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Management Forum

Pharmacovigilance Training Course

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

★★★★★ "All of the speakers were absolutely great, the talks were very interesting, informative and on a hig... more (37)"

5-7 February 2025
+ 11-13 June 2025, 15-17 October 2025 »
from £1349

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Format: Live online
CPD: 18 hours for your records
Certificate of completion

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Course overview

This comprehensive three-day pharmacovigilance training course has been designed to provide an introductory guide for all those concerned with vigilance industry. 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 training 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)

This course is part of our Vigilance training course collection; for information on the basics of PhV, consider taking a look at our beginner-friendly Pharmacovigilance training course.

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

Enrol or reserve

This course will cover:

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

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?

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

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

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

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Shelley Gandhi
NDA Regulatory Science Ltd

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.

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Saad Shakir
Drug Safety Research Unit

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit in Southampton. The DSRU is an academic unit associated with the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards. Saad serves as a Chairman or member of Safety Advisory Boards and Data Safety Management Committees. He is an author of many book chapters and publications in scientific journals on pharmacovigilance, pharmacoepidemiology and risk management and is a member of the editorial boards for the journals Drug Safety and Pharmacoepidemiology and Drug Safety. Saad Shakir has led and co-ordinated many post graduate educational and training programmes including the MSc programme in Pharmacovigilance at the DSRU. He supervises post graduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London; a Fellow of the Faculty of Pharmaceutical Medicine; a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK.

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Seema Jaitly
Essjay Solutions Ltd

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.

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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

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NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:

30% off the 2nd delegate*
40% off the 3rd delegate*
50% off the 4th delegate*

Please contact us for pricing if you are interested in booking 5 or more delegates

5-7 February 2025

Live online

09:30-17:00 UK (London) (UTC+00)
10:30-18:00 Paris (UTC+01)
04:30-12:00 New York (UTC-05)
Timings may be different for each day
Course code 14469

GBP 1,349 1,649
EUR 1,939 2,359
USD 2,201 2,669

Until 01 Jan

3 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

11-13 June 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 14745

GBP 1,349 1,649
EUR 1,939 2,359
USD 2,201 2,669

Until 07 May

3 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

15-17 October 2025

Live online

09:00-17:00 UK (London) (UTC+01)
10:00-18:00 Paris (UTC+02)
04:00-12:00 New York (UTC-04)
Course code 14992

GBP 1,349 1,649
EUR 1,939 2,359
USD 2,201 2,669

Until 10 Sep

3 days live online training
Browser-based, no download usually required
See presenters and interact with fellow attendees
Download documentation and certification of completion
Fair transfer and cancellation policy

View basket

Not ready to book yet?

for 7 days, no obligation

* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price; and apply only when booking multiple delegates on the same date.

Reviews of IPI's Pharmacovigilance training course

All of the speakers were absolutely great, the talks were very interesting, informative and on a high level.

Jan 31 2024

Yulia Buberman Israel
PVG , Kamada LTD

Jan 31 2024

Excellent speakers and very experienced.

Joanna Jakubowicz Ireland
Deputy QPPV, Ovelle

Dec 14 2022

I was hoping to gain better knowledge and better understanding of how PV works, and by attending this course I believe I have achieve that.

Christian Boateng United Kingdom
PV Scientist, Norgine Ltd

Dec 14 2022

Content: very good. Presentation: Good Speakers: very good

Beatriz Blanco-Rodriguez Germany
Global Regulatory Affairs & Pharmacovigilance , Life Molecular Imaging

Dec 14 2022

Good

Laetitia Boldini France
Specialist Regulatory Affairs Junior, Lallemand

Dec 6 2021

I hoped to get an overview on all aspects of PV - my expectations were totally met

Bettina Bannert Switzerland
Doctor, Universitätsspital Basel/ Department Klinische Forschung

Dec 6 2021

It was a very good webinar - I would use management forum again for other training.

Ellie Sutcliffe United Kingdom
PV Administrator/Associate, Rosemont Pharmaceuticals

Jun 21 2021

Very informative and great 3 days.

Paul Byrne United Kingdom
Deputy QPPV, Nelsons

Dec 2 2019

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 United Kingdom
Pharmacovigilance Associate, Diamond Pharma Services

Jun 24 2019

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 Germany
Medical advisor, Centre for epidemiology and health research (ZEG)

Jun 24 2019

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 Denmark
Pharmacovigilance scientist, Larix

Jun 24 2019

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 Netherlands
Consultant Medical Safety Physician, DADA Consultancy BV

Jun 24 2019

Obviously all speakers have huge experiences within the PV processes.

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

Dec 3 2018

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

Sam Allen United Kingdom
Drug Safety Operations Medic, Mundipharma Research Ltd.

Dec 3 2018

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 United Kingdom
Drug Safety & Information Officer , Wockhardt UK Limited

Dec 3 2018

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 United Kingdom
Drug Safety & Information Officer, Wockhardt UK Limited

Dec 3 2018

Amazing speakers with a wealth of knowledge and experience.

Dalal Abdulaziz Kuwait
Regulatory Manager, Al Hafez Trading Est

Jun 19 2018

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

Willem van Lierop Netherlands
Drug Safety Manager, ApotheekZorg

Jun 19 2018

Exactly what we need. Very good.

Gabriel Georgescu Romania
Regulatory Affairs Manager, Ewopharma AG

Dec 4 2017

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 Czech Republic
PV Project Specialist, Arriello s.r.o.

Dec 4 2017

The course was very useful and interesting to me personally

Darya Pospíšilová Czech Republic
Pharmacovigilance Project Manager, Arriello

Jun 20 2017

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

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

Jun 20 2017

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 Germany
Director Pharmacokinetics Expert, Bayer AG

Dec 4 2017

All the speakers are knowledgable and have good experience

Negin Goudarz United Kingdom
Pharmacovigilance Associate , Emas Pharma Ltd

Dec 4 2017

Very nice and informative course, very satisfied

Birgitte Wolf Denmark
Senior Safety Specialist , LEO Pharma

Jun 20 2017

Found the content delivered from the speakers very good.

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

Dec 6 2016

Well organised and the speakers were very knowledgeable

Claire McLaughlin United Kingdom
Drug Safety Specialist, Kyowa Kirin International

Dec 6 2016

Excellent. Very good speakers and interactions.

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

Dec 6 2016

Very passionate speakers

Sabrina Montante Belgium
Safety Scientist, GlaxoSmithKline

Dec 6 2016

It was very good, I had a great time

Camille Soulet France
Vigilances Training Officer, Pierre Fabre

Jun 20 2016

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

Liron Weisman Israel
Pharmacovigilance Compliance Associate, Teva Pharmaceuticals Industries Ltd

Jun 20 2016

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

Oresta Makaruha Stegic Croatia
FDF RA manager, xellia

Dec 6 2016

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

Camille Soulet France
Vigilances Training Officer, Pierre Fabre

Dec 6 2016

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

Lee Rolfe United Kingdom
Actavis plc

Dec 6 2016

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 United Kingdom
Pharmacovigilance Officer, Kyowa Kirin

Dec 6 2016

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 United Kingdom
Actavis plc

Jun 20 2016

Informative and well-organised but quite heavy going in parts

Gemma Anthony United Kingdom
PV & Regulatory Administrator, Meda Pharma Ltd

United Kingdom