The Drug Information Association (DIA), in collaboration with the China Center for Pharmaceutical International Exchange of the State Food and Drug Administration (SFDA), will host the First China Annual Meeting: Drug Development in a Flat World-Innovation, Regulation and Globalization from November 1-3, 2009 in Beijing, China.
Speakers from major regulatory agencies, industry, and academia will lead workshops and sessions on how drug development impacts China as the country takes on an increasingly preeminent role in the global arena. Session topics will include:
· Drug Development and Regulation in the 21st Century
· Simultaneous Global Development and Multi-regional Trials
· Evolving Innovation Ecology and Innovation Cluster in China
· Transformational Bioinformatics
· Good Regulatory Practice
· Biosimilars
· Developing High-quality Clinical Study Sites
· Ethical Review of Clinical Trials
· Implementation of Global GCP Standards
· Biometrics in China
Professor Sang Guowei, vice chairman, Standing Committee of the National People's Congress of PRC and member, Chinese Academy of Engineering, China, will deliver the keynote address titled, "The Pharmaceutical Industry and Innovative Drug and R&D in China Under the Environment of Financial Crisis."
Shao Mingli, Commissioner of the SFDA, will address the conference in the opening session. Representatives from the SFDA, FDA, EMEA, PMDA, KFDA, and TGA, will participate in presentations and discussions.
Pre-conference workshop topics will include:
· Translating the Principles of GCP to Practicalities of Effective Site Management
· Pharmacovigilance Audit, Risk Management, and Introduction to MedDRA
· Forum for Young Professionals: Emerging Career Opportunities in the Emerging Market
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