Benefits and Potential Challenges of Moving to the New FDA Module 1

September 14, 2016 10:00–11:00 Eastern Time (US & Canada)

As of June 15, 2015, the FDA is accepting submissions using the new Module 1 specifications (v.2.3). Although the previous version of Module 1 (v.1.3) is still acceptable, filing submissions in the new format may be highly beneficial for the sponsor and regulators.

This Webinar will discuss the benefits of using the new specifications, as well as provide a summary of potential challenges sponsors may encounter during preparation, filing, and management of regulatory submissions.

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