Safety Management Plan Workshop with Dr Jan Petracek in China, July 2017
May 23, 2017
This two-days intensive training course is organized by DIA on July 10 - 11, 2017 in Beijing, China.
The agenda was prepared with the aim to bring the latest information from European to Chinese Pharmacovigilance and Regulatory Affairs Professionals on the following topics:
- Legal possibilities for benefit optimisation and risk minimisation of products in the EU
- Designing benefit-risk management systems using current regulatory tools, including EU Risk Management Plans (EU-RMPs), Development Safety Update Report (DSUR), Periodic Safety Update Report (PSUR)
- Best study designs for safety and efficacy follow-up, and how to measure their effectiveness
Dr. Petracek is an internationally known pharmacovigilance expert with a long history of professional trainings and speaking courses for DIA events worldwide. He is scheduled to cover seven sessions out of thirteen sessions which are on the agenda of this training course.
For the agenda and registration details please visit the DIA website.