Accelerating CMC Workshop

Menu Back to Accelerating-CMC-Workshop

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

Want to learn more about Accelerating CMC Workshop? You've come to the right site!

Exhibits

Learn more

Short Course or Primer

To keep you at the forefront.

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

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