James Norton

Company: Meira GTx

Job title: Director - Analytical Development

Seminars:

PANEL DISCUSSION: Advancing Gene Therapy Manufacturing: Automated Analytical Tools for Precision & Efficiency 9:30 am

Characterising methods to assess CQAs throughout manufacturing, storage, and shipment Increasing analytical throughput for in-process and release quality testing to GMP compliance in preparation for phase three or commercial launch Introducing automation or in-process analytics to establish effective parameters for reproducibilityRead more

day: Day One

Understanding the Changes in Regulatory Scrutiny Throughout the EarlyLate Stage Transition in Order to Optimise Phase-Appropriate Assay Design Strategy 4:30 pm

Discussing ICH guidelines during progression towards clinical trials Establishing regulatory perspectives on late-phase cGMP Ensuring appropriate data integrity and instrument qualification through the early-late stage transition to suit regulatory demands What are the most important factors to show regulators during AAV extended characterisationRead more

day: Day One