Browse Resources

Stakeholders interactions – Patients Affairs Staff

Published by IRDiRC

Patient Engagement Research and Drug Development Regulatory Affairs Clinical Development Early Access Support Patient Advice FDA Regulatory Advice Patient Affairs Staff Patient Support

At the FDA, the Patient Affairs Staff (PAS) is devoted to supporting cross-cutting patient engagement activities across the FDA. Its mission is to coordinate and support patient engagement activities across FDA to facilitate awareness and collaboration with patients, their advocates and the FDA

View this resource Bookmark this resource

Adaptive Pathways

Published by IRDiRC

Clinical Development Regulatory Affairs Clinical Trial Design Adaptative Pathway Early Access Support

The adaptive pathways approach is part of the European Medicines Agency’s (EMA) efforts to improve timely access for patients to new medicines

View this resource Bookmark this resource

EU Compassionate Use Programs

Published by IRDiRC

EMA Compassionate Use Research and Drug Development Regulatory Affairs Clinical Development Orphan Drug Early Access Support European Union Compassionate Use

Compassionate use is a treatment option that allows the use of an unauthorised medicine. Under strict conditions, products in development can be made available to groups of patients who have a disease with no satisfactory authorised therapies and who cannot enter clinical trials.

View this resource Bookmark this resource