External Lecturer, Department of Pharmacy, University of Copenhagen and Director, Abbvie USA.
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.
This course is a part of
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.
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.
Course content
Requirements and recommendations for interaction with the FDA are presented for each step in the drug and biologics development process, including meeting requests, briefing materials and documentation, and dispute resolution. Technical and regulatory requirements for non-clinical, clinical, and chemistry and manufacturing portions of IND, NDA, BLA, and ANDA submissions are described, and the impact of key FDA Guidance documents explained.
Course faculty have worked in the FDA or are individuals experienced in FDA interactions, and the lectures encourage students to understand, apply and integrate the topics and their applications in various regulatory situations. Each topic is supplemented with additional regulatory and technical references, to provide students with current literature. Web-based demonstrations provide real examples of important FDA specific topics.
For more details about the course, please refer to the course curriculum.
Course directors on »The US Regulatory Environment«
Course details for »The US Regulatory Environment«
Dates and examination
Course dates
22–24 October 2025
The course is available every year.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
On completion of the course, you will be able to:
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understand the structure of the FDA and the legal basis for its role in US drug regulation, as well as the requirements and deadlines for written and oral communication with the FDA
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understand the specific regulatory requirements (cGLP, cGCP, cGMP) for data submitted to the FDA
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use relevant websites and understand the key differences between FDA and EMA regulatory processes and requirements
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participate in and lead teams in understanding and meeting FDA requirements, advising on the impact of current and draft FDA Guidance notices, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics
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enhance your understanding of drug development processes to ensure product alignment with FDA expectations
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prepare written meeting requests, draft questions, assemble background packages, and document interactions with the FDA.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent.
- Have a minimum 2 years of relevant job experience.
- Be proficient in English.
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Partnership with Atrium
Atrium is a partner of Master of Medicines Regulatory Affairs. This course is one of 5 courses at the Master's programme, which are offered in collaboration with Atrium.
Atrium is one of Europe’s leading private course providers of practice-based courses in Regulatory Affairs. Their courses are based on collaboration with academia, industry experts and representatives from healthcare authorities.
International educational academy
Atrium is an international educational academy established by The Danish Association of the Pharmaceutical Industry (Lif). As a part of the Danish Association of the Pharmaceutical Industries, Atrium has a close connection to the experts in the Pharmaceutical Industry.
Tuition fees
EU/EEA citizens
Master student: 20,830 DKK
Single course: 22,830 DKK
Non-EU/EEA citizens
Master student: 23,230 DKK
Single course: 25,230 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Location
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel: +45 35 33 60 66