Dr. Petracek to Teach at Benefit/Risk Management Training Course, 21-22 Nov 2016 in Basel
Oct 20, 2016
Dr. Jan Petracek will share his expertise with attendees of the DIA Benefit/Risk Management Training Course that is taking place on November 21-22 in Basel, Switzerland. He will be joined by renowned expert in risk assessment, Dr. Michael Forstner former chair of the Risk Management Working Group for Roche.
The agenda and registration details can be found on the DIA website.
Dr. Jan Petracek and Dr. Michael Forstner will cover the following topics:
- New legal possibilities for benefit optimization and risk minimization of products in the EU
- Designing benefit/risk management systems using current regulatory tools, including: EU Risk Management Plans (EU-RMPs), Risk Evaluation and Mitigation Strategies (REMS), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR), Follow-Up Measures (FUMs), and potentially EU Benefit Risk Management Plan (EU-BRMP)
- Choice of effectiveness of study design for safety and efficacy follow-up
- How to manage a media, legal and regulatory crisis
Dr. Petracek is available for on-site private trainings depending on availability. To inquire, please fill out our online form.