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Hotel Ilunion Alcora Sevilla

Sep 27, 2022 8:30 AM - Sep 28, 2022 3:00 PM

San Juan de Aznalfarache, 41920 Sevilla, Spain

Accelerating CMC Workshop

This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective.

Session 2: Lifecycle Management

Session Chair(s)

Frank  Montgomery, PhD

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.


Hugo  Hamel, MBA, MSc

Q12 - Implementation in Canada

Hugo Hamel, MBA, MSc

Health Canada, Canada

Associate Director, BRDD

Mahesh R. Ramanadham, PharmD, MBA

Role of PQS in implementing Q12

Mahesh R. Ramanadham, PharmD, MBA

FDA, United States

Deputy Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER

Thierry  Gastineau, PharmD

Q12 Training Materials for Vaccines

Thierry Gastineau, PharmD

Sanofi , France

Global Head Quality Innovation, Culture & Engagement

Carolyn  Gordon, PhD

Q1/5C Revision Scope and Potential Impact on LCM

Carolyn Gordon, PhD

AstraZeneca, United Kingdom

Senior Director, Regulatory CMC, Global Regulatory Affairs

Christof  Finkler, DrSc

Panel discussion with Q&A

Christof Finkler, DrSc

F. Hoffmann-La Roche AG, Switzerland

Senior Technical Advisor Biotech Development

Hanan  Amin Rizk Hamoda

Panel discussion with Q&A

Hanan Amin Rizk Hamoda

Egyptian Drug Authority, Egypt

Head of Centeral adminstration of Pharmaceutical Products

Nélio Cézar  de Aquino, MSc

Panel discussion with Q&A

Nélio Cézar de Aquino, MSc

ANVISA, Brazil

General Manager of Medicines

Mijeong  Kim

Panel discussion with Q&A

Mijeong Kim

MFDS, Korea, Republic of

Director- Pharmaceutical Standardization Division, NIFDS

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