|
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. The international agreement to assemble all quality, safety and efficacy information for a drug or biologic product into a common format-common technical document (CTD)-has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is also 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. The speaker will also provide a brief overview of the difference between submissions to US and Rest of the World (ROW) and give you a basic understanding how the regions differ.
Key Learning Objectives
- Identify best practices with software used to generate electronic submission content
- Understand the acronyms and terms surrounding eCTD and electronic submissions
- Apply ICH and regional requirements for the content of an eCTD submission
- Produce and review eCTDs to minimize the chance of Refusal to Review and Refuse to File (RTF) actions by FDA
- Obtain an understanding of what is required to transition into submitting in the eCTD format
|
|
|
|
|
|
|
|
Peggy J. Berry
Ms. 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. SHe is the author of the 2011 book "Communication & Negotiation" (RAPS, MD).
|
|
View More
|
|
|
|
|
Host This Webinar At Your Organization
Become a Speaker
