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.”

WHAT YOU WILL LEARN

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.

COURSE CONTENT

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.

PARTICIPANTS

Participants must meet the following criteria: 
• A relevant bachelor degree or equivalent 
• A minimum of 2 years working experience within regulatory affairs 
• Be proficient in English

COURSE DETAILS

Course dates

Expected to be scheduled in Autumn 2020

Course fee

EU/EEA citizens Master student DKK 10,000

Non EU/EEA citizens Master student DKK 11,500

EU/EEA citizens Single course student DKK 12,000

Non EU/EEA citizens Single course student DKK 13,500

Application deadline

To be announced.

EXAMINATION

The student will be assessed based on a written assignment.

Credit

3 ECTS

Examination dates

To be announced.