Transparency and Trustworthiness in Drug Development

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. 

WHAT YOU WILL LEARN

After the course you will be able to:

• Understand and deal with contemporary issues affecting transparency and trustworthiness in the development, approval, accessibility and use of pharmaceutical products 
• Develop innovative ways to increase transparency and trustworthiness throughout the whole life cycle of drug development using pharmaceutical ethic awareness
• Understand how the values embedded in pharmaceutical ethics, beyond simply complying with legislation, will enable you to prepare a more sound and trustworthy regulatory dossier.

COURSE CONTENT

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

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

PARTICIPANTS

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

COURSE DETAILS

Course dates

Expected to be scheduled in Spring 2020

Course fee

EU/EAA citizens Master student DKK 12,800

Non EU/EAA citizens Master student DKK 14,868 

EU/EEA citizens Single course student DKK 19,900

Non EU/EEA citizens Single course student DKK 19,900

Application deadline

To be announced

EXAMINATION

The exam is obligatory for master’s students. The exam consists of a written assignment based on a case and an extended literature list. The assignment should be handed in two weeks after completion of the course.