Summary
Module 1
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.
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
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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 & lecturers
- Gitte DyhrCourse leaderDivisional Director
H. Lundbeck A/S - Stine Gregers HørsøeCourse leaderSpecialkonsulent, Legal & international Advisor
Lægemiddelstyrelsen
Is this course for you?
This course is for you if you work as a regulatory affairs specialist, employed in the industry, a regulatory agency, or a consulting firm.
What you will learn
- The principles of the EU legislative framework underpinning each step of the drug development process from pre-approval to post-approval
- The roles and responsibilities of the key players in the EU regulatory process
- How the legislation helps establish an on-going benefit-risk evaluation throughout the life cycle of a medicinal product
- How to analyze and critically appraise a medicinal product in the context of the EU legislative framework
- How to use good regulatory practices as a means of improving the regulatory environment
What your company will get
- A regulatory professional who understands the EU regulatory process and collaboration between EU institutions
- A regulatory professional who can provide valuable input to all other team members in projects concerning EU regulations and directives
- An employee who can play an important strategic role in any project team working on obtaining a marketing authorization in the EU
Course calendar
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
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
Day 3
- Pharmacovigilance
- Liability, labeling and pharmacovigilance
- Orphan medicinal products
- Advanced therapies medicinal products (ATMP)
- Group work
Registration
Registration deadline2 Apr 2024
Lersø Parkallé 101
2100 København Ø
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
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
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Contact Client Manager Mette Ribergaard Rasmussen at +45 39 15 09 30
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