SMRMIF002U  Ethics in regulatory affairs of pharmaceutical products - dilemmas in decision-makings

Volume 2017/2018
Education

Compulsory Course for Master of Medicines Regulatory Affairs (MRA)

Course is open for master students and single course students.

Content

The course addresses the role and responsibility of regulatory professionals from an ethical point of view. The course will address all stages of drug development and lifecycle management, relevant to all stakeholders involved with development of drugs, e.g.  pharmaceutical industries, regulatory bodies, heath technology functions and academia.

The topics will include:

  • Setting the scene regarding:

    • a regulatory professional responsibilities in a pharmaceutical industry and regulatory authorities

    • Requirements to obtain marketing authorisations in EU and USA, including benefit-risk assessment of drugs and patients aspects

  • Regulatory compliance as important aspects of roles and responsibilities of regulatory professionals

  • Ethical challenges for decision-making:

    • Phase 1 to 4 seen from various stakeholders perspectives

    • Why, when and how to involve patients

    • Why, when and how to involve HTA bodies

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 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.

  • Explain how ethics are included in the HTA models.

 

Skills

  • Identify and analyse ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint, including pharmaceutical industry stories on lifesaving medicines versus fake medicines.

  • 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 prioritisations from a regulatory professional’s point-of-view, including consequences for interested parties.

  • Independently take responsibility to further develop professionally as a regulatory professional, e.g. in balancing professional ethics, benefit-risk and other assessments as a part of the life cycle of a medicine, requirements and interests of stakeholders.

The syllabus comprises relevant books, book chapters, scientific papers and review papers.

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
Lectures, Panel discussion with Experts and workshops.
Credit
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
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

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

  • Explain and discuss the basic issues of Good Regulatory Practice, 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.

  • Explain how ethics are included in the HTA models.

 

Skills

  • Identify and analyse ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint, including pharmaceutical industry stories on lifesaving medicines versus fake medicines.

  • 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 prioritisations from a regulatory professional’s point-of-view, including consequences for interested parties.

  • Independently take responsibility to further develop professionally as a regulatory professional , e.g. in balancing professional ethics, benefit-risk and other assessments as a part of the life cycle of a medicine, requirements and interests of stakeholders

  • Category
  • Hours
  • Preparation
  • 35
  • Lectures
  • 28
  • Project work
  • 32
  • Exam
  • 15
  • Total
  • 110