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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.”

 


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
    Ben Thompson Vice President, CMC and Non-clinical Regulatory Affairs
    GlaxoSmithKline, United Kingdom
  • Frank  Montgomery, PhD
    Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
    AstraZeneca, United Kingdom
  • Susanne  Ausborn, PhD
    Susanne Ausborn, PhD Global Head International Regulatory Policy
    F. Hoffmann-La Roche Ltd., Switzerland
  • Sylvie  Meillerais, MSc
    Sylvie Meillerais, MSc Director Global CMC Policy
    MSD (Europe) Inc., Belgium
  • Ursula  Busse, PhD, MBA
    Ursula Busse, PhD, MBA Head of Regulatory Intelligence & Policy
    Boehringer Ingelheim, Germany
  • Sara  Torgal, MPharm
    Sara Torgal, MPharm Senior Manager, Scientific Programs
    DIA, Switzerland
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