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Meet the training leader

  • Dr. Helmut Vigenschow
  • Pharmaceutical Consultant
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Course description

Understand the specific regulatory & 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, including ICH Q12.

Benefits of attending

Understand

how to overcome the specific challenges related to the development and registration of generic medical products in the EU

Update

your knowledge on marketing authorisation procedures

Design

regulatory strategies tailored to your products and your company

Manage

an integrated regulatory life-cycle of your products

Ticket

Online Live Stream

from 1098 € Buy

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Based on your specific needs and goals, we will build a training program that will equip your employees with the right set of skills and practical knowledge to achieve your organization's targets.

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