Clinical Trials Japan 2011(日本临床试验学会)

时间: 2011/7/6 至 2011/7/8
地点:日本 Sheraton Miyako Hotel Tokyo
主办单位: IBC Asia
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会议简介

Clinical Trials Japan

7-8 July 2011, Hilton Japan

www.clinicaltrials-japan.com

With world attention, support and confidence in the resilience and strength of Japan, facing the aftermath of the triple disaster, the certainty is not whether, but how quickly the nation will recover. In the Life Science industry, Japan will remain a leader in early research. It is also a much desired market, with its aging population and strong purchasing power making it the world’s second biggest pharmaceutical market.

Yet drug development in Japan has huge potential for growth, with up to six-fold expansion year on year since 2007. It comes as no surprise then, that it is becoming increasingly importance as a venue for global clinical development.

Clinical Trials Japan will bring together experts in clinical development, top clinicians, investigators, heads of Clinical Operations and Clinical Research from global and Japanese pharma, medical device companies, biotechs, CROs and research institutes to discuss operational excellence and strategies in clinical development, updates in regulatory and compliance and other timely issues.

To view the full programme agenda, click on www.clinicaltrials-japan.com.

Key themes and issues to be discussed include:

Ø  Regulatory Reforms to Support Clinical Development in Japan

Ø  Understanding & Addressing Key Challenges in Japanese Trials

Ø  Adapting Global Clinical Trial Strategies

Ø  Application of Global Best Practice and Experience

Ø  Key Barriers to Optimising Speed and Cost Effectiveness in Japan

Ø  Expediting Trials through Collaborations with External Stakeholders

Ø  Future Growth and Opportunities in Clinical Trials in Japan

View the latest agenda and speaker line-up and book online at: www.clinicaltrials-japan.com or email us at register@ibcasia.com.sg / call +65 6508 2401.

2011年7月6日到8日在东京召开Clinical Trials Japan。不只是日本,世界各国的制药公司、医疗机器关连企业、生物技术企业、医药品开发业务受托机关(CRO)、研究机关等所属临床开发专家、临床医学的著名研究者、治验责任医师、临床试验业务及临床研究的负责人员等齐聚一堂,针对临床开发的最佳经验、作业优势(operational excellence)、策略等展开热烈的讨论,除报告法规、法规遵循(Compliance)等的最新动向,亦予定针对具备高技能的专门人员不足、日本募集参加临床试验的患者等目前所面临的课题进行研究发表。

推荐参加此学会的7个理由:
能解决在日本实施临床试验时的成本与期间等相关课题。
由于聆听亚洲地区与世界各国从事临床试验实务者的宝贵意见,学习最佳经验,藉由重新检讨既有的手法,能改善临床开发制程。
能深掘有关临床开发的日本法规与运用之现状,并作分析。
能检讨进入日本市场的计划与实现扩大业务计划的可能性。
学会前一天召开的研究会中,各领域的专家说明实践的经验与详细的指针等,能有助于今后的实务。
能确保在日本有效实施临床试验的适当方法。
能从面临与临床开发有关之相同课题的企业等事例获得构思或汲取经验。

此学会选择的主题与课题:
日本以支持临床开发作为目的之法规改革
掌握和因应与日本的临床试验有关之重要课题
应用世界各国导入的临床试验策略
在世界各国能获得的最佳经验与活用经验
在日本阻碍工作迅速化与成本方面效率化的主要原因
藉由外部组织的合作来扩大临床试验
在日本进行的临床试验将来增加的可能性与商机

预定发表临床试验关联各种个案研究:
国立医院机构大阪医疗中心 院长 楠冈英雄
Eisai株式会社、信赖性保证本部副本部长、E.Stewart Geary
横滨市立大学 临床试验支持管理室 室长枣田丰
Merck、Clinical Science、Assistant Director-Oncology Group、Yoshinobu Tanaka
盐野义制药株式会社 医药开发本部 战略企划部门副group leader Pabel Delgado
日本Eli Lilly株式会社 安全性情报部医学部长/一般财团法人 日本制药医生学会副理事长西马信一
GlaxoSmithKline、Clinical Operations、General Manager、Jeroze Dalal
Novonordisk株式会社开发本部长 杉井宽
Mebiopharm株式会社代表董事藤泽忠司
InnoBio Ventures、Vice President — Quality Management and Regulatory Affairs、Dr Shivraj Dasari, (Qualified Assessor for Clinical Trials, Ministry of Health, Malaysia)
议程

第1天

第1天:2011年7月7日(星期四)

9:00
Chairperson’s Welcome and Opening Remarks
Pabel Delgado
Deputy Group Leader,
Strategic Planning, Pharmaceutical Development Division, Shionogi & Co., Ltd

日本以支持临床开发作为目的之法规改革

9:10
Current State of Clinical Development in Japan

  • Overview of clinical trials in Japan and trials conducted by Japanese companies overseas
  • Update on government-led initiatives to support and promote clinical development in Japan
  • A review of recent industry developments which will impact
    Japanese clinical trials

9:50
Clinical Innovations In Japan: How to Secure the Synergistic Effect of Pan-Asian Trials in Asia’s Complex Clinical and Regulatory Framework

Hiroshi Sugii, Vice President Clinical Development, Novo Nordisk

10:30
Morning Refreshments

11:00
Achieving Efficiency through Harmonization?

  • Fostering cooperation to achieve efficiency
  • Dissecting specific challenges in data bridging and other issues

Moderator:
Dr Shivraj Dasari,
Qualified Assessor for Clinical Trials, Ministry of Health, Malaysia, Vice President – Quality Management and Regulatory Affairs, InnoBio Ventures

Panellists:
Hiroshi Sugii,
Vice President Clinical Development, Novo Nordisk
E.Stewart Geary,
Vice President, Deputy Director of Corporate Regulatory Compliance and Quality Assurance Headquarters, Eisai Co., Ltd.

掌握在日本临床试验的重要课题

11:40
Gaining Approvals in Japan: Resolving the ‘Drug Lag’

  • What are the current primary causes of the huge drug lag?
  • Latest figures and studies to indicate the changing pattern of drug lag
  • Strategies to address and eliminate the drug lag

Dr Yutaka Natsumeda, Director of Office of Clinical Trials, Yokohama City University Hospital

12:20
Networking Lunch

2:00
Periodic Safety Reporting in Clinical Development

  • A Comparison of PMDA & Global Requirements
  • Current requirements for periodic reporting during clinical development in the EU and USA
  • The new Development Safety Update Report (DSUR)
  • Implementation of the DSUR outside Japan

E.Stewart Geary, Vice President, Deputy Director of Corporate Regulatory Compliance and Quality Assurance Headquarters, Eisai Co., Ltd.

2:40
Understanding Patient Safety Management in Japan

Shinichi Nishiuma, Vice-chairperson, Japanese Association of Pharmaceutical Medicine (JAPhMed), Lead Physician / Senior Medical Advisor, Global Patient Safety Japan, Eli Lilly and Co.

在日本阻碍工作迅速化与成本方面效率化的主要原因

3:20
Addressing the Pressing Need for Effective Patient Recruitment

  • The problem of patient recruitment and why it is difficult to address
  • Public vs private approaches in solving the patient recruitment problem
  • Assessing the effectiveness of policy changes to address patient recruitment and result in more and better trials

4:00
Afternoon Refreshments

4:30
Global Sponsor and Local Teams - Overcoming the Language Barrier in Chiken

  • Understanding the needs of the Japanese clinician
  • Generating cooperation to address language concerns through training
  • Incorporating Japanese trials when developing global protocols

5:10
Perception vs Reality - Are Clinical Trials in Japan Still Expensive and Slow?

  • How are industry stakeholders including regulators, sponsors and CROs able to reverse this perception?
  • Novel approach to drastically reduce the cost, improve speed and quality of clinical trials in Japan
  • What other initiatives could help to improve the reality?

Moderator:
Tadashi Matsumoto,
President, ReqMed

Panellists:
Yoshinobu Tanaka,
Assistant Director-Oncology Group, Clinical Science, Merck
Dr Yutaka Natsumeda,
Director of Office of Clinical Trials, Yokohama City University Hospital
Shinichi Nishiuma, Vice-chairperson,
Japanese Association of Pharmaceutical Medicine (JAPhMed), Lead Physician / Senior Medical Advisor, Global Patient Safety Japan, Eli Lilly and Co.
Dr Hideo Kusuoka,
Director General, Osaka National Hospital

5:50
Chairperson’s Remarks & End of Day One

联系方式

E-mail:

电 话:+65 6508 2401

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