The electronic Common Technical Document (eCTD) has transformed submissions to the US 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 But, with the release of a new draft guidance in April 2015 and an update to ICH’s M1 in June, the FDA now is enabling companies to submit their ad-promo submissions using eCTD. Soon, this will shift to a mandatory submission. Join Veeva to learn more about this process and hear the latest updates from FDA.
Learning Levels: Intermediate and Advanced
Upon the webcast's conclusion, you will be able to:
- Understand the timeline for FDA's transition
- Distinguish the voluntary aspects of FDA's guidance from the mandatory aspects
- Appreciate the operational challenges in making this transition
- Ask key questions to vendors to avoid headaches later
Who Should Attend?
- Regulatory professionals
- Marketing and sales professionals
- Compliance specialists
Jason Sundberg, director, Vault PromoMats Strategy, Veeva
With over 16 years experience in pharmaceutical management consulting, Jason has led significant project teams and initiatives supporting promotional content management and the digital marketing space. Leading projects for some of the largest pharmaceutical companies in the world, he's managed the design and implementation of promotional content management systems, HCP portals and global multichannel marketing programs.
Dale Cooke, owner, PhillyCooke Consulting
Dale Cooke is owner of PhillyCooke Consulting, which provides advice and training to companies about using 21st century technologies to communicate about FDA-regulated products while remaining compliant with FDA regulations written in the 1960s. Cooke has worked with more than 30 pharmaceutical and medical device clients around the world. He is an active member of the Regulatory Affairs Professionals Society (RAPS), Drug Information Association (DIA), Food and Drug Law Institute (FDLI) and the Alliance for a Stronger FDA. He also serves on the faculty of the University of California San Francisco’s American Course in Drug Development and Regulatory Sciences program.