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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official (San Francisco, CA, United States - August 24-25, 2017) - Research and Markets
[June 19, 2017]

eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official (San Francisco, CA, United States - August 24-25, 2017) - Research and Markets


Research and Markets has announced the addition of the "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop by Ex-FDA Official" conference to their offering.

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 implmentation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.

Who Should Attend:


- Regulatory Affairs

- Quality Assurance

- Pharmacovigilance

- Project Management

- Regulatory Operations

- Medical and Technical writers

- Professionals preparing IND, DMFs, NDAs and other submissions

- IT Professionals

- Anyone responsible for providing content for the CTD

For more information about this conference visit https://www.researchandmarkets.com/research/knz6jl/ectd_submissions


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