Regulatory Innovation

Patient-Focused Drug Development: From Concept to Reality

3:00 PM–4:00 PM Jun 5, 2019 (US - Eastern)

111AB, Level 100


Increased patient engagement in medicine development and regulatory approval decisions is occurring at a time when stakeholders - companies, patient groups and regulators - are formalizing the processes and considerations for this engagement.

This session highlights efforts to build a framework and standard for patient engagement with an eye toward advancing an approach that facilitates drug development across the medicine lifecycle, including how the stakeholders are preparing to generate and use patient experience data when developing medicines, approving applications and in support of marketed medicines.

Ability Level: Intermediate

Session ID: 501450