Since November 2005, an EU Risk Management Plan (EU-RMP) has been mandated as part of the marketing application for all new chemical entities in the EU. In the EU-RMP, the safety profile of the medicine has to be described and the pharmacovigilance activities proposed during the post-marketing period. These activities include, e.g., collection of spontaneously reported adverse events and post-authorization safety studies (PASS).
There is relatively little known on the temporal trends of post-marketing requirements in the EU, on the relative frequency and types of PASS authorized (e.g. Phase IIIB Open Label, cohort study, etc), or on safety concerns (e.g. important identified risks; important potential risks; or important missing information) identified by drug type.
This Webcast will provide an overview of recent trends in EU PASS, including an analysis of a sample of EU-RMP summary data, description of PASS types requested and comparison/contrast of characteristics between drug types.
Implications for Pharmaceutical Companies and lessons learnt will be discussed.
Who Should Attend
- Medical Affairs
- Drug Safety
- Benefit Risk/Safety Research
- Corporate strategy
Key Learning Objectives
- Real world information on current PASS characteristics and trends
- Implications for new marketing applications in the EU
David E. Neasham Ph.D, MSc, MFPH, EU Director and Senior Research Scientist, Health Economics and Epidemiology
Ravi Sadasivan, MS, Project Manager, Evidera