Back to Agenda
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)
Q12 - Implementation in Canada
Hugo Hamel, MBA, MSc
Health Canada, Canada
Associate Director, BRDD
Role of PQS in implementing Q12
Mahesh R. Ramanadham, PharmD, MBA
FDA, United States
Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER
Q12 Training Materials for Vaccines
Thierry Gastineau, PharmD
Sanofi , France
Global Head Quality Innovation, Culture & Engagement
Q1/5C Revision Scope and Potential Impact on LCM
Carolyn Gordon, PhD
AstraZeneca, United Kingdom
Senior Director, Regulatory CMC, Global Regulatory Affairs
Panel discussion with Q&A
Christof Finkler, DrSc
F. Hoffmann-La Roche AG, Switzerland
Senior Technical Advisor Biotech Development
Panel discussion with Q&A
Hanan Amin Rizk Hamoda
Egyptian Drug Authority, Egypt
Head of Centeral adminstration of Pharmaceutical Products
Panel discussion with Q&A
Nélio Cézar de Aquino, MSc
ANVISA, Brazil
General Manager of Medicines
Panel discussion with Q&A
Mijeong Kim
MFDS, Korea, Republic of
Director- Pharmaceutical Standardization Division, NIFDS
Have an account?