This course is planned to review the continuously evolving global regulations and methods in pharmacovigilance which are primary for drug safety. It is divided into eight modules – Basic principles of pharmacovigilance, the pharmacovigilance process & good pharmacovigilance practices (GvPv), Risk Management, Data bases and management, Signal detection, Role of epidemiology & social media/literature searches, Pharmacovigilance Audits, PV of devices, New tools for better pharmacovigilance. The course additionally includes a workshop on Vaccine vigilance & a session on case histories followed by Q&A session. The seminar will serve as a medium of disseminating concise concepts and knowledge to all professionals working in the fields of Clinical research, drug safety, pharmacovigilance, regulatory affairs and Medical reviewers who deal with PV on a daily basis to update their knowledge and practice PV in a global environment with the aim of minimizing risk to the patient – the ultimate goal! The course is intended to add value to practice the science based on firm principles with unique examples between drugs, vaccines and devices to enable better PV compliance for the regulators. The case studies will be demonstrative of successful PV outcomes and reinforce the intricate steps in establishing a relationship between an adverse event and its occurrence in real time settings.
As pharmacovigilance is an evolving and dynamic process an overview of the current concepts and impact of revised legislation or regulations in the EU and USFDA- and their redressals will be an important take away for participating scientists. The vaccine pharmacovigilance will address the needs unique to vaccines which remain the most important preventive intervention for disease prevention in the most sensitive and vital age group of children, more so in the golden era of vaccination with newer vaccines, newer schedules and effectiveness, as also emergence of rare adverse events with increased usage. The pivotal role of the Uppsala Monitoring Centre (WHO) and amendments strengthening PSUR as a tool require enhanced training and knowledge to effectively comply with regulations and better exchange of electronic data and AE Management. In the Era of new drugs explosion – strengthening pharmacovigilance knowledge and its implementation is the need of the hour and this course will be a positive step in that direction.
Learning Objectives:
- Basics of pharmacovigilance - Definitions, scope, regulations, New Eudravigilance and its impact, Four elements, AE, ADR, SAE, SUSAR, Seriousness, Expectedness, Listedness, SPC, CCDS, CCSI, Causality assessment, CIOMS, ICH, classification, Dictionaries, Coding.
- Pharmacovigilance process - Collection of data, assessment & Evaluation, reporting and communication, ICSR, Medical assessment, causality assessment, PSUR, aggregate reporting, expedited reporting, EU Vs USFDA. Spontaneous AE, reporting AEs in clinical trials & post marketing studies.
- Good Pharmacovigilance practices - An overview of current GvPv Practices in EMA and USA.
- Signal detection - Definition, Sources, generation, increased frequency ( cluster),signal work up, review, computerized tools, investigation & interpretation, FDA Guidance, EU 9A on signal detection. Good reporting practices.
- Risk management - Definition, The need for RM, when is it required, risk evaluation and minimization systems, EU REMS and its components, USFDA guidance, safety, clinical &PV Plan.
- Databases and their management - Access to data, Uppsala monitoring Centre, Vigibase, WHO, FDA AERS, Eudravigilance, Motherisk, MHRA, Registries and databases. Data privacy, Agreements for data exchange. Database support and migration E2BR3. Drug analysis prints, yellow card reporting system, black box. Commonly used databases.
- Epidemiology, Social media and literature searches - Epidemiological studies, observational & case control studies, retrospective & prospective studies, how to deal with AE reports in social media, literature sources of AEs and their rational use.
- Pharmacovigilance audit - Scope, rules, Common findings, CAPA, how to prepare for an inspection.
- Case studies – One each for drugs, devices and vaccines.
- Device regulations (optional)
- Pharmacovigilance and GCP regulations
- Outsourcing PV ( optional)
- Comparison of USFDA & EMA regulations for pharmaceutical risk management
- Vaccine Vigilance Workshop - this workshop will describe how AE Detection differs between drugs and vaccines, commonly expected reactions, SAEs, methods for detecting SAEs, size of vaccine studies, VAERS, AEFI (WHO), Brighton collaboration group, Vaccine safety datalink, Global Commission on Vaccine safety, how to investigate Vaccine reactions. Real time examples with detailed workup. Q&A.
Who will Benefit:
The professionals involved in clinical research, pharmacovigilance, medical reviewers, data managers, drug safety managers, regulatory affairs personnel, nurse, junior doctors planning to work in PV. Pharmaceutical & Vaccines (biologicals) industry.
Pharmacy and dental students wanting to work in the pharma industry should also attend this course.
- Clinical research: Associate directors, Managers, Nurses, Dentists, data entry personnel.
- Pharmacovigilance: Leads, Associate directors, research workers, triage personnel, doctors, dentists interested in PV Careers.
- Regulatory affairs: Vaccine & pharma directors lead, Associate directors, research workers.
- Pharmacologists: Directors, Associate Directors, Managers, Assistant Managers, involved in trials and/or PV.
- Vaccine industry: Directors, Assistant directors, Senior Managers, Managers, Export staff.
- Consultants: involved in drug safety, pharmacovigilance, devices, and drugs.
- New entrants: with science background intending to work in the pharmaceutical & biologicals industry
- 8:30 AM - 8:59 AM: Registration and Meet & Greet.
- 9:00 AM - 10:00 AM: Lecture 1
- Seminar objectives review, expectations and scope.
- BASICS OF PHARMACOVIGILANCE.
- Definitions
- Scope
- Regulations
- Four elements
- Types of Adverse reactions (ADR, AE, SAE, SUSAR) & seriousness.
- Expectedness, listedness, causality assessment.
- SPC, CCDS, CCSI, CIOMS1, PSUR.
- 10:00 AM - 11:00 AM: Lecture 2: PHARMACOVIGILANCE PROCESS
- Collection of data
- Assessment and evaluation.
- Reporting and communication.
- Individual case safety report
- Medical assessment
- Causality assessment
- Collection of data
- Aggregate reporting
- Expedited reporting
- Spontaneous adverse events.
- Reporting clinical trial AEs.
- Reporting post marketing AEs.
- Comparison & discussion of the EU & USFDA guidelines and their impact.
- Pivotal role of Uppasala Drug monitoring Centre (UMC) Sweden.
- Impact of PSUR enhanced in better detection of AEs.
- Definition
- Need for risk management
- REMS (Risk Evaluation & minimization systems)
- USFDA guidance
- EU REMS
- Safety plans
- Clinical plans.
- Pharmacovigilance plan.
- PSUR enhanced and its impact.
- Definition, sources, generation.
- Increased frequency (cluster?)
- Signal work up and review.
- Investigation and interpretation.
- USFDA guidance
- European Union 9A regulations.
- Good reporting practices.
- Role of pharmacoepidemiology in PV.
- Observational studies.
- Case Control studies.
- Randomized controlled double blind studies.
- Data mining.
- SOCIAL MEDIA REPORTS
- How to deal with social media reports?
- How to conduct meaningful literature searches.
- 8:30 AM - 8:59 AM: Registration and Meet & Greet.
- 9:00 AM -10:00 AM: Lecture 7: DATABASES AND THEIR MANAGEMENT
- Access to data.
- Uppsala Monitoring Centre Sweden (WHO)
- Vigibase
- Eudravigilance, implications for the future.
- FDA AERs.
- WHO AEFIs.
- Mediwatch.
- VAERS.
- Motherisk.
- MHRA
- 10:00 AM - 11:00 AM: Lecture 8: Registries and databases.
- Agreements for data exchange.
- Database support and migration. (E2RB3)
- Yellow card reporting system.
- Data analysis prints. DAP.
- Black box.
- Commonly used databases and future.
- 11:00 AM - 12:00 Noon: Lecture 9: PHARMACOVIGILANCE AUDIT
- Scope
- Rules
- Common findings
- CAPA
- How to prepare for a PV audit.
- PHARMACOVIGILANCE & GCP regulations
- COMPARISON OF EU/USFDA risk management.
- 12:00 Noon - 1:00 Lunch
- 1:00 PM - 2:00 PM: Lecture 10: WORKSHOP ON VACCINE VIGILANCE
- How vaccines differ from drugs in Pharmacovigilance.
- Commonly expected reactions to bacterial/ viral vaccines.
- SAE management in vaccines with examples.
- Causality assessment when multiple vaccines are given.
- Methods for detecting SAEs to vaccines.
- Sample size of immunogenicity and safety studies in clinical trials.
- Sample sizes of Post marketing studies and their significance.
- VAERS
- Vaccine safety datalink.
- Global Commission on Vaccine safety
- How to investigate Vaccine SAE?
- Case study on vaccine adverse event.
- 2:00 PM - 3:00 PM:
- Workshop continued/ Case study.
- 3:00 PM - 4:00 PM:
- Case studies on devices.
- Case study on drugs.
- Outsourcing PV.
- Device regulations, salient features.
- 4:00 PM - 4:30 PM
- Questions and answers.
- Conclusion/ certification.
Subodh Bhardwaj
Consultant
Dr Subodh Bhardwaj is a Physician and Clinical Pharmacologist with 30 years of experience leading research, development and pharmaco-vigilance across varied therapeutic areas with Sanofi group, Serum Institute of India, Arable Corporation USA & Surgipharm Uganda. He is MBBS from Medical College Jammu India (1981) and following 7 years in Internal Medicine, he was awarded- MD Pharmacology from the prestigious AMU, India (1990). His initial work included pioneer studies of epidemiological profile of adverse drug reactions in India in 1988 with the ICMR, where he also researched trace elements, hypertension and Diabetes mellitus. He joined the industry in 1993 and then diversified across pharmacovigilance of r-DNA infertility drugs, Growth hormone/ Somatostatin Viral and Bacterial vaccines, Mabs for Rabies & ONCO-BCG for superficial bladder cancer, Meningococcal & pandemic, seasonal influenza vaccines. Leading pharmacovigilance in association with WHO Biologicals he assisted teams to investigate SAEs, SUSARS, and spontaneous AEs globally.
As Director Scientific affairs, Regulatory affairs & Public policy with Sanofi Pasteur he headed the PV operations in India for all licensed products and AEs during clinical trials on INDs, post marketing AEs for all products according to EU/ USFDA regulations reporting to GPVD, Lyon ensuring high standard of compliance & product life cycle management. Well versed with pharmacovigilance principles & practices including Audit- he chaired the Pharmaco-vigilance & clinical trials 4th International conference in London in 2015 -conducting a workshop on Vaccine vigilance. He has planned and conducted more than 50 multicentric, multi-country ICH-GCP Compliant clinical trials including a large sample size post marketing phase IV study (MMR) on 500,000 Egyptian children. He has 60 publications in peer reviewed National and International journals and recently authored a chapter in Pharmaceutical Medicine & Translational Clinical Research published by Elsevier in 2018. He is Member BRAPP, ESOP, Phd guide, and currently works as an Independent Global Biopharmaceutical consultant in New York with acclaimed agencies sharing his knowledge on topics of clinical research and pharmaco-vigilance.
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