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Virtual Seminar on eCTD Submissions of INDNDA to the US FDA, EU and Canada - ResearchAndMarkets.com

May 23, 2019

DUBLIN--(BUSINESS WIRE)--May 23, 2019--

The “6-Hour Virtual Seminar on eCTD Submissions of INDNDA to the US FDA, EU and Canada” webinar has been added to ResearchAndMarkets.com’s offering.

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

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.

Who Should Attend:

Agenda

Lecture 1 - CTD > eCTD

Lecture 2 - eCTD Preparation

For more information about this webinar visit https://www.researchandmarkets.com/r/tnp9kg

View source version on businesswire.com:https://www.businesswire.com/news/home/20190523005409/en/

CONTACT: ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

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Related Topics:Pharmaceutical Manufacturing

KEYWORD:

INDUSTRY KEYWORD: HEALTH PHARMACEUTICAL

SOURCE: Research and Markets

Copyright Business Wire 2019.

PUB: 05/23/2019 08:53 AM/DISC: 05/23/2019 08:53 AM

http://www.businesswire.com/news/home/20190523005409/en

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