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

  • ID: 4871950
  • Webinar
  • December 2019
  • Region: United States, Canada, Europe
  • 12 Hours
  • Compliance Online
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This four day webinar series (each day 3 hrs) 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.

Date:

December 16-19, 2019
(10:00 AM to 1:00 PM PDT)

Viewing formats:

  • One dial in attendee (live)
  • Group - Max. 10 Attendees (live)
  • One user recorded version (unlimited viewing for 6 months)
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Day 1 & 2: Review of CTD content and Structure

Day 1:

  • 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

Day 2:

  • Placement of content into the CTD format; including less obvious items
  • Review of different requirements across regions (US, EU, Canada)
  • Implementing tools for the project management of CTD preparation and publishing

Day 3 & 4 : Review the eCTD. Setup and Submission Process

Day 3:

  • Technical requirements for an eCTD submission
  • Document naming requirements
  • Building the folder structure
  • Internal document requirements for the eCTD

Day 4:

  • Performing "pre-publishing" work for each document
  • Tools for tracking and managing eCTD content
  • Performing quality checks on the eCTD
  • Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
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  • Peggy J. Berry Peggy J. Berry,
    President & CEO ,
    Synergy Consulting LLC


    Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

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  • 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
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