The Regulatory Affairs Environment for Generic Products in the EU, module 15

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

2 - 3 Nov 2023

or

4 - 5 Feb 2025

On location

English

13,100 DKK ex VAT

(app. 1,761 EUR ex VAT)

50% DISCOUNT FOR PUBLIC INSTITUTIONS

Summary

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.


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
   

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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

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Course leader & lecturers

  • Adrian Andrews
    Course leader
    Senior Director Regulatory Affairs
    Teva Pharmaceuticals Europe, UK
  • Malin Filler
    Lecturer
    Senior Consultant Regulatory Affairs and Clinical Pharmacokinetics
    UNKNOWN
  • Frank van Strien
    Lecturer
    Vice President Regulatory Affairs
    Synthon Holding BV
  • Christina Bang Clausen
    Lecturer
    Principal Specialist
    Orifarm Generics A/S
  • Anna Mira Hounsgaard
    Lecturer
    Senior Specialist
    Orifarm Generics A/S
  • Sally Silvester
    Lecturer
    Associate Director, EU Steriles & Complex Generics
    Teva Pharmaceuticals Europe, UK
  • Iva Klarica Domjanović
    Lecturer
    MPharm, MSc, PhD
    Agency for Medicinal Products and Medical Devices of Croatia
See all

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

Choose your starting date
Starting 2 Nov 2023
Starting 4 Feb 2025
2 Nov 2023 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
3 Nov 2023 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

30 Nov 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
2 Oct 2023
Atrium
Lersø Parkallé 101
2100 København Ø
Register
2 - 3 Nov
4 Feb 2025 9:00-16:00

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 9:00-16:00

Day 2

  • Application and procedure
  • Clinical Studies
  • BE guidelines
  • Workshop Day 2 - Bioequivalence
  • Trends, future, advantages/ challenges
Practical information

Related exams

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

Registration

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

Course information

Literature

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

Prerequisites

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.

Examination

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.

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Course leader

Adrian Andrews
Senior Director Regulatory Affairs
Teva Pharmaceuticals Europe, UK

Lecturers

Malin Filler
Senior Consultant Regulatory Affairs and Clinical Pharmacokinetics
UNKNOWN
Adrian Andrews
Senior Director Regulatory Affairs
Teva Pharmaceuticals Europe, UK
Frank van Strien
Vice President Regulatory Affairs
Synthon Holding BV
Christina Bang Clausen
Principal Specialist
Orifarm Generics A/S
Anna Mira Hounsgaard
Senior Specialist
Orifarm Generics A/S
Sally Silvester
Associate Director, EU Steriles & Complex Generics
Teva Pharmaceuticals Europe, UK
Iva Klarica Domjanović
MPharm, MSc, PhD
Agency for Medicinal Products and Medical Devices of Croatia

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Want to know more or need help?

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

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