The Pharmaceutical Legal Frameworks in the EU

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

Keywords

• EU legal frameworks

• Life science laws

• National competent authorities

• New pharmaceutical legislation

• EU regulations and directives