Drug Regulatory Science

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.

Participants must

• 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.