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DIA safety conference to explore solutions to challenges facing pharmacovigilance and risk management (11/19)

November 19, 2009
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The Drug Information (DIA) will host its 9th Annual Conference on Contemporary Pharmacovigilance and Risk Management Strategies from January 10-13, 2010, in Washington, DC, according to a DIA press release.

This comprehensive three-day program will discuss the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use, how to optimally utilize epidemiological, clinical pharmacological and other techniques, risk management strategies, and how to create an effective organizational “system.” Session topics will include:
  • Latest international regulatory developments
  • How to generate and assess critical safety data during development
  • Compliance with clinical safety and post-marketing pharmacovigilance regulatory requirements in an evolving global environment
  • Recent multinational initiatives under the International Conference on Harmonization (ICH) and Council for International Organizations of Medical Sciences (CIOMS) on Drug Safety Update Reports (DSURs) in premarketing clinical trial safety
  • New approaches to risk management, risk communication, labeling and packaging to optimize medical product benefit while minimizing preventable harm
“Robust drug safety systems and processes and thorough ongoing safety surveillance are more critical than ever in the development and evaluation of the safe use of marketed medicinal products,” says, Program Committee Member Mariette Boerstoel-Streefland, MD, MBA, MS(epi), Executive Director, Pharmacovigilance/Risk Management, Forest Research Institute, Forest Laboratories Inc. “This conference will provide safety professionals with the latest pharmacovigilance regulatory advances and state-of-the-art risk management strategies."

Pre-conference tutorials on January 9 will focus on:
  • Signal Detection, Case Assessment and Data Mining in Pharmacovigilance: Current State of the Art
  • Periodic Safety Update Reports (PSUR): A Guide to the Construction and Analysis of PSURs, ASRs, and DSURs
  • Applied Epidemiology Techniques for Pharmacovigilance Risk Management
  • Applying MedDRA® in Clinical Safety, Pharmacovigilance and Labeling
  • Pharmacovigilance and Risk Management Planning
To register, go here.

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