DIA's Pharmacovigilance And Risk Management Conference To Address Current Complexities And Controversies

Main Category: Pharma Industry / Biotech Industry
Also Included In: Pharmacy / Pharmacist;  Regulatory Affairs / Drug Approvals
Article Date: 14 Nov 2008 - 2:00 PST

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The Drug Information Association will host its 8th Annual DIA Conference for Contemporary Pharmacovigilance and Risk Management Strategies (January 11-15; Washington, DC). This annual event addresses the current complexities and controversies in pharmacovigilance and risk management throughout all phases of development and marketed use. This year's topics include:

- US FDA and EMEA risk management initiatives

- Generating and assessing critical safety data during development

- Compliance with global clinical safety and postmarketing pharmacovigilance regulatory requirements

- Relationship between compliance and quality in safety-related processes and procedures

- 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 in risk management, risk communication, labeling, and packaging to optimize medical product benefit while minimizing preventable harm

- Patient safety

"The field of medical product safety continues to grow in complexity, with both clinical trial safety and postmarketing pharmacovigilance becoming ever more critical in the development and ongoing evaluation of safe use of marketed medical products," explains Program Chair Stephen A. Goldman, MD, FAPM, DFAPA,Managing Member, Stephen A. GoldmanConsulting Services, LLC. "The inherent limitations of premarketing testing and constant focus on the risks associated with medical product use have fostered new thinking and methods for monitoring the evolving safety profiles of marketed products throughout their life cycle. Further, risk management requires ongoing refinement in order to enhance its applicability and value to public health."

Exhibiting companies will present their products and services throughout the conference.

About the Drug Information Association (DIA)

DIA serves more than 30,000 professionals in the biotechnology, pharmaceutical and regulatory industries worldwide. Through its domestic and international meetings, training courses, workshops and webinars, DIA provides a neutral global forum for the exchange of information critical to the advancement of the drug discovery and lifecycle management processes. Headquartered in Horsham, PA (USA), and with offices in Basel, Switzerland, Tokyo, Japan, and Mumbai, India, the Association is led by its volunteer-based Board of Directors and executive management team.

Drug Information Association