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