概览

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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Exhibits

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Exhibits

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谁应该参加？

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

学习目标

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:

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2018 年 06 月 19 日

CMC Short Course:

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项目委员会

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