.
Post-marketing surveillance (PMS) monitors drug and medical device safety after market release using approaches like spontaneous reporting databases, prescription monitoring, and health records. PMS identifies potential safety issues through data review and helps detect rare or long-term adverse effects not seen in pre-market clinical trials which have limited patient populations and durations. PMS provides additional safety and efficacy information on marketed products and allows monitoring of special patient groups. Common PMS methods include spontaneous reporting, observational studies, randomized trials, and active surveillance networks.
Adverse drug reaction monitoring and reportingTHUSHARA MOHAN
This document discusses types of adverse drug reactions and factors influencing them. It describes types A-E reactions, which include augmented, bizarre, chemical, delayed and end of treatment reactions. Polypharmacy, age, drug characteristics, gender, race and genetic factors can influence susceptibility. Detection methods include pre-marketing studies, post-marketing surveillance, underreporting and communicating reactions. Healthcare professionals should monitor high-risk patients and gather information to assess causality between drugs and adverse events. Underreporting is common due to various barriers but can be addressed through improved reporting systems and education.
Organization and objectives of ICH, expedited reporting, ICSR, PSURs, post approval expedited reporting, pharmacovigilance Planning, good clinical practices
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) assessment of individual reports and pooled data, and 3) interpretation of signals based on the available data. Initiatives have been taken to widen reporting bases to include pharmacists and nurses. Special focus has been given to reporting reactions related to HIV drugs, pediatric drugs, and herbal products to improve surveillance in underreported areas.
The spontaneous reporting system is a passive surveillance system where health professionals voluntarily report adverse drug reactions directly to regulatory authorities or pharmaceutical companies. It involves 3 main processes: 1) data acquisition from reported cases, 2) data assessment of individual cases and pooled data, and 3) data interpretation to generate safety signals. Countries have different reporting forms, like the Yellow Card used in the UK since 1964. Factors like educational campaigns and inclusion of reporting options in prescription pads have helped increase reporting rates in the UK. India's Pharmacovigilance Programme similarly encourages voluntary reporting of all suspected adverse reactions via established adverse drug monitoring centers.
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
This document discusses different methods for assessing the causality of adverse drug reactions (ADRs). It describes three main types of methods: 1) Expert opinion or clinical judgment methods like the WHO causality assessment scale, 2) Algorithmic methods like the Naranjo scale that use questionnaires and scoring systems, 3) Probabilistic or Bayesian methods that calculate the probability of drug causation based on prior probabilities. The WHO scale and Naranjo scale are discussed in detail as examples of each method.
Detection, reporting and management of adverse eventsKatla Swapna
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Institutional review board by akshdeep sharmaAkshdeep Sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
Establishing Pharmacovigilance Centres In Hospital.pptxRushikeshTidake
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
procurement and storage of investigation productfarmanadeeb
The document discusses the responsibilities of clinical investigators and research teams regarding investigational products in clinical trials. It outlines that investigators are responsible for ensuring trials follow regulations and protecting subjects. They must also account for investigational products, maintaining records of delivery, inventory, use, and returns. The document then describes the steps research teams and pharmacies take to order, receive, verify, store, and label investigational drugs according to the protocol. Proper storage, labeling, and limited access are important to control investigational products.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
The IRB/IEC is an independent body that reviews clinical trial protocols and protects participant rights and well-being. It consists of at least five qualified members from diverse backgrounds. The IRB/IEC reviews trials annually, ensures informed consent, and maintains documentation for regulatory review.
Expedited report criteria in pharmacovigilance by isa hassan abubakarISAHASSANABUBAKAR
The document discusses expedited reporting criteria for adverse drug reactions. It defines expedited reports and what should be reported, including single cases of serious unexpected adverse reactions. It outlines the minimum reporting requirements, time frames for reporting, and criteria for making expedited reports. The key data elements for inclusion in expedited reports of serious adverse reactions are described, including patient details, suspected products, other treatments, reaction details, and administrative information. The CIOMS-I form for expedited adverse event reporting is also mentioned.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
This document discusses various methods used to assess causality in pharmacovigilance. It describes three broad categories of causality assessment methods: expert judgment, algorithms, and probabilistic/Bayesian approaches. For algorithms, it provides examples like the French method, Kramer method, and Naranjo scale. It also discusses some probabilistic methods like the Australian method and Bayesian Adverse Reactions Diagnostic Instrument (BARDI). Overall, the document provides an overview of the different existing approaches for determining if a suspected adverse drug reaction is actually caused by the drug in question.
This document discusses Contract Research Organizations (CROs) and their role in supporting pharmaceutical clinical trials. It provides the following key points:
- CROs are service organizations that conduct clinical trials and other drug development work on behalf of pharmaceutical companies. They help companies that lack sufficient resources or expertise to conduct all required trials themselves.
- Selecting the right CRO is important for a successful clinical trial. Sponsors should clearly define study specifications, evaluate a CRO's capabilities and compatibility, and consider cost. Ongoing management of the sponsor-CRO relationship also impacts success.
- Common issues like selecting an inappropriate CRO, unclear study specifications from the sponsor, or poor management can lead
This document reviews Good Clinical Practice (GCP) guidelines. It aims to study GCP principles and their application. The document outlines the objectives, contents, and introduction to GCP. It describes 14 GCP principles regarding ethical conduct of clinical trials, including protocol development, risk identification, benefit-risk assessment, review by ethics committees, informed consent, qualifications of investigators and staff, record keeping, confidentiality, manufacturing standards, and quality systems. The document provides examples of how each principle is applied in clinical research. It concludes with a bibliography on GCP guidelines and resources.
This document outlines the rules and regulations for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the various forms and permissions required, including Form 44 for new drug approval and Form 12 for importing study drugs. It also describes the responsibilities of sponsors, investigators, and ethics committees. The document explains the different phases of clinical trials from human pharmacology to post-marketing surveillance. It lists the data that must be submitted with applications and included in clinical study reports.
This document provides guidelines for expedited reporting of adverse drug reactions during clinical drug development. It defines key terms like adverse event, adverse drug reaction, and serious adverse reaction. It recommends that single cases of serious and unexpected adverse drug reactions be reported to regulatory authorities within 7 or 15 days depending on severity. It also provides guidance on data elements that should be included in individual case safety reports that are transmitted during expedited reporting.
Clinical research : Drug regulatory affairs and Pharmacovigilance.ProfDnyaneshwariJosh
Schedule Y, FDA, Appendices, Post marketing surveillance,Clinical trial,WHO,ICH-GCP, FDA-CFR, Safety,Adverse Drug reaction, Adverse Event(AE), Serious Adverse Event(SAE),Reporting, IND , 3500A form
SEVERITY AND SERIOUSNESS ASSESSMENT OF ADR’S
Definitions, Severity assessment, Seriousness assessment
Naranjo algorithm, Preventability assessment
By
Ms. B. Mary Vishali
Department of Pharmacology
This document discusses different methods for assessing the causality of adverse drug reactions (ADRs). It describes three main types of methods: 1) Expert opinion or clinical judgment methods like the WHO causality assessment scale, 2) Algorithmic methods like the Naranjo scale that use questionnaires and scoring systems, 3) Probabilistic or Bayesian methods that calculate the probability of drug causation based on prior probabilities. The WHO scale and Naranjo scale are discussed in detail as examples of each method.
Detection, reporting and management of adverse eventsKatla Swapna
This document discusses adverse drug reactions (ADRs), including definitions, classifications, detection, reporting, and management. It notes that ADRs are a major clinical problem that can cause suffering and increased healthcare costs. It emphasizes the importance of monitoring and reporting ADRs to improve patient safety. Pharmacists can play an important role by monitoring high-risk patients and drugs, educating on ADR reporting, and assisting in the detection and assessment of ADRs. Timely reporting of ADRs is crucial to help prevent human suffering and unnecessary costs from drug-related injuries.
Designing of clinical study protocol rumana hameedRumana Hameed
This document provides guidance on designing clinical study documents, including protocols and case report forms (CRFs). It discusses key components of trial master files, protocols, and their amendments. Protocols should include background information, objectives, design, endpoints, inclusion/exclusion criteria, and plans for statistical analysis and publication. CRFs are important trial documents used to collect patient data uniformly. Their design should follow guidelines, with clear instructions and formatting. Errors in CRFs should be addressed through queries. Overall, the document outlines best practices for developing the main documents used to conduct clinical trials and collect trial data.
Spontenous adr reporting in india
PASSIVE survillence system, data assement
data aciqsition, data interpretation, what all information required in ADR form, WHEN TO REPORT
BLUE CARD,YELLOW CARD, WHO CODES
Institutional review board by akshdeep sharmaAkshdeep Sharma
The Institutional Review Board/Independent Ethics Committee (IRB/IEC) serves as an independent body that reviews and approves clinical trials to protect participant safety and rights. The IRB/IEC consists of at least five members with diverse qualifications to evaluate scientific and ethical aspects of trials. The IRB/IEC's responsibilities include reviewing trials, providing continuing oversight, ensuring informed consent, and maintaining records for regulatory review.
This presentation gives a brief knowledge of CIOMS, its history, missions and collaborations of CIOMS. This presentation also contains CIOMS organizational structure, detailed knowledge of CIOMS Former and Present Working Groups. This will also guide about CIOMS form, its reporting and details to be filled while reporting an ADR.
institutional review board and independent ethics committeeMOHAMMAD ASIM
The document discusses the role and responsibilities of institutional review boards (IRBs) in protecting human subjects in clinical research. It provides details on:
- The composition and quorum requirements of IRBs, including the need for diverse expertise and community representation.
- The functions of IRBs, which include reviewing research protocols, approving studies, overseeing informed consent processes, and ensuring ongoing ethical review of approved studies.
- The responsibilities of IRBs in evaluating risks and benefits to research participants, assessing payment amounts and methods, and requiring modifications or halting studies when necessary.
- The necessary components of informed consent forms used in clinical studies, including study details, risks/benefits, confidentiality
Establishing Pharmacovigilance Centres In Hospital.pptxRushikeshTidake
The document discusses establishing pharmacovigilance centers in hospitals to monitor adverse drug reactions. It outlines the steps to set up a center, including obtaining approvals, designing reporting forms, educating staff, and establishing infrastructure for data collection and analysis. Key requirements for an effective center include adequate trained staff, proper facilities, communication systems, and a sustainable source of funding. The center would operate by collecting ADR reports from healthcare professionals and entering the data into a database to help detect safety issues and inform regulation.
procurement and storage of investigation productfarmanadeeb
The document discusses the responsibilities of clinical investigators and research teams regarding investigational products in clinical trials. It outlines that investigators are responsible for ensuring trials follow regulations and protecting subjects. They must also account for investigational products, maintaining records of delivery, inventory, use, and returns. The document then describes the steps research teams and pharmacies take to order, receive, verify, store, and label investigational drugs according to the protocol. Proper storage, labeling, and limited access are important to control investigational products.
Requirements And Guidelines For Permission To Import / or Manufacture of New Drugs For Sale or To Undertake Clinical Trials
Schedule Y was introduced under the Drugs and Cosmetics Act 1940, to
introduce requirements for countries to get permission for:
Importing
Manufacturing new drugs
Conducting Clinical Trials.
Application for permission
Clinical Trial
Studies in specific population
Post marketing surveillance
Special studies: BA/BE studies
The IRB/IEC is an independent body that reviews clinical trial protocols and protects participant rights and well-being. It consists of at least five qualified members from diverse backgrounds. The IRB/IEC reviews trials annually, ensures informed consent, and maintains documentation for regulatory review.
Expedited report criteria in pharmacovigilance by isa hassan abubakarISAHASSANABUBAKAR
The document discusses expedited reporting criteria for adverse drug reactions. It defines expedited reports and what should be reported, including single cases of serious unexpected adverse reactions. It outlines the minimum reporting requirements, time frames for reporting, and criteria for making expedited reports. The key data elements for inclusion in expedited reports of serious adverse reactions are described, including patient details, suspected products, other treatments, reaction details, and administrative information. The CIOMS-I form for expedited adverse event reporting is also mentioned.
The Investigator's Brochure (IB) is a comprehensive document summarizing the body of information about an investigational product (IB) obtained during a drug trial.
This document discusses various methods used to assess causality in pharmacovigilance. It describes three broad categories of causality assessment methods: expert judgment, algorithms, and probabilistic/Bayesian approaches. For algorithms, it provides examples like the French method, Kramer method, and Naranjo scale. It also discusses some probabilistic methods like the Australian method and Bayesian Adverse Reactions Diagnostic Instrument (BARDI). Overall, the document provides an overview of the different existing approaches for determining if a suspected adverse drug reaction is actually caused by the drug in question.
This document discusses Contract Research Organizations (CROs) and their role in supporting pharmaceutical clinical trials. It provides the following key points:
- CROs are service organizations that conduct clinical trials and other drug development work on behalf of pharmaceutical companies. They help companies that lack sufficient resources or expertise to conduct all required trials themselves.
- Selecting the right CRO is important for a successful clinical trial. Sponsors should clearly define study specifications, evaluate a CRO's capabilities and compatibility, and consider cost. Ongoing management of the sponsor-CRO relationship also impacts success.
- Common issues like selecting an inappropriate CRO, unclear study specifications from the sponsor, or poor management can lead
This document reviews Good Clinical Practice (GCP) guidelines. It aims to study GCP principles and their application. The document outlines the objectives, contents, and introduction to GCP. It describes 14 GCP principles regarding ethical conduct of clinical trials, including protocol development, risk identification, benefit-risk assessment, review by ethics committees, informed consent, qualifications of investigators and staff, record keeping, confidentiality, manufacturing standards, and quality systems. The document provides examples of how each principle is applied in clinical research. It concludes with a bibliography on GCP guidelines and resources.
This document outlines the rules and regulations for conducting clinical trials and importing or manufacturing new drugs in India. It discusses the various forms and permissions required, including Form 44 for new drug approval and Form 12 for importing study drugs. It also describes the responsibilities of sponsors, investigators, and ethics committees. The document explains the different phases of clinical trials from human pharmacology to post-marketing surveillance. It lists the data that must be submitted with applications and included in clinical study reports.
This document provides guidelines for expedited reporting of adverse drug reactions during clinical drug development. It defines key terms like adverse event, adverse drug reaction, and serious adverse reaction. It recommends that single cases of serious and unexpected adverse drug reactions be reported to regulatory authorities within 7 or 15 days depending on severity. It also provides guidance on data elements that should be included in individual case safety reports that are transmitted during expedited reporting.
Clinical research : Drug regulatory affairs and Pharmacovigilance.ProfDnyaneshwariJosh
Schedule Y, FDA, Appendices, Post marketing surveillance,Clinical trial,WHO,ICH-GCP, FDA-CFR, Safety,Adverse Drug reaction, Adverse Event(AE), Serious Adverse Event(SAE),Reporting, IND , 3500A form
pharmacovigilance in INDIA,US,EUROPEAN UNIONgarimasaini33
The document discusses pharmacovigilance requirements and methods in India, the US, and the European Union. It outlines key pharmacovigilance methods like passive surveillance using spontaneous reports, stimulated reporting, and active surveillance. It also discusses additional requirements like periodic safety update reports, post-marketing trials, adverse event reporting to regulatory authorities, and considerations for vaccine pharmacovigilance including investigating serious rare adverse reactions and batch-related adverse reactions.
Safety data reconciliation involves comparing safety data between a clinical database and safety database to ensure consistency. Key fields like adverse event term, action taken, causality, and outcome are reconciled. Discrepancies between the databases are identified and queries are issued to sites for resolution. The process aims to clean 100% of agreed upon safety data points and document any acceptable discrepancies.
Relationship Between Pharmacovigilance And Patient Safety[1]siddharthchachad
This document discusses challenges in pharmacovigilance and patient safety, including issues with accurate safety profiling, differences in safety reporting guidelines between countries, and limitations of only focusing on patient safety. It provides examples of drugs like thalidomide, vioxx, and celebrex that highlighted safety issues. Regulatory environments and safety reporting practices differ between countries like India, EU, and US. Standardization of terms and processes is important for effective pharmacovigilance.
This document discusses the importance of pharmacovigilance, which is the science of monitoring the safety of pharmaceutical products. It defines pharmacovigilance and outlines its key aims such as improving patient safety and promoting rational drug use. The document then covers various topics related to pharmacovigilance including adverse event reporting, signal detection, risk management plans, and the assessment of the risk-benefit profiles of drugs. It emphasizes that pharmacovigilance is an ethical practice aimed at ensuring drugs cause less harm to patients.
ICH Guidelines for Pharmacovigilance.pptxsana916816
Serious and unexpected AEs: FDA recommends report to be submitted within 15 days
Follow up - Up to 15 days alert reports should be
submitted within 15 days
This document discusses the individual case safety report (ICSR) process in pharmacovigilance. It defines an ICSR and outlines the validity and seriousness criteria. It then describes the 9 step ICSR process: 1) case receipt, 2) validation, 3) duplicate check, 4) registration, 5) data entry, 6) narrative writing, 7) quality review, 8) medical review, and 9) regulatory reporting. Key aspects of each step like coding adverse events, identifying duplicates, and medical review for causality assessment are highlighted.
This document discusses clinical trial safety and pharmacovigilance responsibilities in Europe. It outlines legislation and definitions for adverse events, serious adverse reactions, and unexpected serious adverse reactions. It describes investigator responsibilities to notify sponsors of suspected unexpected serious adverse reactions within 24 hours. It also outlines sponsor responsibilities to report fatal or life-threatening unexpected serious adverse reactions to competent authorities and ethics committees within 7 days. Finally, it discusses periodic safety reporting requirements including annual safety reports and periodic safety update reports required for marketed products.
AN OVERVIEW AND IMPORTANCE OF PHARMACOVIGILANCERamakrishna K
An introduction to pharmacovigilance, basic types like active pharmacovigilance and passive pharmacovigilance, purpose, adverse event reporting, data processing, causality, assessement, signal detection, risk management plans and analysis
Development safety update report (dsur) pharmacovigilance and safetyAzierta
According to ICH guideline E2F (Step 5) on Development Safety Update Reports (DSURs) already implemented since 2011, companies must submit DSURs on a yearly basis for medicinal products involved in clinical trials. The focus of the DSUR is on data and findings from clinical trials of drugs and biologicals, whether they are authorized or not.
DSURs are internationally-harmonized, safety documents covering the safety summary of medicinal products during their development or clinical trial phase.
They are based heavily on the PSUR format already used for updating the safety record of drugs in their marketing phase.
A DSUR should be prepared after the first authorization of a clinical trial worldwide. A copy of the DSUR should be submitted to each concerned European Member State (MS) if a clinical trial is authorized in this MS for this investigational drug (still using the DIBD). Therefore, the first DSUR can be submitted to a concerned MS earlier than 1 year, but the covered reporting period should not be longer than 1 year.
The DSUR presents an annual review & evaluation of safety information:
• Information reported during the current review period and analysis based on previous knowledge of the products’ safety
• Description of new issues that may impact the overall program or specific clinical trials.
• Summarization of current understanding and management of known and potential safety risks to exposed patients.
• Provide an update on the status of the clinical development program.
In Azierta, scientific and healthcare consulting, we are experts in Pharmacovigilance and we have a team of highly qualified drug safety experts who support our clients to manage pharmacovigilance in an optimal way. Our work covers all areas of pharmacovigilance, both at the level of medicines, as well as medical devices and cosmetic products.
If you are interested in the contents of the good practices of pharmacovigilance (GVPs), as well as in other products related to pharmacovigilance visit our safety reports website for more details and feel free to contact us, we will be pleased to help you.
The document discusses regulatory requirements and procedures for approval of new vaccines in India. It provides definitions of key terms like drugs, new drugs and vaccines. It describes the information and data required to be submitted for approval, including safety and efficacy data from clinical trials. It also discusses post-marketing surveillance requirements and procedures for investigating and reporting adverse events following immunization.
This presentation discusses various topics related to clinical research management including:
- Preparation of clinical studies according to ICH guidelines.
- The difference between audits and inspections, who conducts them, and what they audit.
- Monitoring clinical studies to ensure adherence to protocols, SOPs, and regulations.
- Pharmacovigilance including adverse event reporting procedures.
- Documentation requirements for clinical research.
- Budgeting considerations for clinical trials including personnel, technology, data management.
- Vendor management activities like contracting, governance, and relationship management.
Safety Monitoring and Reporting in Clinical Trials DIA Poster 2015KCR
How to get the plausible and precise safety data, maintaining the highest ethical standards
during clinical development?
KCR’s article presents critical points in safety monitoring and reporting at different stages of the clinical trial, as well the main difficulties faced by medical personnel and clinical team during their everyday practice.
Reporting Methods _ Global Pharmacovigilance1Hafsa Hafeez
This document discusses pharmacovigilance reporting methods and signal detection in the USA. It outlines several methods for reporting adverse drug reactions including passive surveillance like spontaneous reporting and case series, as well as active surveillance through sentinel sites and clinical investigations. It describes the FDA's role in pharmacovigilance including maintaining the FAERS database and evaluating safety signals. Signals are detected through data mining this database and can be validated by obtaining additional information from various sources.
This document outlines 10 key regulatory requirements for conducting clinical trials in India. It defines what constitutes a new drug and clinical trial. It discusses the need for ethics committee approval and registration, informed consent, reporting of adverse events, and compensation for injuries. The document emphasizes that clinical sites must be prepared for inspection and certain non-drug intervention studies still require ethics approval and registration. Overall, it provides an overview of the regulatory framework and responsibilities for investigators conducting clinical research in India.
Pharmacovigilance is the science of monitoring approved drugs to detect adverse effects. It aims to identify new risks, assess known risks, and prevent harm. Pharmacovigilance relies on collecting data on adverse drug reactions (ADRs) through passive and active methods. Data is analyzed to detect safety signals and assess risks and benefits of medicines to optimize safe use. Regulatory authorities use pharmacovigilance data to take actions like updating product information or withdrawing approval if risks outweigh benefits.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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APPLICATIONS OF ARTIFICIAL INTELLIGENCE IN PHARMACEUTICAL RESEARCH.pdfAmeena Kadar
This document discusses various applications of artificial intelligence in pharmaceutical research including drug discovery, repurposing, personalized medicine, clinical trials, and biomarker discovery. It then describes several AI tools that can assist with literature searching, writing, grammar and paraphrasing, citations, and illustrations for research article preparation. These tools include Litmaps, Semantic Scholar, Google Bard, ChatGPT, Grammarly, QuillBot, Zotero, and Canva AI. The pros and cons of using AI tools for research are also examined.
REVIEW OF LITERATURE AND SOURCES OF INFORMATIONAmeena Kadar
Different types of reviews of literature and it's sources are included in this PowerPoint. A review of the literature is an inevitable part of the research process.
GENETIC POLYMORPHISM IN DRUG METABOLISM.pptxAmeena Kadar
Genetic Polymorphism is one of the factors that affects the Drug metabolism. Cytochrome P - 450, one of the prominent group of metabolizing enzymes. In this ppt, genetic polymorphism of cytochrome p 450 is discussed.
This document provides information on schizophrenia, including its epidemiology, types, symptoms, etiology, diagnosis, and treatment. It describes schizophrenia as a complex psychiatric disorder characterized by disorganized thoughts and behaviors. The lifetime prevalence is reported to be 0.3-0.7%, most commonly onset in late adolescence to early adulthood. Treatment involves both pharmacological approaches using antipsychotics like clozapine and risperidone, and non-pharmacological psychosocial rehabilitation programs.
The document discusses the importance of effective communication for achieving quality use of medicines. It notes that clear communication is needed between doctors and patients to explain why medicines are prescribed, address any barriers to understanding, and identify all medications patients are taking. Poor communication has been shown to be a leading cause of medication errors and patient harm. The document emphasizes the role of communication skills like briefings, handovers, patient education materials, and electronic prescribing in improving safety. Overall, it stresses that open communication between healthcare providers and patients is critical to negotiate treatment outcomes, minimize risks, and promote appropriate medication use.
Rheumatoid arthritis is a chronic inflammatory disease that causes pain, stiffness, and swelling in the joints. It occurs when the immune system mistakenly attacks the joints, causing inflammation and damage over time. Common symptoms include pain and stiffness in the small joints of the hands and feet that is usually worse in the morning. If not treated early, rheumatoid arthritis can lead to joint deformity and increased disability. The cause is unknown but is believed to involve genetic and environmental factors. Diagnosis involves physical exam, blood tests for rheumatoid factor and anti-CCP antibodies, and x-rays of affected joints.
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Responding to minor ailments - headache, food and drug allergy.pptxAmeena Kadar
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1. DRUG SAFETY REPORTING
AMEENA KADAR K A
FIRST SEM M PHARM
DEPT. OF PHARMACY PRACTICE
SANJO COLLEGE OF PHARMACEUTICAL SCIENCES
2. 2
INTRODUCTION
It is important to harmonize the way to gather and, if necessary, to take action on
important clinical safety information arising during clinical development.
It must be recognized that a medicinal product will be under various stages of
development and/or marketing in different countries, and safety data from marketing
experience will ordinarily be of interest to regulators in countries where the medicinal
product is still under investigational-only (Phase 1, 2, or 3) status.
For this reason, it is both practical and well-advised to regard pre-marketing and post-
marketing clinical safety reporting concepts and practices as interdependent, while
recognizing that responsibility for clinical safety within regulatory bodies and
companies may reside with different departments, depending on the status of the
product (investigational vs. marketed).
3. 3
There are two issues within the broad subject of clinical safety data management that
are appropriate for harmonization at this time:
1. The development of standard definitions and terminology for key aspects of clinical
safety reporting, and
2. The appropriate mechanism for handling expedited (rapid) reporting, in the
investigational (i.e., pre-approval) phase.
4. 4
DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH
CLINICAL SAFETY EXPERIENCE
A. Basic Terms
1. Adverse Event (or Adverse Experience)
“Any untoward medical occurrence in a patient or clinical investigation
subject administered a pharmaceutical product and which does not necessarily have
to have a causal relationship with this treatment”.
• An adverse event (AE) can therefore be any unfavorable and unintended sign
(including an abnormal laboratory finding, for example), symptom, or disease
temporally associated with the use of a medicinal product, whether or not
considered related to the medicinal product.
5. 5
2. Adverse Drug Reaction (ADR)
“A response to a drug which is noxious and unintended and which occurs at doses
normally used in man for prophylaxis, diagnosis, or therapy of disease or for
modification of physiological function.”
3. Unexpected Adverse Drug Reaction
“An adverse reaction, the nature or severity of which is not consistent with the
applicable product information (e.g., Investigator's Brochure for an unapproved
investigational medicinal product).”
6. 6
B. Serious Adverse Event or Adverse Drug Reaction
The term "severe" is often used to describe the intensity (severity) of a specific event
(as in mild, moderate, or severe myocardial infarction); the event itself, however, may
be of relatively minor medical significance (such as severe headache).
This is not the same as "serious," which is based on patient/event outcome or action
criteria usually associated with events that pose a threat to a patient's life or
functioning.
Seriousness serves as a guide for defining regulatory reporting obligations.
A serious adverse event (experience) or reaction is any untoward medical occurrence
that at any dose:
• results in death,
• is life-threatening
• requires inpatient hospitalization or prolongation of existing hospitalization
• results in persistent or significant disability/incapacity, or
• is a congenital anomaly/birth defect
7. 7
C. Expectedness of an Adverse Drug Reaction
The purpose of expedited reporting is to make regulators, investigators, and other
appropriate people aware of new, important information on serious reactions.
Therefore, such reporting will generally involve events previously unobserved or
undocumented, and a guideline is needed on how to define an event as "unexpected"
or "expected.”
an "unexpected" adverse reaction is one, the nature or severity of which is not
consistent with information in the relevant source documents. Until source documents
are amended, expedited reporting is required for additional occurrences of the
reaction.
8. 8
The following documents or circumstances will be used to determine whether an
adverse event/reaction is expected:
1. For a medicinal product not yet approved for marketing in a country, a
company's Investigator's Brochure will serve as the source document in that
country.
2. Reports which add significant information on specificity or severity of a known,
already documented serious ADR constitute unexpected events.
For example, an event more specific or more severe than described in the Investigator's
Brochure would be considered "unexpected".
Eg: (a) Acute renal failure as a labeled ADR with a subsequent new report of interstitial
nephritis
(b) Hepatitis with a first report of fulminant hepatitis.
9. 9
3. STANDARDS FOR EXPEDITED REPORTING
A. What Should be Reported?
1. Single Case of Serious, Unexpected ADRs
• All adverse drug reactions (ADRs) that are both serious and unexpected are subject to
expedited reporting.
• This applies to reports from spontaneous sources and from any type of clinical or
epidemiological investigation, independent of design or purpose.
• It also applies to cases not reported directly to a sponsor or manufacturer (for
example, those found in regulatory authority-generated ADR registries or in
publications).
• The source of a report (investigation, spontaneous, other) should always be
specified.
• Expedited reporting of reactions which are serious but expected will ordinarily be
inappropriate.
10. 10
• It is also inappropriate for serious events from clinical investigations that are
considered not related to study product, whether the event is expected or not.
• Similarly, non-serious adverse reactions, whether expected or not, will ordinarily not
be subject to expedited reporting.
2. Other Observations
• There are situations in addition to single case reports of "serious" adverse events or
reactions that may necessitate rapid communication to regulatory authorities;
appropriate medical and scientific judgment should be applied for each situation.
• In general, information that might materially influence the benefit-risk assessment of a
medicinal product or that would be sufficient to consider changes in medicinal product
administration or in the overall conduct of a clinical investigation represents such
situations.
11. 11
• Examples include:
a) For an "expected," serious ADR, an increase in the rate of occurrence which is judged
to be clinically important.
b) A significant hazard to the patient population, such as lack of efficacy with a medicinal
product used in treating life-threatening disease.
c) A major safety finding from a newly completed animal study (such as carcinogenicity).
12. 12
B. Reporting Time Frames
1. Fatal or Life-Threatening Unexpected ADRs
Certain ADRs may be sufficiently alarming so as to require very rapid notification to
regulators in countries where the medicinal product or indication, formulation, or
population for the medicinal product are still not approved for marketing, because such
reports may lead to consideration of suspension of, or other limitations to, a clinical
investigations program.
Fatal or life-threatening, unexpected ADRs occurring in clinical investigations qualify
for very rapid reporting.
Regulatory agencies should be notified (e.g., by telephone, facsimile transmission, or
in writing) as soon as possible but no later than 7 calendar days after first knowledge
by the sponsor that a case qualifies, followed by as complete a report as possible within
8 additional calendar days.
13. 13
This report must include an assessment of the importance and implication of the
findings, including relevant previous experience with the same or similar medicinal
products.
2. All Other Serious, Unexpected ADRs
Serious, unexpected reactions (ADRs) that are not fatal or life-threatening must be
filed as soon as possible but no later than 15 calendar days after first knowledge by
the sponsor that the case meets the minimum criteria for expedited reporting.
C. How to Report
No matter what the form or format used, it is important that certain basic
information/data elements, when available, be included with any expedited report,
whether in a tabular or narrative presentation. All reports must be sent to those
regulators or other official parties requiring them (as appropriate for the local situation)
in countries where the drug is under development.
14. 14
Responsibilities of the investigator
The medical management of the AE/ADR rests on the investigator.
According to the DCR-6th Amendment the investigator should report all SAEs to the
drug regulatory body of India (DCGI), sponsor of the trial, and the concerned EC that
approved the trial protocol within 24 h of occurrence of the SAE.
If the investigator comes to know about the AE after 24 hours of occurrence, then
“occurrence of SAE” is interpreted as “within 24 h of a Principal Investigator (PI)
getting to know of the SAE”.
The investigator is responsible to further send a detailed report after due analysis to
the DCGI, the EC Chairman, and the head of the institution where the trial is being
conducted within 14 calendar days of the occurrence of SAE.
If the investigator fails to report any SAE within the stipulated period, the reason for
the delay to the DCGI along with a copy of the SAE report must be furnished.
Reporting Requirements
15. 15
Timeline for safety reporting in case of Serious Adverse Events
16. 16
Responsibilities of sponsor
The sponsor must report, after due analysis, any SAE during a clinical trial within 14
days of their occurrence to the DCGI and the EC that approved the study protocol.
The sponsor provides the AE reporting forms to the trial site.
The sponsor is also responsible for notifying SAEs to the PI, IECs at other trial sites.
The study protocol designed by the sponsor must include a financial plan (including
insurance) to manage the AEs/ADRs and compensation for trial-related injury.
According to the Indian Good Clinical Practice, Indian Council of Medical Research
guidelines, DCRs, the sponsor, whether a pharmaceutical company, or an institution, must
agree in a clinical trial agreement before the study begins, to provide medical treatment as
well as financial compensation to research participants for any physical or mental injury
which they may suffer during the clinical trial.
17. 17
In addition, in the case of study-related death, the participant's legal heir(s) is/are
entitled to material compensation.
Compensation must also be given to a child injured in utero because of a parent's
participation in a trial.
The DCR-6th Amendment states that medical treatment should be provided for as
long as required or until such time it is established that the injury is not related to the
clinical trial, whichever is earlier.
When the participant suffers no permanent injury, the quantum of compensation
should be proportionate to the nature of the nonpermanent injury and loss of wages.
18. 18
Responsibilities of Ethics Committee
The DCR-6th Amendment states that the EC must provide its report on the SAE, along
with its opinion on financial compensation, if any, to be paid by the sponsor or his/her
representative, to the DCGI within 30 days of notification by the PI.
Responsibilities of regulatory authority, Drug Controller General of India
In case of SAE, the expert committee constituted by DCGI looks into the inputs from
EC and gives it recommendation to DCGI.
Depending on the report of expert committee, DCGI determines the compensation of
the SAE.
19. 19
If the sponsor fails to provide compensation to a research participant for trial-related
injuries or to his/her legal heir in case of death, the DCGI may, after giving an
opportunity to show cause why such an order should not be passed, by a written order,
suspend or cancel the clinical trial and restrict the sponsor/clinical research
organization (CRO)/local representative of a foreign sponsor from conducting any
further clinical trials in India or take any other action deemed fit.
Research participants who have suffered physical injury as a result of their
participation in a clinical trial are entitled to financial compensation commensurate
with their temporary or permanent impairment or disability subject to confirmation
from EC.
In case of death, their dependents are entitled to material compensation.
20. 20
KEY DATA ELEMENTS FOR INCLUSION IN EXPEDITED REPORTS
OF SERIOUS ADVERSE DRUG REACTIONS
• The minimum information required for expedited reporting purposes is:
an identifiable patient, the name of a suspect medicinal product, an identifiable
reporting source, and an event or outcome that can be identified as serious and
unexpected and for which, in clinical investigation cases, there is a reasonable
suspected causal relationship.
1. Patient Details
Initials
Other relevant identifier (clinical investigation number, for example)
Gender
Age and/or date of birth
Weight
Height
21. 21
2. Suspected Medicinal Product(s)
Brand name as reported
International Non-Proprietary Name (INN)
Batch number
]Indication(s) for which suspect medicinal product was prescribed or tested
Dosage form and strength
Daily dose and regimen (specify units - e.g., mg, ml, mg/kg)
Route of administration
Starting date and time of day
Stopping date and time, or duration of treatment.
3. Other Treatment(s)
For concomitant medicinal products (including non-prescription/OTC medicinal products)
and non-medicinal product therapies, provide the same information as for the suspected
product.
22. 22
4. Details of Suspected Adverse Drug Reaction(s)
Full description of reaction(s) including body site and severity, as well as the criterion (or
criteria) for regarding the report as serious should be given.
In addition to a description of the reported signs and symptoms, whenever possible,
attempts should be made to establish a specific diagnosis for the reaction.
• Start date (and time) of onset of reaction
• Stop date (and time) or duration of reaction
• Dechallenge and rechallenge information
• Setting (e.g., hospital, out-patient clinic, home, nursing home)
23. 23
Outcome:
Information on recovery and any squeal; what specific tests and/or treatment may
have been required and their results; for a fatal outcome, cause of death and a
comment on its possible relationship to the suspected reaction should be provided.
Any autopsy or other post-mortem findings (including a coroner's report) should
also be provided when available.
Other information: anything relevant to facilitate assessment of the case, such as
medical history including allergy, drug or alcohol abuse; family history; findings
from special investigations.
24. 24
5. Details on Reporter of Event (Suspected ADR)
Name
Address
Telephone number
Profession (specialty)
6. Administrative and Sponsor/Company Details
Source of report: was it spontaneous, from a clinical investigation (provide details),
from the literature (provide copy), other?
Date event report was first received by sponsor/manufacturer
Country in which event occurred
25. 25
Type of report filed to authorities: initial or follow-up (first, second, etc.)
Name and address of sponsor/manufacturer/company
Name, address, telephone number, and FAX number of contact person in reporting
company or institution
Identifying regulatory code or number for marketing authorization dossier or clinical
investigation process for the suspected product (for example IND number, NDA
number)
Sponsor/manufacturer's identification number for the case (this number must be the
same for the initial and follow-up reports on the same case).
26. 26
REFERENCES
1. ICH Topic E 2 A Clinical Safety Data Management: Definitions and Standards for
Expedited Reporting, European Medicines Agency.
2. Ethics of Safety Reporting of a Clinical Trial,
https://doi.org/10.4103%2Fijd.IJD_273_17
3. Textbook of Pharmacovigilance, SIA Publications.
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