Overview
This course, a Thomson Reuters Cortellis Regulatory Online Learning module, provides an in-depth review of the post-marketing activities for medical products authorized via the centralised procedure. The course covers the following aspects of this European process:
- Maintaining marketing authorisation validity
- Updating the terms of a marketing authorisation through variations, including urgent safety restrictions
- Enlarging the terms of a marketing authorisation through extension applications
- Fulfilling post-authorisation commitments, such as follow-up measures and specific obligations
- Submitting annual reassessments
- Applying for renewals
Featured Topics
Post-marketing activities for medical products authorized via the centralized procedure
Who Should Attend
Professionals and experts in the pharmaceutical, biotechnology, and medical device fields
Learning Objectives
Participants who complete this course should be able to:
- Maintaining marketing authorisation validity
- Updating the terms of a marketing authorisation through variations, including urgent safety restrictions
- Enlarging the terms of a marketing authorisation through extension applications
- Fulfilling post-authorisation commitments, such as follow-up measures/specific obligations
- Submitting annual reassessments
- Applying for renewals
The module takes an average of 1.5 hours to complete.
Contact Information
Technical Requirements
Click here for minimum system requirements.