Janet Glassford

Company: Medicines & Healthcare Products Regulatory Agency (MHRA)

Job title: Senior Quality Assessor

Seminars:

PANEL DISCUSSION: Getting to Grips With Potency Assay Regulatory Guidance & Guidelines 10:00 am

• Current potency guidance is largely designed to address challenges for biologics, thus what trends or shifts are we likely to observe (which may not be stated in any kind of guidance) • What is currently driving the trends of potency assay development and regulatory communications? • Are we any closer to an industry wide…Read more

day: Day One AM

PANEL DISCUSSION: Addressing Phase Appropriate Potency Assay Development Challenges 12:30 pm

• Discuss the fields most common and pressing challenges in translating your early phase potency assays into late phase assaysRead more

day: Day One Track A AM