Startdate:
7 November 2012 - 8 November 2012

Purpose:
The aim of the course is to give the participants an understanding of the regulatory affairs environment for generic products and generic companies in the EU. The course will focus on the characteristic of generic products and the registration and marketing of generic products. The participants 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 the course 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.

During the course, students will meet very experienced lecturers and benefit from their individual competences in different regulatory disciplines. All lecturers have been carefully chosen and represent both the Competent Authorities and the Pharmaceutical Industry. Further, learning activities will be enhanced through interaction with other students and group work on case stories, illustrating specific challenges and situations from the generic regulatory business.

By the end of this module, the student should be able to:
- understand the background for generic product and the possibilities in the legislation for obtaining marketing authorizations with abridged documentation.
- advise and decide bioequivalence studies
- analyse and evaluate on strategy and choice of regulatory procedure and reference product.

Download Program

Content:
• Definitions and 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
• Trends, Future, Advantages/Challenges

Course Leaders:

Kamma Martensen Hansen
Head of Regulatory Affairs, Alternova, Denmark

Inge Abildgaard
Inge Abildgaard, Regulatory Affairs Manager, International Regulatory Affairs, Nycomed: a Takeda Company, Denmark
 

Target:
It is targeted at regulatory employees from any kind of companies and from the health authorities who wish to get an understanding of the regulatory affairs environment for generic products and generic companies in the EU.

Prerequisites:
In order to secure the professional level of the education. The participants must have a educational background at bachelor level within a relevant area and at least two years’ experience within Regulatory Affairs or equivalent qualifications. Please note that applications will be considered in order of receipt.

Literature:
A list of recommended literature will be send to the participants approx. 4 weeks prior to the start of the module.