The world of clinical research underscores the importance of providing evidence to ensure process compliance and therapeutic safety.
One of the earliest examples of the significant importance of patient participation in Research and Development comes from a major regulatory body responsible for overseeing proper processes – a practice now codified under patient engagement frameworks.
First of all, the European Medicines Agency (EMA) is committed to engaging real-life experiences, along with specific knowledge and skills/expertise, as invaluable contributions to therapeutic development and scientific discussions.
This cooperation between regulatory agencies and expert patients with their patient advocacy organisations is a pivotal roadmap for collaborative efforts that enhance trust and improve decision-making.
The Patient Affairs engagement would like to be an inspiring source for all activities related to patients and their respective stakeholders.
The patient involvement framework endorsed by EMA becomes a tool to raise awareness about the "toolbox" available in R&D to:
- Include the patient’s perspective based on their life experience.
- Improve patient-oriented information for better understanding.
- Support the active role of patient organisations within the healthcare system, fostering trust in clinical research processes and access to care.
A necessary introduction to Patient Affairs in Life Sciences, starting with the incipit.