Andrew Raven

Company: Health Canada

Job title: Head of the Biostatistics and Epidemiology Unit

Seminars:

Panel Discussion: Working Together to Harmonize the Global Regulatory Landscape for Utilizing RWE in Regulatory Submissions 2:00 pm

What do we need to see from industry collaboration bodies to achieve international harmonization around RWE?  What challenges are currently being faced by the pharmaceutical industry across the product lifecycle (regulatory and HTA) due to heterogeneity in guidance's.  What will it take to harmonize these processes and align globally? Read more

day: Conference Day One

Current Challenges & Future Considerations – Leveraging the FDA’s External Controls Draft Guidance to Execute Clinical Trials with External Control Arms 11:35 am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on the use of RWD to develop RWE for regulatory decision making, in February the FDA expanded upon this to release the draft guidance ‘Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products’ or the External Controls Draft Guidance.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