Our Embase expert, Ian Crowlesmith and PV expert Sherry Winter covered the following in this webinar:
- Reviewed the indexing and features and functionality in Embase, which support pharmacovigilence related workflows for drugs and devices
- Walked through integrated Embase and Pharmapendium practical examples, showing how easy it is to build comprehensive searches.
The document discusses challenges in pharmacovigilance including developing common platforms across locations and groups, integrating multiple databases, and implementing workflow management. It outlines Elsevier solutions to these challenges like automated literature monitoring to avoid missing safety signals, literature triage tools to save time, and integration with case reporting systems to connect literature to the broader ecosystem. The solutions aim to make pharmacovigilance teams more efficient, compliant, and able to better mitigate risk.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.
Signifcance of pharmacovigilance & risk management planAnsuman Parida
Pharmacovigilance is concerned with monitoring the safety of pharmaceutical drugs. It involves collecting, detecting, and assessing adverse drug reactions and preventing harm to patients. A risk management plan describes the known safety risks of a drug and outlines activities to further characterize risks, minimize risks to patients, and evaluate the effectiveness of risk minimization measures. Key parties in a risk management plan include patients, healthcare professionals, regulators, payers, pharmaceutical companies, and politicians. Risk management plans help ensure medications are reasonably safe and effective for their intended uses.
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...KCR
This document discusses post-authorization safety studies (PASS) and ongoing safety surveillance. It provides background on the legal basis and guidelines for PASS from the EMA and ICH. It notes that about 25% of products under additional monitoring by EMA have PASS requirements. The number of studies registered in the EU PAS register has risen significantly in recent years. PASS can be either imposed as an obligation or conducted voluntarily. Key differences between PASS and pre-approval studies are also outlined. The role and significance of PASS is increasing as a way to decrease drug development costs and times while increasing the collection of real-world data.
The document discusses pharmacovigilance, which involves monitoring the safety of medical products. It outlines various methods for collecting and analyzing adverse event reports, including spontaneous reports from healthcare professionals and patients, literature reviews, and solicited reports from clinical trials. It also discusses prioritizing cases, signal detection methods, and actions that may be taken in response to potential safety issues. The main objectives are to minimize risks for patients and the company while meeting regulatory requirements.
The document discusses challenges in pharmacovigilance including developing common platforms across locations and groups, integrating multiple databases, and implementing workflow management. It outlines Elsevier solutions to these challenges like automated literature monitoring to avoid missing safety signals, literature triage tools to save time, and integration with case reporting systems to connect literature to the broader ecosystem. The solutions aim to make pharmacovigilance teams more efficient, compliant, and able to better mitigate risk.
Adverse drug reaction, pharmacovigilance, spontaneous ADR monitoring, Good Pharmacovigilance Practices, drug safety, patient safety, an overview of regulatory guidelines, medicine safety, medical regulations.
Providing timely, evidence-based information on the safe and effective use of medicines, facilitating changes to healthcare practices, supporting risk minimization behavior.
Signifcance of pharmacovigilance & risk management planAnsuman Parida
Pharmacovigilance is concerned with monitoring the safety of pharmaceutical drugs. It involves collecting, detecting, and assessing adverse drug reactions and preventing harm to patients. A risk management plan describes the known safety risks of a drug and outlines activities to further characterize risks, minimize risks to patients, and evaluate the effectiveness of risk minimization measures. Key parties in a risk management plan include patients, healthcare professionals, regulators, payers, pharmaceutical companies, and politicians. Risk management plans help ensure medications are reasonably safe and effective for their intended uses.
KCR: Post-Authorisation Safety Studies (PASS) - Is the Ongoing Surveillance a...KCR
This document discusses post-authorization safety studies (PASS) and ongoing safety surveillance. It provides background on the legal basis and guidelines for PASS from the EMA and ICH. It notes that about 25% of products under additional monitoring by EMA have PASS requirements. The number of studies registered in the EU PAS register has risen significantly in recent years. PASS can be either imposed as an obligation or conducted voluntarily. Key differences between PASS and pre-approval studies are also outlined. The role and significance of PASS is increasing as a way to decrease drug development costs and times while increasing the collection of real-world data.
The document discusses pharmacovigilance, which involves monitoring the safety of medical products. It outlines various methods for collecting and analyzing adverse event reports, including spontaneous reports from healthcare professionals and patients, literature reviews, and solicited reports from clinical trials. It also discusses prioritizing cases, signal detection methods, and actions that may be taken in response to potential safety issues. The main objectives are to minimize risks for patients and the company while meeting regulatory requirements.
New global regulations have increased requirements for measuring and assessing the benefit-risk profiles of medicines. Quintiles can help companies comply with these changing regulations through safety reporting and benefit-risk assessment services. They have experienced staff across eight global hubs who are trained in pharmacovigilance and regulatory requirements to deliver timely and compliant reports and analyses.
This document discusses pharmacovigilance, which is the science of monitoring the safety of pharmaceutical drugs. It aims to improve patient safety, public health, assess risk and benefits of drugs, and promote effective communication. A functional pharmacovigilance system requires a national center, reporting system, database, advisory committee, and communication strategy. Any adverse drug reactions or lack of efficacy should be reported. Periodic safety update reports provide an evaluation of the risk-benefit balance of drugs and are submitted to regulatory authorities on defined timelines.
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
This document discusses pharmacovigilance (PV), which involves monitoring the safety of medicines. PV focuses on detecting adverse drug reactions through spontaneous reporting systems. Signal detection involves data mining to identify unexpected adverse reactions requiring further evaluation. Signals are strengthened by evaluating factors like case reports and biological plausibility. National PV centers play a key role by collecting reports, communicating signals to WHO databases, and taking necessary actions. The WHO PV program has grown from 10 countries in 1968 to over 130 currently.
Common arab guidelines in pharmacovigilanceNahla Amin
The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
This document discusses pharmacovigilance in India, both past and present. It notes that India did not previously have a formal pharmacovigilance system, but initiated activities in 1986 and joined the WHO program in 1997. The National Pharmacovigilance Program was launched in 2004 and became operational in 2005. It has since expanded to include 90 monitoring centers across India. The program aims to ensure drug safety, identify new adverse drug reactions, and support regulatory decision making. Future prospects include expanding the program further and implementing hemovigilance and biovigilance initiatives to monitor blood and medical devices.
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.
Spontaneous adverse event reporting to the US FDA was encouraged using an easy-to-use Web and mobile app along with engagement of a Facebook patient group, specifically for Essure, a hysteroscopic sterilization device. A total of 1349 valid reports were received through the app over approximately 19 months, equivalent to 15 times more reports than through traditional channels, with high completeness scores. The reports were characterized including symptoms and outcomes reported, and the motivations and incentives in this engagement model for pharmacovigilance are discussed.
The document summarizes key points about pharmacovigilance from an industry perspective. It discusses the historical milestones that demonstrated the importance of pharmacovigilance. It then describes pharmacovigilance processes, including adverse event reporting, signal detection, and risk management plans. Finally, it outlines the new EU legislation's aim to strengthen and rationalize the EU pharmacovigilance system through requirements for pharmacovigilance systems and increased transparency.
Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP P...Until ROI
The document discusses several challenges related to pharmacovigilance when the same drug is marketed by different sponsors, such as generic manufacturers. It notes issues around aggregate safety reporting, signal detection, and obtaining safety data from other companies. The document also proposes "Safety in a Capsule" as a software solution that could help address these challenges by providing a unified platform for adverse event reporting, signal detection, and analytics across multiple drug manufacturers.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
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.
New global regulations have increased requirements for measuring and assessing the benefit-risk profiles of medicines. Quintiles can help companies comply with these changing regulations through safety reporting and benefit-risk assessment services. They have experienced staff across eight global hubs who are trained in pharmacovigilance and regulatory requirements to deliver timely and compliant reports and analyses.
This document discusses pharmacovigilance, which is the science of monitoring the safety of pharmaceutical drugs. It aims to improve patient safety, public health, assess risk and benefits of drugs, and promote effective communication. A functional pharmacovigilance system requires a national center, reporting system, database, advisory committee, and communication strategy. Any adverse drug reactions or lack of efficacy should be reported. Periodic safety update reports provide an evaluation of the risk-benefit balance of drugs and are submitted to regulatory authorities on defined timelines.
Pharmacovigilance Training in Oracle Argus Safety DatabaseGratisol Labs
Pharmacovigilance training is essential for pharmaceutical and healthcare organizations to ensure your operations comply with the latest regulatory guidelines, laws and standards. At Gratisol Labs, we provide industry-leading pharmacovigilance training courses with hands on experience on safety databases & medical coding that cover the basics of Pharmacovigilance till advanced drug safety topics, the regulatory requirements of pharmacovigilance, signal detection, and pharmacovigilance audits are covered in the complete Gratisol Labs Pharmacovigilance Training Programme.
This document discusses pharmacovigilance (PV), which involves monitoring the safety of medicines. PV focuses on detecting adverse drug reactions through spontaneous reporting systems. Signal detection involves data mining to identify unexpected adverse reactions requiring further evaluation. Signals are strengthened by evaluating factors like case reports and biological plausibility. National PV centers play a key role by collecting reports, communicating signals to WHO databases, and taking necessary actions. The WHO PV program has grown from 10 countries in 1968 to over 130 currently.
Common arab guidelines in pharmacovigilanceNahla Amin
The document outlines guidelines for good pharmacovigilance practices for Arab countries. It discusses 10 modules that cover key aspects of pharmacovigilance systems including quality systems, the pharmacovigilance system master file, inspections, audits, risk management, safety reporting and communication. The guidelines were developed by the Arab League to harmonize pharmacovigilance standards across countries in the region based largely on European Union guidelines. The guidelines aim to help national regulatory authorities ensure marketing authorization holders have appropriate systems, processes and resources for pharmacovigilance obligations.
This document discusses pharmacovigilance in India, both past and present. It notes that India did not previously have a formal pharmacovigilance system, but initiated activities in 1986 and joined the WHO program in 1997. The National Pharmacovigilance Program was launched in 2004 and became operational in 2005. It has since expanded to include 90 monitoring centers across India. The program aims to ensure drug safety, identify new adverse drug reactions, and support regulatory decision making. Future prospects include expanding the program further and implementing hemovigilance and biovigilance initiatives to monitor blood and medical devices.
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.
Spontaneous adverse event reporting to the US FDA was encouraged using an easy-to-use Web and mobile app along with engagement of a Facebook patient group, specifically for Essure, a hysteroscopic sterilization device. A total of 1349 valid reports were received through the app over approximately 19 months, equivalent to 15 times more reports than through traditional channels, with high completeness scores. The reports were characterized including symptoms and outcomes reported, and the motivations and incentives in this engagement model for pharmacovigilance are discussed.
The document summarizes key points about pharmacovigilance from an industry perspective. It discusses the historical milestones that demonstrated the importance of pharmacovigilance. It then describes pharmacovigilance processes, including adverse event reporting, signal detection, and risk management plans. Finally, it outlines the new EU legislation's aim to strengthen and rationalize the EU pharmacovigilance system through requirements for pharmacovigilance systems and increased transparency.
Challenges In Pharmacovigilance Dr Vishwas, by Dr. Vishwas Sovani MD ,VP P...Until ROI
The document discusses several challenges related to pharmacovigilance when the same drug is marketed by different sponsors, such as generic manufacturers. It notes issues around aggregate safety reporting, signal detection, and obtaining safety data from other companies. The document also proposes "Safety in a Capsule" as a software solution that could help address these challenges by providing a unified platform for adverse event reporting, signal detection, and analytics across multiple drug manufacturers.
What you need to know about the Pharmacovigilance guidelines for companies marketing drugs in India. A concise overview of the six modules in the Guidance Document and the responsibilities of the Marketing Authorization Holders.
The competitiveness of drug development has been the impetus for new and accelerated regulatory pathways. While the growing patient-centric healthcare market coupled with a vested interest in safety information from a range of governmental and regulatory stakeholders has driven pharmacovigilance to reach a new paradigm in drug development. The consequence of which has led to tighter post-marketing surveillance systems on the global scale and a rapidly expanding volume of reported safety events impelling the industry to adopt new strategies to managing pharmacovigilance throughout the product lifecycle. In view of all these changes, it is timely to provide an overview on the concept of Pharmacovigilance, and here i3 Consult has published in this Slide Share, some key topics on Pharmacovigilance such as Signal Detection, Detection Management, Risk Management and Risk Reduction Strategies. At i3 Consult, our core team of experts & our 200,000+ network bring innovative ideas, cost effective solutions and game changing services to healthcare, pharma & life science, for more details, visit www.i3consult.com
Pharmacovigilance: Regulators’ Perspective on Proactive Risk Management, Chal...Bhaswat Chakraborty
The prescription drug sales have been growing globally at a rate of 12-20%, which is lucrative by any standards, especially when top companies’ total sales are approaching 25-40 billion USD a year. Such market forces create tremendous pressure on one side on the drug sponsors to launch their product as early as possible, and on the other hand on the significantly regulators to decide on the product safety for approval with a tremendous time constraint. In such a scenario, drug regulatory authorities in US, Europe and elsewhere have renewed their mandate to fortify the “safety” regulations so that the drugs released to the market are highly safe and effective. The FDA Amendment Act, 2007 (FDAAA) have now authorized FDA to significantly increase the user fees for safety initiatives and evaluations. The FDA initiatives include its authority to ask from a drug sponsor a Risk and Evaluation Mitigation Strategy (REMS) with a detailed risk minimization action plan. FDA can now require the sponsor to develop a comprehensive safety surveillance system as well. For each new drug, FDA will now also establish an internal committee for a safe use of this drug in pediatric population. Similar approaches and authorities have also been given to European drug regulatory agencies.
This presentation will take you through the current proactive risk management approaches used or proposed by the prominent regulatory agencies for both pre- and post- market safety surveillance of new drug and new drug products. It will also discuss the challenges and collaborative efforts of both regulators and industry to work with a multidisciplinary safety management system to identify and assess the risk signals as early as possible in drug development process. Further it will discuss the reporting and evaluation of this data such that it helps pre-market approval of the safest possible product and a transparent post-market surveillance plan.
Overcoming the Challenges of Benefit Risk Assessment for Established ProductsSGS
Conducting/Implementing a benefit/ risk assessment can be very challenging for “old” established products. Scientific assessment on benefit/ risk is conducted based on the best evidence available. The main objective of this presentation is to discuss how this approach can be applied for different type of regulatory documents that are to be prepared for established products.
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.
passive_serviallance and responsibilities in pharmacovigilance pptxAyodhya Paradhe
The document discusses the roles and responsibilities in pharmacovigilance and passive surveillance. It defines pharmacovigilance as the monitoring of drugs for safety issues post-marketing. The key roles include investigators who conduct trials, coordinators who manage studies, sponsors who fund studies, monitors who oversee trials, and contract research organizations who assist with management. Passive surveillance involves spontaneous reporting of adverse drug reactions (ADRs) from healthcare professionals and patients, case series which are collections of ADR reports, case reports on individual patients, and stimulated reporting which encourages ADR notification. The goal of pharmacovigilance is to improve drug safety for patients.
Scientific and medical literature is an important source of information for pharmacovigilance and detecting adverse drug reactions. However, marketing authorization holders face challenges in systematically reviewing literature due to a lack of harmonization across regulatory authorities and in developing effective search strategies. Literature screening is important for evaluating drug safety and can impact decisions regarding a drug's risk-benefit analysis. It is important that literature screening is done systematically and documented properly.
PMS are the studies done after the drug is marketed to ensure the safety and efficacy of drugs. Here detailed about the need for PMS, sources of informations and methods of PMS
Pharmacovigilance is the science of detecting, assessing, understanding, and preventing adverse effects or any drug-related problems. The goals of pharmacovigilance are to improve patient safety, assess benefits and risks of medicines, and ensure their safe use. It involves collecting reports of adverse drug reactions (ADRs) from healthcare professionals and patients and analyzing the data to identify new safety issues and risk factors. Pharmacovigilance relies on spontaneous reporting systems but also uses active surveillance methods like cohort studies and registries to monitor drug safety post-marketing. It is a shared responsibility between drug regulators, healthcare professionals, and pharmaceutical companies to help prevent drug-related harm and protect public health.
PHARMACOVIGILANCE COMMON JOB INTERVIEW QUESTIONS WITH ANSWERS-Updated IN 202...Pristyn Research Solutions
Quick Job interview short guide For Pharma and all Life science jobseekers.All Medical | Biotech |Micro |B.Sc., M.Sc.
These are the commonly asked questions with their answers asked in job interviews. The file was updated in 2022.
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Sample Questions are:
What is Pharmacovigilance (PV)?
What are the objectives of PV?
What is MedDRA?
WHAT ARE THE Role of Drug Safety
Associate?
What should narratives consist of?
What are Data assessments in PV?
Which products are covered by PV?
Methods of signal detection?
Why PV is required after clinical
trial?
What is an Adverse Drug Event (ADE)?
What
is the minimum criterion required
for a valid case according to WHO?
When
do you consider an event to be
serious?
What do you mean by causality?
Types of
Unsolicited reports
Sources of Solicited Reports
Name the core regulatory bodies
What is Volume 9A
What do you know
about E2a, E2b and E2c guidelines?
When do you consider a case to be medically confirmed?
What is CemFlow?
What is the yellow card in PV?
What are Comorbid conditions?
What is a medication error?
What is a signal?
Rechallenge
Dechallenge
What are WHO ART, WHO DD and MedDRA and the difference between them?
What is SUSAR?
Adverse Drug Reaction (ADR)
Effectiveness/risk
harm
Essential medicines
Frequency of ADRs
Individual Case Safety Report
ADR Reporting process in PV
VigiFlow
VigiMed
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Pharmacovigilance is defined as, The pharmacological science and activities concerned with the detection, assessment, understanding and prevention of adverse reactions to medicines or Pharmacovigilance is the name given to the mechanisms and controls that together map and ensure the safety of a medicine throughout its life span – from test tube to patient.
Literature monitoring for pharmacovigilance – outsourcing or in house solutionJulio dos Anjos
• A brief introduction about relevance of literature screening for P V.
• Challenges of literature screening in general.
• Benefits and risks of completely outsourcing literature screening for PV.
• Business case elements that need to take into consideration when deciding on outsourcing or in-sourcing PV literature screening.
The safe use of medicines is perhaps the single most important criteria that any regulatory authority within a given country has to ensure in order both to protect the public health and the integrity of its health care system. For the same purpose pharmacovigilance was established. According to WHO, Pharmacovigilance is the science and activities related to the collection, detection, and assessment of ADR’s. It promotes the systematic, rational use and assures the confidence for the safety of drugs. It improves patient care and safety. Significance of pharmacovigilance is growing as the patients or consumers have become more responsive about the advantage and hazard of medicines. Pharmacovigilance is a complex process and a robust system is essential to undertake the activity. A good pharmacovigilance system will identify the hazard aspects in the short period of time. This review article tries to explain the some basic principles, history and developments, methods and some scope of this developing field i.e. Pharmacovigilance in India.
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve relatively small groups of patients and may miss rare or long-term adverse effects only seen in larger populations. The document outlines various methods for PMS, including spontaneous reporting, cohort studies, and case-control studies. It also discusses the benefits of PMS for improving product quality and safety monitoring, as well as manufacturers' role in establishing PMS procedures and evaluating feedback.
This document discusses post-marketing surveillance (PMS), which involves monitoring the safety of pharmaceutical drugs and medical devices after they have been approved and released on the market. PMS is important because pre-approval clinical trials involve limited numbers of patients and cannot detect all potential adverse effects. The document outlines the history of PMS, sources of PMS information, benefits of PMS systems, methods of surveillance including spontaneous reporting and cohort studies, and how manufacturers can establish PMS procedures and systems to gather feedback on their products.
This document discusses establishing pharmacovigilance centers in industry and national pharmacovigilance programs. It outlines the basic steps in setting up a pharmacovigilance center, including making contacts, designing reporting forms, educating staff, establishing a database, and promoting reporting. The document also discusses establishing pharmacovigilance programs in industry and the roles of contract research organizations and India's national pharmacovigilance program organization in monitoring drug safety.
ICH Guidelines for Pharmacovigilance.pdfNEHA GUPTA
The "ICH Guidelines for Pharmacovigilance" PDF provides a comprehensive overview of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines related to pharmacovigilance. These guidelines aim to ensure that drugs are safe and effective for patients by monitoring and assessing adverse effects, ensuring proper reporting systems, and improving risk management practices. The document is essential for professionals in the pharmaceutical industry, regulatory authorities, and healthcare providers, offering detailed procedures and standards for pharmacovigilance activities to enhance drug safety and protect public health.
The document discusses the importance of immunization safety and adverse event following immunization (AEFI) surveillance. It outlines key elements of an effective immunization safety system including rapid notification, evaluation, and response to AEFI reports. The objectives of AEFI monitoring are to identify safety issues, estimate rates of serious AEFIs, and create awareness of vaccine risks. National regulatory authorities play an important role in vaccine safety surveillance.
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 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.
These are some frequently asked questions in Pharmacovigilance Interview & its Preparation.
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FREQUENTLY ASKED QUESTIONS IN PHARMACOVIGILANCE INTERVIEWS & Its PREPARATIONSJonaid Ali
FREQUENTLY asked questions about pharmacovigilance in an interview. Pharmacovigilance is fastest growing career in these days in the healthcare sector specially for pharmacy students although some corporates allow non pharm candidates also
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Embase webinar: Building searches for drug safety and post market device surveillance 26 Nov 2014
1. Building searches for drug safety and
device postmarket surveillance
Presented by Sherry Winter
and Ian Crowlesmith
26 November 2014
s.winter.1@elsevier.com
i.crowlesmith@elsevier.com
Embase® is a registered trademark of Elsevier BV.
2. Building searches for drug safety and
device postmarket surveillance
AGENDA
1. Introduction
2. Finding adverse reactions for drugs
3. Post marketing surveillance for
medical devices
4. Drug safety and risk
5. Conclusion
Embase® is a registered trademark of Elsevier BV.
3. 3
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.
• Increasingly important in
today’s world of big data
analysis and regulation
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
4. 4
What Are Governments Doing?
Growing regulatory pressure and focus on literature monitoring in EU & US
VI.B.1.1.2. Literature reports
The scientific and medical literature is a significant source of
information for the monitoring of the safety profile and of the risk
benefit balance of medicinal products, particularly in relation to the
detection of new safety signals or emerging safety issues. Marketing
authorization holders are therefore expected to maintain awareness of
possible publications through a systematic literature review of widely
used reference databases (e.g. Medline, Excerpta Medica or Embase)
no less frequently than once a week. The marketing authorization
holder should ensure that the literature review includes the use of
reference databases that contain the largest reference of articles in
relation to the medicinal product properties
A. Good reporting Practice
Spontaneous case reports of adverse events submitted to the sponsor
and FDA, and reports from other sources, such as the medical
literature or clinical studies, may generate signals of adverse effects of
drugs. The quality of the reports is critical for appropriate evaluation
of the relationship between the product and adverse events. FDA
recommends that sponsors make a reasonable attempt to obtain
complete information for case assessment during initial contacts and
subsequent follow-up, especially for serious events, and encourages
sponsors to used train…
Marketing authorization holders are therefore
expected to maintain awareness of possible
publications through a systematic literature
review of widely used reference databases
(e.g. Medline, Excerpta Medica or Embase)
no less frequently than once a week.
The quality of the reports is critical for
appropriate evaluation of the relationship
between the product and adverse events.
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
5. 5
The Increasing Volume of Literature Is Making Adverse
Event Monitoring a More Difficult Challenge
2013
2012
2011
2010
2005
2000
1995
1990
1985
1980
1975
0 5 10 15 20 25
30
Millions
• Reliable tools for finding adverse events are needed
Embase, October 2014
• Complex search strategies need to be employed to find the most relevant articles among the
thousands that are published each year
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
6. 6
Our Framework
Elsevier provides the capabilities necessary for Pharmacovigilance and Drug
Safety groups to be more efficient, stay compliant and mitigate risk
1. Avoid missing critical
information
2. Save time with better
article pipeline
management
3. Connect literature
to broader ecosystem
4. Manage risk of
late-stage failure
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
7. EMBASE FOCUSES ON DETECTING ADVERSE
EVENTS IN THE SCIENTIFIC LITERATURE
Every year >1,000,000 biomedical articles and
300,000 conference papers are published
7
Of all adverse events reported, 14%
comes from the literature
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
8. Building searches for drug safety and
device postmarket surveillance
AGENDA
1. Introduction
2. Finding adverse reactions for drugs
3. Post marketing surveillance for
medical devices
4. Drug safety and risk
5. Conclusion
Embase® is a registered trademark of Elsevier BV.
9. FINDING ADVERSE REACTIONS FOR DRUGS
TOPICS COVERED
9
• Searching with drug subheadings
Used for: fully indexed records
• Searching with free text (keywords)
Used for: automatically indexed records
• Saving search strategies
• Setting up Email alerts
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
10. POSTMARKET SURVEILLANCE FOR MEDICAL DEVICES
SEARCH OPTIONS
10
• Searching with device subheadings
Used for: fully indexed records from 2014
• Searching with keywords and other terms
Used for: automatically indexed AND older records
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
11. Building searches for drug safety and
device postmarket surveillance
AGENDA
1. Introduction
2. Finding adverse reactions for drugs
3. Post marketing surveillance for
medical devices
4. Drug safety and risk
5. Conclusion
Embase® is a registered trademark of Elsevier BV.
12. 12
Output Analysis: Risk Mitigation
Key Challenges
• How can we better manage risk?
• Are we gathering all available
safety/AE data about a drug/
class of drugs?
• Are we leveraging best practices
from precedent preclinical/
clinical studies?
• Have all the potential and
unanticipated risks been captured?
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
13. EMBASE & PHARMAPENDIUM
IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING
13
A single drug search in Embase seamlessly links
to PharmaPendium to deliver:
• Comprehensive information that better
informs a risk management /
pharmacovigilance strategy
• Drug safety information reported
in the literature
• FDA/EMA approval and drug review
reports that provides insights into historical
regulatory precedents
• A direct link to preclinical and clinical
observations and reported adverse events
(AERs) to better monitor and anticipate
safety risks
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
14. EMBASE & PHARMAPENDIUM
IMPROVING BIOMEDICAL LITERATURE SEARCH AND RISK MONITORING
By accessing regulatory data as well as published literature, you can:
14
• Link critical post marketing findings to the drug and validate its relevance in the
context of the studies that were performed as part of the drug approval process
• Look at post marketing findings and understand how they could be relevant
across different drugs and drug classes
• Go directly to a study that was done to find ways in which study designs could be
optimized in order to reduce the chance of seeing those same events take place
with a drug that you are currently developing
• Develop risk mitigation strategies that establish inclusion and exclusion criteria
for patients who wish to participate in trials (for example by predicting the
effect of drug-drug interactions with medications they are already on)
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
15. IDENTIFY AE REPORTED IN LITERATURE
FIND AE ON ROFECOXIB IN EMBASE (SHOWN BY IAN)
15
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
16. ACCESS INFORMATION FROM REGULATORY DATA
DELVE INTO MORE DETAILS WITH THE FDA APPROVAL PACKAGE
16
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
17. FIND DRUG-DRUG INTERACTIONS
17
E.g., search for drug interactions
to find those identified with
existing drugs.
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
18. FIND ADVERSE EVENTS REPORTED IN FDA/EMA
PACKAGE
18
Search the FDA package
for mentions of reported
adverse events
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
19. ACCESS AE DATA AND AERS REPORTS
19
Access Preclinical and
Clinical data on adverse
events and Post-marketing
(AERS reports)
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
20. 20
• Post-market surveillance of drugs
• Post-market surveillance of medical devices
• For drug safety/risk mitigation during drug development
• Other
POLL – WHAT IS YOUR MAIN REASON FOR
SEARCHING FOR ADVERSE EVENTS IN EMBASE?
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
21. IN CONCLUSION…
21
Embase supports your pharmacovigilance workflow by:
Finding adverse events in the literature
Comprehensive content, deep drug, device and disease indexing and dedicated
search tools mean you will avoid missing critical information
Unique access to regulatory data
Manage the risk of late stage failure by making more informed risk
management/mitigation decisions with information reported in the literature as
well as adverse events and drug-drug interactions reported in FDA/EMA documents
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
22. 22
• Q&A will be sent to you by email and for more information and
questions please contact your regional office
• Our next Embase webinar will take place January 2015 and will focus
on Systematic Reviews.
• Please click on at Embase.com for all Embase training materials
and a webinar overview
THANK YOU
SEE YOU NEXT TIME!
Please fill out the survey that appears on your
screen after leaving the webinar.
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
23. THANK YOU
ANY QUESTIONS?
23
Sherry Winter
Product Marketing Manager
s.winter.1@elsevier.com
Ian Crowlesmith
Sr Product Manager, Content Development
i.crowlesmith@elsevier.com
Sherry Winter & Ian Crowlesmith | 26 November 2014 |
Drug safety and post-marketing surveillance for devices
Editor's Notes
Welcome to our Embase webinar, my name is Sherry Winter. I’m the Product Marketing Manager for Embase and I will be one of your speakers today. I am here with our Embase expert Ian Crowlesmith. Ian will be familiar to regular Embase webinar attendees, but for those of you who don’t know him, Ian has been with Embase for over 30 years and he is currently Senior Product Manager for Content Development, playing a key role in managing the content and coverage of Embase. Ian has carried out several roles in his time at Elsevier, including leading the team that set up the Emtree thesaurus in the late 1980s and early 90’s.
Today, Ian and I will discuss the key things to think about searching for adverse drug events and for drug safety, and Ian will also demonstrate how you can do post-market surveillance for medical devices in Embase. This webinar is aimed at users with some Embase experience, but we also offer introductory webinars regularly and will share more details on upcoming webinars at the end.
We will share the slides and recording directly after this webinar, so you can review or share with your colleagues. During the session you can send us your questions by using the chat or Ask a Question function on the webinar control panel and we will answer as many of your questions as possible during the webinar. All questions will be answered and included in a Q&A email that will be sent to you after the webinar.
If you wish to have a full screen view, please click on the red arrow. Your control panel will be hidden. Click again on the red arrow to see your control panel.
Today we’ll be discussing important considerations for your pharmacovigilance workflows and how Embase is a key resource for post-market surveillance of adverse drug or device events, and also for drug safety, or risk mitigation.
Pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem, and thorough PV strategies are key to protect patients from drugs that are unsafe or ineffective and also to comply with increasingly strict reporting requirements. Not performing adequate pharmacovigilance can result in heavy fines and can also damage the company’s reputation.
There is growing regulatory pressure and focus on literature monitoring in EU & US. Embase is mentioned as a source for biomedical literature in European Medical Association guidelines: (Marketing authorization holders are therefore expected to maintain awareness of possible publications through a systematic literature review of widely used reference databases (e.g. Medline, Excerpta Medica or Embase) no less frequently than once a week)
The FDA notes that the quality of reports generated from sources, such as the medical literature, is critical for appropriate evaluation of the relationship between the product and adverse events.
The increasing volume of literature makes finding adverse events more challenging every year.
This graph demonstrated just how many more records have been added to Embase each year from 1974. With such an increase in information, the search strategies and tools that are used to find adverse events are critical to ensure that the most relevant information is found and that nothing is missed.
More adverse events are also being reported due to our aging population that results in more chronic conditions (meaning that more people are on drugs and they are on more than one drug, which can lead to harmful drug-drug interactions).
With these challenges in mind, Elsevier has developed the capabilities necessary for Pharmacovigilance and Drug Safety groups to be more efficient, stay compliant and mitigate risk. Although these capabilities extend into case processing and output with the use of Quosa, in today’s Embase-focused webinar, we will take a closer look at Case Input – searching the literature for reported adverse events and Risk Mitigation, or managing the risk of late-stage failure during drug development by using Embase to search for information found in the literature and in the regulatory information from PharmaPendium.
Adverse events are reported in a variety of forums; the majority are reported directly to a health professional (these will then be reported to the FDA or other regulatory body and (for example) will be entered into the FDA Adverse Event Reporting System, which I’ll describe later on in the webinar).
Although only 14% of adverse events are reported in the scientific literature, it’s critical to not miss any mentions of these, and this is where Embase comes in. Every year, more than 1,000,000 non-conference records and 300,000 conference abstracts are added to Embase.
At this point, I’ll hand the presenter rights over to Ian, who will demonstrate in detail how to find adverse reactions for drugs and how you can also do post-market surveillance for medical devices using Embase. It may just take a minute or 2 while we change presenters…
Switch presentation to Ian
In addition to post-market surveillance, risk mitigation is another important aspect of pharmacovigilance, and is critical for any drug development/post-market surveillance plan.
Typical questions that you might consider when thinking about a risk mitigation strategy are:
How can we better manage risk?
Are we gathering all available safety/AE data about a drug/class of drugs?
Are we leveraging best practices from precedent preclinical/clinical studies?
Have all the potential and unanticipated risks been captured?
To answer these questions, it’s important to have all the information possible, which means accessing published biomedical literature as well as the vast amount of information that’s reported to the FDA or EMA during and after drug development.
This is where Embase and PharmaPendium work together to provide the information that allows you to develop a better risk management or pharmacovigilance strategy. A single drug search in Embase will search PharmaPendium at the same time. If there is information in PP on that particular drug, then an information panel in Embase appears with links to drug safety information reported in FDA or EMA approval documents and to preclinical and clinical adverse events.
Together, Embase and PharmaPendium provide more information and insights into historical regulatory precedents and allow you to better monitor and anticipate safety risks.
Read slide
As Ian showed you earlier, you can identify adverse events for rofecoxib that have been reported in the literature. Here I’ve done a search for any adverse events reported for rofecoxib. At the same time, PharmaPendium was automatically being searched for information on rofecoxib. You can see the results in this panel on the right-hand side of the screen that shows information including the chemical structure, brand and chemical names, and links to FDA and EMA regulatory documents.
Access regulatory data found in the medical, chemistry, statistical and clinical pharmacology /biopharmaceutics reviews sections of the FDA’s drug approval packages, and similar input from the European Medicines Agency.
In the case of Rofecoxib, PharmaPendium includes FDA approval package information. For example, a closer look at the Medical/Clinical Review section shows results of clinical trials and includes dosage, efficacy and safety information.
You can search for specific information in the approval package - for example, for any reported drug-drug interactions. This allows you to anticipate drug-drug interactions that might be observed during the development of a similar drug, and to develop risk mitigation strategies with this in mind (for example, by excluding study participants who are on drugs that might interact, or by finding alternate drugs for them to be on)
You can also search the FDA approval package for mentions of adverse events that were reported during the approval process for the drug
And you can access adverse events directly from the PharmaPendium information window in Embase. From here, you can access preclinical Adverse events (e.g., those seen in preclinical animal models), or from clinical trials or post-clinical reports (these are the Adverse Events Reporting System reports I mentioned earlier, which may be generated when an adverse event is reported directly to a healthcare professional).
An example of such a report for rofecoxib is shown here.
At this point, I’d like to ask our audience if they’d mind sharing with us their main reason for looking for adverse events in Embase?
Please select the reason that best applies to you from the poll now appearing on your screens.
Thank you for your response. According to the poll, the majority of our uses look for AEs to …..
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