White Paper
Safety First: The Impact Of New Regulations On Clinical Development
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•White Paper: Safety First: The Impact Of New Regulations On Clinical Development
By ICON Clinical Research
A series of high-profile drug withdrawals in recent years has brought safety concerns to the fore, prompting more rigorous monitoring requirements from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). Many of the new initiatives - which include the creation of a clinical trials databank, systems for the collection of adverse events, and increasing use of post-marketing surveillance as a condition of drug approval - are designed to ensure that medications are monitored for their safety and effectiveness over the long-term and across wide populations.
How are companies responding to the new safety imperatives at a time when they are already facing some of their biggest challenges? ICON, a global provider of outsourced development services to the pharmaceutical, biotechology and medical devices industries, commissioned IMS Health to undertake a program of research to address several key questions.
Click Here To Download:•White Paper: Safety First: The Impact Of New Regulations On Clinical Development
