Points for selecting and negotiating with CROs, SMOs, central labs, etc., focusing on management rather than oversight!? Specific examples and considerations.
This seminar provides an overview of quality management based on ISO 9001 to correctly understand the messages of the revised ICH-GCP. As one approach to effectively operate a QMS and lead to process improvement, we will learn about vendor management. We will explain the key points for selecting clinical trial sites, CROs, SMOs, central labs, etc., including specific case studies on appropriate management. If you participate in both of the following two seminars, including this one, you will be eligible for the GCP seminar set application discount. June 26: GCP Audit of Global Standards July 10: GCP Vendor Management of Global Standards *For details, please check the related links or the seminar details in the catalog.
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<Event Information> Format: In-person attendance / Live streaming (Zoom) Location: Japan IR Co., Ltd. Headquarters Seminar Room Date and Time: July 10, 2026 (Friday) 13:30 - 16:30 Participation Fee: 19,800 yen (tax included) Instructor: Tomohiro Niimi (Representative Employee, Antele Group LLC)
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<Seminar Program (Tentative)> Chapter 1: Terminology Chapter 2: Quality Management according to ISO 9001 Chapter 3: ISO 9001 and ICH-GCP Chapter 4: QMS in Pharmaceutical Development Chapter 5: Vendor Management in Pharmaceutical Development QMS
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We support Japan's "monozukuri" (manufacturing) with reliable services ranging from patent research and other intellectual property business solutions to technical translation services and intellectual property/engineer education. We offer high-quality services backed by over 40 years of experience at reasonable prices.
