eCTD Submissions of IND/NDA to the US FDA, EU and Canada

Date : 5th April 2018 to 6th April 2018

Place : United States, baltimore, md

Website :https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901660SEMINAR?allconferencealerts-April-2018-SEO

Contact Person:Event Manager

Description:

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 will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD. Areas Covered in the Session: Overview of the drug development program and source of relevant submission documents Discussion of the roles and responsibilities for CTD preparation Review of the CTD format requirements Discussion on the successful transition from other formats to the CTD Implementing tools for the project management of CTD preparation and publishing Technical requirements for an eCTD submission Document naming requirements Building the folder structure Performing "pre-publishing" work for each document Tools for tracking and managing eCTD content Performing quality checks on the eCTD Updating content in the CTD and eCTD (amendments, supplements, variations, etc.) Click to Continue Reading: https://www.globalcompliancepanel.com/control/globalseminars/~product_id=901660SEMINAR?allconferencealerts-April-2018-SEO

eCTD Submissions of IND/NDA to the US FDA, EU and Canada will be held in baltimore, md,United States on date 2018-04-06

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Deadline for abstracts/proposals : 3rd April 2018

Keynote Speakers : Peggy J. Berry, MBA, RAC, 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

Conference Highlights :Regulatory Affairs Quality Assurance Pharmacovigilance Project Management Regulatory Operations Anyone responsible for providing content for the CTD

Venue :Baltimore, MD, USA

Check the event website for more details.