SMRMIF002U Transparency and Trustworthiness in Drug Development

Volume 2023/2024
Education

This course is a compulsory course at Master of Medicines Regulatory Affairs (MRA) at the University of Copenhagen.

 

See course calendar for course dates

 

This course is compulsory at the 2016-curriculum.

Course is open for master students and single course students.

Content

Over the past few decades or so there has been a move towards a  participatory-transparent model of regulation especially in Europe and North America. This call for increased transparency may have been brought about by a number of regulatory scandals, such as the Cox-e2 inhibitor scandal. Some of the key components in this more deliberative and transparent model of regulation is ensuring that the policy-making process is as transparent as possible. This includes making regulatory decision making public, having the pharmaceutical industry share information on clinical trials and other safety related data; and encouraging scientists to debate scientific uncertainties in public.

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.

 

The need for transparency and focus on making almost everything transparent if a big trend in these years, and also in regulatory decision- making. Therefore, a lot of information and documents are now available not just to the professionals but also to the public. This makes the knowledge of where and what is available and why key in drug development and not least it poses a dilemma as there is also time-money and proprietary/confidential information to consider. So does transparency come without costs?

There is many ethical considerations present in the development of medicines, but we don’t often revisit the true definition of biomedical ethics, and after gaining work experience being reminded of the definition can often cause new reflections on practice.

Before the course, you will work on 1-2 homeassignments that will be discussed at the course.

Learning Outcome

After the course you will be able to:

Knowledge

  • Define basic principles behind transparency in relation to drug development
  • Understand contemporary issues affecting transparency in the development, approval, accessibility and use of pharmaceutical products
  • Describe the basic principles within biomedical ethics, including perspectives of different stakeholders.
  • Understand the role of stakeholders in a regulatory context.

 

Skills

  • 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.
  • Prepare a 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 stakeholders.
  • Take responsibility 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, TED-talks and review papers.

 

Applicants must meet the following criteria:
• A bachelor's degree or a master’s degree in health and medical sciences, natural sciences, applied sciences or equivalent
• At least 2 years work experience in the pharmaceutical industry, in a medicines agency or in another relevant organization or company
• Proficiency in English
lectures and workshops
  • Category
  • Hours
  • Lectures
  • 12
  • Preparation
  • 40
  • Theory exercises
  • 12
  • Project work
  • 40
  • Total
  • 104
Continuous feedback during the course of the semester
Credit
4 ECTS
Type of assessment
Written assignment
Type of assessment details
Written exam based on a case.
Aid
All aids allowed
Marking scale
7-point grading scale
Censorship form
External censorship
Exam period

Please see the exam schedule on mra.ku.dk

Re-exam

Please see the exam schedule on mra.ku.dk

Criteria for exam assesment

To achieve the grade 12 the student should be able to:

Knowledge

  • Define basic principles behind transparency in relation to drug development
  • Understand contemporary issues affecting transparency in the development, approval, accessibility and use of pharmaceutical products
  • Describe the basic principles within biomedical ethics, including perspectives of different stakeholders.
  • Understand the role of stakeholders in a regulatory context.

 

Skills

  • 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.
  • Prepare a 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 stakeholders.