SMRMIF002U Transparency and Trustworthiness in Drug Development
This course is a compulsory course at Master of Medicines Regulatory Affairs (MRA) at the University of Copenhagen.
See course calender for course dates
This course is compulsory at the 2016-curriculum.
Course is open for master students and single course
students.
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 centres around five real life cases illustrating contemporary dilemmas affecting transparency and trustworthiness in the development, approval and use of pharmaceutical products. Moreover, we will cover the viewpoints of the main stakeholders involved in these processes.
Module 1: Ethical dilemmas linked to data-intensive healthcare: a cross-country comparison about citizens’ and professionals’ distrust on public administration of healthcare data.
Module 2: Adapting the regulatory framework towards the patient’s needs: ethical challenges faced when making regulatory decision based on scarce scientific evidence.
Module 3: Revisiting the paradigm of autonomy and informed consent in light of the ever increasing globalization of clinical trials.
Module 4: Ethics after post-authorization: communicating benefit/risk proactively and with transparency.
Module 5: When drugs are available but not affordable: ethical dilemmas on unequal access to pharmacological treatments.
After the course you will be able to:
Knowledge
Understand and deal with contemporary issues affecting transparency and trustworthiness in the development, approval, accessibility and use of pharmaceutical products
Describe the basic principles within biomedical ethics, including perspectives of different stakeholders.
Explain and discuss the basic issues of regulatory compliance and good practices, including expectations to regulatory professionals.
Describe the development of patient involvement in medicines development and its use, including use of patients reported outcome measure and development of questionnaire to capture new knowledge about prioritised patients’ perspectives.
Skills
Identify and analyse ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint.
Discuss the role and responsibilities of regulatory affairs professionals within the pharmaceutical field.
Identify and account for the role of assessing benefit-risk as a part of the life cycle of medicines.
Prepare a more sound and trustworthy regulatory dossier based on the understanding of values embedded in pharmaceutical ethics, beyond the fulfillment of law.
Competencies
Argue for ethical prioritisations from a regulatory professional’s point-of-view, including consequences for interested parties.
Take responsability for developing innovative ways to increase transparency and trustworthiness throughout the whole life cycle of drug development using pharmaceutical ethics awareness.
A complete list of reading material will be distributed electronically before the course. The syllabus comprises relevant books, book chapters, scientific papers and review papers. For example
Beauchamp TL, Childress JF. (2012) Principles of Biomedical Ethics. 7th ed. Oxford University Press
Salek S, Edgar A (2002). Pharmaceutical Ethics. John Wiley & Sons, Ltd
O’Neill Onora. Autonomy and Trust in Bioethics (2002). Cambridge University Press,
Stirrat GM and Gill R. Autonomy in medical ethics after O’Neill. Journal of Medical Ethics. 2005; 31:127–130.
Wadmann S and Hoeyer K. Dangers of the digital fit: Rethinking seamlessness and social sustainability in data-intensive healthcare. Big Data & Society. January–June 2018: 1–13
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
- Category
- Hours
- Exam
- 30
- Lectures
- 15,5
- Preparation
- 44,5
- Project work
- 20
- Total
- 110,0
See course calender for course dates
Application deadline is 8 weeks before the first day of instruction. If we have empty seats after the application deadline, it is possible to apply after deadline.
- Credit
- 4 ECTS
- Type of assessment
- Written assignmentWritten exam based on a case. The exam consists on a written essay based on a case that will be provided and discussed during the course.
- Aid
- All aids allowed
- Marking scale
- 7-point grading scale
- Censorship form
- External censorship
- Exam period
The written essay should be delivered two weeks after completion of the course
Please see the exam schedule on http://mra.ku.dk/calender/exams/
- Re-exam
Please see the exam schedule on http://mra.ku.dk/calender/exams/
Criteria for exam assesment
To achieve the grade 12 the student should be able to:
Knowledge
Understand and deal with contemporary issues affecting transparency and trustworthiness in the development, approval, accessibility and use of pharmaceutical products
Describe the basic principles within biomedical ethics, including perspectives of different stakeholders.
Explain and discuss the basic issues of regulatory compliance and good practices, including expectations to regulatory professionals.
Describe the development of patient involvement in medicines development and its use, including use of patients reported outcome measure and development of questionnaire to capture new knowledge about prioritised patients’ perspectives.
Skills
Identify and analyse ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint.
Discuss the role and responsibilities of regulatory affairs professionals within the pharmaceutical field.
Identify and account for the role of assessing benefit-risk as a part of the life cycle of medicines.
Prepare a more sound and trustworthy regulatory dossier based on the understanding of values embedded in pharmaceutical ethics, beyond the fulfillment of law.
Competencies
Argue for ethical prioritisations from a regulatory professional’s point-of-view, including consequences for interested parties.
Take responsability for developing innovative ways to increase transparency and trustworthiness throughout the whole life cycle of drug development using pharmaceutical ethics awareness.
Course information
- Language
- English
- Course code
- SMRMIF002U
- Credit
- 4 ECTS
- Level
- Part Time Master
- Duration
- 5 days
- Placement
- Spring And Autumn
- Schedule
- 5 days full time
- Course capacity
- 25
- Continuing and further education
- Price
Prices vary according to type of enrolment and nationality. For details please visit:
- Study board
- Study Board for the Professionel Master´s Degree Programmes at The Faculty og Health and Medical Science
Contracting department
- Department of Pharmacy
Contracting faculty
- Faculty of Health and Medical Sciences
Course Coordinators
- Lourdes Cantarero Arevalo
(13-76797f386d6b787e6b7c6f7c794a7d7f786e38757f386e75)
Main course responsible
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 Eurpean Medicines Aagency, 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
Additional speakers will be included.