Overview of laws and regulations related to regenerative medicine, trends, and current perspectives.
S50103
Background and Overview of the "Pharmaceuticals and Medical Devices Act, Act on Safety Assurance for Regenerative Medicine, and GCTP Ministerial Ordinance"
【Speaker】 Mizutani Manabu, Specially Appointed Researcher, Graduate School of Engineering, Osaka University, Department of Advanced Molecular Engineering 【Venue】 Tokyo Chuo City Industrial Hall, 4th Floor, Meeting Room 3 [Chuo City, Tokyo] 【Date and Time】 January 29, 2015 (Thursday) 13:20-16:20
Inquire About This Product
basic information
**Keywords** 1. Regenerative Medicine 2. Pharmaceuticals and Medical Devices Act 3. Regenerative Medicine Safety Assurance Act 4. GCTP Ordinance 5. Certified Regenerative Medicine Committee **Lecture Summary** In November 2014, as a specific response to safely promote regenerative medicine, amendments to the Pharmaceuticals and Medical Devices Act concerning regenerative medicine products and the Regenerative Medicine New Law, which imposes certain regulations on stem cell treatments conducted by medical institutions to ensure safety, were enacted. Since regenerative medicine, which treats living cells as products, faces significant challenges in supplying products safely, securely, and affordably while complying with existing regulations, the enactment of this law has garnered considerable attention. In this lecture, I will explain the aspects of the Pharmaceuticals and Medical Devices Act related to regenerative medicine and the Regenerative Medicine New Law, including their framework and current thinking. Additionally, I will provide an overview of the requirements necessary for ensuring the quality of regenerative medicine products (cell processing products) from development to manufacturing.
Price information
35640
Price range
P2
Delivery Time
P2
Applications/Examples of results
1. What is regenerative medicine? 1-1 Differences from conventional pharmaceuticals and medical devices 1-2 Classification of regenerative medicine 1-3 Challenges of regenerative medicine in conventional methods 1-4 Amendments to the Pharmaceutical Affairs Law related to regenerative medicine and new laws 2. About the amended Pharmaceutical Affairs Law (Law on Pharmaceuticals and Medical Devices) 2-1 Overview of the Law on Pharmaceuticals and Medical Devices (related to regenerative medicine) 2-2 Early approval system (conditional and time-limited approval system) 2-3 GCTP ministerial ordinance 2-4 Validation and verification 3. About the new law (Regenerative Medicine Safety Assurance Law) 3-1 Overview of the Regenerative Medicine Safety Assurance Law 3-2 Provision standards and their classification 3-3 Certified Regenerative Medicine Committee and Specific Certified Regenerative Medicine Committee 3-4 Procedure flow (Regenerative Medicine Provision Plan) 4. About cell culture processing facilities 4-1 Regulations on the structure and equipment of pharmacies, etc. 4-2 Introduction of typical facility examples 4-3 Economic evaluation (cost calculation) 5. Ensuring the quality of final products 5-1 Procedures for quality control of final products 5-2 Form, storage, and transportation of final products 6. Future developments 【Individual consultation session including Q&A (please contact the secretariat in advance)】
Company information
Our company has developed its business from "seminar planning" to various forms such as "lecturer dispatch," "publishing planning," "technical consultant dispatch," "trend research," "business matching," and "business development consulting," in order to support clients in a wide range of fields including chemistry, electronics, automotive, energy, medical devices, food, and building materials. By doing so, we have advanced our company and opened up new markets. AndTech promises to continue listening to our clients' voices, entering the business areas and markets they desire, and to remain a company that is loved by our clients, as we share their challenges, think together, and forge new paths.