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2009 Workshops > MRCT

Multi-Regional Clinical Trials WorkshopInauguration of the APEC Harmonization Center (AHC)

APEC ministers specifically approved the establishment of the AHC in Seoul in 2009 to provide workshops to government policy makers, regulators, academics, and other public and private sector stakeholders on the harmonization of standards and regulations in life science products.

The workshop will provide participants with various plenaries ranging from topics involving the values and difficulties of MRCTs to ICH guidelines and more, followed by panel breakout sessions for more experts to engage in dialogue regarding MRCTs. Highly qualified speakers as well as panelists have been invited to partake in this landmark event, and workshop attendees can expect to gain much useful information about the critical value of MRCTs in the international spectrum. The workshop will also close with the first meeting of the Regulatory Harmonization Steering Committee (RHSC) meeting.

Workshop Overview - Multi-Regional Clinical Trials Workshop : Title, Date, Venue, Hosted by, Supported, Language
Title MULTI-REGIONAL CLINICAL TRIALS SEOUL WORKSHOP Inaugural Workshop of the APEC Harmonization Center
Date June 15 (Mon) - 18 (Thu) 2009
Venue Grand Hilton Hotel, Seoul (Grand Ballroom, 2F)
Hosted by Korea Food and Drug Administration (KFDA)
Organized by Korea Health Industry Development Institute (KHIDI)
Supported by APEC Life-Sciences Innovation Forum (LSIF)
Website www.apec-ahc.org
Language English
Workshop Main Topics
  • The Values and Challenges of Multi-Regional Clinical Trials
  • Intra-Regional Efforts to Streamline the Conduct of Clinical Trials:
  • The Tripartite Initiative and the ASEAN Pharmaceutical Product Working Group
  • ICH Overview
  • Multi-Regional Clinical Trial Design Issues that Clinical Researchers should understand in order to Succeed
  • Operational Aspects
  • Regulatory Guidance / Perspectives / Issues
  • Breakout Sessions
    • Regional Specific Issues
    • Site Management, Data Management and Good Clinical Practice
    • Multi-Regional Clinical Trial Design Issues that Clinical Researchers Should Understand in order to succeed
    • Specific Therapeutic Areas