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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

    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
      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, Switzerland
    • Sylvie  Meillerais, MSc
      Sylvie Meillerais, MSc Director Global CMC Policy
      MSD Europe Inc., Belgium
    • Sara  Torgal, MPharm
      Sara Torgal, MPharm Senior Manager, Scientific Programs
      DIA, Switzerland
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    Contact us

    Registration Questions?

    Send Email
    +41 61 225 51 51

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