Regardless of the region in which you are operating clinical trials, sites can be scrutinised by the FDA, EMA and local inspectors – and just because you are operating in one geographic region doesn’t mean that you are exempt from inspections by authorities that govern another geographic region. Between 1994 and 2010, the FDA performed 230 inspections in CEE – as well as numerous inspections in a multitude of other countries.
Emerging markets are often criticised for conducting clinical trials that do not comply with regulatory guidelines – although this is often a misconception. Recent analysis indicates that CEE is in fact the region with the lowest percentage of inspections that required follow-up action*. Regardless of the region, it is important to ensure that clinical trial sites are regulatory compliant and inspection ready.
At the 2012 BioPharma LatAm Convention, Ludmila Matai delivered the presentation âEnsuring site quality for FDA/EMA and local inspections'. This presentation provides a statistical overview of site inspections, an overview of FDA/EMA processes and standards and discussion on maintaining GCP.
Interested in finding out more about clinical trials, and/or the pharmaceutical industry in Central and Eastern Europe? Have a look at the BioPharma CEE Convention 2013, and its dedicated Pharma Trials stream.
* Source: Caldron PH et al. Why (not) go east? Comparison of findings from FDA Investigational New Drug study site inspections performed in Central and Eastern Europe with results from the USA, Western Europe, and other parts of the world. Drug design, development and therapy. 2012; 6:53-60. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22563236