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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


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


your knowledge on marketing authorisation procedures


regulatory strategies tailored to your products and your company


an integrated regulatory life-cycle of your products

Join us in Barcelona

Can you imagine Paris without the famous metal sculpture? Or the Eiffel Tower in Barcelona? Gustave Eiffel’s original idea was to pitch the proposal to the city of Barcelona, and so he did. However, it didn’t go as planned and the city wasn’t too convinced so they rejected. They thought the tower wouldn’t be anything special and might even be an ‘unsightly addition’ to Barcelona’s landscape. After the rejection, Gustave decided to pitch to Paris and the rest is history! Also, did you know that the Eiffel Tower was only meant to be a temporary exhibit?


Delegate Fee

from 2196 € Buy


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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