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How to Register Medicinal Products through the Mutual Recognition Procedure

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Overview 

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical using the EU’s mutual recognition procedure (MRP). The course reviews the administrative aspects of a submission and aspects relating to the quality section of the submission. The course details the initial steps of the procedure, the application assessment, and the referral to the coordination group level CMD(h). The decision-making process by the Committee on Human Medicinal Products (CHMP) related to arbitration and post-arbitration is also reviewed. The course concludes by describing member states' prerogatives, post-authorization activities, and transparency rules.

Featured Topics 

  • Pharmaceutical registration using the EU’s MRP
  • CHMP arbitration and post-arbitration decision-making process

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:

  • Identify the legal basis and scope of the MRP
  • Provide procedural background information
  • Review the administrative aspects of a submission
  • Explore the aspects related to the quality section of the dossier
  • Describe what occurs during the evaluation process, from the initial steps of the MRP to the decision-making process
  • Explain national Member States prerogatives, post-authorisation activities and transparency

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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