Download Presentation: Ensuring clinical trial site quality for FDA, EMA and local inspections

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 – …

Statistics show increase in clinical trials in emerging markets

Latin America, Central and Eastern Europe (CEE) and parts of Asia are often classified as ‘emerging markets' within the pharmaceutical sector. Recent years have seen huge growth in pharmaceutical operations within these regions – more R&D, more manufacturing, more outsourcing service providers and more partnering/M&A opportunities. As is depicted below, the number of clinical trials initiated in the CEE region …

Pharma and Biotech Speaker Opportunities at BioPharma CEE Convention 2013

The  BioPharma CEE Convention, taking place from 28-29 May in Budapest in 2013 is looking for Global and Local CEE Clinical and Manufacture Heads of Pharma and Biotech to deliver case study presentations or sit on panels at this exclusive event. The event is positioned as the region's obvious choice of a scientific and commercial congress for senior executives from …

Download: eBook – 10 Key Insights into Clinical Trials in Central and Eastern Europe

Did you know there are statistically lower amount of adverse findings in FDA inspections conducted in Central and Eastern Europe (CEE) than in Western Europe?   Outside of the obvious BRIC countries, many pharmaceutical companies are now turning towards the CEE region as an alternative region in which to locate their clinical trials. As with any emerging market, CEE offers …

5 Challenges of Operating Clinical Trials in CEE

Central and Eastern Europe (CEE) is a current hotspot for clinical trial operations. There are many factors that make this region an attractive site for clinical trials, but there are some challenges to overcome too. We've been talking to experts in the region to uncover the difficulties they face. 1. Complex regulatory systems Each CEE country has different processes and …

5 Advantages of Operating Clinical Trials in CEE

Central and Eastern Europe (CEE) is a current hotspot for clinical trial operations. There are many factors that make this region an attractive site for clinical trials. We've been talking to experts in CEE to uncover what the key advantages of this region are. 1. Large pool of treatment-naive patients The CEE region has over 300 million inhabitants, many of …