Dr. Martine Dehlinger-Kremer, global vice president of medical and regulatory affairs, will present “The New EU Clinical Trials Regulation: What Does it Change and What Will the Impact Be to Drug Development in the EU?” on Thursday, Nov. 19th, at 11:50 a.m. Her presentation will address the rationale behind changing the previous clinical trials directive as well as the following:
- Timeline for the new EU CT Regulation to go into effect
- Core components and country-specific aspects of the Regulation
- Differences between the EMA’s and FDA’s expectations
- The advantages of the New EU CT Regulation and the impact that this will have on sponsors
Named one of the 2015 PharmaVOICE 100 Most Inspiring People in Life Sciences, Dr. Dehlinger-Kremer is a leading expert in regulatory affairs. As an advocate for harmonization among regulatory bodies in different countries, she hosted a webinar and has been featured in multiple media outlets on the topic of the New EU Clinical Trials Regulation.
Attendees who would like to schedule an appointment with SynteractHCR at PCT Europe may contact Sebastien Duval, vice president business development Europe, at +33 6 01 61 21 81. See SynteractHCR’s full schedule of events and follow its social channels on LinkedInand Twitter for live updates during the PCT Europe conference.