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EVENT DATE
Aug 2017
M T W T F S S
21222324252627
EXPO DATE
Aug 2017
M T W T F S S
21222324252627

Venue

DoubleTree by Hilton San Francisco Airport 835 Airport Blvd
Burlingame , CA 94010
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Type: Indoor - Hotel

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ECTD Submissions Of IND And NDA/BLA To The US FDA, EU And Canada

DoubleTree by Hilton San Francisco Airport
B2B 30

EVENT DESCRIPTION

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

Note: Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/us-fda-canada-ectd-submissions-of-ind-and-nda-bla-seminar-training-80480SEM-prdsm?channel=eventsinamerica

Contact the event managers listed below for more information about how you can participate at the ECTD Submissions Of IND And NDA/BLA To The US FDA, EU And Canada.

EVENT CONTACTS

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EVENT DETAILS

Primary Industry:
Sciences
Other Industries:
Business, Sciences
Audience:
Regulatory Affairs
Quality Assurance
Pharmacovigilance
Project Management
Regulatory Operations
Medical and Technical writers
Professionals preparing IND, DMFs, NDAs and other submissions
IT Professionals
Notes:
Show Owner:
ComplianceOnline
Sponsorship:

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ComplianceOnline

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