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Overview
This workshop will focus on current challenging topics in chemical manufacturing and controls (CMC) within the global pharmaceutical/ biopharmaceutical arena, such as Accelerated Development Programmes, Global Regulatory Convergence, and new & future ICH topics. The format will allow participants to engage in constructive dialogue with experts from Regulatory Agencies and Industry, enabling interactive cross-functional discussions.
Featured topics
- Regulators’ updates on CMC
- Opportunities for CMC in accelerated development programmes
- Hot topics under development - Experience with recent regulatory guidelines
- Reliance Programmes
- Devices & Combination products
Who should attend?
- CMC Regulatory Affairs
- CMC Writing
- CMC policy
- Global Development
- Quality Assurance/Quality Control
- Regulatory Compliance
- API Development and ManufacturingS1S
- Technical Research and Development
- ICH Guidelines Implementation and Development
- Formulation Development and Manufacturing
- Analytical Development
- CMC Lifecycle Management
- CMC Project Management
- Medical Devices and Combination Products
- All professionals involved in CMC
Learning objectives
- Understand how the companies and regulators deal with challenges for CMC in accelerated development programmes for biological and chemical molecules
- Gain insights of current CMC trends from international Regulators and their efforts to simplify the regulatory frameworks
- Have a clear overview on global/ regional harmonisation initiatives and how they drive regulatory convergence
Program Committee
-
Frank Montgomery, PhD • Global Head Regulatory CMC, GRAPSQA
AstraZeneca, United Kingdom -
Helen L Fitton • Vice President Regional Regulatory Affairs (Pharma)
GlaxoSmithKline, United Kingdom -
Susanne Ausborn, PhD • Global Head International Regulatory Policy
F. Hoffmann-La Roche Ltd., Switzerland -
Sylvie Meillerais, MSc • Director Global CMC Policy
MSD (Europe) Inc., Belgium -
Ursula Busse, PhD, MBA • Global Head of Quality Intelligence & External Affairs
Novartis, Switzerland