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

Featured

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Exhibits

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Exhibits

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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
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