Drug Regulatory Science
Direct your company towards a more robust decision-making process based on scientific evidence as well as administrative and legal aspects of regulation.
Regulation of medicines should be based on reliable science. With Regulatory Science we study both intentional as well as unintentional effects of drug regulation, regulatory instruments and regulatory decision-making, on drug development and innovation and on public health. Per Sindahl, PhD fellow at Copenhagen Centre of Regulatory Science, has an interesting take on that:
“As we demand that medicines are effective, this should also be the case for the system overseeing medicines. In other words, the regulation of medicines must contribute to the patients’ safety, and we should know to what extent it does.”
This course introduce the concept of regulatory science as the foundation of both regulatory and legislative decisions.
At this course, you will be presented with fundamental scientific investigations that challenge your perception and incentive to use new tools and standards to evaluate the efficacy, safety, quality and performance of medical products.
You will be taught how to evaluate the performance of drug regulations and regulatory instruments, the gaps of the tools and how to choose tools and methods that support regulatory decision-making.
Teaching includes lectures, case-studies, oral presentations and group discussions. Participants are trained to critically reflect on pharmaceutical legislation and guidelines, which are critical to ensure a quality-based storyline.
The scientific approach enables you to challenge current concepts of benefit/risk assessment. You will get skills to facilitate a sound and transparent regulatory decision-making and rethink your approval strategies based on clinical relevance and scientific legitimacy.
Regulatory affairs specialists striving to 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 2 years of relevant job experience
- Be proficient in English
Find detailed information about the admission criteria.
- Course responsible:
Christine Erikstrup Hallgreen, Associate Professor, Department of Pharmacy, University of Copenhagen, Denmark
This course is offered as a compulsory part of 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.
|Duration:||3 days on campus|
|Dates:||Expected to be offered next time in autumn 2024|
|Frequency:||Only available every second year|
|Place:||University of Copenhagen, Copenhagen, Denmark
|Course fee:||EU/EEA citizens
Master student: 10,000 DKK
Single course participant: 12,000 DKK
The fee includes lunch/coffee.
|Level and credit:||Master course; 3 ECTS|
|Examination date:||See the exam schedule|
|Application deadline:||8 weeks prior to course start|
|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