V Didier Clenet, Sanofi Pasteur
V Andrew Lennard, Amgen Limited
V Megan Powdrill, Health Canada
V Mats Welin, Swedish Medical Products Agency
V Kayla Woodlief, Biogen
V Boris Zimmermann, Genentech, a Member of the Roche Group
V Susan Burke, Amgen Inc.
IP Phil de Vilmorin, Biogen
V Steffen Gross, Paul-Ehrlich-Institut
V Ashutosh Rao, CDER, FDA
V Fengqiang Wang, Merck & Co., Inc.
“Knowledge is of no value unless you put it into practice.” -- Anton Chekhov
Significant knowledge and a strong understanding of raw materials and their impact on process and product, combined with the ongoing efforts to enable science and risk-based regulatory strategies, provide opportunities to implement new mechanisms for facilitating the use of alternative materials or material suppliers and enhanced raw material supply resilience. Tactical approaches may include incorporating alternatives into the process design, the use of PACMPs or other ICH Q12 concepts, or making use of other quality risk management concepts in which risk tolerances and material and product attribute criticality will play key roles. This session will focus on potential regulatory strategies to support adaptable raw materials management based on application of contemporary knowledge and regulatory concepts.