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

24-26 Jun 2019

& 2-4 Dec 2019

GBP 1,849
EUR 2,589
USD 2,884

Book now

Course overview

This course aims to provide basic training for those concerned with pharmacovigilance. New entrants as well as experienced operators in drug safety monitoring will benefit from the mixture of scientific knowledge and practical guidance. In addition, detailed information will be provided on regulatory developments in pharmacovigilance in Europe, the USA and Japan.

Key topics to be addressed include:

  • Principles of pharmacovigilance and data resources
  • Risk management, causality assessment and PASS/PAES studies
  • Pharmacoepidemiological studies and evolution of PSURs, PBRERs and DSURs
  • Proactive pharmacovigilance pre- and post-marketing, risk-benefit assessment
  • Pharmacovigilance regulations, clinical trial ADR reporting requirements n Drug surveillance in countries outside Europe
  • Post-marketing surveillance: observational cohort studies
  • An overview of signal detection and risk management plans

Who should attend?

All those 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 studies

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

Overview of requirements which will include:

  • The role of pharmacovigilance risk assessment committee 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
  • Risk management plans and risk minimisation
  • Post-authorisation safety and efficacy studies (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 and detailed guidance (CT-3)
  • US IND requirements
  • Development safety update reports (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 risk management plan

- Requirements of risk management plans from an industry point of view
- How to write a successful risk management plan
- Reporting results of outcomes of activities in the risk management plan
- Updating a risk management plan

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


Saad Shakir (24-26 Jun 2019)

Saad Shakir is Director of the Drug Safety Research Unit, Southampton, UK. He qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then at the international pharmaceutical industry. He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. He is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time. 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. He has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Carol Markwell (24-26 Jun 2019)

Carol Markwell is Principal Consultant at Director Drug Safety Solutions Ltd a consultancy providing assistance and Pharmacovigilance solutions to Pharmaceutical companies large and small across Europe: process review and optimisation; specification, implementation and validation of global safety databases; pharmacovigilance training, and interim management. She has worked in Pharmacovigilance since 1988, being 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.

John Parkinson (24-26 Jun 2019)

John Parkinson is a Data and Pharmaco-epidemiology Consultant having recently retired as the Director of the Clinical Practice Research Datalink (CPRD) at the MHRA. CPRD is the English NHS data and interventional research service. CPRD developed out of the GPRD and the NIHR Research Capability Programme. The CPRD provides data and research services around Drug safety/outcomes and risk-benefit. He joined the Medicines & Healthcare Products Regulatory Agency (MHRA) in September 2005 to run the GPRD (General Practice Research Database). He gained his PhD in Medical Biochemistry in 1972 and joined the Pharmaceutical Industry that year. From 1972 to 1996 he has worked in the Industry or as a Consultant and from 1989 in conjunction with the University of Dundee. In 1996 he moved from working on Medical Education Projects to work at MEMO, a Pharmacoepidemiology Research group, at the University. 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. John is a Fellow of the Royal Society of Medicine as well as a Livery member of the Worshipful Society of Apothecaries of London

John Talbot (24-26 Jun 2019)

Dr John Talbot BPharm, MSc,PhD is Senior Lecturer, Pharmacovigilance within the School of Life Sciences at the University of Hertfordshire. Until mid-2011 he was Director Patient Safety, Processes & Standards based at AstraZeneca R&D Charnwood in Loughborough UK. He had been with AstraZeneca (and formerly Astra) since 1996 initially leading the Drug Safety function at one of its R&D sites and later having a global role encompassing Patient Safety processes and standards across the organisation. Before joining Astra, John was Head of the Spontaneous Reports Group, International Product Safety and Pharmacovigilance at GlaxoWellcome having worked with both investigational and marketed products over the past 15 years at Glaxo. Before joining the pharmaceutical industry, he was a hospital pharmacist at a number of UK teaching hospitals and held a joint appointment at the Department of Therapeutics in the University of Birmingham Medical School and the Queen Elizabeth Hospital where he did his PhD on adverse drug reaction monitoring.
He has written papers and book chapters on various aspects of drug safety. He is co-editor with Jeff Aronson of Stephens’ Detection and Evaluation of Adverse Drug Reactions 6th edition published by Wiley Blackwell in early 2012. Over the past 25 years, he has made many presentations at universities and international symposia on several drug safety topics and helped create the postgraduate course in Pharmacovigilance at the University of Hertfordshire.

Glyn Belcher (24-26 Jun 2019)

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 (24-26 Jun 2019)

Bill Richardson qualified in medicine in 1980, and subsequently trained as an anaesthetist. He took up his first post in the pharmaceutical industry as a Medical Adviser in 1987. The next 15 years were spent in the industry 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. He left the MHRA in 2014 to become a pharmacovigilance consultant for NDA Group.

Ian Douglas (24-26 Jun 2019)

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 (24-26 Jun 2019)

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.

Book now

24-26 Jun 2019
24-26 Jun 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now
2-4 Dec 2019
2-4 Dec 2019 Rembrandt Hotel, London GBP 1,849.00
EUR 2,589.00
USD 2,884.00
+ VAT @ 20.00%
Enrol now

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Previous customers include...

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  • Astrazeneca R&D
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  • Bayer Pharma AG
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  • Sanofi Pasteur MSD
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A greatly organised and informative course given by driven and well informed speakers.

Willem van Lierop, Senior Drug Safety employee, ApotheekZorg

Exactly what we need. Very good.

Gabriel Georgescu, Regulatory Affairs Manager, Ewopharma AG

Very nice and informative course, very satisfied

Birgitte Wolf, Senior Safety Specialist , LEO Pharma

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.

The course was very useful and interesting to me personally

Darya Pospíšilová, Pharmacovigilance Project Manager, Arriello

All the speakers are knowledgable and have good experience

Negin Goudarz, Pharmacovigilance Associate , Emas Pharma Ltd

Found the content delivered from the speakers very good.

Priya Cutts, Report Specialist, Procter and Gamble Technical Centres Ltd

The course was well structured and covered all important aspects of PV. Everything was presented in clear presentations with helpful examples. Interactions between participants and speakers was easy and helpful.

Birte Hofmann, Director Pharmacokinetics Expert, Bayer AG

I was happy about the location, the presenters and the organizers for this course

Abdullah Al Dawood, QPPV and Regulatory Affairs Supervisor , Apotex Saudi Arabia

I think the course and its content were very well run and I would be happy to attend another course by Management Forum

Lee Rolfe, , Actavis plc

I feel this course gives a good amount of information and is presented well. The speakers are very knowledgeable

Lee Rolfe, , Actavis plc

High level training with great speakers, very good welcome and accommodation

Camille Soulet, Vigilances Training Officer, Pierre Fabre

Well organised and the speakers were very knowledgeable

Claire McLaughlin, Drug Safety Specialist, Kyowa Kirin International

Overall I found the course to be very informative. Not only did I learn new information, but it helped me realise how much information I have picked up through my short time working in the industry and it reinforced this knowledge. I liked that there were a number of different speakers from different backgrounds who effectively cover different aspects of the topic in depth.

Sarah Bruce, Pharmacovigilance Officer, Kyowa Kirin

Very passionate speakers

Sabrina Montante, Safety Scientist, GlaxoSmithKline

It was very good, I had a great time

Camille Soulet, Vigilances Training Officer, Pierre Fabre

Excellent. Very good speakers and interactions.

Susanne Mathias, Senior GCP Advisor Specialist, Novo Nordisk A/S

It was a comprehensive, professional course, well organized and beneficial

Liron Weisman, Pharmacovigilance Compliance Associate, Teva Pharmaceuticals Industries Ltd

Very nice course which provides good instruction into PV and overall picture of PV requirements/obligations

Oresta Makaruha Stegic, FDF RA manager, xellia

Informative and well-organised but quite heavy going in parts

Gemma Anthony, PV & Regulatory Administrator, Meda Pharma Ltd