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How to Maintain Marketing Approvals in Europe for Centrally Authorised Products

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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.

Contact Information 

Linda Belmont, DIA
Phone +1.215.293.5818
Linda.Belmont@diahome.org

Technical Requirements 

Click here for minimum system requirements.

Registration Fees 

Other Fees

Individual
$495.00
Register Online

Unless otherwise disclosed, the statements made by speakers represent their own opinions and not necessarily those of the organization they represent, or that of the Drug Information Association. Speakers, agenda and CE information are subject to change without notice. Recording of any DIA educational material in any type of media is prohibited without prior written consent from DIA.

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