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 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.
Requirements and recommendations for interaction with the FDA are presented for each step in the drug and biologics submission 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.
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participate and lead teams in understanding and meeting FDA requirements, and advise teams on the impact of current and draft Guidance notices from the FDA, new US laws, and international (ICH) regulations on the study and registration of new drugs and biologics.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.
Innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialist employed in industry, regulatory agencies or consulting.
• Hold a relevant bachelor degree or equivalent
• Have a minimum of 2 years working experience within regulatory affairs
• Be proficient in English
Find detailed information about the admission criteria.
- Lene Jørgensen, Associate Professor and Head of Studies, Department of Pharmacy, University of Copenhagen, Denmark
- Robert Babilon
This course is offered as a compulsory part of the Master of Medicines Regulatory Affairs.
Priority is given to students enrolled on Master of Medicines Regulatory Affairs. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
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.
|Dates:||7-9 June 2023|
|Frequency:||Once per year|
|Place:||Atrium, Greater Copenhagen, Denmark|
|Course fee:||EU/EEA citizens
Master student: 19,730 DKK
Single course participants: 21,730 DKK
The fee includes lunch/coffee.
|Level and credit:||Master course; 4 ECTS|
|Examination date:||See exam schedule|
|Application deadline:||26 April 2023|
|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