Topics
- Designing benefit / risk management systems using regulatory tools, including Management Plans (EU-RMP), EU Risk, Development Safety Update Report (DSUR), Risk Evaluation and Mitigation Strategies (REMS), Follow -Up Measures (FUMs), Periodic Safety Update Report (PSUR) and potentially EU Benefit Risk Management Plan (EU-BRMP)
- The new legal possibilities for benefit optimisation and risk minimisation of your products in the EU
- Situations when benefit - risk of your product is at stake and you need to manage a legal, media and regulatory crisis
- Which study designs are best for safety and efficacy follow -up, and how to measure their effectiveness
Who should Attend
Professionals from the pharmaceutical industry involved in risk management, regulatory affairs, drug safety, pharmacovigilance and medical affairs.
