The new EU clinical trials regulation will go into effect for Europe in 2016 – are you prepared?
This presentation on the new EU clinical trials regulation will identify what’s happening with the regulation that governs clinical trials in Europe. With a knowledge base and work history that spans the globe and more than 20 years, Dr. Dehlinger-Kremer understands the nuances of variations in regulatory standards around the world. Join our webinar on the new EU clinical trials regulations where she will help you anticipate the regulatory issues you must address in multi-country studies and will identify some key differences between EMA and FDA regulations.
Attendees of this webinar will learn:
- The rationale behind the changes in the previous Clinical Trials Directive
- Timeline and meeting the preconditions for the new EU clinical trials regulation
- Core components
- Country-specific aspects of the regulation
- Impacts on sponsors
- Some cautions: Differences between FDA and EMA regulations
- Advantages of the new EU clinical trials regulation
Dr. Martine Dehlinger-Kremer, Global VP, Medical and Regulatory Affairs, SynteractHCR
Dr. Dehlinger-Kremer has more than 28 years of experience in the research industry, including more than 24 years of regulatory affairs leadership. For 19 years, she served as a vice president of International and Global Regulatory Affairs and Global Medical Affairs at various CROs headquartered in the U.S.
Martine has contributed to the global development of numerous products, including orphan drugs and biosimilars. She has participated in 100+ NDAs/MAAs in local and CTD/eCTD/NeeS format, in the maintenance of products on the market, and in numerous clinical studies across all phases. She has also served as the chair of the Pediatric Working Group of EUCROF, and as lead member of the Pediatric Franchise at Research Pharmaceutical Services, a division of PRA International.
Dr. Dehlinger-Kremer holds a PhD from the University of J.W. Goethe in Frankfurt, Germany; a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France; and a Master of Sciences degree from the University Moulin de la Housse in Reims, France. She is also a registered member of The Organization for Professionals in Regulatory Affairs (TOPRA).
Who Should Attend?
Clinical research professionals in pharmaceutical, biotech and medical device companies who conduct international trials and need to be informed and updated with the regulatory aspects.
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device and Pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and 60 countries, offering expertise across multiple therapeutic areas, with notable depth in oncology, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy and ICD+ approach, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data so clients get to decision points faster.