eCTD Submissions of IND/NDA to the US FDA, EU and Canada (NTZ) at The DoubleTree Baltimore-BWI Airport For more information: https://www.eventbrite.com/e/ectd-submissions-of-indnda-to-the-us-fda-eu-and-canada-ntz-tickets-43440570917?aff=RMV
DESCRIPTION ============= eCTD Submissions of IND/NDA 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.
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
etc...
For more information: https://www.eventbrite.com/e/ectd-submissions-of-indnda-to-the-us-fda-eu-and-canada-ntz-tickets-43440570917?aff=RMV
Who will benefit: =================== Regulatory Affairs
Quality Assurance
Pharmacovigilance
Project Management
Regulatory Operations
Anyone responsible for providing content for the CTD
SPEAKER
Peggy Berry President & CEO, Synergy Consulting
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. ----------------------------------
For more information: https://www.eventbrite.com/e/ectd-submissions-of-indnda-to-the-us-fda-eu-and-canada-ntz-tickets-43440570917?aff=RMV
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