Preparing Compliant eCTD Submissions: Are you prepared for upcoming FDA mandate on e-submissions?


Peggy J. Berry, MBA, RAC, is Keynote Speaker at ComplianceKey.She is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs departmen........

Overview

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

Why should you attend this webinar?

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD

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Webinar Id: LSHCPJB001

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Duration: 90 mins

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 Recorded: [Six month unlimited access]

 $167 (Single Attendee)  $599 (Unlimited Attendee)

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