SMRMIF001E Exam in Regulatory Affairs in the USA
This exam 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 exam as a single course student.
differences between FDA and EMA requirements
- Category
- Hours
- Exam
- 3
- Exam Preparation
- 24
- Total
- 27
- Credit
- 1 ECTS
- Type of assessment
- Written assignment, 3 hours3 hours written assignment with descriptive questions held on Digital Exam - The online platform for examination at the University of Copenhagen.
- Exam registration requirements
Students must have passed the course SMRMIF001U Regulatory Affairs in the USA in order to participate in the examination
- Aid
- All aids allowed
- 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:
Knowledge
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
Skills
Correctly identify timelines and requirements for FDA interactions, submissions, and reviews
Competencies
- Correctly identify FDA-specific regulatory requirements and key differences vs EMA
Course information
- Language
- English
- Course code
- SMRMIF001E
- Credit
- 1 ECTS
- Level
- Part Time Master
- Placement
- Autumn
to be announced
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Course Coordinators
- Lourdes Cantarero Arevalo
(13-74777d366b69767c697a6d7a77487b7d766c36737d366c73)
Head of studies
Steven Johnson, s.johnson1@medpace.com (chief responsibility)
David Horton, d.horton@medpace.com