Transparency and trustworthiness in drug development

Course content

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.

Education

Compulsory Course for Master of Medicines Regulatory Affairs (MRA)

Course is open for master students and single course students.

Learning outcome

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.

The course combines group work, lectures, and panel discussion with experts, decision-makers, patients’ representatives and industry professionals.

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

  1. Beauchamp TL, Childress JF. (2012) Principles of Biomedical Ethics. 7th ed. Oxford University Press

  2. Salek S, Edgar A (2002). Pharmaceutical Ethics. John Wiley & Sons, Ltd

  3. O’Neill Onora. Autonomy and Trust in Bioethics (2002). Cambridge University Press,

  4. Stirrat GM and Gill R. Autonomy in medical ethics after O’Neill. Journal of Medical Ethics. 2005; 31:127–130.

  5. 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

 

Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English

Continuous feedback during the course of the semester
ECTS
4 ECTS
Type of assessment
Written assignment
Written 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
Criteria for exam assessment

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.

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 27
  • Lectures
  • 15,5
  • Project work
  • 20
  • Exam
  • 48
  • English
  • 110,5