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Pharmacovigilance Training Course

Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.

6-8 Dec 2021

& 21-23 Jun 2022 , 20-22 Sep 2022 , 14-16 Dec 2022

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Details

Course overview

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 postauthorisation 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

Programme

Principles of pharmacovigilance and data resources

  • Basic principles of monitoring drug safety
  • An overview of 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
  • PASS/PAES
  • 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 development of small molecules and biologics
  • What specific and non-specific safety monitoring should be done?
  • Handling safety signals in 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

Presenter

Glyn Belcher (More...)

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.

Book now

Book now

6-8 Dec 2021
Live webinar
6-8 Dec 2021
Live webinar
GBP 1,549 1,249
EUR 2,015 1,595
USD 2,325 1,857
Until 1 Nov*
Enrol now
to attend
Live webinar
21-23 Jun 2022
Live webinar
21-23 Jun 2022
Live webinar
GBP 1,549 1,249
EUR 2,015 1,595
USD 2,325 1,857
Until 17 May 22*
Enrol now
to attend
Live webinar
20-22 Sep 2022
Face-to-face, (venue not yet confirmed)
20-22 Sep 2022
Face-to-face
(venue not yet confirmed)
GBP 1,849 1,549
EUR 2,589 2,169
USD 2,884 2,416
Until 16 Aug 22*
Enrol now
to attend
Face-to-face
(venue not yet confirmed)
  • 3 days classroom-based training
  • Meet presenters and fellow attendees in person
  • Lunch and refreshments provided
  • Download documentation and certification of completion
  • Fair transfer and cancellation policy
14-16 Dec 2022
Live webinar
14-16 Dec 2022
Live webinar
GBP 1,549 1,249
EUR 2,015 1,595
USD 2,325 1,857
Until 9 Nov 22*
Enrol now
to attend
Live webinar

Learn more about our face-to-face and webinar training formats.

* Note the early booking discount cannot be combined with any other offers or promotional code

Continuing professional development

This course qualifies for 18 hours for your CPD records.
More about CPD

Customised in-house training

We can customise this course to meet the requirements of your organisation and deliver it at your location and/or online.

Contact us

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Previous customers include...

  • Abbott Laboratories
  • Astrazeneca R&D
  • AVENTIS PHARMA
  • Biogen IDEC Ltd
  • DAIICHI PHARMACEUTICALS UK LTD
  • Daiichi Sankyo UK Ltd
  • Eli Lilly & Co Ltd
  • Emas Pharma Ltd
  • Epic Database Research Company Ltd
  • Ewopharma International s.r.o
  • F. Hoffmann La Roche
  • Fresenius Kabi Deutschland GmbH
  • Ginsana SA
  • GMClinical
  • Idis Limited
  • Janssen-Cilag Ltd
  • LFB Biotechnologies
  • NDA Regulatory Science Ltd
  • NorthStar Healthcare Ltd
  • Octapharma Pharmazeutika Produktionsges.m.b.H.
  • Pfizer Limited
  • Piramal Healthcare Ltd
  • Product Life Limited
  • Q-Med AB
  • Reckitt Benckiser
  • Regional QC Laboratory
  • Romastru Trading Srl
  • Rosemont Pharmaceuticals Limited
  • Schering-Plough CE AG
  • UCB Celltech

Very informative and great 3 days.

Paul Byrne, Deputy QPPV, Nelsons, Jun 21

I loved the course and it was amazing to be taught by people who are very experienced in the topics and be able to get their insights and hear their experiences.

Tina Tayebi, Pharmacovigilance Associate, Diamond Pharma Services, Dec 19

Obviously all speakers have huge experiences within the PV processes.

Haiping Ma, Senior Safety Quality Professional, Novo Nordisk A/S, Jun 19

The course gave overall understanding on pharmacovigilance. The presentations were clear and with helpful examples. Interaction between participants and speakers was great. All the speakers have good experiences and knowledge.

Teodora Crowe-Wijasa, Consultant Medical Safety Physician, DADA Consultancy BV, Jun 19

Workshop is very good because you have to USE the knowledge you gain. Interaction between speaker and attendees is very good too!

Anna Bøgelund Møller, Pharmacovigilance scientist, Larix, Jun 19

The course was very well organised and useful. The choice of speakers was very good and balanced. Overall, I was very happy with the course.

Karl Pauls, Medical advisor, Centre for epidemiology and health research (ZEG), Jun 19

Co-ordinators were great, material provided was concise and well presented. Time for breaks and lunches were spot on. Most of the speakers were excellent. I have 18 months experience in PV and I felt like the course was at my level. This course is not suitable for beginners.

Bhupesh Panchal, Drug Safety & Information Officer, Wockhardt UK Limited, Dec 18

My overall opinion is very positive, I am not disappointed at all. Speakers did a very good job - being approachable, giving examples, sharing his/her professional experiences, etc. Very knowledgeable speakers with relevant experience.

Vania Horta, Drug Safety & Information Officer , Wockhardt UK Limited, Dec 18

Amazing speakers with a wealth of knowledge and experience.

Dalal Abdulaziz, Regulatory Manager, Al Hafez Trading Est, Dec 18

Expert presenters with engaging and thoughtful presentations that allow plenty of time for questions and discussion. All very knowledgeable and engaging.

Sam Allen, Drug Safety Operations Medic, Mundipharma Research Ltd., Dec 18

Exactly what we need. Very good.

Gabriel Georgescu, Regulatory Affairs Manager, Ewopharma AG, Jun 18

A greatly organised and informative course given by driven and well informed speakers.

Willem van Lierop, Senior Drug Safety employee, ApotheekZorg, Jun 18

Very nice and informative course, very satisfied

Birgitte Wolf, Senior Safety Specialist , LEO Pharma, Dec 17

All the speakers are knowledgable and have good experience

Negin Goudarz, Pharmacovigilance Associate , Emas Pharma Ltd, Dec 17

The course was very useful and interesting to me personally

Darya Pospíšilová, Pharmacovigilance Project Manager, Arriello, Dec 17