SAN DIEGO–(BUSINESS WIRE)– SynteractHCR, een bedrijf in volledig uitbesteed onderzoek, deelt zijn expertise in medisch onderzoek en kennis over regelgeving op Partnerships in Clinical Trials Europe (PCT Europe), dat van 17 tot 19 november plaatsheeft in Hamburg. Experts van het internationale bedrijf bespreken in stand #503 hun diensten, die medicijnontwikkeling door kleine tot middelgrote biofarmaceutische bedrijven ondersteunen.
Dr. Martine Dehlinger-Kremer, internationaal vicepresident van de afdeling voor medische en wettelijke zaken, geeft op donderdag 19 november om 11.50 uur een presentatie met de titel ‘The New EU Clinical Trials Regulation: What Does it Change and What Will the Impact Be to Drug Development in the EU?’ Dehlinger-Kremer bespreekt onder meer de denkwijzen achter de wijziging van de richtlijn voor medisch onderzoek.
SynteractHCR to Share Insights on the New EU Clinical Trials Regulation at 2015 Partnerships in Clinical Trials Europe
SAN DIEGO–(BUSINESS WIRE)– Full-service contract research organization (CRO) SynteractHCR will share its Phase I-IV clinical trials expertise as well as its regulatory affairs knowledge at Partnerships in Clinical Trials Europe (PCT Europe), to be held Nov. 17-19 in Hamburg, Germany. The CRO’s global clinical trial experts will be at booth #503 to discuss their services that support the drug development programs of small to mid-sized biopharma companies.
Dr. Martine Dehlinger-Kremer, global vice president of medical and regulatory affairs, will present “The New EU Clinical Trials Regulation: What Does it Change and What Will the Impact Be to Drug Development in the EU?” on Thursday, Nov. 19 th, at 11:50 a.m. Her presentation will address the rationale behind changing the previous clinical trials directive as well as the following:
- Timeline for the new EU CT Regulation to go into effect
- Core components and country-specific aspects of the Regulation
- Differences between the EMA’s and FDA’s expectations
- The advantages of the New EU CT Regulation and the impact that this will have on sponsors
Named one of the 2015 PharmaVOICE 100 Most Inspiring People in Life Sciences, Dr. Dehlinger-Kremer is a leading expert in regulatory affairs. As an advocate for harmonization among regulatory bodies in different countries, she hosted a webinar and has been featured in multiple media outlets on the topic of the New EU Clinical Trials Regulation.
Attendees who would like to schedule an appointment with SynteractHCR at PCT Europe may contact Sebastien Duval, vice president business development Europe, at +33 6 01 61 21 81. See SynteractHCR’s full schedule of events and follow its social channels on LinkedIn and Twitter for live updates during the PCT Europe conference.
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.
Amanda Whitlock, 760-230-2424