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Radisson Blu

2019年11月25日 (月) 午前 9:00 - 2019年11月26日 (火) 午後 5:30

Steinentorstrasse 25, 4001 Basel, Switzerland

Advancing CMC Workshop

Accelerated pathways, EU CMC trends and global opportunities

概要

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.

特集トピック

  • 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

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Exhibits

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参加対象

  • 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

学習目的

  • 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

プログラム委員会

  • 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 (Pharma)
    GlaxoSmithKline, United Kingdom
  • Susanne Ausborn, PHD
    Susanne Ausborn, PHD Global Head International Regulatory Policy
    Roche, Switzerland
  • Sylvie Meillerais, MSC
    Sylvie Meillerais, MSC Head of CMC Excellence
    Institut De Recherches Internationales Servier, France
  • Ursula Busse, PHD, MBA
    Ursula Busse, PHD, MBA CMC Regulatory Affairs Advisor
    Self employed, France

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