Ethical, societal and assessment aspects of the regulation of medicines

Course content

The course addresses the role and responsibility of a regulatory professional in the pharmaceutical field. The student will obtain knowledge about benefit/risk assessment methods (qualitative and quantitative) in the context of Health Technology Assessment, the basic issues of Good Regulatory Practice, and professional ethical considerations and dilemmas. In addition, the student will discuss the patient perspective and involvement in medicines development and regulatory assessment. After completion the student will be able to explain the role and discuss the ethical responsibilities of a regulatory professional, identify and account for the role of HTA incl. health economic aspects, benefit-risk assessment and the increasing involvement of patients in medicines development.

Education

Master of Medicines Regulatory Affairs (MRA)

Learning outcome

On completion of the course participants should be able to:

Knowledge

  • Describe the basic principles within biomedical ethics, including perspectives of different stakeholders

  • Explain and discuss the basic issues of Good Regulatory Practice (GRP), including expectations to regulatory affairs professionals

  • Explain methods used to assess benefit/risk of medicines (qualitative, e.g. content analysis, and quantitative, e.g. pharmacoepidemiological data)

  • Describe the components of HTA and their role in pharmaceutical regulatory science

  • Describe the development of patient involvement in drug development and drug use

 

Skills

  • Identify and analyse ethical dilemmas within the pharmaceutical regulatory field

  • Discuss conflicts between ethics and regulations

  • 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

  • Identify and discuss ethical, societal and HTA aspects of regulation of medicines

           

Competencies

  • Argue for ethical prioritizations from a regulatory professional’s point-of-view, including consequences for interested parties

  • Independently take responsibility to further develop professionally as a regulatory professional within the pharmaceutical field, e.g. in balancing professional ethics, risk/benefit and other assessments, and requirements and interests of interested parties

Reading literature and writing assignment 1
Lectures and seminars (2 days)
Reading literature and writing assignment 2
Lectures and seminars (2 days)

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

Beyer AR, Fasolo B, de Graeff PA, Hillege HL. Risk attitudes and personality traits predict perceptions of benefits and risks for medicinal products: a field study of European medical assessors. Value in health : the journal of the International Society for Pharmacoeconomics and Outcomes Research. 2015 Jan;18(1):91-9.

Mt-Isa S, Hallgreen CE, Wang N, Callreus T, Genov G, Hirsch I, et al. Balancing benefit and risk of medicines: a systematic review and classification of available methodologies. Pharmacoepidemiol Drug Saf. 2014 Jul;23(7):667-78.

Sashegyi, A., Felli, J., and Noel, R. (2014) Benefit-Risk Assessment in Pharmaceutical Research and Development, CRC Press, ISB-13: 978-1-4398-6794-5

A complete list of reading material will be distributed electronically before the course. In total corresponding to approximately 400 pages of self-study.

 

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

ECTS
4 ECTS
Type of assessment
Oral examination, 1 hour
The oral exam is based on a written assignment handed in during the course as well as based on the course literature. No exam preparation.
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

  • Describe the basic principles within biomedical ethics, including perspectives of different stakeholders

  • Explain and discuss the basic issues of Good Regulatory Practice (GRP), including expectations to regulatory affairs professionals

  • Explain methods used to assess benefit/risk of medicines (qualitative, e.g. content analysis, and quantitative, e.g. pharmacoepidemiological data)

  • Describe the components of HTA and their role in pharmaceutical regulatory science

  • Describe the development of patient involvement in drug development and drug use

 

Skills

  • Identify and analyse ethical dilemmas within the pharmaceutical regulatory field

  • Discuss conflicts between ethics and regulations

  • 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

  • Identify and discuss ethical, societal and HTA aspects of regulation of medicines

           

Competencies

  • Argue for ethical prioritizations from a regulatory professional’s point-of-view, including consequences for interested parties

Part time Master and Diploma courses

  • Category
  • Hours
  • Preparation
  • 50
  • Lectures
  • 28
  • Project work
  • 32
  • Exam
  • 2
  • English
  • 112