Conference Description:

Course "eCTD Submissions of IND/NDA to the US FDA, EU and Canada" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

Overview:
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 should you attend:

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

Areas Covered in the Session:

• 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.)

Who will benefit:

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


Agenda:

Day 1 Schedule

Lecture 1:
Overview of the drug development program and source of relevant submission documents
Lecture 2:
Discussion of the roles and responsibilities for CTD preparation
Lecture 3:
Review of the CTD format requirements
Lecture 4:
Discussion on the successful transition from other formats to the CTD
Lecture 5:
Implementing tools for the project management of CTD preparation and publishing
Lecture 6:
Technical requirements for an eCTD submission


Day 2 Schedule

Lecture 1:
Document naming requirements
Lecture 2:
Building the folder structure
Lecture 3:
Performing "pre-publishing" work for each document
Lecture 4:
Tools for tracking and managing eCTD content
Lecture 5:
Performing quality checks on the eCTD
Lecture 6:
Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)


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