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Follow on Google News | Simbec gains MHRA supplementary accreditationSimbec Research (Merthyr Tydfil, UK) is among the first group of Phase I units in the UK to pass the Medical and Healthcare products Regulatory Agency inspection for standard and supplementary accreditation.
By: Jobs4DD Ltd The accreditation scheme was devised by the MHRA to give it more information about trial facilities, and to restore public confidence following the Tegenero TGN1412 trial incident in 2006, in which six subjects were admitted to intensive care. “Although the scheme is currently a voluntary process, it will become increasingly difficult for sponsors to justify the use of centres that do not have the appropriate level of accreditation,” Simbec recently completed a first-in-man study of the first immunomodulating monoclonal antibody to be tested under the new UK regulatory process for higher risk compounds. The programme will now proceed to clinical studies in rheumatoid arthritis and psoriasis patients, which are expected to start at the end of 2008. Article submitted by www.jobs4dd.com - for latest international clinical research, requlatory affairs and pharmacovigilance jobs. # # # www.jobs4dd.com is a specialist online recruitment service for the clinical trial and drug development sectors. Latest news and jobs in the industry are listed on a daily basis. Latest international clinical research jobs, CRM jobs, regulatory affairs jobs, data management jobs, statistician jobs, pharmacovigilance jobs and many more vacancies are listed on the www.jobs4dd.com website. Visit our news archive section at www.jobs4dd.com/ End
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