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Session 2: Lifecycle Management
Session Chair(s)
Frank Montgomery, PhD
Global Head Regulatory CMC, GRAPSQA, AstraZeneca, United Kingdom
A number of additional country pilots for implementation of ICH Q12 are initiating. This session will describe Health Canada’s approach, FDA’s progress, and the importance of quality systems to the successful implementation of Q12. Additionally, we will go through new examples developed by the IWG to support the training materials for ICH Q12. Experts from the soon to kick off ICH Q1/5C will describe the scope of the work for this revision and the opportunities for it to help accelerate LCM and availability of medicines.
Speaker(s)
Hugo Hamel, MBA, MSc
Associate Director, BRDD, Health Canada, Canada
Q12 - Implementation in Canada
Mahesh Ramanadham, PharmD, MBA
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER , FDA, United States
Role of PQS in implementing Q12
Thierry Gastineau, PharmD
Global Head Quality Innovation, Culture & Engagement, Sanofi , France
Q12 Training Materials for Vaccines
Carolyn Gordon, PhD
Senior Director, Regulatory CMC, Global Regulatory Affairs, AstraZeneca, United Kingdom
Q1/5C Revision Scope and Potential Impact on LCM
Christof Finkler, DRSc
Senior Technical Advisor Biotech Development, F. Hoffmann-La Roche AG, Switzerland
Panel discussion with Q&A
Hanan Amin Rizk Hamoda
Head of the Central Administration of Pharmaceutical Products (CAPP), EDA, Egypt
Panel discussion with Q&A
Nélio Cézar de Aquino, MSc
General Manager of Medicines, ANVISA, Brazil
Panel discussion with Q&A
Mijeong Kim
Director- Pharmaceutical Standardization Division, NIFDS, MFDS, Korea, Republic of
Panel discussion with Q&A
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