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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

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
    Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
    AstraZeneca, United Kingdom
  • Helen L Fitton
    Helen L Fitton Vice President Regional Regulatory Affairs
    GlaxoSmithKline, United Kingdom
  • Susanne  Ausborn, PhD
    Susanne Ausborn, PhD Regulatory Policy Lead
    F. Hoffmann-La Roche Ltd, Switzerland
  • Sylvie  Meillerais, MSc
    Sylvie Meillerais, MSc Director Regulatory Policy
    MSD (Europe) Inc., Belgium
  • Ursula  Busse, PhD, MBA
    Ursula Busse, PhD, MBA Global Head of Quality Intelligence & External Affairs
    Novartis, Switzerland
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Registration Questions?

Send Email
+41 61 225 51 51

 

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