SynteractHCR Global Medical and Regulatory Affairs Expert Dr. Martine Dehlinger-Kremer Speaking at Nordic ePharma Day and Pediatric Drug Development Conferences in April

Senior executive from SynteractHCR brings her considerable experience
and knowledge to hot topics in pharma industry

SAN DIEGO–(BUSINESS WIRE)–#CRO–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.

Contacts

For SynteractHCR
Beth Walsh, 760-230-2424
beth@clearpointagency.com