Overview:
The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product.
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. 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