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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.

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