Overview

Hear from Frank Montgomery: What can you expect from this year's workshop?

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 reliance and global regulatory convergence, post-approval changes to COVID-19 vaccines and treatments, impact of digitalisation in CMC submissions, updates on global ICH Q12 implementation & training, 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

Regulatory Convergence
PRIME toolbox
Post-Approval Changes: WHO Guidance and European variations
Post-Approval Changes to COVID-19 vaccines/treatments
Update on ICH Q12 implementation & training
Impact of digitalisation in CMC submissions
Innovation & CMC preparedness
Medical Devices & Combination Products

90% of previous participants will recommend this workshop to colleagues and friends. Voices that make us happy:

“Thank you very much for this productive and fruitful event!”

“The event is of high quality and very informative!”

“The principle of Panel discussions after short presentations and possibility to ask questions online were very positive.”

Featured

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

Exhibits

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Exhibits

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Who should attend?

Professionals involved in:

CMC Regulatory Affairs
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

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 Head of CMC Excellence
Institut De Recherches Internationales Servier, France
Ursula Busse, PhD, MBA Head of Regulatory Affairs
Tigen Pharma SA, Switzerland
Sara Torgal, MPharm Senior Manager, Scientific Programs
DIA, Switzerland