Time filter

Source Type

Hayakawa T.,Kindai University | Harris I.,Janssen Research and Development | Joung J.,Korean Ministry of Food and Drug Safety | Kanai N.,Tokyo Women's Medical University | And 17 more authors.
Biologicals | Year: 2016

The development of human cell therapy and gene therapy products has progressed internationally. Efforts have been made to address regulatory challenges in the evaluation of quality, efficacy, and safety of the products. In this forum, updates on the specific challenges in quality, efficacy, and safety of products in the view of international development were shared through the exchange of information and opinions among experts from regulatory authorities, academic institutions, and industry practitioners.Sessions identified specific/critical points to consider for the evaluation of human cell therapy and gene therapy products that are different from conventional biological products; common approaches and practices among regulatory regions were also shared. Certain elements of current international guidelines might not be appropriate to be applied to these products. Further, international discussion on the concept of potency and in vivo tumorigenicity studies, among others, is needed.This forum concluded that the continued collective actions are expected to promote international convergence of regulatory approaches of the products.The Pharmaceuticals and Medical Devices Agency and Japanese Society for Regenerative Medicine jointly convened the forum with support from the National Institutes of Biomedical Innovation, Health and Nutrition. Participants at the forum include 300 experts in and outside of Japan. © 2016.


PubMed | Kindai University, European Directorate for the Quality of Medicines and HealthCare, Forum for Innovative Regenerative Medicine, Tokyo Women's Medical University and 14 more.
Type: Journal Article | Journal: Biologicals : journal of the International Association of Biological Standardization | Year: 2016

The development of human cell therapy and gene therapy products has progressed internationally. Efforts have been made to address regulatory challenges in the evaluation of quality, efficacy, and safety of the products. In this forum, updates on the specific challenges in quality, efficacy, and safety of products in the view of international development were shared through the exchange of information and opinions among experts from regulatory authorities, academic institutions, and industry practitioners. Sessions identified specific/critical points to consider for the evaluation of human cell therapy and gene therapy products that are different from conventional biological products; common approaches and practices among regulatory regions were also shared. Certain elements of current international guidelines might not be appropriate to be applied to these products. Further, international discussion on the concept of potency and invivo tumorigenicity studies, among others, is needed. This forum concluded that the continued collective actions are expected to promote international convergence of regulatory approaches of the products. The Pharmaceuticals and Medical Devices Agency and Japanese Society for Regenerative Medicine jointly convened the forum with support from the National Institutes of Biomedical Innovation, Health and Nutrition. Participants at the forum include 300 experts in and outside of Japan.


Receive press releases from SGS North America Inc.: By Email New State-of-the-Art Agriculture and Food Testing Laboratory Opened by SGS in South Korea On November 14, 2016, SGS opened a new dedicated state-of-the-art food testing and agricultural services laboratory in Uiwang City, near Seoul, South Korea. Rutherford, NJ, December 15, 2016 --( The new laboratory offers the full-range of testing facilities, including: · Food chemical testing – e.g. nutrition, vitamins, preservatives and sugars · Food contaminant testing – e.g. pesticide residues, heavy metals, animal drug residues, melamine, histamine, mycotoxins and PAHs · Microbiological and DNA testing – e.g. microbiological limit testing, including microorganisms identification, allergens, GMO’s, norovirus and antibiotics effectiveness The new facility will be capable of offering these tests across a broad range of food categories, including beverages, dairy, grains and cereals, pastry, meat, poultry and seafood, fruit and vegetables, herbs and spices, tea and coffee, processed, canned and frozen foods, oils and fats, bottled water, and confectionary and chocolate. Accredited to the ISO 17025 standard, the new laboratory employs 53 dedicated full-time staff members and a further 24 part-time members. ISO 17025 is the benchmark standard for technical competency, demonstrating rigorous testing standards and a meticulous laboratory management system. The facility has also been accredited as an official food laboratory by the South Korean Ministry of Food and Drug Safety, and the National Agricultural Products Quality Management Service has authorized it as an agricultural product testing laboratory. Furthermore, the National Institute of Environmental Research has designated the facility a norovirus testing laboratory. In addition to food and agricultural testing, the facility also offers comprehensive auditing services, including supplier and hygiene audits, training, Standard Operating Procedures development, food label review services and inspection services for agricultural, food and fishery products. Conveniently located in Uiwang City, close to Seoul, SGS’s new food and agricultural testing laboratory has become the benchmark for testing services in South Korea; offering expert analysis, testing, auditing, training and inspection services to the country’s agricultural and food sectors. For further information contact: Stephen Min Food Team Manager Agriculture, Food & Life food@sgs.com Tel: (+82) 31 460 8121 About SGS SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world. Rutherford, NJ, December 15, 2016 --( PR.com )-- SGS has established a new 2,340 m2 state-of-the-art laboratory in Uiwang City, near Seoul, South Korea. Opened on November 14, 2016, the new laboratory creates a new benchmark standard for food testing and agricultural services in Korea and continues the growth SGS has already achieved in the Korea market.The new laboratory offers the full-range of testing facilities, including:· Food chemical testing – e.g. nutrition, vitamins, preservatives and sugars· Food contaminant testing – e.g. pesticide residues, heavy metals, animal drug residues, melamine, histamine, mycotoxins and PAHs· Microbiological and DNA testing – e.g. microbiological limit testing, including microorganisms identification, allergens, GMO’s, norovirus and antibiotics effectivenessThe new facility will be capable of offering these tests across a broad range of food categories, including beverages, dairy, grains and cereals, pastry, meat, poultry and seafood, fruit and vegetables, herbs and spices, tea and coffee, processed, canned and frozen foods, oils and fats, bottled water, and confectionary and chocolate.Accredited to the ISO 17025 standard, the new laboratory employs 53 dedicated full-time staff members and a further 24 part-time members. ISO 17025 is the benchmark standard for technical competency, demonstrating rigorous testing standards and a meticulous laboratory management system.The facility has also been accredited as an official food laboratory by the South Korean Ministry of Food and Drug Safety, and the National Agricultural Products Quality Management Service has authorized it as an agricultural product testing laboratory. Furthermore, the National Institute of Environmental Research has designated the facility a norovirus testing laboratory.In addition to food and agricultural testing, the facility also offers comprehensive auditing services, including supplier and hygiene audits, training, Standard Operating Procedures development, food label review services and inspection services for agricultural, food and fishery products.Conveniently located in Uiwang City, close to Seoul, SGS’s new food and agricultural testing laboratory has become the benchmark for testing services in South Korea; offering expert analysis, testing, auditing, training and inspection services to the country’s agricultural and food sectors.For further information contact:Stephen MinFood Team ManagerAgriculture, Food & Lifefood@sgs.comTel: (+82) 31 460 8121About SGSSGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 85,000 employees, SGS operates a network of over 1,800 offices and laboratories around the world. Click here to view the list of recent Press Releases from SGS North America Inc.

Loading Korean Ministry of Food and Drug Safety collaborators
Loading Korean Ministry of Food and Drug Safety collaborators