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