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Advanced Pharmacovigilance Training Course

This course will be of maximum benefit to those drug safety professionals who are working both in the clinical and post-marketing safety arena including QA for auditing.

22-24 Sep 2021

& 29 Sep-1 Oct 2021

Book now


Course overview

Pharmacovigilance has undergone rapid regulatory change in recent years, which has resulted in a complex range of safety and risk assessment activities to perform. This three-day course is designed for those with at least two years’ knowledge in drug safety and will provide a comprehensive, yet practical assessment of the main regulations required to produce a compliant reporting company.

Key topics to be addressed:

  • Audits and expectations – risk-based inspections
  • Compliance and drug safety
  • Overview of the PSMF in the EU
  • Product safety reviews – purpose and function (incorporating the latest EU signal analysis requirements)
  • Safety reporting in licensing agreements
  • Developing company core safety information (CCSI) – CIOMS III
  • PSURs – timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
  • Implications for safety reporting in global clinical trials
  • Risk-benefit determinations
  • Risk management plans (RMPs)

By attending this event, you will:

  • Expand your global safety knowledge
  • Enhance your team’s capabilities and compliance in both the regulations and your company’s expectations
  • Help ensure you build and maintain a quality pharmacovigilance department ready for any pharmacovigilance inspection
  • Participate in group workshop sessions and discuss how to apply the legislation to ensure compliance, especially to satisfy regulatory inspections

Who should attend?

This course would be of maximum benefit to those safety professionals who are working both in the clinical and post–marketing safety arena including QA for auditing. The course covers very diverse activities within the safety department and would be advantageous to those who have either multifunction responsibilities or medical directors who manage teams in the various disciplines.

Book now

Book now

22-24 Sep 2021
Live webinar
22-24 Sep 2021
Live webinar
GBP 1,549 1,249
EUR 2,229 1,809
USD 2,524 2,056
Until 11 Aug*
Enrol now
to attend
Live webinar
29 Sep-1 Oct 2021
Face-to-face, (venue not yet confirmed)
29 Sep-1 Oct 2021
(venue not yet confirmed)
GBP 1,849 1,549
EUR 2,589 2,169
USD 2,884 2,416
Until 18 Aug*
Enrol now
to attend
(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

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...

  • Alfa Wassermann S.p.A.
  • Abbott Laboratories GmbH
  • Actelion Pharmaceutical Ltd
  • Alfa Wassermann S.p.A.
  • Amgros
  • Bausch & Lomb Inc
  • Bayer Turk Kimya San. Ltd. Sti
  • Celgene
  • CSL Behring AG
  • Eisai Europe Ltd
  • Eisai Limited
  • Ethypharm
  • Ewopharma International s.r.o.
  • Ferrer Internacional
  • Genzyme Europe BV
  • Grunenthal GmbH
  • Grupo Ferrer Internaional S.A.
  • Jubilant Draximage Inc.
  • Merck Serono
  • MSD AH Innovation GmbH
  • Mundipharma Research GmbH & Co Kg
  • Napp Pharmaceutical Group Ltd
  • OrPha Swiss GmbH
  • Pierre Fabre Medicament
  • Piramal Healthcare Ltd
  • Pliva Croatia Ltd
  • Roche
  • Sanofi
  • Syntaxin Ltd
  • TEVA

Very good webinar. Well structured, interactive questions, small group, advanced topics (not easy to find elsewhere), competent speaker, good platform.

Bettina Isler, Medical Information Manager, OrPha Swiss GmbH, Mar 21

Inspiring speaker. I was very excited about all the anecdotes that he told.
Overall a very rewarding course.

Helle Ribjerg, Global Safety Specialist, LEO Pharma, Mar 21


Sidse Schjøtz, Complinace Manager, ALK , Sep 20

Generally very good and good to have the anecdotes from real life.

Sanne Mathias, Head of Compliance, ALK , Sep 20

Good course and the leader was very clear in what he wanted to say. Exercises were fun..

Amrita Kang, drug safety scientist, GE healthcare, Sep 20

Parts of the presentation especially Day 3 were informative as it was more tailored to my role. I enjoyed the talk of RMPs, PSURs and crisis management. A lot of basics however were covered in this 'advanced course' in the CT directive topic, would be nice just to state what's changed and what's not changed almost like presenting a gap analysis, instead of covering basic definitions such as definition of an SAE and SUSAR and investigator reporting timelines. There was a 2 minute discussion on Brexit related changes on Day 2 which could have been a formal session as a presentation as I found that very useful for my role.

Maria Sajid, Safety Evaluation Scientist, Eisai Europe Ltd, Sep 20

Very nice course - will recommend to colleagues

Tina Rishoej Clausen, Global Safety Specialist, LEO Pharma, Sep 20

I was hoping to get more knowledge about the topics listed in the course presentation and I actually got a lot more, as we were not only given information related to the legislation in force but also very useful examples of applicability and some non-compliance cases. The speaker is undoubtedly an expert in the field with excellent presentation skills of all the proposed topics, including the most complex ones from a regulatory point of view. His experience and his analytic method facilitated my understanding of some critical passages of the law.

Ilaria Gargano, Global Safety Specialist, Leo Pharma, Sep 19

[Graeme] was a very good presenter with very good industry knowledge and experience. Very interactive sessions and answered all our questions.

Smitha Bhat, Principal CMG Scientist, GlaxoSmithKline, Sep 19

The speaker was able to make a dry topic really exciting and I particularly liked the interaction with the group.

Margot Börgartz, Stewardship Manager, Bayer AG, Sep 19

Overall, the best seminar I've attended in format, topics, and speaker. I had hoped to learn about PV in general and all the different reporting requirements and report types – I learned much more than that. The speaker was great and I particularly liked the real-life stories and examples.

Jane Bateman, Senior Drug Safety Scientist, GE Healthcare, Sep 19

Graeme has superb knowledge of the regulations and guidelines around pharmacovigilance and talks in a passionate and engaging manner. An excellent course that really gives the students a much better understanding of pharmacovigilance and the opportunity to share knowledge. The content was spot on and Graeme's presentation style was engaging.

Christopher Harper, Senior Medical Information Manager, Astellas Pharma Europe Ltd, Mar 19

Great presentations, great time keeping, good balance between exercises and presentations

Ida Mizera, Local Responsible Person for PV, Grunenthal Ltd, Mar 19

The content of the course was excellent for an all round view of PV, the presentations were good and flowed from one aspect of PV to another. Graeme's passion and energy for drug safety was evident throughout the three days. I really enjoyed this course.

Ciara Walsh, Head of Regulatory Affairs and Pharmacovigilance, Noden Pharma DAC, Mar 19

Very valuable with real examples. I liked that future elements of PV regulation were pointed out and not just the current one.

Dorthe Lundmark, Drug Safety Coordinator, Pharmacosmos A/S, Mar 19