Overview
This Workshop will focus on the currently most relevant topics in the CMC (Chemistry, Manufacturing and Controls) regulatory space with a global perspective. With topics ranging from reliance, regulatory convergence and harmonisation to ICH guidelines’ update, lifecycle management, inspections PBBM modelling, and many other key topics within this space, this Workshop will be a prime opportunity to discuss lessons learned, challenges, and the next steps which will be necessary to drive us towards the future.
Designed to allow engaging dialogue with experts from Regulatory Agencies, International Organisations, and experts from Industry, this Workshop will enable you to partake in interactive cross-functional discussions and hear directly from key stakeholders in this space.
Featured topics
- Regulatory Convergence, Reliance, Collaboration and Work-sharing
- The impact of the new pharma regulation in CMC
- Lifecycle Management
- ICH Q Guidelines: implementation and revision
- Quality innovation
- New modalities in CMC: ATMPs, peptides and others
- Digital Data Dossier: The future of CMC submissions
- Unmet Medical Needs: PBBM modelling
- Inspections
- The role of CMC in sustainability
- Medical Devices & Combination Products
Featured
Short Course or Primer
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Sep 27, 2022
Networking Dinner for the CMC Workshop
Learn more
Who should attend?
Professionals involved in:
- CMC Regulatory Affairs
- CMC Policy
- Global Development
- Regulatory Convergence and Reliance
- Quality Assurance/Quality Control
- Quality Intelligence
- Regulatory Compliance
- Regulatory Policy
- Technical Research and Development
- ICH Guidelines implementation and development
- CMC Lifecycle Management
- CMC Project Management
- Medical Devices and Combination Products
Program Committee
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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 • Director Global CMC Policy
MSD Belgium, Belgium -
Sara Torgal, MPharm • Senior Manager, Scientific Programs
DIA, Switzerland