eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (Newark, NJ, United States - November 8th-9th, 2018) - ResearchAndMarkets.com

September 17, 2018

DUBLIN--(BUSINESS WIRE)--Sep 17, 2018--The “eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada” conference has been added to ResearchAndMarkets.com’s 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 implementation 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


Day 01 (8:30 AM - 4:30 PM)

Lecture 1: Overview of the drug development program and source of relevant submission documents

Lecture 2: Discussion of the roles and responsibilities for CTD preparation

Lecture 3: Review of the CTD format requirements

Lecture 4: Discussion on the successful transition from other formats to the CTD

Lecture 5: Placement of content into the CTD format; including less obvious items

Lecture 6: Review of different requirements across regions (US, EU, Canada)

Lecture 7: Implementing tools for the project management of CTD preparation and publishing

Day 02 (8:30 AM - 4:30 PM)

Lecture 8: Technical requirements for an eCTD submission

Lecture 9: Document naming requirements

Lecture 10: Building the folder structure

Lecture 11: Internal document requirements for the eCTD

Lecture 12: Performing “pre-publishing” work for each document

Lecture 13: Tools for tracking and managing eCTD content

Lecture 14: Performing quality checks on the eCTD

Lecture 15: Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

For more information about this conference visit https://www.researchandmarkets.com/research/4mvqpm/ectd_submissions?w=4

View source version on businesswire.com:https://www.businesswire.com/news/home/20180917005541/en/

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Laura Wood, Senior Manager


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Related Topics:Pharmaceutical Manufacturing



SOURCE: Research and Markets

Copyright Business Wire 2018.

PUB: 09/17/2018 12:16 PM/DISC: 09/17/2018 12:16 PM


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