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How to Register Medicinal Products through the Centralized Procedure

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Overview 

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical using the centralized procedure. It details the products the procedure applies to and the steps that need to be considered in the pre-submission phase. Participants learn the administrative aspects of a submission and the procedural steps that need to be completed, from day 1 to day 210. The course concludes by reviewing the procedure’s decision-making process and the main post-authorization activities.

Featured Topics 

Register a pharmaceutical using 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:

  • Identify the legal basis and scope of the centralised procedure
  • Describe the procedural and administrative aspects of a submission
  • Clarify the aspects related to the quality section of the dossier
  • Outline the steps to take before the procedure commences
  • Review the steps and actions taken from Day 1 through Day 210 of the review process
  • Explore the aspects taken in the decision-making process
  • Identify the main post-authorization activities

The course takes an average of two 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
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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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