Tri-Conference 2008
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Clinical Trials Asia 概要

[  概要   |   プレカンファレンス   |   1日目   |   2日目   |   3日目   |   カタログ(PDF)  ]


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
  1. インド、中国、東南アジアにおける治験デザインと企画
  2. 倫理レビュー委員会プロセスの管理
  3. 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
  4. アジアにおける規制動向案内
  5. 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
  6. 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

FEATURED PRESENTATIONS:

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

Country and Site Selection for Global Clinical Trials
Fidela Ll. Moreno, M.D., Executive Director, Global Development
Operations, Asia and Latin America, Amgen Inc.

Recent Regulatory Changes in India
Chandrashekhar Potkar, M.D., Director, Clinical Research,
Pfi zer Ltd. (India)

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.

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

Safety Reporting in India Clinical Research Environment
Kamala Rai, M.D., Research Director, MSD Pharmaceuticals Pvt
Ltd; Medical Director, Merck (India)

Accelerate Oncology Clinical Development in Asia
Michael Shi, Director and Biomarker Project Leader, Exploratory
Oncology Development, Novartis Oncology

Are You Ready for an FDA Inspection?
Cherif Benattia, M.D., Vice President, Pharmacovigilance &
Public Health, Vertex Pharmaceuticals

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

SESSIONS:

  • Designing and Planning Trials in India, China and Southeast Asia

  • Managing the Ethical Review Committee Process

  • Safety Reporting and Implementation of Pharmacovigilance Practices at Indian Sites

  • Effectively Identifying, Selecting and Engaging Clinical Sites

  • Navigating the Regulatory Landscape throughout Asia

  • Strategic and Tactical Considerations when Designing and Conducting Trials in Asia: Learning from Others

  • Overcoming Logistics, Managing Partners and Ensuring Compliance

INTERACTIVE PANELS:

  • Utilizing and Integrating Local Clinical Data from Asia to Mutually Support Global and Regional Applications

  • Effectively Identifying, Selecting and Engaging Clinical Sites

  • Navigating the Regulatory Landscape throughout Asia

  • Realistic Opportunities and Main Challenges to Conducting Trials in India, China and Southeast Asia

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