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同時開催会議
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Clinical Trials Asia 概要
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第2回
アジアにおける治験
インド、中国、東南アジアにおける治験の企画、設定、実施戦略
2008年3月26〜28日
- インド、中国、東南アジアにおける治験デザインと企画
- 倫理レビュー委員会プロセスの管理
- インドのサイトにおける安全性報告と医薬品安全対策実施
- アジアにおける規制動向案内
- アジアで治験をデザインし実施する上での戦略的、戦術的検討事項:他の事例からの教訓
- 物流問題の克服とパートナーの管理、コンプライアンスの保証
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FEATURED
PRESENTATIONS: |
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Utilizing and Integrating Data from China to Mutually
Support Global and Local Applications
James Cai, M.D., Vice President, R&D and Business
Development, AstraZeneca Pharmaceuticals, China |
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Country and Site Selection for Global Clinical Trials
Fidela Ll. Moreno, M.D., Executive Director, Global Development
Operations, Asia and Latin America, Amgen Inc. |
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Recent Regulatory Changes in India
Chandrashekhar Potkar, M.D., Director, Clinical Research,
Pfi zer Ltd. (India) |
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Optimizing Return on Investment
(ROI) of Multinational
and Domestic Clinical Trials in China
Min Irwin, M.D., Ph.D., Medical Director of BSP China, Bayer
HealthCare Company Ltd. |
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Roles and Functioning of Institutional and Independent
Ethics Committees in India
Y.K. Gupta, Head, Dept. of Pharmacology; Coordinator, Zonal
Pharmacovigilance Centre, All India Institute of Medical Sciences |
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Safety Reporting in India Clinical Research Environment
Kamala Rai, M.D., Research Director, MSD Pharmaceuticals Pvt
Ltd; Medical Director, Merck (India) |
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Accelerate Oncology Clinical Development in Asia
Michael Shi, Director and Biomarker Project Leader, Exploratory
Oncology Development, Novartis Oncology |
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Are You Ready for an FDA Inspection?
Cherif Benattia, M.D., Vice President, Pharmacovigilance &
Public Health, Vertex Pharmaceuticals |
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The Strategic Planning Behind the Clinical Site Allocation
in Emerging Economies: An Industry-Wide View
Fabio Thiers, M.D., M.Sc., Ph.D., Research Associate, MIT Center
for Biomedical Innovation, MIT |
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SESSIONS:
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Designing and Planning Trials in India, China and Southeast Asia
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Managing the Ethical Review Committee Process
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Safety Reporting and Implementation of Pharmacovigilance Practices at
Indian Sites
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Effectively Identifying, Selecting and Engaging Clinical Sites
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Navigating the Regulatory Landscape throughout Asia
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Strategic and Tactical Considerations when Designing and Conducting
Trials in Asia: Learning from Others
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Overcoming Logistics, Managing Partners and Ensuring
Compliance
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INTERACTIVE
PANELS:
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Utilizing and Integrating Local Clinical Data from Asia to
Mutually Support Global and Regional Applications
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Effectively Identifying, Selecting and Engaging Clinical Sites
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Navigating the Regulatory Landscape throughout Asia
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Realistic Opportunities and Main Challenges to Conducting
Trials in India, China and Southeast Asia
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