Post-Authorisation Safety Studies, Amsterdam, 18-19 June 2014
May 26, 2014
As the second of a two part lecture series on Drug Safety Dr. Jan Petracek and Dr. Jan-Willem van der Velden will be teaching a training course on Post-Authorisation Safety Studies in Amsterdam at the end of June. The course is specifically designed for industry professionals who are involved in the Pharmacovigilance/Drug safety life-cycle with specific regards to the areas of Research & Development, Medical & Regulatory Affairs, and Clinical Safety and Pharmacovigilance.
The participants will be given a fundamental understanding of the GVP Module VIII and its practical application with regards to: Post-authorisation safety studies, principles of pharmacoepidemiology, methodology, study types and sources for information. Dr Petracek and Dr Van der Velden will also provide their insight on the best practices when dealing with the latest EMA/CHMP/PRAC and EnCePP requirements for PASS studies.
This two day course has been organized by DIA and will be held in Amsterdam on June 18th and 19th June 2014.
For the detailed agenda and course registration please view the attached program or go to DIA.
- Programme (PDF, 549.53 KiB)