Transparency and Trustworthiness in Drug Development

This course centers on topics that cover some of the contemporary dilemmas affecting transparency, ethics, communication and trustworthiness in the development, approval and use of pharmaceutical products. This is done by:

• Introducing the students to key concepts of bioethics and transparency.
• Present and discussing case studies of dilemmas of transparency in drug development and regulatory decision-making.
• Introduce and discuss principles for communication of medical benefit-risk decision-making under uncertainty.

After the course you will be able to:

• Understand contemporary issues affecting transparency in the development, approval, accessibility and use of pharmaceutical products.

• Take responsibility for developing innovative ways to increase transparency and trustworthiness throughout the whole life cycle of drug development using pharmaceutical ethics awareness.

• Describe the basic principles within biomedical ethics, including perspectives of different stakeholders

• Identify and analyse ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint.

• Identify and produce timely communication of benefit-risk to relevant stakeholders.

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.

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.