eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day Workshop (Burlingame CA, United States - November 14-15, 2019)
/EIN News/ -- Dublin, Oct. 16, 2019 (GLOBE NEWSWIRE) -- The "eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada" conference has been added to ResearchAndMarkets.com's offering.
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.
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.
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
Agenda
Day 1
- Registration Process - (8:30 am till 8:45 am)
- 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 2
- 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/r/rlt8fv
Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.
CONTACT: ResearchAndMarkets.com Laura Wood, Senior Press Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900
EIN Presswire does not exercise editorial control over third-party content provided, uploaded, published, or distributed by users of EIN Presswire. We are a distributor, not a publisher, of 3rd party content. Such content may contain the views, opinions, statements, offers, and other material of the respective users, suppliers, participants, or authors.