The Pharmaceutical Law Frameworks in the EU, module 1

Understand the pharmaceutical law frameworks and how legislation is developed in the EU
17 Jan 2023

3 days course

English

18,000 DKK ex VAT
(app. 2,420 EUR ex VAT)
50% DISCOUNT FOR PUBLIC INSTITUTIONS

module 1

summary

On this course, you will gain an understanding of the background of the EU legal system and the EU legislative framework underpinning each step of the drug development process. You will learn about the roles and responsibilities of the key players in the EU regulatory process, and about collaboration between institutions. After the course, you will be able to analyze and critically appraise a medicinal product in the context of the EU legislative framework.

Keywords

  • Regulatory Affairs in the EU
  • EU Regulations and Directives
  • Notes for Guidance
  • The EU Commission
  • European Medicines Agency (EMA)

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Course leader(s) & Lecturer(s)

  • Gitte Dyhr
    Course leader
    Divisional Director
    H. LUNDBECK A/S
  • Sameer Kohli
    Course leader
    Chief Legal Advisor
    Danish Health and Medicines Authority
  • Carla Schoonderbeek
    Lecturer
    Partner EU Pharma Regulatory Law
    Hoyng ROKH Monegier
See all

IS THIS COURSE FOR YOU?

Whether you are new to the field or have several years of experience, this course is relevant if you are a Regulatory Affairs Professional who wants to improve your knowledge and skills.

What you will learn

  1. The principles of the EU legislative framework underpinning each step of the drug development process from pre-approval to post-approval
  2. The roles and responsibilities of the key players in the EU regulatory process
  3. How the legislation helps establish an on-going benefit-risk evaluation throughout the life cycle of a medicinal product
  4. How to analyze and critically appraise a medicinal product in the context of the EU legislative framework
  5. How to use good regulatory practices as a means of improving the regulatory environment  

What your company will get

  1. A regulatory professional who understands the EU regulatory process and collaboration between EU institutions
  2. A regulatory professional who can provide valuable input to all other team members in projects concerning EU regulations and directives
  3. An employee who can play an important strategic role in any project team working on obtaining a marketing authorization in the EU

Course calendar

Starting 17 Jan 2023
17 Jan 2023 8:30-16:30

DAY 1

  • The European System for Medicinal Products - General Background to the EU and its Institutions
  • The European system for medicinal products - EMA
  • The European system for medicinal products - The role and responsibilities of National Competent Authorities (NCAs)
  • Group work
18 Jan 2023 8:00-16:35

DAY 2

  • Marketing authorization system for pharmaceuticals in the EU
  • Clinical trials (CTs)
  • Clinical trials - the new CT regulation
  • Referrals
  • Variations
  • Regulatory data protection
  • Regulation on medicinal products for pediatric use
  • Group work
19 Jan 2023 8:00-15:15

DAY 3

  • Pharmacovigilance
  • Liability, labeling and pharmacovigilance
  • Orphan medicinal products
  • Advanced therapies medicinal products (ATMP)
  • Group work
Practical information

Related exams

7 Feb 2023 10:00-13:00
Go to exam page

Registration

Registration deadline
20 Dec 2022
Atrium
Lersø Parkallé 101
2100 København Ø
Register
17 - 19 Jan
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, as a minimum, two years of 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 this programme

Regulatory Affairs Diploma

The regulatory affairs diploma gives you an understanding of the entire ‘regulatory affairs platform’ of the medicinal product lifecycle. All courses have been designed in collaboration with highly acclaimed experts, that are on our regulatory affairs faculty board

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Course leader(s)

Gitte Dyhr
Divisional Director
H. LUNDBECK A/S
Sameer Kohli
Chief Legal Advisor
Danish Health and Medicines Authority

Lecturer(s)

Carla Schoonderbeek
Partner EU Pharma Regulatory Law
Hoyng ROKH Monegier

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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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