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1st Edition  Conference

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

  • 05-06 Aug 2019 New Date Reminder
  • Courtyard by Marriott Newark Liberty International Airport, Newark,  USA

"Quality, Safety and Efficacy information for a drug or biologic product into a common format"
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.

Highlights

  • Overview of the drug development program and source of relevant submission documents
  • Discussion of the roles and responsibilities for CTD preparation,Document naming requirements
  • Discussion on the successful transition from other formats to the CTD,Building the folder structure
  • Implementing tools for the project management of CTD preparation and publishing
  • Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)

Timings

8:30 AM - 4:30 PM (Aug 05) (General)
8:30 AM - 4:30 PM (Aug 06) (General)

Entry Fees

Paid Ticket Starts from 1699 USD View Details

Participants

20 Delegates
5 Exhibitors Estimated Count

Category & Type

Conference
Medical & Pharma
Education & Training

Editions

05-06 Aug 2019 1st Edition


Frequency Bi-annual
Next edition likely in Feb 2020 Interested

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ComplianceOnline USA

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User Community [Users who have shown interest for this Event]

GOURAV DHiMAN

GOURAV DHiMAN

partnership at S.M ENGG. & foundry works Rajpura, India
Gurwinder Singh

Gurwinder Singh

Owner at Gurwinder singh Ludhiana, India
dawn

dawn

scientist at qcr New York, United States
Dawn Oro

Dawn Oro

Life Science consultant at QCR Global New York, United States

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Visitor Ticket Price

1699 USDAttendee Seminar One Registration
40.709398 -74.172534

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map of Courtyard by Marriott Newark Liberty International Airport

Courtyard by Marriott Newark Liberty International Airport

600 US 1 &, Courtyard by Marriott Newark Liberty International Airport, 9, Newark, NJ 07114, USA
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