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 nonclinical, 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.
Course Directors on The US Regulatory Environment
Course details about The US Regulatory Environment
Dates and examination
Course dates
Spring 2025
The course is available every year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Medicines Regulatory Affairs.
Learning outcomes
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.
You will enhance your understanding of drug development processes to ensure alignment product alignment with FDA expectations.
After the course, you will be able to prepare written meeting request, draft questions, assemble background packages, and document interactions with the FDA.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
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: 20,273 DKK
Single course participant: 22,273 DKK
Non-EU/EEA citizens
Master student: 22,673 DKK
Single course participant: 24,673 DKK
The fee includes lunch/coffee.
Location
Atrium
Lersø Parkallé 101
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
Tel.: +45 35 33 60 66