Transparency and Trustworthiness in Drug Development
Identify ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint and learn how to communicate benefit-risk assessments to relevant stakeholders.
Over the last few decades, complex systems of accountability have been designed to increase transparency and build trustworthy relations between healthcare institutions, the pharmaceutical industry, patients and society as a whole. However, many of these systems have had the converse effect and do not always work as intended.
Dilemmas of transparency and trustworthiness are unavoidable when working in drug development. This course provides a space where you can debate real life cases with relevant stakeholders.
Pharmaceutical ethics awareness enables you to develop innovative ways to increase transparency and trustworthiness throughout the whole life cycle of a medicinal product. Understanding the different stakeholders’ perspectives and dilemmas, will provide you with better tools and arguments to put together a trustworthy regulatory dossier.
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.
- 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
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
- Course coordinators:
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:||Next time in Spring 2024 semester|
|Frequency:||Only available every second year|
|Place:||University of Copenhagen, Copenhagen, Denmark
|Course fee:||EU/EEA citizens
Master student: 12,800 DKK
Single course participants: 14,800 DKK
The fee includes lunch/coffee.
|Level and credit:||Master course; 3 ECTS|
|Examination date:||See the exam schedule|
|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