Navigating Regulatory DtP Considerations
Navigating Regulatory DtP Considerations: from Theory to Practice
Clinical trials are undergoing a paradigm shift towards decentralization, now the participant, rather than site, is at the center of the design and execution of a trial. Direct-to-patient supply is key to enabling clinical trial decentralization, whether partial or full in nature. Enabling DtP requires understanding the regulatory requirements and guidance to streamline planning and ensure a compliant and robust DtP process.
This webinar aims to introduce the main regulatory themes, during and beyond the pandemic, as well as provide a practical insight into the converting regulatory theory to practical steps to enable DtP on global studies.
You will learn:
- Regulatory common themes for DtP planning and execution
- Practical DtP considerations, including CRO and participant perspectives