Korean Ministry of Food and Drug Safety

Korean, South Korea

Korean Ministry of Food and Drug Safety

Korean, South Korea

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NEW YORK--(BUSINESS WIRE)--Medidata (NASDAQ: MDSO), the leading global provider of cloud-based solutions and data analytics for clinical research, announced today that Medytox, a global biopharmaceutical company based in Korea, will expand its use of the Medidata Clinical Cloud® for domestic and global clinical trials. Using Medidata’s state-of-the-art strategic monitoring and mobile health (mHealth) solutions, Medytox will effectively evaluate and monitor study risk factors while pioneering patient-focused research practices—leading to better, more nuanced clinical trial data and higher quality R&D programs. A leader in the botulinum toxin (commercially known as “Botox”) sector, Medytox is increasingly extending its clinical trial practices beyond Korea, adopting a number of global standards put forth by such industry non-profits as TransCelerate, Clinical Data Interchange Standards Consortium (CDISC) and Critical Path Institute (C-Path). The biopharmaceutical has also been using Medidata’s globally validated, unified solution for EDC, management and reporting (Medidata Rave®) and trial randomization and supply management (Medidata Balance®) since 2015. Now, by furthering its use of Medidata’s technology platform, Medytox is improving the quality of its clinical research programs by proactively addressing study performance issues, streamlining workflows and ensuring the safety of its patients. “With our unique R&D capacity, Medytox is working to create a new paradigm in the biopharmaceutical industry. In order for us to deliver on our mission of creating happier, healthier lives for patients, it is important that we apply advanced technology to our R&D efforts and evolve our expertise beyond Korea,” said Woo-Shun Lee, MD, head of medical at Medytox. “By integrating Medidata’s solutions—which have a proven track record in the global market—into our clinical trial practices, we hope to improve the accuracy and quality of our clinical data while increasing the efficiency of new drug development processes.” Medytox will be the first company in Korea to adopt Medidata TSDV® and Medidata SQM in pursuit of a risk-based monitoring approach to its clinical trials. The biopharmaceutical company will use the tools in tandem to improve the quality of its clinical research data, tapping into TSDV to enhance its source document verification (SDV) process and SQM to monitor and evaluate the level of risk associated with data collected at each of its clinical study sites. Additionally, Medytox will incorporate Medidata’s electronic patient-reported outcomes (ePRO) solution into a select number of its studies. Part of the Medidata Patient Cloud®, Medidata ePRO replaces paper questionnaires and patient diaries with a mobile application, allowing patients to easily input health information—which is available to sponsors immediately—on an ongoing basis. Edwin Ng, the VP of field operations for Medidata APeJ, said, “We are proud to strengthen our partnership with Medytox, a company dedicated to making our world a better place with top-class R&D expertise in the botulinum toxin area. By providing the Medytox team with top-of-the-line technology and the tools to extract real-time insight into study performance and data quality, we’re excited to help further Medytox’s efforts of becoming a true global leader in the biopharmaceutical space.” Medytox, an R&D based global biopharmaceutical company, engages in the development, manufacture, marketing and sales of botulinum toxin and hyaluronic acid dermal filler products as its main business. Since the successful development of the fourth botulinum toxin type A product Neuronox in the world, Medytox has continued moving forward by maintaining a strong position in medical aesthetics as well as therapeutic indications which is associated with movement disorder. Consequently, Medytox launched HA Filler Neuramis series which may generate synergy effects along with botulinum toxin product and launched the world’s first liquid formulation botulinum toxin type A product INNOTOX in the Korean and Japanese markets. And recently, it obtained an approval from the Korean Ministry of Food and Drug Safety to sell “Coretox®,” botulinum toxin product that is safer than its previous versions because it excludes any animal-derived ingredients and non-toxin proteins. Today, Medytox is exporting its products to about 60 countries including Japan, Thailand, Iran and Brazil. Moreover, Medytox has been making efforts to penetrate into US and European market in the near future. Ultimately, Medytox is going to show its presence as a leading global biopharmaceutical company. Medidata is reinventing global drug and medical device development by creating the industry's leading cloud-based solutions for clinical research. Through our advanced applications and intelligent data analytics, Medidata helps advance the scientific goals of life sciences customers worldwide, including over 850 global pharmaceutical companies, biotech, diagnostic and device firms, leading academic medical centers, and contract research organizations. The Medidata Clinical Cloud® brings a new level of quality and efficiency to clinical trials that empower our customers to make more informed decisions earlier and faster. Our unparalleled clinical trial data assets provide deep insights that pave the way for future growth. The Medidata Clinical Cloud is the primary technology solution powering clinical trials for 18 of the world's top 25 global pharmaceutical companies and is used by 16 of the top 20 medical device developers—from study design and planning through execution, management and reporting.


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.

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