16 April 2024

The US Regulatory Environment

Learn how to identify and apply correct timelines for written and verbal FDA interactions and documentation necessary for marketing authorisations in the United States of America. Evaluate and propose strategic scenarios on different regulatory pathways for various US situations.

The US Regulatory Environment

The course provides an in-depth overview of the US FDA organization, history, legal standing and roles and responsibilities in the new drug and biologics approval, registration, and marketing process.

Specific similarities and differences between the FDA and EMA are presented, especially major differences in technical requirements and regulatory authority, so that students understand the US FDA in the context of world-wide regulatory submissions. 















During the course, you will get an understanding of the structure of the FDA and the legal basis for the FDA’s role in the US drug regulation, and the requirements and deadlines for written and oral communication with the FDA.

You will learn to understand the specific regulatory requirements (cGLP, cGCP, cGMP) for data submitted to the FDA. Finally, you will learn to use relevant websites and understand the key differences between FDA and EMA regulatory processes and requirements.

You will be taught to participate and lead teams in understanding and meeting FDA requirements, and advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics.  

After the course, you will be able to prepare written meeting request, draft questions, assemble background packages, and document interactions with the FDA.
























  • David Horton,External Lecturer, Department of Pharmacy, University of Copenhagen and Director, Abbvie USA
    • Robert Babilon, External Lecturer, Department of Pharmacy, University of Copenhagen and President, Prosoft Clinical


















Course details

Duration: 3 days
Dates: 16-18 April 2024
Frequency: Once per year
Place: Atrium, Greater Copenhagen, Denmark
Course fee: EU/EEA citizens
Master student: 20,273 DKK
Single course participants: 22,273 DKK

Non-EU/EEA citizens
Master student: 22,673 DKK
Single course participants: 24,673 DKK

The fee includes lunch/coffee.
Payment conditions

Level and credit: Master course; 4 ECTS
Examination date: See exam schedule
Application deadline: extended till 19 March 2024
Admission: To be admitted, you must meet the admission criteria for Master of Medicines Regulatory Affairs

Course dates and application deadlines are announced via the programme newsletter.
Download course curriculum