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Upcoming Pharmacovigilance Training Course - December 6-8, 2021: Interactive Introductory Guide

·7-min read

Dublin, Nov. 08, 2021 (GLOBE NEWSWIRE) -- The "Pharmacovigilance Training Course" conference has been added to's offering.

This comprehensive three-day course has been designed to provide an introductory guide for all those concerned with pharmacovigilance. The interactive programme will cover topics from basic pharmacovigilance principles and terminologies through to the current regulatory framework and its global impact, including drug surveillance in the EU, US and Japan. Proactive pharmacovigilance pre- and post-marketing will be addressed as will risk management, the challenges of causality assessments, and effective signal detection.

Our panel of experts will offer practical guidance throughout the course and use real-world examples and case studies to contribute to the development of your knowledge. There will also be ample opportunity to share experiences with the speakers and fellow professionals, which will further enhance your understanding of pharmacovigilance issues.

Key topics to be addressed include:

  • Principles of pharmacovigilance and data resources

  • Risk management, causality assessment and post authorisation safety and efficacy studies (PASS/PAES)

  • Pharmacoepidemiological studies and evolution of periodic safety update reports (PSURs), periodic benefit-risk evaluation reports (PBRERs) and development safety update reports (DSURs)

  • Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment

  • Pharmacovigilance regulations, clinical trial ADR reporting requirements n Drug surveillance in countries outside Europe

  • Drug surveillance in countries outside Europe

  • Post-marketing surveillance: observational cohort studies

  • An overview of signal detection and risk management plans (RMPs)

Who Should Attend:

Anybody involved and interested in the daily practice of pharmacovigilance, including pharmaceutical physicians and those working in:

  • Drug safety

  • Adverse reaction monitoring

  • R&D

  • Regulatory affairs

  • Registration

Key Topics Covered:

Principles of pharmacovigilance and data resources

  • Basic principles of monitoring drug safety

  • An overview of the methodology

  • Data resources available for monitoring and evaluating drug safety

  • Responding to drug safety signals

Risk management and risk minimisation: basic principles

  • Basic principles

  • Proactive strategies

  • Principles of risk minimisation

  • PASS and PAES

Causality assessment: clinical diagnosis of adverse events

  • The principles of causality assessment with practical examples

  • Medical evaluation of individual reports of adverse events

  • Strategies for follow-up

The current regulatory framework and its global impact

  • Overview of European regulatory framework, including 2012 EU pharmacovigilance legislation

  • Implications for the global environment - the links to ICH and CIOMS recommendations

  • Inspections and penalties for non-compliance

  • Practical applications of definitions

European post-marketing pharmacovigilance regulations

  • The role of the Pharmacovigilance Risk Assessment Committee (PRAC) and SCOPE initiative

  • Quality management systems and the pharmacovigilance system master file (PSMF)

  • QPPV

  • Expedited reporting: solicited vs spontaneous

  • Periodic reports and signal management and use of EudraVigilance

  • RMPs and risk minimisation


  • Additional monitoring

  • Pharmacovigilance inspections/audit

  • Public hearings including first EMA hearing - September 2017

  • Stakeholder involvement initiatives such as PROTECT, WEB-RADR

  • New electronic reporting standards, E2B (R3), IDMP

Proactive pharmacovigilance pre- and post-marketing

  • Anticipating drug safety issues in the development of small molecules and biologics

  • What specific and non-specific safety monitoring should be done?

  • Handling safety signals in the development

  • Differences between pre-marketing studies and post-marketing experience

Risk-benefit assessment

  • General principles

  • Quantifying risk

  • Taking action to optimise risk-benefit

  • Monitoring the effectiveness of risk management measures

Clinical trial ADR reporting requirements

  • ICH E2A and general requirements

  • Expedited reports

  • EU Clinical Trials Directive, Clinical Trial Regulation and detailed guidance

  • US IND requirements

  • DSURs

Pharmacoepidemiological studies - basic designs, strengths, weaknesses and examples

  • Real-world data is the king

  • Randomisation in the real world

  • Drugs and devices - it's all 'exposure'

  • Tracking all patients?

Periodic reporting - PSURs and PBRERs

  • Evolution of the PSUR, PBRER and DSUR

  • What do we submit and when to submit it

  • Practical aspects of compiling PSURs and PBRERs

  • Linking DSURs, RMPs, PSURs, PBRERs and core safety information

Drug surveillance in countries outside Europe

  • US culture

  • NDA and IND safety reporting

  • Inspections

  • Japan culture

  • Post-marketing safety surveillance programmes in Japan

  • Pharmacovigilance in other countries

Practicalities of signal detection

  • Definitions of signals

  • Regulatory guidances on signal detection by industry and regulators

  • Resources for signal detection

  • Quantitative vs qualitative signal detection

Examples of pharmacoepidemiological studies used in risk management

  • How we weigh evidence

  • Observational cohort studies

  • Case control studies

  • Drug registries (anti-TNFs)

  • Pregnancy registries

Practicalities of risk management

  • A real-world example of the development of a successful EU RMP

  • Requirements of RMPs from an industry point of view

  • How to write a successful RMP

  • Reporting results of outcomes of activities in the RMP

  • Updating a RMP

Practical pharmacovigilance workshop

  • A practical case study with valuable hands-on experience

  • Handling an important safety alert from regulators

  • Assessment of risk

  • Determining measures to respond to previously unidentified risks

  • Continuing assessment and communication of risk-benefit


Glyn Belcher

Dr Glyn Belcher has over 25 years experience in clinical development and drug safety in the pharmaceutical industry. He qualified in medicine from Oxford and Cambridge and received his PhD in neuropharmacology from the latter university. After a number of years in hospital medicine he joined Schering and worked in clinical research in the UK affiliate before moving to headquarters in Berlin, first as head of cardiovascular clinical research and later as head of a new safety department covering clinical development activities. He then became Director of Clinical Drug Safety and EU QPPV for Takeda Europe and a global safety officer of Takeda headquarters in Osaka. His most recent position in the industry was Vice President of Drug Safety and Risk Management for all ex-USA territories of Biogen Idec and EU QPPV for the company. He now has his own consultancy company, PV Consultancy Ltd, and works with a number of companies in the areas of clinical development and drug safety, as well as undertaking an increasing commitment to teaching and training in these areas.

Shelley Gandhi

Shelley Gandhi joined NDA Group AB in 2012 and previously was with the MHRA (UK Regulatory Authority) for 19 years. She has extensive knowledge of all European regulatory processes relating to monitoring the safety of licensed medicinal products and ancillary devices and has investigated possible risks and has taken appropriate actions to minimise risk to public health through both European and National Committees.
She was Vigilance and Intelligence Research Group Unit Manager where she led a team of 30 whose primary role is to carry out risk assessment. In her final year at the MHRA, she mainly focussed on delivering the new pharmacovigilance legislation in Europe and ensuring the MHRA would be ready.
She is currently using this regulatory experience to work with industry to ensure they implement the new pharmacovigilance legislation.

Seema Jaitly

Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in hospital medicine for four years. She has worked in the pharma industry for over 18 years at CROs and companies spanning clinical research, medical affairs, pharmacovigilance and the EU QPPV role. In 2010 she founded Essjay Solutions to offer pharmacovigilance services, consultancy and contracting services.
She is currently studying for an MSc in epidemiology with the London School of Hygiene and Tropical Medicine.

John Parkinson

John Parkinson is a Data and Pharmaco-epidemiology Consultant. He previously worked as Director of the Clinical Practice Research Datalink (CPRD) at the MHRA, which developed out of the General Practice Research Database (GPRD) and NIHR Research Capability Programme. He has been instrumental in enabling record linkage of NHS data and of its wide use in the many aspects of pharmacoepidemiology as well as providing input to the pharmaceutical industry on studies and types of studies that companies may find helpful in their quest to make available effective and safe medicines

Saad Shakir

Saad Shakir is Director of the Drug Safety Research Unit. After qualifying and working in Medicine he has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then within the Pharmaceutical Industry. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial boards of the journals of Pharmacoepidemiology and Drug Safety.

For more information about this conference visit

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