Bringing a new therapy from an experimental concept into clinical development involves more than generating convincing scientific data. Decisions must be made under uncertainty, while considering regulatory requirements, ethical responsibilities, feasibility, and the expectations of different stakeholders.
This interactive workshop explores how such decisions are made in practice. Participants will be introduced to key principles that guide the transition from preclinical research to clinical development, including the assessment of evidence, benefit and risk, remaining uncertainty, and participant protection. Relevant aspects of medical devices and drug-device combinations will also be briefly discussed.
A central focus of the workshop is the fact that the same evidence may be viewed differently by sponsors, investigators, regulators, ethics committees, clinicians, and patients. Working with realistic case scenarios, participants will take on different stakeholder roles, identify evidence gaps and concerns, and discuss possible ways forward.
Rather than searching for a single "correct" answer, the workshop will focus on making the reasoning behind a decision explicit and defensible. Participants will experience how scientific evidence, ethical considerations, regulatory expectations, and different levels of risk tolerance come together when decisions in drug development are negotiated.
No prior expertise in regulatory science or research ethics is required.
pharmakologisch tätige Ärzt:innen und Wissenschafter:innen
Überregional
Dr. EVA MARIA ZEBEDIN-BRANDL