Drug Information Association Conference To Explore Global Pharmacovigilance And Risk Management Strategies And Regultory Frameworks

Main Category: Pharma Industry / Biotech Industry
Also Included In: Regulatory Affairs / Drug Approvals;  Pharmacy / Pharmacist
Article Date: 28 Oct 2008 - 1:00 PDT

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The field of medical product safety continues to grow in complexity, with both clinical trial safety and post-marketing pharmacovigilance becoming ever more critical in the development and marketed use of medical products. In response, the Drug Information Association (DIA) will host Safety is Global: Contemporary Pharmacovigilance and Medical Product Risk Management Strategies (December 10-12; Marina Square, Singapore).

This unique three-day conference will explore the latest safety-related regulatory initiatives, how to optimally utilize epidemiological, clinical pharmacological and other techniques, state-of-the-art risk management strategies, and how all of this can be pulled together to create a "system." Featured topics will include:

- Latest international regulatory developments
- Generating and assessing critical safety data during development
- Compliance with clinical safety and post-marketing pharmacovigilance regulatory requirements in an evolving global environment
- 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)
- New approaches in risk management, risk communication, labeling, and packaging to optimize medical product benefit while minimizing preventable harm
- Patient safety


"Safety professionals from countries and regions that do not participate in ICH will learn about the latest pharmacovigilance regulatory advances, how to optimize epidemiological and clinical pharmacological techniques in both clinical safety and post-marketing, and state-of-the-art risk management strategies," says Program Chair Stephen A. Goldman, MD, FAPM, DFAPA, Managing Member, Stephen A. Goldman Consulting Services, LLC. "In addition, there will be updates on regulatory frameworks for pharmacovigilance in the US, EU, Japan, Australia, New Zealand, Singapore, Thailand, India and China in an effort to foster greater cooperation and collaboration for global patient safety."

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