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

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Course Description/Agenda

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. Beginning in May 2017, the eCTD will be required in the US for all marketing applications.

Why you should attend

This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.

Who Will Benefit

Regulatory Affairs
Quality Assurance
Pharmacovigilance
Project Management
Regulatory Operations
Anyone responsible for providing content for the CTD

Agenda

- - 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
    
    Implementing tools for the project management of CTD preparation and publishing
    
    Technical requirements for an eCTD submission
    
    Document naming requirements
    
    Building the folder structure
    
    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.)

Instructor:

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).

More Webinar Information

Global Compliance Panel
Course Summary	This webinar will provide you with information to ensure that you are ready for implementing the mandated requirements of the CTD/eCTD.
Delivery Method	Virtual Classroom (Live)
Who Should Attend	• Regulatory Affairs • Quality Assurance • Pharmacovigilance • Project Management • Regulatory Operations • Anyone responsible for providing content for the CTD