Module 6

03/10/2024

In this presentation we will cover

⚫ What is pharmacovigilance?

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

⚫ High-level PV process (from safety data via signals to SmPC)

⚫ Aggregate reports (PSURs, PBRERs, etc.) and risk management

⚫ High-level responsibilities and requirements for data management.

⚫ Safety reporting requirements (types of ADR reporting, why do we collect postmarketing reports, who do we report to).

⚫ Signal detection and evaluation.

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

⚫ Risk management

⚫ Future developments ⚫ Social media and pharmacovigilance

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Pharmacovigilance in perspective

37 minutes If we eliminate drug-induced harm ● Life expectancy increases by how much? ? If we remove the benefits of medicines ● Life expectancy decreases by ? Seconds Weeks Minutes Months Hours Years Days NO CHANGE Seconds Weeks Minutes Months Hours Years 15 years 15 years Days NO CHANGE

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