Pre-Marketing Clinical Safety, Amsterdam, 16-17 June 2014
May 26, 2014
In June 2014 PharmInvent CEO, Dr. Jan Petracek and his esteemed colleague Dr. Jan-Willem van der Velden will co-present an intensive course in the processes of managing and practicing Pre-marketing Clincal Safety. The course has been organized by DIA as part one of a two part lecture series on drug safety to be held in Amsterdam.
Dr Petracek and Dr Van der Velden will guide the participants through the relevant regulations and guidelines pertaining to pre-marketing safety in the EU. Attendees will be instructed in the processes of creating DSURs, EU-RMPs and FDA relevant Risk Evaluation and Mitigation Strategies (REMS). All is done with the goal of training the participants for dossier preparation and submission.
This course is specifically designed for professionals involved in management of safety information of clinical trials in the EU and will be held in Amsterdam on June the 16th and 17th.
For the detailed agenda and course registration please view the attached program or go to DIA.
- Programme (PDF, 602.35 KiB)