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How to Register Medicinal Products through the Decentralized Procedure

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Overview 

This course, a Thomson Reuters Cortellis Regulatory Online Learning module, covers how to register a pharmaceutical or medical product using the decentralized procedure. The course examines the products the procedure applies to and describes the steps for completing and submitting a marketing authorization application. The phases and key events of the evaluation process and the possible outcomes of the procedure are discussed. The course concludes by examining the tasks that occur after the decentralized procedure is finalized and the parties responsible for completing them.

Featured Topics 

Registering a pharmaceutical or medical product using the decentralized 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:

  • Understand to which products the decentralised procedure applies
  • Clarify the aspects to consider when defining a strategy for submission
  • Identify the authorities that can provide regulatory and/or scientific advice
  • Understand the role the Reference Member State plays in the procedure
  • Differentiate the phases of the decentralized procedure
  • Review the activities involved in the procedure's timetable
  • List the content of the various assessment reports
  • Explore the possible outcomes of the decentralized procedure
  • Examine post-authorization activities

The module takes an average of one hour 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
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