Challenges in achieving excellence and ensuring compliance in the rapidly evolving global drug safety environment

image Sciformix is a scientific knowledge-based global service provider for the Pharmaceutical, Biopharmaceutical, Medical Devices and Consumer Products industry. They partner with their clients through the entire drug development cycle, to provide a full range of services from study design to post marketing surveillance and commercialization support. Areas of specialization include Safety and Risk Management, Clinical Development, Biometrics, Scientific Writing, and Regulatory Affairs.

As the premium sponsor, Sciformix will be hosting the keynote address at World Drug Safety Americas. Dr. Sidney Kahn, Senior Principal, Pharmacovigilance Practice, will discuss "Challenges in achieving excellence and ensuring compliance in the rapidly evolving global drug safety environment".

Abstract

The recent major changes in pharmacovigilance regulations are relatively trivial compared with the much more profound technological changes anticipated during the coming decade. This keynote presentation will discuss new and rapidly evolving trends in biomedical and information technologies and their potential impact on the identification, characterization, and communication of important risks attributable to traditional medications and innovative medical interventions. These include:

•    Innovative therapies with well-characterized molecular targets tailored to narrowly defined disease states and specific patient characteristics ("individualized medicine")
•    Enhanced understanding of the impact of genetics and epigenetics
•    Access to "big data" from medical record databases and other sources, including analysis of social media
•    Use of sophisticated data mining and analysis tools to find unanticipated and unsuspected associations
•    Evaluation of true drug effectiveness under real-world clinical conditions
•    Full transparency of development and ongoing usage data.

These new tools will transform pharmacovigilance into a scientifically and statistically robust discipline that will essentially replace the historical approach of post hoc responses to anecdotal data.

Are you interested in meeting Sciformix? World Drug Safety Congress Americas 2013 takes place 24 – 25 April in Boston. Find out more information here.

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