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Submitting eCTDs for Drug Advertising & Selecting an Outsourcing Partner: Two Topics We’re Discussing At Conferences This Winter

Submitting eCTDs for Drug Advertising & Selecting an Outsourcing Partner: Two Topics We’re Discussing At Conferences This Winter
31 January 2017

Our senior managers, including Thomas Christensen and Erin Parker, are continuing to spread their knowledge on drug development and regulatory issues with speaking engagements scheduled at three industry shows this winter: DIA Regulatory Submissions, Information, and Document Management Forum on February 6 – 8; Outsourcing in Clinical Trials West Coast on February 22 - 23 and Outsourcing in Clinical Trials Southeast on March 21 – 22.

Thomas Christensen, Senior Regulatory Affairs Manager at Synteract, RAC will discuss “Lessons Learned for First Time OPDP Submissions, Promotional Material, and Labeling” on Tuesday, February 7 at 10:30 a.m. – noon at DIA Regulatory Submissions, Information, and Document Management Forum, in Bethesda, MD. He will offer insights on submitting Electronic Common Technical Documents for drugs and biologics advertising and promotional submissions, set to go into effect in May 2017 in the U.S., including: working with the FDA, guidelines for preparing Form 2253, and XML attributes required in submissions. 

Erin Parker, senior director, Global Medical Operations at Synteract will speak on “Key Considerations for Selecting a Safety Services Provider” on Wednesday, February 22 at 11:30 a.m. at Outsourcing in Clinical Trials West Coast in Burlingame, CA and again on Tuesday, March 21 at 12 noon at Outsourcing in Clinical Trials Southeast in Cary, NC. She will discuss important factors to consider in partnering with an outsourcing vendor to address safety needs throughout the product development lifecycle, from Phases I through IV. She’ll also address benefits and pitfalls and provide specific case study examples on how to best partner with a CRO. 

Do your travel plans include heading to Maryland for the DIA Conference or Northern California or North Carolina for Outsourcing in Clinical Trials? Join us at these sessions or contact our Executive Director of Business Development Kim Martinez at 760-529-3440 or kim.martinez@Synteract.com to set up a time to talk. And check back on our blog regularly for summaries of and updates on these and other upcoming speaking opportunities.

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