プレナリーレクチャー
| 3大会合同
| プレナリーレクチャー

[PL-A] プレナリーレクチャー

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Sat. Dec 1, 2018 9:00 AM - 10:00 AM Room 1 (1F Main Hall)

Chairs: Beth Moulaison (Vertex / President of SQA), Barney Horne (Worldwide Clinical Trials / RQA), Yoko Morimoto (Medidata / JSQA), Naoki Tsutsumi (AstraZeneca K.K. / JSQA),
Panelists: Ryo Iwase(Office of International Regulatory Affairs, Pharmaceutical Safety and Environmental Health Bureau / MHLW Japan), Tomoko Ohsawa, Ph.D.(Director, Office of Non-clinical and Clinical Compliance / PMDA Japan), Chrissy J Cochran,Ph.D.(Bioresearch Monitoring Program Director, Office of Regulatory Affairs / FDA US), Andrew Gray BSc, Ph.D.(Deputy Director IE&S, Group Manager MHRA Inspectorate / MHRA UK), Gabriele Schwarz(Head of GCP Inspectorate, Federal Institute for Drugs and Medical Devices / BfArM Germany) , Thomas Lucotte(Trials and Vigilances Department, Inspection directorate / ANSM France), Louise Calder(Accreditation Manager, GLP Program Adviser / NATA Australia), Yi-Ting Chen(Associate Reviewer, Section of Clinical Trial Management Division of Medicinal Products / TFDA Taiwan), Nicholas Chun Wei Leow, RPh.(Senior Principal Asistant Director Good Clinical Practice (GCP) Compliance Section / NPRA Malaysia), Amaresh Tumbagi (Additional Drugs Controller and Licensing Authority, Office of the Drugs Controller for the state of Karnataka,India / India)