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 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.
Course Directors on Transparency and Trustworthiness in Drug Development
Course details about Transparency and Trustworthiness in Drug Development
Dates and examination
Course dates
6-8 March 2024
The course is available every second year.
Examination
Please find the exam dates in the exam plan.
You can find further information about the course and the exam in the course curriculum.
See an overview of all courses on Master of Medicines Regulatory Affairs.
Learning outcomes
After the course you will be able to:
-
Understand contemporary issues affecting transparency in the development, approval, accessibility and use of pharmaceutical products.
-
Take responsibility for developing innovative ways to increase transparency and trustworthiness throughout the whole life cycle of drug development using pharmaceutical ethics awareness.
-
Describe the basic principles within biomedical ethics, including perspectives of different stakeholders
-
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.
Admission criteria
Regulatory affairs specialists striving to innovate and strengthen the regulatory process
The course is intended for regulatory affairs specialists employed in industry, regulatory agencies or consulting.
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/coffee.
Place
University of Copenhagen
Department of Pharmacy/
Department of Drug Design and Pharmacology
Universitetsparken 2
2100 Copenhagen
Denmark
Contact
Annette Villumsen
Study Administration Officer
master@sund.ku.dk
Tel.: +45 35 33 60 66
Newsletter
Sign up for the newsletter of Master of Medicines Regulatory Affairs to receive course dates, call for applications, and other related programme news.