SMRMIF001U Course in Regulatory Affairs in the USA
This course is offered in collaboration between University of Copenhagen and Medicademy as part of the Master of Medicines Regulatory Affairs. It is possible to follow the course as a single course student.
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. The structure of the FDA and its relationship to the US government, international pharmaceutical companies, and the EMA is defined. 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. 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. Post approval areas regulated by the FDA including direct-to consumer advertising and risk management compliance, are discussed. Interactive web-based demonstrations are used to introduce students to the FDA website, navigate to critical areas of the website and retrieve information, and understand key concepts in drug marketing. A group exercise of a mock interaction with the FDA reinforces the concepts discussed in the lectures. After completing this Module, the student will have an overview of the FDA structure, specific recommendations for communicating with the FDA during all phases of drug and biologics development, and how regulatory affairs professionals can interact and lead drug development teams in obtaining approval for new drugs and biologics in the US.
This course is connected to the exam SMRMIF001E Exam in Regulatory Affairs in the USA. To earn the full 5 ECTS credits, you are required to pass the exam.
After completing the course the student is expected to be able to:
- Understand the structure of the FDA and the legal basis for the FDA’s role in US drug regulation
- Understand the requirements and deadlines for written and oral communication with the FDA from the pre-IND through post-approval stages of drug and biologics submissions
- Understand the specific regulatory requirements (cGLP, cGCP, cGMP) for data that are submitted to the FDA
- Understand how to use websites, especially FDA.gov, to research and retrieve important Guidance documents, legal action notices, and clinical trials information.
- Understand key differences between FDA and EMA regulatory processes and requirements
- Participate and lead teams in understanding and meeting FDA requirements for the study and registration of new drugs and biologics in the US
- Prepare written meeting requests, draft questions, assemble background packages, and document interactions with the FDA
- 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
- Explain the structure of FDA and areas of legal responsibility
- Identify and apply correct timelines for written and verbal FDA interactions
- Identify where and how key information can be found
- Recognize key differences between FDA and EMA requirements
The syllabus comprises selected guidances, acts, etc. A list of reading material will be distributed electronically approx. 4 weeks before the course. The course participants are expected to familiarize themselves with the syllabus, corresponding to approximately 1200 pages.
• A relevant bachelor degree or equivalent
• A minimum of 2 years working experience within regulatory affairs
• Proficiency in English
Besides lectures the students must prepare by reading the course literature
- 4 ECTS
- Type of assessment
- Course participationParticipation in the course is a requirement for participating in the exam SMRMIF001E Exam in Regulatory Affairs in the USA
- Marking scale
- passed/not passed
- Censorship form
- No external censorship
Criteria for exam assesment
To achieve the grade passed, the student shall (in an adequate level) be able to:
Understand the structure of the FDA and the legal basis for the FDA’s role in US drug regulation
Describe requirements for key FDA submissions
Correctly match regulatory compliance requirements for CMC, nonclinical, and clinical study content
Correctly identify timelines and requirements for FDA interactions, submissions, and reviews
- Correctly identify FDA-specific regulatory requirements and key differences vs EMA
- Theory exercises