Summary
On this three day course, you gain an overview and understanding of the EU legal system and the legislative frameworks underpinning each step of the drug development process.
Special focus will be on the roles and responsibilities of the key players in the EU regulatory process and on collaboration between institutions, such as the European Medicines Agency (EMA) and the National Competent Authorities (NCAs).
These insights will enable you to maneuver and operate, taking the law framework into considerations.
You will get to know about liability for medicinal products and the necessity of making a benefit-risk evaluation on an ongoing basis. You will also learn about the regulations around referrals, variations, and regulatory data protection, which is important knowledge to manage your daily regulatory assignments. Finally, you will get to know the legal framework for Orphan medicinal products, focusing on designation, authorisation, and maintenance.
Other course participants say
"When working in pharmacovigilance, it's very useful to have a good collaboration with Regulary Affairs. The course gives a good overall view of regulatory aspects and terms. "
Tina Buch, Global Pharmacovigilance Manager, Ferring Pharmaceuticals A/S
"Atrium offers an educational, well-designed, and well-organised course that provides an overview of the structure of authorities and pharmaceutical legislation"
Gregor Mandlz, Main Association of Austrian Social Security Institutions
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Keywords
EU legal frameworks
Life science laws
National competent authorities
New pharmaceutical legislation
EU regulations and directives
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Course leader & lecturers
- Gitte DyhrCourse leaderDivisional Director
H. Lundbeck A/S - Stine Gregers HørsøeCourse leaderSpecialkonsulent, Legal & international Advisor
Lægemiddelstyrelsen - Mette Aaboe HansenLecturerDeputy Director, Centre for Medicines Licensing & Pharmacovigilance
Lægemiddelstyrelsen
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Is this course for you?
This course is for you if you want to get a better understanding of the EU legal framework. You may work in regulatory affairs in the life science industry, in a regulatory agency, or a consulting firm. You don’t need a law degree to attend, however this course is a good introduction for e.g. life science lawyers.
What you will learn
- The principles of the EU legislative framework.
- The roles and responsibilities of the key players in the EU regulatory processes.
- How the legislation helps establish an on-going benefit-risk evaluation throughout the life cycle of a medicinal product.
- How to analyse and critically appraise a medicinal product in the context of the EU legislative framework.
What your company will get
- A regulatory professional who understands the EU regulatory process and the collaboration between EU institutions.
- A regulatory professional who can provide valuable input to other team members in projects concerning EU regulations and directives.authorization in the EU.
- An employee who can play a central strategic role in project teams working on obtaining and maintaining a marketing.
Course calendar
Day 1
Marketing authorisation procedures for medicinal products in the EU
The European system for medicinal products: EMA.
The European system for medicinal products: the roles and responsibilities of National Competent Authorities (NCAs).
Day 2
Liability for defective medicinal products
- Referrals
- Variations
- Regulatory data protection
Orphan medicinal products
- Regulation on medicinal products for paediatric use.
Day 3
- Clinical trials (CTs) on medicinal products
- The new clinical trial regulation
- Pharmacovigilance
Registration
Registration deadline26 Feb 2025
Lersø Parkallé 101
2100 København Ø
Course information
Literature
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.
You sign up and pay for the exam separately from the course, as the exam is optional.
This course is a part of a diploma
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 moreCourse leaders
H. Lundbeck A/S
Lægemiddelstyrelsen
Lecturer
Lægemiddelstyrelsen
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