News and challenges from the regulatory point of view

The original intent of the Clinical Trials Directive 2001/20/EC was to simplify and harmonize the administrative provisions governing clinical trials in the European Union. However, experience has proven that a coordinated approach to the regulation of clinical trials has been only partly achieved, making it difficult to perform a clinical trial in several Member States. As a consequence the European Commission determined to develop a legal Regulation that would repeal the earlier Directive and harmonize the procedures for conducting clinical trials. The Regulation of the European Parliament and of The Council on Clinical Trials on Medicinal Products for Human Use, repealing Directive 2001/20/EC was published in the Official Journal on 27th May 2014 and is expected to become effective in June 2016 if the given preconditions are met.

The scope of the new Regulation is extensive, with several primary components covered in the core text and multiple appendices, including: Authorization procedures; Start of trial, suspension or temporary holds, early termination; Protection of subjects, informed consent; Conduct of trials; Safety reporting; IMP manufacturing, labelling and import; Insurance.

Certain aspects are not covered by the Regulation and remain country specific, including: Ethics; Legal representative of the subject not able to provide IC, Substantial rules of liability in the case of damages; Requirements for investigators and site qualification; Requirements for country/site specific documents such as originals and copies, notarization, language. Additional approvals might still be required in some countries.
That said, there are several advantages and simplifications brought by the new Regulation and at the same time some challenges.

The presentation will provide an overview of the Regulation from the Regulatory point of view as well as some of the challenges the Regulation might bring.

About the speaker
Dr. Martine Dehlinger-Kremer

Dr Martine Dehlinger-Kremer has more than 28 years of experience in the clinical research industry including more than 24 years of progressively higher levels of Regulatory and Medical Affairs leadership responsibility. For the past 20 years, she served as a Vice President of International and Global Regulatory Affairs as well as Vice President of Global Medical Affairs, in global CROs with headquarters in the US. She also worked in fundamental research at the CNRS Institute of Physiology in Strasbourg, France and the Max-Planck Institute for BioPhysics in Francfort, Germany.

Dr Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars, from early development stages through clinical studies and final registration. She has participated in more than 100 new product registrations, NDAs and MAAs) in local and common technical document format, including eCTD and NeeS format; in the maintenance of products on the market and in numerous clinical studies across all phases and countries. In addition, she has an impressive background in multiple levels of paediatric drug development and has worked closely with various stakeholders and authorities to help improve clinical research in children. Her experience in this area includes serving as the chair of the Paediatric Working Group of the European CRO Federation (EUCROF). Dr Dehlinger-Kremer has co-authored numerous papers for industry and scientific publications and has chaired and participated in regulatory sessions at the European Medicines Agency (EMA), Drug Information Association (DIA), OCT, New Paradigms, Bio2Device Group, International Quality & Productivity Center and more.

Dr Dehlinger-Kremer holds a doctorate in sciences from the University of J.W. Goethe in Frankfurt, a general academic studies degree in neurophysiology from the Louis Pasteur University in Strasbourg, France, and a Master of Science from the University Moulin de la House in Reims, France.

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