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:
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Project Management
Regulatory Operations
Medical and Technical writers
Professionals preparing IND, DMFs, NDAs and other submissions
IT Professionals

Note: Use coupon code REFERRAL10 and get 10% off on registration.

For Registration:
http://www.complianceonline.com/us-fda-canada-ectd-submissions-of-ind-and-nda-bla-zurich-seminar-training-80488SEM-prdsm?channel=eleventary (from )

complianceonline.com/us-fda-canada-ectd-submissions-of-ind-and-nda-bla-zurich-seminar-training-80488SEM-prdsm?channel=eleventary

• This event has passed.
  Through August 30, 2017

  August 29, 2017 to August 30, 2017
• Hilton Zurich Airport, Switzerland
  10 Hohenbühlstrasse, Opfikon, ZH

  Directions to event · Directions from event
• Contact Referral for more information
  8887172436 or [email protected]
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