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Upcoming Seminar on Clinical Trial Drug GMP for Practitioners

The I.R. Technical Education Institute is set to hold a public seminar aimed at professionals involved in pharmaceutical development. This event will focus on the fundamentals of Good Manufacturing Practice (GMP) for clinical trial drugs, with emphasis on essential points pertaining to drug development and trial strategies.

Seminar Overview

The seminar, titled 'Introduction to Clinical Trial Drug GMP for Practitioners to Avoid Mistakes', is designed following the guidelines of the PIC/S GMP A13 and the amended GMP regulations. It addresses the importance of quality, efficacy, and safety verification through clinical trials, which are essential as per pharmaceutical laws.

Compliance with GMP entails maintaining proper manufacturing and quality control practices while upholding stipulated standards for the necessary structural and facility requirements designated for clinical trial drugs. In recent years, adapting to the standards set forth by PIC/S GMP and the amended GMP regulations has become increasingly crucial for professionals in pharmaceutical development and manufacturing. An understanding of quality risk management is paramount when managing clinical trial drugs and preparing for approval applications. There is a clear need for a systematic way to grasp the similarities and differences between clinical trial drug GMP and general drug GMP, especially for newcomers and those newly involved in clinical trial drug production.

Seminar Details

• - Date and Time: September 11, 2026, from 10:00 AM to 4:00 PM
• - Location: Japan I.R. Corporation Main Office, Seminar Room, Akihabara, Tokyo
• - Capacity: 16 participants
• - Fee: 49,500 JPY per person (including tax)
• - Instructor: Wataru Kokubo (Representative, Farn Consulting Office)

Agenda Breakdown

This seminar will primarily cover key points in drug development related to clinical trial drug formulation and production, targeting administrators and researchers actively participating in the manufacturing of clinical trial drugs.

Program Outline

• - Chapter 1: Introduction to Pharmaceuticals and Clinical Trial Drugs

- 1-1 What are Pharmaceuticals?
- 1-2 Clinical Trials and Clinical Trial Drugs
- 1-3 Differences and Similarities between Clinical Trial Drugs and Pharmaceuticals

• - Chapter 2: GMP for Clinical Trial Drugs vs. GMP for Pharmaceuticals

- 2-1 Quality Risk Management in Pharmaceuticals
- 2-2 Implementation of GMP for Clinical Trial Drugs
- 2-3 Preparing for Approval Applications

• - Chapter 3: Key Points of Clinical Trial Drug GMP

- 3-1 GMP and Validation Overview
- 3-2 Requirements for Structural Facilities
- 3-3 Manufacturing Management of Clinical Trial Drugs
- 3-4 Quality Management of Clinical Trial Drugs

• - Chapter 4: Drug Development and Clinical Trials

- 4-1 Clinical Trials in New Drug Development
- 4-2 Rules and Implementation Procedures for Clinical Trials
- 4-3 Quality Characteristics of Active Pharmaceutical Ingredients and Formulations

This seminar will simplify complex topics for beginners, ensuring that all attendees can gain a clear understanding. Participants will benefit from practical knowledge applicable to their day-to-day operations.

For more details about this seminar, please visit: I.R. Technical Education Institute.

The Japan I.R. Corporation upholds a longstanding tradition of offering expert services in patent and intellectual property solutions, technical information research, manufacturing training, and the creation of technical content, aiming to provide knowledge and expertise relevant to the manufacturing industry.

Company Information:

• - Website: Japan I.R. Corporation
• - Educational Institute: I.R. Technical Education Institute
• - Address: 3rd Floor, CYK Kanda Iwamoto-cho, 15-1 Kanda Iwamoto-cho, Chiyoda-ku, Tokyo 101-0033
• - Phone: 03-6206-4966