Transparency and Trustworthiness in Drug Development
Identify ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint and learn how to communicate benefit-risk assessments to relevant stakeholders.
This course is a part of
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.
Course content
This course centres 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
- presenting and discussing case studies of dilemmas of transparency in drug development and regulatory decision-making
- introducing and discussing principles for communication of medical benefit-risk decision-making under uncertainty.
For more details about the course, please refer to the course curriculum.
Course director and lecturers on »Transparency and Trustworthiness in Drug Development«
Course details for »Transparency and Trustworthiness in Drug Development«
Dates and examination
Course dates
The next course is not yet scheduled. Exact dates will follow.
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
Learning outcomes
On completion of the course, you will be able to:
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understand contemporary issues affecting transparency in the development, approval, accessibility and use of pharmaceutical products
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take responsibility for developing innovative ways to increase transparency and trustworthiness throughout the whole life cycle of drug development using pharmaceutical ethics awareness
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describe the basic principles within biomedical ethics, including perspectives of different stakeholders
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identify and analyse ethical dilemmas for the pharmaceutical industry seen from a societal viewpoint
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identify and produce timely communication of benefit-risk to relevant stakeholders.
Admission criteria
You must meet the following criteria to be admitted to this course:
- Hold a relevant bachelor degree or equivalent.
- Have a minimum 2 years of relevant job experience.
- Be proficient in English.
Find detailed information in the admission criteria on Master of Medicines Regulatory Affairs.
Priority is given to enrolled students
This course is offered as a compulsory course in the Master of Medicines Regulatory Affairs programme. Priority is given to students already enrolled. Once the enrolled students have been admitted to the course, the remaining seats are distributed on a first-come, first-served basis.
Tuition fees
EU/EEA citizens
Master student: 11,250 DKK
Single course participant: 12,250 DKK
Non-EU/EEA citizens
Master student: 13,050 DKK
Single course participant: 14,050 DKK
The fee includes lunch and coffee.
More information
All course information is available in the course curriculum:Faculty of Health and Medical Sciences
Department of Pharmacy and Department of Drug Design and Pharmacology
Universitetsparken 2
DK-2100 Copenhagen
