Simbec gains MHRA supplementary accreditation

July 16, 2008 - PRLog -- Simbec 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.  This means Simbec can undertake trials of all types of drugs, including those considered higher risk and therefore requiring review by the MHRA’s expert advisory group (EAG).

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,” said Simbec’s scientific director, Dr Trevor Tanner.

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.

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