This course will look into the overarching principles, available guidelines & initiatives in Europe on Patient Engagement in Clinical Drug Development as well as an outlook for the future.
This course will highlight the importance of Patient Engagement and provides for a basic understanding of Patient Engagement throughout the drug development lifecycle, also following the recent FDA guidance for PFDD (patient focused drug development) and recommendations of the EMA.
The following key elements will be part of the programme:
- Principles, guidelines & initiatives in Europe (from history to future outlook)
- Overview of best practices / processes to achieve patient relevance in clinical development
- Different roles of patient organizations /communities to drive clinical drug development
- Case studies
Clinical Operations, Clinical Development, R&D Strategy, Patient Affairs/Relations, Patient Experts, Medical Affairs, R&D Project Management belonging to pharmaceutical, biotech companies and academia.
No previous experience in patient engagement is necessary. Basic knowledge on clinical development is preferred.
Case studies, procedures and methodology tools for use in practice
Moderated exchange of practical experience regarding challenges and solutions
Interactive training course, to put learning into practice