Description

This session will focus on the challenges with the establishment of quality oversight and systems from the initial patient interface through manufacturing and supply for cell and gene therapies. Experience with the application of cGMPs in the hospital setting will be discussed as well as the conflicting priorities when multiple companies are imposing different demands on the same institutions, notably as these controls are part of the approved applications. The efforts to harmonize standards globally, as well as the regulator experience in determining true compliance risks will be addressed.

Moderator(s):

• Vivianne Arencibia, Independent Consultant, Arencibia Quality Compliance Associates

Speaker(s):

• Ekaterina Allen, PhD, Regulatory Project Manager and CMC Facilities Reviewer, CBER/FDA
• Luciana Mansolelli, Director, Operations & Strategic Planning, Novartis
• Lina Ertle, Head of External Relations EMEA and Japan, F. Hoffmann-La Roche Ltd.