Pharmacovigilance (PV) is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. Information received from patients and healthcare providers via pharmacovigilance reporting form as well as other sources such as the medical literature, plays a critical role in providing the data necessary for pharmacovigilance to take place.
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.
Pharmacovigilance is the science of monitoring the safety of medicines. It involves detecting, assessing, understanding, and preventing adverse effects of drugs. Pharmacovigilance activities begin during clinical trials and continue throughout a product's lifecycle. The goal of pharmacovigilance is to improve patient safety, public health, and understanding of medication risks and benefits. Careers in pharmacovigilance include roles monitoring adverse events, assessing drug safety, and reviewing medical information to evaluate safety profiles.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to detect adverse effects from drugs, understand their causes, and prevent patient harm. Pharmacovigilance programs collect reports of adverse drug reactions and analyze the data to identify safety issues, quantify risks, and communicate safety information to patients and healthcare professionals. The ultimate goals are to protect patients and promote the safe use of medicines.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
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 document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
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.
Pharmacovigilance is the science of monitoring the safety of medicines. It involves detecting, assessing, understanding, and preventing adverse effects of drugs. Pharmacovigilance activities begin during clinical trials and continue throughout a product's lifecycle. The goal of pharmacovigilance is to improve patient safety, public health, and understanding of medication risks and benefits. Careers in pharmacovigilance include roles monitoring adverse events, assessing drug safety, and reviewing medical information to evaluate safety profiles.
Pharmacovigilance is the science of monitoring the safety of medicines. It aims to detect adverse effects from drugs, understand their causes, and prevent patient harm. Pharmacovigilance programs collect reports of adverse drug reactions and analyze the data to identify safety issues, quantify risks, and communicate safety information to patients and healthcare professionals. The ultimate goals are to protect patients and promote the safe use of medicines.
Pharmacovigilance is a scientific discipline concerned with the collection, detection, assessment, monitoring, and prevention of adverse effects of pharmaceutical products.
Pharmacovigilance is a branch of Pharmacoepidemiology and is restricted to the study of adverse effects of drugs.
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 document discusses pharmacovigilance, which involves monitoring the safety of drugs after they have been approved. It defines pharmacovigilance and explains why it is needed given limitations of clinical trials. It describes types of adverse drug reactions and how they are classified. It outlines the goals and processes of pharmacovigilance programs, including reporting adverse reactions, conducting causality assessments, and submitting periodic safety update reports. The overall aim is to ensure safe and effective use of medicines through continual monitoring and regulatory action.
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
This document discusses post-marketing surveillance of drugs. Post-marketing surveillance is important to identify undesirable drug effects that were not detected in pre-market clinical trials due to limited sample sizes. Several methods are used for post-marketing surveillance including spontaneous reporting, cohort studies, and case-control studies. The key goals of post-marketing surveillance are to obtain additional safety and efficacy information on drugs used in real-world settings and to detect rare or long-term adverse effects.
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 presents information about pharmacovigilance from Nilesh Jawalkar, including definitions, aims and objectives, types of adverse drug reactions, importance of pharmacovigilance, partners in pharmacovigilance like WHO and national regulatory authorities, how pharmacovigilance works in drug regulation and clinical practice, and the RaPID program. It also discusses contributions that can be made at the levels of clinicians, pharmacists, pharmacologists, and students through activities like reporting adverse drug reactions, creating drug alerts and bulletins, and presenting information through animations. The conclusion emphasizes thinking more about patient safety, using and reacting to concerns, and considering the impact of decisions.
This document provides definitions and information related to pharmacovigilance. It discusses adverse event reporting, international collaboration, and national drug regulatory authorities. Key aspects of pharmacovigilance include collecting, monitoring, and preventing adverse effects of pharmaceutical products to assure their safe use.
This document discusses post marketing surveillance of drugs. It defines post marketing surveillance as monitoring drugs once they reach the market to evaluate their safety and efficacy in wider patient populations than clinical trials. Several methods of post marketing surveillance are described, including spontaneous reporting, cohort studies, and case control studies. The goals of post marketing surveillance include identifying unexpected side effects, assessing drug interactions, and ensuring safe use of medications. It is an important part of pharmacovigilance, the science of monitoring pharmaceutical safety and outcomes.
Lanzule is a pharmaceutical company involved in drug safety, including pharmacovigilance, drug discovery, and drug development. It reports to regulatory authorities in Nigeria, Ghana, the EU, and the US. The document discusses the process of evaluating drug safety from pre-clinical trials through post-marketing surveillance. It outlines the changing requirements for documenting pharmacovigilance systems in Europe, including phasing out DDPS in favor of the PSMF. The key aspects of drug safety are assessing safety during development, monitoring adverse events after approval through pharmacovigilance, and reporting any serious safety issues to regulatory authorities.
Lanzule is a pharmaceutical company involved in drug safety, including pharmacovigilance, drug discovery, and drug development. It reports to regulatory authorities in Nigeria, Ghana, the EU, and the US. The document discusses the evolution of the drug safety system in the EU from the DDPS to the new PSMF system. It also provides an overview of drug development stages from preclinical testing to post-marketing pharmacovigilance and adverse event reporting requirements to regulatory authorities. The roles and activities involved in pharmacovigilance include data collection and review, medical review, quality review, literature searching, writing safety reports, and regulatory inspection preparation.
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...SIRAJUDDIN MOLLA
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
Pharmacovigilance (gpv p) training in india Radhika Nagare
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Pharmacovigilance is the science of monitoring the safety of medicines. It plays a key role in identifying adverse drug reactions and preventing harm to patients. The goal of pharmacovigilance is to monitor drug safety, identify health risks, and prevent harm through careful tracking of side effects from clinical trials through a drug's entire lifecycle on the market. Major organizations like the FDA, EMEA, and WHO work to coordinate pharmacovigilance efforts internationally and protect public health.
Significance of pharmacovigilance in clinical research courses pptMayaGaikwad2
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of drugs. Moreover, this field of study is covered in clinical research courses to train professionals to heal patients.
The document discusses the process of drug development from discovery through clinical trials and regulatory approval. It begins with an overview of the iterative process involving biology, animal testing, and medicinal chemistry. It then outlines the typical 5 steps in drug development according to the FDA: discovery/screening, pre-clinical research including in vitro and in vivo testing, clinical research consisting of Phase I-III trials, FDA review, and post-marketing monitoring. The document provides details on each stage of development including pre-clinical and clinical research requirements and processes.
Adverse Drug Reaction (ADR) reporting is a vital process in pharmacovigilance that involves the identification, documentation, and analysis of adverse effects or unexpected reactions to medications. Healthcare professionals, including clinical pharmacists, play a crucial role in reporting ADRs to regulatory authorities. Timely and accurate reporting helps enhance patient safety, contributes to the continuous monitoring of drug safety profiles, and facilitates informed decision-making in healthcare. ADR reporting is a proactive measure to ensure the ongoing assessment and improvement of medication safety for the benefit of patients and the broader healthcare system.
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.
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification.
(Ref. WHO)
The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded...
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
This document discusses post-marketing surveillance of drugs. Post-marketing surveillance is important to identify undesirable drug effects that were not detected in pre-market clinical trials due to limited sample sizes. Several methods are used for post-marketing surveillance including spontaneous reporting, cohort studies, and case-control studies. The key goals of post-marketing surveillance are to obtain additional safety and efficacy information on drugs used in real-world settings and to detect rare or long-term adverse effects.
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 presents information about pharmacovigilance from Nilesh Jawalkar, including definitions, aims and objectives, types of adverse drug reactions, importance of pharmacovigilance, partners in pharmacovigilance like WHO and national regulatory authorities, how pharmacovigilance works in drug regulation and clinical practice, and the RaPID program. It also discusses contributions that can be made at the levels of clinicians, pharmacists, pharmacologists, and students through activities like reporting adverse drug reactions, creating drug alerts and bulletins, and presenting information through animations. The conclusion emphasizes thinking more about patient safety, using and reacting to concerns, and considering the impact of decisions.
This document provides definitions and information related to pharmacovigilance. It discusses adverse event reporting, international collaboration, and national drug regulatory authorities. Key aspects of pharmacovigilance include collecting, monitoring, and preventing adverse effects of pharmaceutical products to assure their safe use.
This document discusses post marketing surveillance of drugs. It defines post marketing surveillance as monitoring drugs once they reach the market to evaluate their safety and efficacy in wider patient populations than clinical trials. Several methods of post marketing surveillance are described, including spontaneous reporting, cohort studies, and case control studies. The goals of post marketing surveillance include identifying unexpected side effects, assessing drug interactions, and ensuring safe use of medications. It is an important part of pharmacovigilance, the science of monitoring pharmaceutical safety and outcomes.
Lanzule is a pharmaceutical company involved in drug safety, including pharmacovigilance, drug discovery, and drug development. It reports to regulatory authorities in Nigeria, Ghana, the EU, and the US. The document discusses the process of evaluating drug safety from pre-clinical trials through post-marketing surveillance. It outlines the changing requirements for documenting pharmacovigilance systems in Europe, including phasing out DDPS in favor of the PSMF. The key aspects of drug safety are assessing safety during development, monitoring adverse events after approval through pharmacovigilance, and reporting any serious safety issues to regulatory authorities.
Lanzule is a pharmaceutical company involved in drug safety, including pharmacovigilance, drug discovery, and drug development. It reports to regulatory authorities in Nigeria, Ghana, the EU, and the US. The document discusses the evolution of the drug safety system in the EU from the DDPS to the new PSMF system. It also provides an overview of drug development stages from preclinical testing to post-marketing pharmacovigilance and adverse event reporting requirements to regulatory authorities. The roles and activities involved in pharmacovigilance include data collection and review, medical review, quality review, literature searching, writing safety reports, and regulatory inspection preparation.
Regulatory terminology of ADR and Establishing pharmacovigilance center's i...SIRAJUDDIN MOLLA
This document defines various regulatory terminology used in pharmacovigilance and adverse drug reaction reporting. It defines terms related to side effects like adverse events, serious adverse events, adverse drug reactions, and others. It also defines drug safety terms like causal relationship, important medical events, and temporal relationship. Further, it defines risk terminology like identified risks, potential risks, important risks, and missing information. Finally, it defines general pharmacovigilance terms like company core data sheet and company core safety information. The document provides clear definitions for specialized terminology to establish a common understanding in the field of pharmacovigilance.
Pharmacovigilance (gpv p) training in india Radhika Nagare
Pharmacovigilance is the approach related to making an assessment, detection, understanding and prevention of inappropriate effects or any other problems to drug-related . So those working in the field of pharmacovigilance must have a good working knowledge of the principles of drug safety, regulations and proactive strategies for risk management. So people who want to pursue a clinical research career, can take up Pharmacovigilance training for adding value to their qualification.
Postmarketing surveillance (PMS) involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved for public use. PMS is important because pre-approval clinical trials involve relatively small numbers of participants and may not detect rare or long-term adverse effects. PMS uses various methods like spontaneous reporting, cohort studies, and case-control studies to monitor drug and device safety in larger populations over longer time periods after approval. The goal of PMS is to further evaluate or confirm the safety profile of products as they are used in real-world clinical settings by more diverse patients than clinical trials.
Pharmacovigilance is the science of monitoring the safety of medicines. It plays a key role in identifying adverse drug reactions and preventing harm to patients. The goal of pharmacovigilance is to monitor drug safety, identify health risks, and prevent harm through careful tracking of side effects from clinical trials through a drug's entire lifecycle on the market. Major organizations like the FDA, EMEA, and WHO work to coordinate pharmacovigilance efforts internationally and protect public health.
Significance of pharmacovigilance in clinical research courses pptMayaGaikwad2
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects of drugs. Moreover, this field of study is covered in clinical research courses to train professionals to heal patients.
The document discusses the process of drug development from discovery through clinical trials and regulatory approval. It begins with an overview of the iterative process involving biology, animal testing, and medicinal chemistry. It then outlines the typical 5 steps in drug development according to the FDA: discovery/screening, pre-clinical research including in vitro and in vivo testing, clinical research consisting of Phase I-III trials, FDA review, and post-marketing monitoring. The document provides details on each stage of development including pre-clinical and clinical research requirements and processes.
Adverse Drug Reaction (ADR) reporting is a vital process in pharmacovigilance that involves the identification, documentation, and analysis of adverse effects or unexpected reactions to medications. Healthcare professionals, including clinical pharmacists, play a crucial role in reporting ADRs to regulatory authorities. Timely and accurate reporting helps enhance patient safety, contributes to the continuous monitoring of drug safety profiles, and facilitates informed decision-making in healthcare. ADR reporting is a proactive measure to ensure the ongoing assessment and improvement of medication safety for the benefit of patients and the broader healthcare system.
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.
Similar to Pharmacovigilance Function at SPL.pdf (20)
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification.
(Ref. WHO)
The pharmaceutical quality system “assures that the desired product quality is routinely met, suitable process performance is achieved, the set of controls are appropriate, improvement opportunities are identified and evaluated, and the body of knowledge is continually expanded...
Good Manufacturing Practice for Pharmaceutical Products.pdfMd. Zakaria Faruki
According to the WHO-
"GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification".
CAREER OPPORTUNITIES OF PHARMACY GRADUATES IN THE PHARMACEUTICAL INDUSTRIES.pdfMd. Zakaria Faruki
Pharmacy is a very important profession, which deals with the manufacturing, handing, proper utilization, dispensing, and administration of life saving drugs.
Training means the process of increasing the knowledge and skills of an employee for doing a particular job. It seeks to improve the job performance and work behaviour of those trained.
Process validation is defined as the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.
The U.S. Food and Drug Administration (FDA) has proposed guidelines with the following definition for process validation: – “PROCESS VALIDATION” is establishing documented evidence which provides a high degree of assurance that a specific process consistently produces a product meeting its predetermined specifications and quality attributes.
Workshop on General Accident Prevention at The workplaces.pdfMd. Zakaria Faruki
Md. Zakaria Faruki, Manager of Quality Assurance at Silva Pharmaceuticals Limited in Bangladesh, presented at a workshop on November 8, 2022. The 26-page presentation covered Good Automated Manufacturing Practice and included sections on quality assurance, documentation, equipment cleaning and maintenance, process validation, and compliance with regulations. The presentation aimed to educate attendees on proper pharmaceutical manufacturing practices.
The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked.
The technical people must have a knowledge and understanding of GMP to enable them to carry out their duties in accordance with GMP. These people must have the level of training and experience that will enable them to do their professional works respectively.
According to US FDA it is illustrated here that,
A recall is a method of removing or correcting products that are in violation of laws administered by the Drug Regulatory Authority.
Recall is a voluntary action that takes place because manufacturers and distributors carry out their responsibility to protect the public health and well-being from products that present a risk of injury or gross deception or are otherwise defective.
21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
Market or Customer complaint is “an expression of dis-satisfaction on a customer’s behalf to a responsible party” when their expectations have not been met! However, Complaint handling is a Good Manufacturing Practice (GMP) requirement, since all complaints concerning potentially defective products must be carefully reviewed according to a written procedure.
Good Documentation Practice (GDocP) is an essential part of the quality assurance and such, related to all aspects of GMP” this definition is based on WHO. It is a systematic procedure of preparation, reviewing, approving, issuing, recording, storing and archival of document.
GMP is the part of Quality Management which ensures that the products are consistently produced and controlled to the quality standard appropriate to their intended use as required by the marketing authorization and product specification. (Reference: WHO)
In contrast, cGMP i.e. ‘c’ before the GMP is indicative of the constantly changing technologies and systems which are up-to-date in order to comply with the regulations. These the dynamic changes in Good Manufacturing Practice to make Pharmaceuticals manufacture foul proof; assuring a high level of confidence in the safety and efficacy of the product.
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
The first generation of biological drugs, which
have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.
GCP: An international ethical and scientific quality standard for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects.
PV: The science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem.
Stability study of Pharmaceutical Products and Regulatory Requirements Md. Zakaria Faruki
A marketed product stability program fulfills registration
commitments and ensures that marketed product is
stable until expiry date stamped on product
label....
Stability studies should be planned on the
basis of pharmaceutical R&D and regulatory
requirements...
Post-marketing drug safety surveillance refers to the monitoring of drugs once they reach the market after clinical trials through a process which evaluates drugs taken by individuals under a wide range of circumstances over an extended period.
Pharmacovigilance is the science and activities relating to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems.
This document provides an overview of the electronic Common Technical Document (eCTD) format used for regulatory drug submissions. It discusses the history and goals of the ICH and eCTD, the components and structure of an eCTD, best practices for preparing documents, and software options. Key points covered include the folder structure, use of XML and metadata, concept of reuse and granularity, and comparing the benefits of eCTD to traditional paper submissions. The conclusion emphasizes that adopting eCTD is essential to joining the electronic bandwagon, while also needing intermediate steps to fully transition from paper CTD formats.
The document is a slide presentation on training for product registration using the Common Technical Document (CTD) format in the global market. It provides an overview of the CTD, which was developed by the International Conference on Harmonization (ICH) to standardize the submission format for pharmaceutical product registration across the United States, Europe and Japan. The CTD format aims to streamline the registration process and reduce duplication by organizing technical documents into five modules covering administrative information, overviews and summaries, quality, nonclinical data, and clinical data. The presentation outlines the structure and content of each CTD module.
Quality must be built into the product, it cannot be inspected into it. The Pharmaceutical industries are experiencing a “knowledge and experience deficit” regarding the use of QbD concepts.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Travel vaccination in Manchester offers comprehensive immunization services for individuals planning international trips. Expert healthcare providers administer vaccines tailored to your destination, ensuring you stay protected against various diseases. Conveniently located clinics and flexible appointment options make it easy to get the necessary shots before your journey. Stay healthy and travel with confidence by getting vaccinated in Manchester. Visit us: www.nxhealthcare.co.uk
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The skin is the largest organ and its health plays a vital role among the other sense organs. The skin concerns like acne breakout, psoriasis, or anything similar along the lines, finding a qualified and experienced dermatologist becomes paramount.
10 Benefits an EPCR Software should Bring to EMS Organizations Traumasoft LLC
The benefits of an ePCR solution should extend to the whole EMS organization, not just certain groups of people or certain departments. It should provide more than just a form for entering and a database for storing information. It should also include a workflow of how information is communicated, used and stored across the entire organization.
These lecture slides, by Dr Sidra Arshad, offer a simplified look into the mechanisms involved in the regulation of respiration:
Learning objectives:
1. Describe the organisation of respiratory center
2. Describe the nervous control of inspiration and respiratory rhythm
3. Describe the functions of the dorsal and respiratory groups of neurons
4. Describe the influences of the Pneumotaxic and Apneustic centers
5. Explain the role of Hering-Breur inflation reflex in regulation of inspiration
6. Explain the role of central chemoreceptors in regulation of respiration
7. Explain the role of peripheral chemoreceptors in regulation of respiration
8. Explain the regulation of respiration during exercise
9. Integrate the respiratory regulatory mechanisms
10. Describe the Cheyne-Stokes breathing
Study Resources:
1. Chapter 42, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 36, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 13, Human Physiology by Lauralee Sherwood, 9th edition
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
DECLARATION OF HELSINKI - History and principlesanaghabharat01
This SlideShare presentation provides a comprehensive overview of the Declaration of Helsinki, a foundational document outlining ethical guidelines for conducting medical research involving human subjects.
2. Pharmacovigilance (PV/ PVG) also known as drug safety, is the
pharmacological science relating to the collection, detection, assessment,
monitoring, and prevention of adverse effects with pharmaceutical
products. As such, pharmacovigilance heavily focuses on adverse drug
reactions, or ADRs, which are defined as any response to a drug which is
noxious and unintended, including lack of efficacy (the condition that this
definition only applies with the doses normally used for the prophylaxis,
diagnosis or therapy of disease, or for the modification of physiological
disorder function was excluded with the latest amendment of the
applicable legislation).
Medication errors such as overdose, and misuse and abuse of a drug as
well as drug exposure during pregnancy and breastfeeding, are also of
interest, even without an adverse event, because they may result in an
adverse drug reaction.
Information received from patients and healthcare providers via
pharmacovigilance reporting form as well as other sources such as the
medical literature, plays a critical role in providing the data necessary for
pharmacovigilance to take place. In fact, in order to market or to test a
pharmaceutical product m most countries, adverse event data received by
the license holder (usually a pharmaceutical company) must be submitted
to the local drug regulatory authority.
INTRODUCTION TO PHARMACOVIGILANCE ONJOB
2 of 25
Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
3. Adverse event is any untoward medical occurrence in a patient or
clinical investigation subject administered a pharmaceutical
product and which does not necessarily have a causal
relationship with this treatment. An adverse event (AE) can
therefore be any unfavourable and unintended sign (including an
abnormal laboratory finding), symptom, or disease temporally
associated with the use of a medicinal (investigational) product,
whether or not related to the medicinal (investigational) product.
AEs in patients participating in clinical trials must be reported to
the study sponsor and if required could be reported to local ethics
committee. Adverse events categorized as "serious" (results in
death, illness requiring hospitalization, events deemed life-
threatening, results in persistent or significant disability/
incapacity, a congenital anomaly/ birth defect or medically
important condition) must be reported to the regulatory
authorities immediately, whereas non-serious adverse events are
merely documented and sent to the regulatory authority.
ADVERSE EVENT (AE) ONJOB
3 of 25
Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
4. The amount and variety of safety-relevant data gathered from
different patient populations in global clinical trials are enormous;
therefore it is crucial that a concise and systematic approach to
pharmacovigilance be implemented. Systematic safety monitoring
is needed to identify previously recognized and unrecognized
adverse drug reactions and to evaluate the safety and efficacy of
medicinal products during clinical trials and in the post marketing
period.
It is important that pharmacovigilance not be perceived as a
burden put upon the pharmaceutical product development
industry by the regulating bodies. Ongoing pharmacovigilance
should be understood as essential to the only appropriate way to
develop safe medicines, introduce them into the market, and have
them survive in the market once approved. Not only does the
failure to perform ongoing safety assessment activities increase
the chances of placing subjects at risk unnecessarily, it also
increases a company's risk of investing in the development of the
wrong molecules.
THE IMPORTANCE OF IMPLEMENTING:
A SYSTEMATIC PHARMACOVIGILANCE APPROACH
ONJOB
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
5. An operational overview of pharmacovigilance begins with safety
information coming from a variety of sources, including clinical trials
data, safety call centers, spontaneous reports, and literature
searches, each of which has the potential to create an individual
case. Within the pharmacovigilance department each case is
processed, assessed as to its relationship (causality) to the
investigational product, and reported to the regulatory authorities and
other stakeholders, either as an expedited report or as part of an
aggregate report, based upon pharmacovigilance policies,
regulations, and guidance documents. In addition, each case becomes
part of the total safety data set for that medicinal product.
Aggregate data are systematically analyzed for safety issues and
assessed for benefit versus risk, and periodic safety update reports
(PSURs) are submitted to the regulatory authorities as additional
safety information is collected. This continues throughout the
product's life cycle. Safety findings are addressed in order to mitigate
risk. This may include modification to a clinical trial design, changes
in proposed labeling, implementation of a risk mitigation plan, or
discontinuation of development or use of a marketed product.
Operational overview of Pharmacovigilance ONJOB
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
6. Flow Chart of PVG Function at SPL ONJOB
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
7. Organogram of PVG Team at SPL ONJOB
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
8. Now What We Practice at SPL with SOP/QA/045/01:
Management of Pharmacovigilance Function
2. Scope
This SOP applicable for the management of
Pharmacovigilance activity mediated by all types of
medicines which are manufactured by Silva
Pharmaceuticals Limited.
To monitor and management of
Pharmacovigilance activities and informing
to regulatory authority (DGDA) accordingly.
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1. Purpose
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
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3. Responsibility
3.1 Head of Product Management Department will
act as Head of Pharmacovigilance and will monitor
the overall activities of Pharmacovigilance. Manager,
QA will act as a focal point of Pharmacovigilance
activities of Silva Pharmaceuticals Limited and shall
be responsible for receiving of suspected adverse
event from the field force/ patient/ physician/ clinic/
healthcare professionals etc. through PMD & Sales
personnel.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
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3. Responsibility
3.2 Head of Quality Assurance/his designee will
check product quality if any adverse event is
reported and also give other technical support. He
will also provide adverse event (AE) report to
regulatory department if any report is received
including zero report.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
11. 3. Responsibility
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3.3 Head of Drug Regulatory Affairs/ his
designee shall sent adverse event (AE)
report to DGDA including zero report.
3.4 Officer or above of Quality Assurance
Department is responsible for proper
implementation of this SOP.
3.5 Head of Quality Assurance is responsible
for Regulatory Compliance and Approval this
SOP.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
12. Pharmacovigilance: Pharmacovigilance (PV) is defined as the science and
activities relating to the detection, assessment, understanding and
prevention of adverse effects or any other drug-related problem.
Adverse Drug Reaction (ADR): An adverse drug reaction (ADR) is an
unwanted or harmful reaction experienced following the administration of
a drug or combination of drugs under normal conditions of use and is
suspected to be related to the drug. An ADR will usually require the drug
to be discontinued or the dose reduced. The study of ADRs is the concern
of the field known as Pharmacovigilance.
Suspected Adverse Event: Suspected adverse event is an event that may
be occurred due to adverse drug reaction, product quality problem or
medication error
DGDA: Directorate General of Drug Administration
HEALTCARE PROFESIONALS: For the purpose of suspected adverse event
healthcare professionals are defined as medically qualified persons such
as physicians, dentists, pharmacist, chemist, nurses etc.
FOCAL POINT: Focal Point is the key person who will be responsible for
collecting of any type of adverse event and He should have contact
number so that field force/ patient/physician/ other healthcare
professionals may contact with him at any time for informing about
adverse event.
4.0 Abbreviations and Definitions ONJOB
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
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5.0 Materials and Equipment
Not applicable
6.0 Precaution / Health and Safety
Considerations
6.1 During collection of information
regarding suspected adverse event, it
should be collected very carefully and
information must be authentic and
reliable.
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Trainer: Md. Zakaria Faruki, Manager & Head of QA, SPL
14. 7.1 Reporting of Adverse Event
7.1.1 Field force will collect suspected adverse event report from
physicians/ patients/other healthcare professionals or they will fill up
the suspected adverse event reporting form as per DGDA approved
prescribed form (Annexure-I) which is attached with the SOP and will
send it to Focal Point. Physicians / patients/other healthcare
professionals may also submit report through telephone or email.
7.1.2 After receiving of adverse event, Head of Pharmacovigilance
team shall arrange a meeting in presence of all team members to
discuss about event and a team will be formed to investigate the
event and also to find out the root cause.
7.1.3 After investigation if it is found that the event is occurred due
to product quality problem then necessary CAPA to be taken to solve
the problem. If the event was not found regarding product quality
problem then QA personnel will prepare an approval note as per
Annexure-II and Head of QA & Head of Pharmacovigilance will
approve the note. Then finally it will be sent to regulatory affairs
department.
7.0 Procedure (Contd…) ONJOB
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15. 7.1.4 Then Drug Regulatory Affairs department will send it
to drug administration and collect a receiving acknowledgement
paper from drug administration as per Annexure-III.
7.1.5 Then Drug Regulatory Affairs department will send a copy of
acknowledgement paper to QA department.
7.1.6 If no event received, a letter will be sent to drug administration
from QA through regulatory affairs department as per Annexure-III.
7.2 Recording of Adverse Event
7.2.1 After receiving any adverse event, QA shall give the entry in log
book as per Annexure-IV.
7.2.2 7.2.2 The numbering will be as follows
AE/XX/YY
AE=Adverse Event
XX= Serial Number of Adverse Event will started from 01
YY= Last two digit of current year
7.0 Procedure (Contd…) ONJOB
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• 8.0 Reference Document
8.1 WHO Good Manufacturing Practices Guideline
8.2 DGDA Guidelines
• 9.0 Annexure
• 9.1 Annexure-I: SUSPECTED ADVERSE EVENT MONITORING
FORM OF DGDA (SOP/QA/045/01/F01)
• 9.2 Annexure -II: APPROVAL NOTE OF SUSPECTED ADVERSE
EVENT MONITORING REPORT (SOP/QA/045/01/F02)
• 9.3 Annexure -III: ACKNOWLEDGEMENT LETTER
(SOP/QA/045/01/F03)
• 9.4 Annexure -IV: ADVERSE EVENT RECORDING LOG
(SOP/QA/045/01/F04)
Version
No.
Brief Reason for the
Revision
Effective
Date
Remarks
01. First Version 02/09/2023 -
10.0 Revision History
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17. 11.0 Training
11.1 Head of Quality Assurance or His
Nominee is Responsible To Conduct a
Training Session on This SOP.
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