- Home
- Courses
- Pharmacovigilance
Pharmacovigilance
Understanding PhV today – a basic training course on the principles and practice of global PhV for those working in drug safety.
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
Day one
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
Discussion session
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
Day two
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
Discussion session
Risk-benefit assessment
- General principles
- Quantifying risk
- Taking action to optimise risk-benefit
- Monitoring the effectiveness of risk management measures
Discussion session
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
Discussion session
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
Discussion session
Day three
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
Presenters
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.
Carol Markwell
Carol Markwell is a Consultant with more than 30 years experience in pharmacovigilance. She was one of the first to gain the Postgraduate Diploma in Pharmacovigilance from the University of Hertfordshire. In industry she managed a team responsible for international case management, UK/ Eire submissions and the preparation of up to 25 PSURs annually. She then set up own pharmacovigilance consultancy providing assistance and pharmacovigilance solutions to pharmaceutical companies large and small across Europe, from a full PV service to process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management.
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
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.
William Richardson
Bill Richardson is a Medical Assessor at NDA Group. He initially qualified in medicine and trained as an anaesthetist, before moving to the Pharmaceutical Industry, working for 15 years in Medical Affairs, Clinical Development, and Pharmacovigilance. He joined the Medicines Control Agency (now MHRA) in 2002 and had responsibility for monitoring the safety of “black triangle” products; signal generation and assessment; pharmacovigilance assessment for CHM, PRAC and CHMP; assessment of licence variations; assessment of Periodic Safety Update Reports and Risk Management Plans; and assessment of advertising.
Ian Douglas
Professor Ian Douglas is an epidemiologist, currently funded by an MRC Methodology Fellowship. He initially studied physiology and completed a PhD in Manchester. Since then he has spent several years at the UK Medicines & Healthcare Products Regulatory Agency and in the pharmaceutcial industry investigating adverse effects of drugs – both in clinical trials and post-marketing. He completed the MSc in epidemiology at LSHTM in 2005. He is the course organiser for the LSHTM Certificate Course in Pharmacoepidemiology and Pharmacovigilance.
His research interests are primarily in pharmacoepidemiology, and in particular, how we can use large primary care databases to investigate the effects of drugs – both harmful and beneficial. He is exploring methodologies to minimise some of the biases inherent in the research of drug effects, and main current areas of interest are case-only approaches to study design and the use of propensity scores. He is also a member of the UK Medicines and Healthcare Products Regulatory Agency’s Pharmacovigilance Expert Advisory Group.
Shelley Gandhi
Shelley is currently using her regulatory experience to work with the pharmaceutical industry to ensure they implement the new pharmacovigilance legislation. Shelley is part of the NDA Group AB 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.
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.
Book now
| 7-9 Dec 2020 | |||
| 7-9 Dec 2020 | Rembrandt Hotel, London | GBP 1,849.00 EUR 2,589.00 USD 2,884.00 + VAT @ 20.00% |
Enrol now |
| 21-23 Jun 2021 | |||
| 21-23 Jun 2021 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
| 6-8 Dec 2021 | |||
| 6-8 Dec 2021 | Venue not yet confirmed | + VAT @ 20.00% |
Enrol now |
You may also be interested in
Previous customers include...
- Abbott Laboratories
- Apotex Saudi Arabia
- AstraZeneca
- Baxter R&D Europe
- Bells Healthcare
- Chiesi Farmaceutici SPA
- Clinigen
- Diamond Pharma Services
- Ewopharma International s.r.o.
- Glaxo Smithkline Biologicals
- Helsinn Healthcare S.A.
- Kamada Ltd
- Kyowa Kirin International plc
- LFB Biomédicaments
- M&A Pharmachem
- Meda Pharma Ltd
- Meda Pharmaceuticals Limited
- Merck Serono Ltd
- MERCK SHARP & DOHME
- Nicoventures Ltd
- NorthStar Healthcare Ltd
- OY LEIRAS FINLAND AB
- Pronova BioPharma Norge AS
- Rotapharm Ltd
- Schering-Plough
- Schering-Plough CE AG
- Speedel
- Teva UK Limited
- Thornton & Ross Ltd
- Zanza Laboratories Ltd
“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
“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
“Obviously all speakers have huge experiences within the PV processes. ”
Haiping Ma, Senior Safety Quality Professional, Novo Nordisk A/S, 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 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
“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
“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
“Amazing speakers with a wealth of knowledge and experience.”
Dalal Abdulaziz, Regulatory Manager, Al Hafez Trading Est, 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
“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
“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
“Very nice and informative course, very satisfied ”
Birgitte Wolf, Senior Safety Specialist , LEO Pharma, Dec 17
“Enjoyed the course. Although quite intense in the number of topics, it was well organized and stuck only to the important things. Would recommend and am thinking about continuing to The advanced PV one.”
Marta Telebar, PV Project Specialist, Arriello s.r.o., Dec 17