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Overview

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.

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Who should attend?

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

Learning objectives

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

Program Committee

  • Yasmin  de Faria Krim, PharmD, MSc
    Yasmin de Faria Krim, PharmD, MSc
    Chair, CMC Working Group, DIA Regulatory Affairs Community, France
  • Ursula  Busse, PhD, MBA
    Ursula Busse, PhD, MBA Head of Quality Intelligence, External Engagement
    Novartis, 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 (EMA), United Kingdom
  • Jean-Louis  Robert, PhD
    Jean-Louis Robert, PhD Former CHMP/CVMP QWP Chair
    Luxembourg
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