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Your Opportunity to Be Better Prepared for FDA-mandated eCTD Submissions

Your Opportunity to Be Better Prepared for FDA-mandated eCTD Submissions
13 October 2016

As our executives continue to speak at various industry conferences around the globe in October, we wanted to tell you about one that has been added since our last blog post that talked about our fall speaking engagements.

Outsourcing in Clinical Trials Southern California will be held close to home in La Jolla, a beautiful coastal area of San Diego, from Oct. 26-27, 2016. Each OCT event brings together thought leaders to network and to stay abreast of trends and best practices in the clinical research industry.

As most of you already know, the FDA will require electronic common technical document submissions starting in 2017 for the Center for Biologics Evaluation and Research (CBER) and the Center for Drug Evaluation and Research (CDER).

Our Senior Regulatory Affairs Manager Thomas Christensen, who normally works from our East coast office in Research Triangle Park, NC, will speak on “Preparing Proactively for FDA-mandated eCTD Submissions,” on Oct. 26 at 10:15 am. His presentation will provide critical insights into streamlining electronic common technical documents preparation as it becomes the standard submission format.

Specific topics to be discussed include:

  • Specificities of the FDA’s electronic requirements
  • The timetable for initial implementation using eCTD
  • Tips on electronic document preparation and management
  • eCTD publishing and submission management
  • Strategies for sponsors to improve turnaround time and quality

Come and hear Thomas deliver the information you need to know!

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

Follow us on our social channels on LinkedIn and Twitter for live updates during all conferences.

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