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Management Forum

Pharmacovigilance In-house Training

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)"

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Format: Bespoke training
CPD: 18 hours for your records (depending on your requirements)
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

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