RAPS New York/New Jersey Chapter: Getting Ad-Promo on Board the eCTD Train

19 November 2015
5:30–9:00 pm
Bridgewater Manor
Bridgewater, NJ

The Electronic Common Technical Document (eCTD) has transformed submissions to the Food and Drug Administration (FDA) and other regulatory authorities around the world. Until recently, that transformation had bypassed the ad-promo world. But with the release of a new draft guidance in April 2015 and an update to M1 in June, FDA is now enabling companies to submit their ad-promo submissions to using eCTD, and soon this will shift to a mandatory submission. Come learn more about this process during an interactive presentation that will help you:

• Understand the timeline for FDA's transition
• Distinguish the voluntary from the mandatory aspects of FDA's guidance
• Appreciate the operational challenges for your companies in making this transition
• Understand the key questions to ask vendors now to avoid headaches later

A dinner buffet will be available to all meeting participants. Attendees who hold the RAC may claim two RAC recertification credits.

This meeting is sponsored by the RAPS New York/New Jersey Chapter and is intended to promote knowledge advancement and facilitate networking among local regulatory professionals.