The Regulatory Affairs Environment for Generic Products in the EU

Get an understanding of the characteristics of generic products and the registration and marketing (module 15)

Date icon

4 - 5 Feb 2025

Attendance icon

On location

Language icon


Price icon
13,500 DKK ex VAT

(app. 1,815 EUR ex VAT)



This two day 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.

Other course participants say

"Good overview of the basic requirements and considerations needed for generic products."

Jette Børsting, Head of RA, QA and PV, QP & QPPV, Salfarm

"The course provided a perfect overview of registrations in the EU."

Christoph Nicolaus, Senior Zone Specialist, PRO.MED.CS Praha a.s. 


Do you need help choosing the right course? 

We are ready to help you at +45 39 27 60 60 or 

Stay tuned with Atrium's newsletter 


  • 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

Save information for later
Read more

Course leader & lecturers

  • Adrian Andrews
    Course leader
    Senior Director Regulatory Affairs
    Teva Pharmaceuticals Europe, UK

Watch the video

Is this course for you?

This course is for you if you are an experienced Regulatory Affairs professional, employed in the industry, a regulatory agency, or a consulting firm.

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

Course calendar

Starting 4 Feb 2025
4 Feb 2025 8:15-17:00
Day 1
  • Introduction
  • Setting the scene – authority point of view
  • Setting the scene – industry point of view
  • Legal basis and procedures
  • Development of generic products
  • Strategy
  • Workshop Day 1 – Strategy
5 Feb 2025 8:15-16:15
Day 2
  • Application and procedure
  • Clinical Studies
  • BE guidelines
  • Workshop Day 2 - Bioequivalence
  • Trends, future, advantages/ challenges
Practical information

Related exams

7 Mar 2025 10:00-13:00
Go to exam page


Registration deadline
28 Jan 2025
Lersø Parkallé 101
2100 København Ø
4 - 5 Feb
Sometimes things change. This is the expected programme.

Course information


Prior to the course you will get access to mandatory and optional readings via your personal Atrium log-in.

Please familiarize yourself with the mandatory readings before starting the course.

The mandatory readings are also part of the examination syllabus


To enroll in this course, you must have a relevant educational background at bachelor level and experience in regulatory affairs or other equivalent qualifications. We consider all applications upon registration.

If you do not fulfill the requirements, you can still apply for the course if you have experience in the pharmaceutical/biological area that would allow you to benefit from the training and enable you to participate actively during the module. Up to 10% of the positions on our course are filled by applicants who have no or limited experience in regulatory affairs.

We consider applicants on a case-by-case basis.


The exam is held online, usually 4-6 weeks after the course.

You will receive a link with exam questions via your personal Atrium log-in.

In order to participate in the exam, you must have attended the course.

This course is a part of a diploma

Diploma in Regulatory Affairs

The regulatory affairs diploma gives you an understanding of the entire regulatory affairs platform of the medicinal lifecycle. All courses have been designed in collaboration with highly acclaimed experts that are on our regulatory affairs Advisory Board.

Read more

Course leader

Adrian Andrews
Senior Director Regulatory Affairs
Teva Pharmaceuticals Europe, UK

You may also be interested in these courses

Want to know more or need help?

Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30

Send me a message