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Marketing Authorisation & Change Procedures for Generics

  • 03/06/2019 - 04/06/2019
  • Athens, Greece

Meet the masterclass leader:

  • Dr. Helmut Vigenschow
  • Pharmaceutical Consultant
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Course Description

 

Understand the specific legal environment concerning generic medicinal products. Update your knowledge on regulatory procedures for new applications and variations. Get an overview on the documentation for Generic applications. Understand the current integrated life-cycle approach from development to registration and maintenance.

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Key Topics

Marketing Authorisation Procedures in the EU

Development challenges of Generics

Structure and content of the regulatory documentation

Regulatory change management

Key takeaways

Understand the specific challenges related to development and registration of generic medicinal products in the Eu

Design regulatory strategies tailored your products and your company

Update your knowledge on marketing authorisation procedures

Managean integrated regulatory life-cycle of your products

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Delegate Fee

from 2396 € Buy

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Athens is the capital and largest city of Greece. Athens dominates the Attica region and is one of the world's oldest cities, with its recorded history spanning over 3,400 years and its earliest human presence starting somewhere between the 11th and 7th millennium BC.

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