Kelly Zou

Company: Viatris Inc.

Job title: Head, Global Medical Analytics and Real World Evidence

Seminars:

Overcoming Data Quality Challenges; Perspective on the European and US Data Quality Guidelines 9:30 am

• Discover the key differences between the EU and US approaches • Implement data quality solutions into your own frameworksRead more

day: Conference Day Two

Current Challenges & Future Considerations – Leveraging the FDA’s External Controls Draft Guidance to Execute Clinical Trials with External Control Arms 11:35 am

Following the guidance on the use of RWD to develop RWE for regulatory decision making, in February the FDA expanded upon this to release the draft guidance ‘Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products’ or the External Controls Draft Guidance. However, although the guidance shines a light…Read more

day: Pre-Conference Workshop Day