6-Hour Virtual Seminar on Electronic Common Technical Document (eCTD) Submissions of IND/NDA to the US FDA, EU and Canada

Duration: 6 hours
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. Even though the eCTD has increased efficiency for reviewers and improved submission times, the transition to electronic has also made things more complex. Companies are slowly uncovering several burdens as they transition to the electronic common technical document (eCTD) format.
Electronic Common Technical Document (eCTD)
Instructor: Peggy J. Berry
Product ID: 508426
Objectives of the Presentation
  • To understand the common submission intake process with CTD structure
  • Develop plans for the compilation of compliant eCTD submissions
  • Identify processes employed in preparing CTD/eCTD submissions
  • Understand the basics of correct eCTD format and requirements to generate submission-ready documents
  • Identify & access tools and technology used in preparation and review of eCTDs
  • Identify potential Submission pitfalls & real life case studies
  • Best practices that will lead to successful electronic regulatory applications
  • Compare regional specific requirements for electronic submissions in a global market
Why Should you Attend
This seminar will provide you with information to ensure that you are ready for implementing the mandated requirements of the new CTD/eCTD. This training will also provide you with an in-depth review of the content and format requirements of the CTD/eCTD. While focusing on the US requirements, it will also provide a quick overview of current regulatory guidelines of eCTD in other major world market. This common technical document training will provide useful tools for the participants to build eCTD’s from scratch. Industry best practice’s, as well as common submission pitfalls from the reviewer's perspective will be discussed to help the participants in formulating the best strategies and employing the most practical tools to enhance the success of their electronic submissions.

Areas Covered
Lecture 1 - CTD > eCTD
  • 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 content & format requirements
  • Implementing tools for the project management of CTD preparation and publishing
Lecture 2 - eCTD Preparation
  • Technical requirements for an eCTD submission
  • Document naming requirements
  • Building the folder structure
  • Publishing each document, module & submission
  • Tools for tracking and managing eCTD content
  • Performing quality checks on the eCTD
  • Lifecycle management: Updating content (amendments, supplements, variations, etc.)
Who will Benefit
This virtual seminar is beneficial for professionals working in the drugs, biologics or combination products fields who are involved in the preparation of electronic submissions, particularly medical writers, regulatory operations and submissions publishing.
  • Regulatory Affairs professionals
  • Medical and Technical writers
  • Project Managers, Directors
  • Supervisors, and lead workers in Regulatory Affairs
  • Quality Assurance and Quality Control professionals
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • IT professionals looking to make eCTD submissions
  • Anyone responsible for providing content for the CTD
  • Submissions Management
  • Technical and Clinical Writers
  • Documentation Teams
$600
Recorded Session for one participant
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Live Session - How it works
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  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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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