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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day In-Person Seminar by Ex-FDA Official

ComplianceOnline

Wednesday, September 20, 2017 at 8:30 AM - Thursday, September 21, 2017 at 4:30 PM (AEST)

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

Ticket Information

Ticket Type Sales End Price Fee Quantity
Seminar One Registration (USD) Sep 20, 2017 $1,299.00 $19.95

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Event Details

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
  • Anyone responsible for providing content for the CTD

 

For Registrationhttp://www.complianceonline.com/us-fda-canada-ectd-submissions-of-ind-and-nda-bla-seminar-training-80482SEM-prdsm?channel=eventbrite          

 

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

Have questions about eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day In-Person Seminar by Ex-FDA Official? Contact ComplianceOnline

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When & Where


Sydney

Sydney, NSW 2000
Australia

Wednesday, September 20, 2017 at 8:30 AM - Thursday, September 21, 2017 at 4:30 PM (AEST)


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Organizer

ComplianceOnline

Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.

Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.

Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.

Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.

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eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada: 2-Day In-Person Seminar by Ex-FDA Official
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