Advancing CMC Workshop

Global Challenges, Global Opportunities

概览

This workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) Regulatory space within the global pharmaceutical/ biopharmaceutical arena, including early lessons learned from the COVID-19 emergency efforts – including the perspective from 7 global Regulatory Authorities, reliance and global regulatory convergence, global ICH Q12 implementation (including emerging markets), challenges with innovative therapies, global case studies on medical devices and combination products, and many other topics. The format will allow participants to engage in constructive dialogue with experts from Regulatory Agencies, International Organisations and Industry, enabling interactive cross-functional discussions.

谁应该参加？

Professionals involved in:

• CMC Regulatory Affairs
• CMC Writing
• CMC Policy
• Global Development
• Quality Assurance/Quality Control
• Quality Intelligence
• Regulatory Compliance
• Regulatory Policy
• API Development and ManufacturingS1S
• Formulation Development and Manufacturing
• Analytical Development
• Technical Research and Development
• ICH Guidelines implementation and development
• CMC Lifecycle Management
• CMC Project Management
• Medical Devices and Combination Products
• All professionals involved in CMC

项目委员会

Ben Thompson Vice President, CMC and Non-clinical Regulatory Affairs
GlaxoSmithKline, United Kingdom
Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
Susanne Ausborn, PhD Global Head International Regulatory Policy
Roche, Switzerland
Sylvie Meillerais, MSc Head of CMC Excellence
Institut De Recherches Internationales Servier, France
Ursula Busse, PhD, MBA CMC Regulatory Affairs Advisor
Self employed, France
Sara Torgal, MPharm Global Regulatory Policy Lead
DIA, Switzerland

Digital Learning Catalog

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Advancing CMC Workshop

概览

谁应该参加？

项目委员会

Digital Learning Catalog

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