The Regulatory Affairs Environment for Generic Products in the EU

Get an understanding of the characteristics of generic products and the registration and marketing

  • 15. Nov 2018

2 days course

English

11.200,- DKK ex VAT
(app. 1.506,- EUR ex VAT)

Module 15

This course will give you an understanding of the regulatory affairs environment for generic products and generic companies in the EU.

We will focus on the characteristics of generic products and the registration and marketing of generic products. You will also get an understanding of the differences between generic and originator applications.

You will be taken through the life-cycle of generic products from the development of the product through regulatory strategy, evaluation of the dossier and preparation of the marketing authorization application, as well as the post-authorization responsibilities linked to the product, such as pharmacovigilance and life cycle management.

In addition we will compare scenarios such as different challenges at the generic companies for own development products versus in-licensed products.

The module focuses on the current EU regulatory legislation and guidelines.
 

Keywords

Definitions, requirements and socio-economics/ethics
Challenges for generics
Development of generic products
Legal basis and procedures
Strategy
Application and content
Clinical studies relevant for generics
BE guidelines
MAH responsibilities
Future trends
Advantages and challenges

What you will learn

  1. The background for generic products
  2. The possibilities in the legislation for obtaining marketing authorizations with abridged documentation
  3. How to advise and decide in bioequivalence studies
  4. How to analyze and evaluate on strategy and choice of regulatory procedure and reference product

What your company will get

  1. A regulatory professional who understands the characteristics of generic products
  2. A regulatory professional who can navigate within the regulatory affairs environment for generic products
  3. A regulatory professional who can advise and decide in bioequivalence studies
  4. An employee who can play an important strategic role in the analysis, evaluation and decision on regulatory procedure and reference product
Available start dates

Registration quick facts

You can pay by credit card or by invoice. We charge the amount shortly after you register. If you cancel your registration more than 30 days prior to the course, you will receive a full refund. Read our cancellation policy.

Yes, if you experience any technical problems, please call us at + 45 39 27 60 60, or send us an email at contact@atriumcph.com

If you cancel your registration more than 30 days prior to the course, you will receive a full refund. If you get sick on the day of the course, you can hand over your seat to a colleague. To hand over your seat, please contact us at +45 39 27 60 60. Read our cancellation policy.

WANT TO KNOW MORE ABOUT THIS COURSE?

Contact Senior Programme Director Tina Jensen at +45 39 15 09 14

Send an email

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