James Carignan Has Been Appointed as Vice President, Quality Assurance and Regulatory Compliance for Bridge Pharmaceuticals in Beijing, China.SAN FRANCISCO -- Bridge Pharmaceuticals announced today the appointment of James Carignan, B.S. RQAP-GLP as Vice President of Quality Assurance and Regulatory Compliance for its Beijing P.R.C. operations. Mr. Carignan comes to Bridge as a nationally recognized expert in Good Laboratory Practices (GLPs) with 25 years of experience in toxicology and analytical laboratories for multi-national corporations and CRO's. Prior to joining Bridge, Mr. Carignan was responsible for directing the quality assurance program at Novartis (formerly Chiron Corporation at Emeryville, CA). He is an expert in writing and implementing SOPs to support a GLP See gateway location protocol. program, developing and conducting GLP training for all levels of senior staff, scientists, and general staff, and directing internal and external GLP site inspections. Mr. Carignan also previously held the position of Director of Quality Assurance and Regulatory Affairs at TherImmune Research where he was responsible for complete oversight of the QAU QAU Quaid-e-Azam University (Islamabad, Pakistan) including maintaining the Master Schedule, Provantis data collection system validation processes, and preparation/submission of INDs. Mr. Carignan is a member of several professional societies including the Society of Quality Assurance (SQA SQA Scottish Qualifications Authority SQA Software Quality Assurance SQA Supplier Quality Assurance SQA Society of Quality Assurance SQA Singapore Airlines SQA Sperm Quality Analyzer SQA System Quality Assurance SQA Statistical Quality Analysis ) and the Regulatory Affairs Professional Society (RAPS). He also has an HT certification (ASCP ASCP American Society of Clinical Pathologists. ) and has been part of the SQA Regulatory Review Committee, including Chairman (1997-1998); and a long term member and Chairman of the SQA Educational Committee. He has been a Basic GLP Principle Trainer since 1999, and assisted the EPA EPA eicosapentaenoic acid. EPA abbr. eicosapentaenoic acid EPA, n.pr See acid, eicosapentaenoic. EPA, n. in an OECD OECD: see Organization for Economic Cooperation and Development. Submission in 1997. He has been an invited speaker at numerous meetings and conferences and has participated in continuing education continuing education: see adult education. continuing education or adult education Any form of learning provided for adults. In the U.S. the University of Wisconsin was the first academic institution to offer such programs (1904). programs throughout his career. He was invited to participate in the Drug Information Association's Red Apple II conference in 2006 and contributed to the initial RQAP-GLP exam. Mr. Carignan was responsible for establishing numerous training programs within the SQA. He plans to utilize that experience, along with Bridge's facilities and resources, to establish and expand SQA's educational training and testing capabilities in China. "People, process, passion is a company motto and Jim has them all," said Dr. Ada Kung, D.A.B.T, head of the Bridge Beijing Laboratory. "Jim is taking a leading role in quality assurance training and management in China at Bridge and, importantly for the industry, implementing the first ever US and EU level GLP program for drug safety testing in China. It has been a major accomplishment and we are absolutely thrilled to have him part of the team here in Beijing." About Bridge Pharmaceuticals Bridge is a preclinical CRO with state-of-the-art facilities in Gaithersburg, Maryland and Beijing, China, providing US GLP compliant pre-clinical contract research and development services. Services include general and specialized toxicology, developmental and reproductive toxicology (DART), safety pharmacology, gene tox, carcinogenicity carcinogenicity /car·ci·no·ge·nic·i·ty/ (kahr?si-no-je-nis´i-te) the ability or tendency to produce cancer. carcinogenicity the ability or tendency to produce cancer. testing and vaccine development in support of IND and NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any submissions. Studies are backed by in-house bioanalytical chemistry as well as histopathology his·to·pa·thol·o·gy n. The science concerned with the cytologic and histologic structure of abnormal or diseased tissue. Histopathology The study of diseased tissues at a minute (microscopic) level. and clinical pathology services that are all under the direction of US board certified pathologists and toxicologists. For more information, please visit www.bridgecro.com or contact the individuals below. Copyright [c] 2007, Bridge Pharmaceuticals, Inc. All rights reserved. |
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