eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada (com) A
At
San Francisco
For more information: https://www.eventbrite.com/e/certified-coder-boot-camporiginal-blr-s-tickets-54996527093
DESCRIPTION
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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
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 will Benefit:
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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
Please contact the event manager Marilyn below for the following:
- Discounts for registering 5 or more participants.
- If your company requires a price quotation.
Event Manager Contact: marilyn.b.turner(at)nyeventslist.com
You can also contact us if you require a visa invitation letter, after ticket purchase.
We can also provide a certificate of completion for this event if required.
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For more information: https://www.eventbrite.com/e/certified-coder-boot-camporiginal-blr-s-tickets-54996527093
Eventbrite: https://www.eventbrite.com/o/event-promotions-by-new-york-events-list-11118815675
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