CASSS Welcome, CMC Strategy Forum January 2022 Introductory Comments and Workshop Session One - Knowledge Leads to Opportunities

Jan 24, 2022 8:40am ‐ Jan 24, 2022 10:30am

Identification: 31916-18-20

CASSS Welcome, CMC Strategy Forum January 2022 Introductory Comments and Workshop Session One - Use of Predictive Modeling Methodologies

Jan 24, 2022 8:40am ‐ Jan 24, 2022 10:30am

Identification: 31917-19-21

Workshop Session One Discussion – Questions and Answers

Jan 24, 2022 11:15am ‐ Jan 24, 2022 12:30pm

Identification: 31924

Panel Members:
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

Workshop Session One Discussion – Questions and Answers

Jan 24, 2022 11:15am ‐ Jan 24, 2022 12:30pm

Identification: 31923

Panel Members:
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.

Workshop Session Two - Regulatory Expectations and Strategy for Design of In-use Stability Studies

Jan 24, 2022 2:00pm ‐ Jan 24, 2022 3:30pm

Identification: 31927

Workshop Session Two - …to Implement Novel Regulatory Strategies

Jan 24, 2022 2:00pm ‐ Jan 24, 2022 3:30pm

Identification: 31926

“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.

Workshop Session Two Discussion – Raw Materials – Questions and Answers and Closing Remarks

Jan 24, 2022 4:15pm ‐ Jan 24, 2022 5:45pm

Identification: 31929-31

Workshop Session Two Discussion – Stability – Questions and Answers and Closing Remarks

Jan 24, 2022 4:15pm ‐ Jan 24, 2022 5:45pm

Identification: 31930-32