Singapore, Jun 11, 2009: The Korea Health Industry Development Institute (KHIDI) is organizing a four day workshop on Multi-Regional Clinical Trials starting from June 15 in Seoul, Korea in association with the Korea Food and Drug Administration (KFDA). The workshop is the inaugural workshop of the APEC Harmonization Center (AHC).
The objectives of this workshop are to provide information to government policy makers, regulators, academics, and other public and private sector stakeholders on the harmonization of standards and regulations in life science products.
Speakers will be sharing information on different topics such as 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.
Both APEC (Asia Pacific Economic Cooperation) broadly and Life Sciences Innovation Forum (LSIF) have recognized the benefits of regulatory harmonization within APEC, including in the context of APEC's trade facilitation and regional economic integration agendas. The workshop will raise awareness and discuss the challenges and opportunities of conducting multi-regional clinical trials (MRCTs) in a manner appropriate for the complexities of the regulatory decision making process, and commence the first meeting of the LSIF Regulatory Steering Committee.
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