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SynteractHCR Experts Continue Presentations At U.S. And European Events Focused On Outsourcing In Clinical Trials

Published: May 04, 2016

SAN DIEGO--(BUSINESS WIRE)--Full-service, international, contract research organization (CRO) SynteractHCR will offer speaker presentations and exhibits at the Outsourcing in Clinical Trials Europe event in Paris, May 17-18, and at the Outsourcing in Clinical Trials East Coast conference, May 25-26, in King of Prussia, Pennsylvania. Both conferences feature thought leaders who address pressing regulatory topics and electronic innovation that will increase the knowledge base of drug development sponsors worldwide.

“Preparing Proactively for FDA Mandated eCTD Submissions.”

At OCT Europe, the company will exhibit in booth #61. Director of Regulatory Affairs, Europe, Ludwig Baumann, 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 Wednesday, May 18th at 9:15 a.m. His presentation will address the rationale behind changing the previous clinical trials directive as well as the following:

  • The revised 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 this will have on sponsors

At OCT East Coast, SynteractHCR will exhibit at booth #68 and will present its expertise in electronic submission handling. On Wednesday, May 25th at 4:30 p.m., Senior Regulatory Affairs Manager Thomas Christensen will present, “Preparing Proactively for FDA Mandated eCTD Submissions.” Because the FDA will require electronic common technical document (eCTD) submissions starting in 2017, attendees will learn how to streamline eCTD preparation as it becomes the standard submission format. The presentation will cover:

  • The timetable for the initial implementation of electronic submissions using eCTD
  • eCTD publishing, submission management and Regulatory Authority submission
  • Strategies for sponsors to improve turnaround times and higher quality submissions

Attendees interested in meeting with the SynteractHCR team at these events may contact Executive Director of Business Development Kim Martinez at 760-529-3440 or kim.martinez@synteracthcr.com.

See SynteractHCR's full schedule of events and follow its social channels on LinkedIn and Twitter for live updates during all conferences.

About SynteractHCR
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.