SAN DIEGO--(BUSINESS WIRE)--Martine Dehlinger-Kremer, Ph.D., global vice president for medical and regulatory affairs at international contract research organization SynteractHCR, will speak on topics of special interest to the international biopharma community at two conferences this spring. At Nordic ePharma Day, to be held April 21, 2016, in Copenhagen, Dr. Dehlinger-Kremer will present “The New EU Clinical Trials Regulation: What Are the Changes and What Will the Impact Be on Clinical Research in the European Union.” At the Pediatric Drug Development Conference of the Medicines for Children Research Network Hungary in Budapest from April 27-28, she will address the status of pediatric regulations and their impact on drug development for children today.
An expert in working with global regulatory organizations, Dr. Dehlinger-Kremer has more than 29 years of experience in the clinical research industry and has spoken, in both the US and Europe, on the new EU Clinical Trials Regulation multiple times in the past two years since it was initially put forth by the European Commission. The Regulation’s goal is to harmonize trial procedures and make Europe a more attractive location for conducting clinical trials – but it is not just a European issue as it will impact some initial considerations for trials in the United States, too. Dr. Dehlinger-Kremer’s presentation will provide an overview of the CT Regulation from the regulatory point of view, an introduction to national pilot phases, and also will identify some of the challenges the Regulation might bring.
In her role as chair of the Paediatric Working Group for EUCROF (European CRO Federation), Dr. Dehlinger-Kremer will open the conference as keynote speaker at 9:00 a.m. on the first day with a discussion entitled, “The EU Regulatory Situation, Ten Years after Paediatric Regulation,” which addresses the status of drug development for children now. Her experience in this area, in addition to serving as the EUCROF Pediatric Working Group chair, includes being a member of the working group of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency, as well as a member of the EFGCP Children Working Party. In addition, she has an impressive background in multiple levels of pediatric drug development and has worked closely with authorities to help improve clinical research in children.
“With her extensive global industry and regulatory experience, Martine’s knowledge and expertise has augmented the consultative capabilities we offer clients globally, to support them through all stages of their drug development needs,” said SynteractHCR CEO Wendel Barr. “She is tireless in her quest to improve the drug development process for adults and children alike, and we are very proud that she is a thought leader for not only our company but for the international community at large.”
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 Drug Applications (NDAs) and Marketing Authorization Applications (MAAs), in the maintenance of products on the market, and in numerous clinical studies across all phases. She 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), Partnership in Clinical Trials, ePharma Day, New Paradigms, Bio2Device Group, International Quality & Productivity Center (IQPC), and more.
About SynteractHCR (www.synteracthcr.com)
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, immunotherapy, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data to help bring tomorrow’s treatments to patients.
