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.
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
webinar will provide you with information to ensure that you are ready
for implementing the mandated requirements of the CTD/eCTD
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
- Project Management
- Regulatory Operations
- Anyone responsible for providing content for the CTD
Speaker ProfilePeggy 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).
Time: 08:00 AM PDT | 11:00 AM EDT
Lecture 1 - CTD > eCTD
Lecture 2 - eCTD Prepararation
- 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
- 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.)
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