Advancing CMC Workshop

Global Challenges, Global Opportunities

Overview

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.

Featured topics

• Lessons learned from COVID-19 in the CMC Regulatory space
• Enhanced Dialogue and Regulatory Flexibility
• eCPPs – electronic Certificates of Pharmaceutical Product
• Regulatory Frameworks to Support Innovation
• Innovation and its CMC Regulatory Challenges
• Challenges with Medical Devices and Combination Products
• Global ICH Q12 implementation
• Regulatory Convergence

Who should attend?

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

Program Committee

Susanne Ausborn, PhD Global Head International Regulatory Policy
Roche, Switzerland
Ursula Busse, PhD, MBA Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Sylvie Meillerais, MSc Director Global CMC Policy
MSD Belgium, Belgium
Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom
Ben Thompson Vice President, CMC and Non-clinical Regulatory Affairs
GlaxoSmithKline, United Kingdom
Sara Torgal, MPharm Senior Manager, Scientific Programs
DIA, Switzerland

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