Seminar Held for Practical Workers to Learn the Basics of Investigational Drug GMP

IR Engineers Education Institute will hold a public seminar where participants can learn practical knowledge, from the basics of Investigational Drug GMP to key points in drug development and clinical trial strategy, based on PIC/S GMP A13 and the revised GMP Ordinance.

Pharmaceuticals are regulated under the Pharmaceuticals and Medical Devices Act, and their quality, efficacy, and safety must be confirmed through clinical trials during the development process. For investigational drugs, compliance with "Investigational Drug GMP," which stipulates appropriate manufacturing and quality control methods and necessary facilities, is required.

In recent years, with the need to comply with PIC/S GMP and the revised GMP Ordinance, it has become increasingly important for practical workers involved in drug development and manufacturing to understand the management system for investigational drugs based on quality risk management and preparations for marketing approval applications. On the other hand, Investigational Drug GMP has commonalities and differences with Pharmaceutical GMP, and there is a need for opportunities to systematically understand these for beginners and new personnel involved in investigational drug manufacturing.

Seminar Overview

Seminar Name: Introduction to Investigational Drug GMP for Successful Practical Application

Format: In-person

Date and Time: September 11, 2026 (Fri) 10:00 - 16:00

Location: Japan IR Headquarters Seminar Room, Akihabara, Tokyo

Capacity: 16 people

Fee: 49,500 yen/person (tax included)

Lecturer: Wataru Kokubo (Representative, Fern Consulting Office)

Course Details

This seminar will explain the key points of investigational drug development and manufacturing in drug development, primarily targeting researchers, including managers, who are actually involved in investigational drug manufacturing.

Seminar Program

Chapter 1: Pharmaceuticals and Investigational Drugs 1-1 What are Pharmaceuticals? 1-2 Clinical Trials and Investigational Drugs 1-3 Investigational Drug, Test Drug, and Control Drug 1-4 Placebo 1-5 Differences and Similarities between Pharmaceuticals and Investigational Drugs

Chapter 2: Investigational Drug GMP and Pharmaceutical GMP 2-1 Quality Risk Management of Pharmaceuticals 2-2 Investigational Drug GMP in Drug Development 2-3 Differences between Investigational Drug GMP and Pharmaceutical GMP 2-4 Preparations Required for Marketing Approval Application

Chapter 3: Key Points of Investigational Drug GMP 3-1 Overview of GMP and Validation 3-2 Facility and Equipment Requirements 3-3 Manufacturing Control of Investigational Drugs 3-4 Quality Control of Investigational Drugs 3-5 Use of External Testing Laboratories, etc. 3-6 Change Control 3-7 Deviation Management 3-8 CAPA/OOS/OOT 3-9 Handling of Information on Quality, etc., and Quality Defects, etc. 3-10 Recall Procedures 3-11 Self-Inspection 3-12 Training 3-13 Document and Record Management 3-14 Contract Manufacturing

Chapter 4: Drug Development and Clinical Trials 4-1 Clinical Trials in New Drug Development 4-2 Rules and Procedures for Clinical Trials 4-3 Quality Characteristics of Active Pharmaceutical Ingredients and Formulations 4-4 Pharmaceutical Excipients 4-5 First-in-Human (FIH) Study 4-6 Early Exploratory Clinical Trials 4-7 Formulation Changes and Bioequivalence Evaluation 4-8 Clinical Trials for Generic Drugs

Target Audience

Researchers at pharmaceutical companies, including managers, involved in the manufacturing of investigational drugs.

Explanations will be easy to understand for beginners.

*Details of this seminar can be found here:

https://nihon-ir.jp/seminar/gmp-clinical-trial-drug_basic/

IR Engineers Education Institute will continue to provide practical knowledge and know-how through its technical engineer education services (seminars, e-learning, training, publications) for the manufacturing industry.

Japan IR Co., Ltd.

In addition to patent and intellectual property solutions with over 50 years of experience, the company offers a wide range of specialized practical services centered on technology, including technical information research and analysis, technical engineer education for the manufacturing industry, and production of technical content.

◆Company HP: https://nihon-ir.jp/ ◆IR Engineers Education Institute: https://engineer-education.com/

3F, CYK Kanda Iwamotocho Bldg., 15-1 Kanda Iwamotocho, Chiyoda-ku, Tokyo 101-0033 TEL: 03-6206-4966