Seminar on 'GCP Vendor Management' in Compliance with ICH-GCP to be Held
The IR Institute for Engineers Education will hold a seminar on July 10, 2026, focusing on clinical vendor management practices based on ICH-GCP and ISO9001 standards.
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The IR Institute for Engineers Education is hosting an open seminar to provide concrete examples of the selection, negotiation, and management of vendors such as CROs, SMOs, and central labs, based on the principles of pharmaceutical development and clinical QMS required by ICH-GCP.
Following the revision of ICH-GCP (ICH-E6 (R2)), the concepts of "Quality Management System (QMS)" are increasingly demanded in pharmaceutical development and clinical trials. However, a common challenge is a tendency toward individual "symptomatic treatments" without a full understanding of the essence of quality management and risk-based approaches. To improve "efficiency," often cited as a weakness compared to Western countries, understanding operations based on ISO9001 and practical vendor management, including outsourcing partners, is critical.
## Seminar Overview
- Seminar Title: Global Standard GCP Vendor Management (Part of the "ICH-GCP Required Pharmaceutical Development and Clinical QMS Series")
- Format: In-person (Nihon IR HQ Seminar Room) or Zoom (Online)
- Date/Time: July 10, 2026 (Fri), 13:30–16:30
- Fee: 19,800 JPY (tax included) per person (Discounts for multiple participants/set applications available)
- Capacity: 16 in-person seats
- Lecturer: Tomohiro Niimi (Representative Partner, Antele Group LLC)
## Course Details
This course provides an overview of quality management based on ISO9001 to correctly understand the message of the revised ICH-GCP. It will also explain selection points and appropriate vendor management for clinical sites, CROs, SMOs, and central labs with specific examples. By organizing thoughts from GCP audits to internal audits, the seminar aims to achieve QMS operations that improve the "efficiency" of clinical trials and drug development in Japan.
## Seminar Program
- Terminology (Quality/Management/System)
- Quality Management based on ISO9001 (7 principles, 4 performances, etc.)
- ISO9001 vs. ICH-GCP (Differences in quality vs. risk management, messages of revised ICH-GCP, etc.)
- About Pharmaceutical Development QMS (Objectives of "fit for purpose", etc.)
- Vendor Management in Pharmaceutical Development QMS
- CRO/Clinical Sites/SMO/Central Labs/IT Vendors/Investigational Drugs/Consultants/Translation/Regulatory Affairs/IRB/Records, etc.
- What cannot be outsourced? (Must-haves for commissioning entities)
## Target Audience
- Individuals involved in pharmaceutical/medical device development or GCP-related tasks.
- Vendor management personnel, including outsourcing and procurement staff.
- Those concerned about managing external partners such as clinical sites, CROs, SMOs, and central labs.
Following the revision of ICH-GCP (ICH-E6 (R2)), the concepts of "Quality Management System (QMS)" are increasingly demanded in pharmaceutical development and clinical trials. However, a common challenge is a tendency toward individual "symptomatic treatments" without a full understanding of the essence of quality management and risk-based approaches. To improve "efficiency," often cited as a weakness compared to Western countries, understanding operations based on ISO9001 and practical vendor management, including outsourcing partners, is critical.
## Seminar Overview
- Seminar Title: Global Standard GCP Vendor Management (Part of the "ICH-GCP Required Pharmaceutical Development and Clinical QMS Series")
- Format: In-person (Nihon IR HQ Seminar Room) or Zoom (Online)
- Date/Time: July 10, 2026 (Fri), 13:30–16:30
- Fee: 19,800 JPY (tax included) per person (Discounts for multiple participants/set applications available)
- Capacity: 16 in-person seats
- Lecturer: Tomohiro Niimi (Representative Partner, Antele Group LLC)
## Course Details
This course provides an overview of quality management based on ISO9001 to correctly understand the message of the revised ICH-GCP. It will also explain selection points and appropriate vendor management for clinical sites, CROs, SMOs, and central labs with specific examples. By organizing thoughts from GCP audits to internal audits, the seminar aims to achieve QMS operations that improve the "efficiency" of clinical trials and drug development in Japan.
## Seminar Program
- Terminology (Quality/Management/System)
- Quality Management based on ISO9001 (7 principles, 4 performances, etc.)
- ISO9001 vs. ICH-GCP (Differences in quality vs. risk management, messages of revised ICH-GCP, etc.)
- About Pharmaceutical Development QMS (Objectives of "fit for purpose", etc.)
- Vendor Management in Pharmaceutical Development QMS
- CRO/Clinical Sites/SMO/Central Labs/IT Vendors/Investigational Drugs/Consultants/Translation/Regulatory Affairs/IRB/Records, etc.
- What cannot be outsourced? (Must-haves for commissioning entities)
## Target Audience
- Individuals involved in pharmaceutical/medical device development or GCP-related tasks.
- Vendor management personnel, including outsourcing and procurement staff.
- Those concerned about managing external partners such as clinical sites, CROs, SMOs, and central labs.
FAQ
このセミナーの主な対象者は誰ですか？
医薬品・医療機器等の開発やGCP関連業務に携わる方、外注・購買担当者、および治験サイト、CRO、SMO、セントラルラボ等の委託先管理に課題を持つ方を想定しています。
開催日時と受講料はいくらですか？
開催日時は2026年7月10日（金）13:30～16:30で、受講料は1人につき19,800円（税込）です。複数名割引やセット割引も用意されています。
講義の内容はどのようなものですか？
改訂ICH-GCPのメッセージ理解、ISO9001に基づく品質マネジメント、リスクマネジメント、医薬品開発におけるベンダーマネジメントの具体事例、監査への考え方などが含まれます。
開催形式はどのようなものですか？
日本アイアール株式会社本社セミナールームでの会場受講（定員16名）と、Zoomを用いたオンライン講義の2形式から選択可能です。
講師は誰ですか？
アンテレグループ合同会社の代表社員である新見智広氏が担当します。