Module 6

03/10/2024

In this presentation we covered

⚫ Definition of pharmacovigilance

⚫ Overview of the regulatory framework and the role of the EU QPPV.

⚫ High-level PV processes – ICSRs, aggregate reports

⚫ Requirements for data management

⚫ Safety reporting requirements

⚫ Signal detection and evaluation

⚫ Risk management & risk minimisation strategies

⚫ Importance of maintaining the product labelling (CDS, SmPC/PILs)

⚫ GPvP inspections and readiness

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Recommended reading

⚫ Goodyear M. Editorial: Learning from the TGN1412 trial. Br Med J 2006; 332: 677-8. ⚫ International Conference on Harmonisation. Efficacy Guidelines including E2A, E2B(R2), E2C(R2), E2D, E2E, E2F @ https://www.ich.org/page/efficacy-guidelines ⚫ Waller P & Evans S. A model for the future conduct of Pharmacovigilance. Pharmacoepidemiology & Drug Safety 2003; 12: 17-29.

⚫ EMA Good Pharmacovigilance Practices https://www.ema.europa.eu/en/human-regulatory/post authorisation/pharmacovigilance/good-pharmacovigilance-practices

⚫ Hauben M & Bate A. Data Mining in Drug Safety. In: Meyler's Side Effects of Drugs Annual 29. 29 th Edition, Aronson JK (ed), Elsevier Science 2007. ISBN: 978-0444519863. ⚫ Eichler HG et al. Safe drugs and good intentions. NEJM 2009 360 14 1378-80.

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