[Technical Seminar] Manufacturing of Investigational Drugs for Regenerative Medicine Products

Approach and Precautions According to GCTP

This seminar will provide an overview of the rules regarding the manufacturing of investigational drugs for regenerative medicine products, and will explain common issues that may arise during the actual manufacturing process and their corresponding solutions. It will cover the Pharmaceutical and Medical Device Act, the Act on Securing Quality, Efficacy and Safety of Products, related ministerial ordinances and guidelines, and the role of the Pharmaceuticals and Medical Devices Agency in the development and manufacturing of investigational drugs for regenerative medicine products. Additionally, it will address points of caution for each manufacturing process, including the acceptance and storage of raw cells, bank creation, biological raw materials, aseptic operations and manufacturing, cell proliferation, collection, washing, evaluation, product aliquoting, freezing, storage, and transportation. Furthermore, as key points for manufacturing in accordance with GCTP, it will explain risk management, product specifications, facility design, organizational structure, the operation of standard operating procedures, equipment management, training and education, validation, deviation and change management and CAPA, Quality by Design (QbD), Design Space (DS), process management, environmental management, quality control, quality assurance, and self-inspection. *For more details, please check the related links or the seminar details in the catalog.*

Technical Seminar