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Radisson Blu

2018 年 06 月 20 日 7:45 上午 - 2018 年 06 月 21 日 5:00 下午

Steinentorstrasse 25, 4001 Basel, Switzerland

DIA CMC Workshop


This workshop, through plenary and parallel sessions, will focus on current challenging topics within the global pharmaceutical/biopharmaceutical arena. Attendees from the different CMC (chemistry, manufacturing and controls) areas will be able to interact with peers from Regulatory Agencies and Industry in sessions enabling interactive cross-functional discussions.

This program was developed by the CMC Working Group of the DIA Regulatory Affairs Community.

Download Programme


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Professionals involved in:

  • CMC Regulatory Affairs
  • CMC Writing
  • Quality Assurance/Quality Control
  • Regulatory Compliance
  • API Development and Manufacturing
  • Formulation Development and Manufacturing
  • Analytical Development
  • CMC Lifecycle Management
  • CMC Project Management


  • Address technical challenges for biological and chemical molecules
  • Discuss regulatory updates in a globalised environment
  • Outline regulatory harmonisation initiatives

Short Course or Primer

To keep you at the forefront.

2018 年 06 月 19 日

CMC Short Course:


  • Yasmin  de Faria Krim, PharmD, MSc
    Yasmin de Faria Krim, PharmD, MSc CMC working group
    Chair, CMC Working Group, DIA Regulatory Affairs Community, France
  • Ursula  Busse, PhD, MBA
    Ursula Busse, PhD, MBA Head of Regulatory Affairs
    Tigen Pharma SA, Switzerland
  • Sabine  Kopp, PhD
    Sabine Kopp, PhD Group Lead, Medicines Quality Assurance
    World Health Organization (WHO), Switzerland
  • Frank  Montgomery, PhD
    Frank Montgomery, PhD Global Head Regulatory CMC, GRAPSQA
    AstraZeneca, United Kingdom
  • Elaine  Morefield, PhD, RPh
    Elaine Morefield, PhD, RPh Vice President, Regulatory Affairs
    VaxForm, LLC., United States
  • Moheb M. Nasr, PhD, MS
    Moheb M. Nasr, PhD, MS Principal
    Nasr Pharma Regulatory Consulting, United States
  • Peter  Richardson, PhD
    Peter Richardson, PhD Head of Quality, Specialised Scientific Disciplines Department
    European Medicines Agency, Netherlands
  • Jean-Louis  Robert, PhD
    Jean-Louis Robert, PhD Former CHMP/CVMP QWP Chair

Digital Learning Catalog

DIA Learning: eLearning Soultions