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Risk Management: The Route to Safety

According to the European Medicines Agency (EMEA), there were 57 marketing authorisation withdrawals and suspensions for medicinal products for human use between 2000 and 2008. In 2008 alone, 12 products were withdrawn. This should be a clear sign of the need to improve the safety assessment of a new chemical entity (NCE) as early as possible during the development process.

The first step towards the development of safer drugs occurs at the pre-marketing stage. Preclinical data and, more importantly, clinical data are used to obtain an initial understanding of the riskbenefit profile of an NCE. In recent years, although there has been an increasing amount of regulation aimed at improving the quality of clinical research, this was initially focused on data quality and the appropriate assessment of efficacy. However, the assessment of safety came further into focus after the withdrawals of Baycol and Vioxx. Yet, despite this increased emphasis, drug safety and pharmacovigilance are typically still viewed as activities that are best conducted on large data pools that are only available once the drug is marketed.


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Peter Schüler, MD, is board certified in Neurology and in Pharmaceutical Medicine. After eight years in basic and clinical CNS research at a neurological university hospital, he joined Pharmacia in 1995. As Head of Medical Affairs, CNS, he oversaw all CNS compounds marketed by Pharmacia in Germany. In October 2000, he moved into the CRO business. In October 2007, Peter took over the position of VP Medical Affairs & Drug Safety at ICON, overseeing more than 150 safety experts and physicians in Europe and Asia. He lectures in Pharmaceutical Medicine at the University of Duisberg/Essen as Head Lecturer.
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Peter Schüler
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