Latest Updates on the EU Clinical Trials Regulation 536/2014

The goal of Clinical Trials Regulation EU No. 536/2014 is to create an environment that is favourable to conducting clinical trials in the EU, with the highest standards of safety for participants and increased transparency of trial information. The Regulation will allow consistent rules for conducting clinical trials throughout the EU and information on the authorisation, conduct and results of each clinical trial carried out in the EU to be publicly available. In order to be able to apply the EU Clinical Trials Regulation, an EU clinical trial portal and database will be required. The portal will be the single entry point for submitting clinical trial information in the EU, which will be stored in the database. EMA will make information stored in the database publicly available subject to transparency rules.

The presentation will provide an overview of the status of the Portal and Database, now called Clinical Trial Information System (CTIS).

About the speaker
Dr Martine Dehlinger-Kremer

Dr. Martine Dehlinger-Kremer is Vice President, Pediatric Development at Synteract, an innovative contract research organization. Dr. Martine Dehlinger-Kremer has 30 years of experience in the clinical research industry including 28 years in Regulatory and Medical Affairs. She has also been involved in Pediatrics in the last 10 years. Dr. Martine Dehlinger-Kremer has contributed to global development of numerous products, including orphan drugs and biosimilars. She has participated in 100+ New Drug Applications and Marketing Authorization Applications globally and in clinical studies across all phases. She is Chair of the Pediatric Working Group of EUCROF since 2008, Chair of the European Forum for GCP (EFGCP) Children Medicines Working Party, an Observer Member of the Coordinating Group of Enpr-EMA, the European Network of Pediatric Research at the European Medicines Agency (EMA) and since many years a member of Working Parties of Enpr-EMA. Dr. Martine Dehlinger-Kremer is President of EUCROF, the European CRO Federation, and a Board Member of EFGCP. Dr Dehlinger-Kremer was Named One of PharmaVOICE 100’s Most Inspiring People in Life Sciences (Industry leader recognized for impact, experience and advocacy in clinical research) in August 2015.

Dr. Dehlinger-Kremer holds a Doctorate in Sciences, a Master of Advanced Study in Neurophysiology degree, and a Master of Science degree.

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