Quality management and evaluation of cell processing facilities based on the new regenerative medicine law and amendments to the Pharmaceutical Affairs Law.
S50702
Understanding of the early approval system, sterilization, contamination risks, and facility validation measures.
【Speaker】 Mizutani Manabu, Specially Appointed Researcher, Graduate School of Engineering, Osaka University, Department of Advanced Molecular Engineering Venue: Kawasaki City Industrial Promotion Hall, 10th Floor, Conference Room 3 [Kawasaki City, Kanagawa Prefecture] ◆ 5 minutes walk from JR Kawasaki Station Date and Time: July 27, 2015 (Monday) 13:30-16:30
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basic information
【Course Objectives and Goals】 Regenerative medicine has traditionally followed the regulations for pharmaceuticals and medical devices, but there have been challenges in treating living cells as products. Therefore, as a specific response to safely promote regenerative medicine, a partial amendment to the Pharmaceutical Affairs Law concerning regenerative medicine products and a new law ensuring the safety of treatments conducted by medical institutions were enacted in November 2014. In this lecture, I will discuss the key ministerial ordinances and notifications related to the amended Pharmaceutical Affairs Law (Pharmaceutical and Medical Device Act) and the new Regenerative Medicine Law (Regenerative Medicine Safety Assurance Act), outlining the requirements necessary for ensuring the quality of regenerative medicine products from development to manufacturing.
Price information
After July 9, the application fee is 57,240 yen (including tax, lunch, and textbook costs).
Price range
P2
Delivery Time
P2
Applications/Examples of results
**Program** 1. What is regenerative medicine? 2. About the Pharmaceuticals and Medical Devices Act (Application under the Revised Pharmaceutical Affairs Law) 2-1 Overview of the revisions 2-2 Early approval system (conditional and time-limited approval system) 2-3 GCTP Ordinance 2-4 Validation and verification 3. About the New Regenerative Medicine Law (Treatment under the Medical Care Act/Medical Practitioners Act) 3-1 Overview of the New Regenerative Medicine Law 3-2 Flow of procedures (Provision standards and regenerative medicine provision plans) 3-3 Certified Regenerative Medicine Committee and Specific Certified Regenerative Medicine Committee 3-4 Outsourcing of cell culture processing 3-5 Commonalities and differences with the Pharmaceuticals and Medical Devices Act 4. Product development of regenerative medicine products and cell culture processing facilities 4-1 Partial revision of the Pharmacy Structural Equipment Regulations and GQP Ordinance 4-2 Requirements for sterile environments and facilities 4-3 Introduction of typical facilities 4-4 Facility qualification evaluation and validation 4-5 Economic evaluation (cost calculation) 5. Ensuring the quality of final products 5-1 Form, storage, and transportation of final products 5-2 Quality control standards and safety confirmation tests (non-clinical, in vitro) 6. Future developments **[Q&A and Business Card Exchange]**
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