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.

• • Course coordinators:
    Lene Jørgensen, Associate Professor and Head of Studies, Department of Pharmacy, University of Copenhagen, Denmark
  • Christine Erikstrup Hallgreen, Associate Professor, Department of Pharmacy, University of Copenhagen, Denmark
    
    Lecturers:
    Marieke De Bruin, Professor, Director of the Copenhagen Centre for Regulatory Science (CORS), University of Copenhagen
    Klemens Kappel, Professor, Department of Media, Cognition and Communication, University of Copenhagen
    Dr. Mark Flear, Senior lecturer, School of Law, Queens University, Belfast
    Sofia K. Sporrong, Associate Professor in Social and Clinical Pharmacy, University of Copenhagen
    Sinan Badakci Sarac, Chief Medical officer at the Danish Agency, member of the European Medicines Agency, CHMP
    Birthe Ryskov, European Rare Diseases, Eurordis Denmark
    Henrik Harksen, External Associate professor, Department of Pharmacy, University of Copenhagen
    Dr. Rosemarie Bernabe, Marie Curie Postdoctoral Fellow, Centre for Medical Ethics, University of Oslo
    Karen Brøndum-Nielsen, Professor, Chair of the National Committee on Health Research Ethics, Denmark
    Karin Friis-Bach, Danish Politician, Copenhagen Capital Region
    Vibeke Bjerregaard, Former Senior Regulatory Affairs Project Manager Novo Nordisk
    Dr. Jonathan Ives, Senior Lecturer, Deputy Director - Centre for Ethics in Medicine, Bristol Medical School, University of Bristol

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.