Regulators in the pharmaceutical industry are now demanding increasingly proactive surveillance programs that include comprehensive risk management plans and pharmacovigilance signal detection and analysis throughout a product's lifecycle.
In addition to meeting these new regulation requirements, pharmaceutical companies are faced with the task of regaining the trust of patients, healthcare providers and regulators. Recent drug withdrawals have led to calls for pharmaceutical companies to show a demonstrated commitment to safety that goes beyond mere compliance. In May, U.S. regulators restricted use of London-based GlaxoSmithKline Plc (GSK)’s Avandia, after a study showed a 43 percent increased risk of heart attacks among patients taking the medicine. The drug was ordered pulled from pharmacy shelves and subsequently was available only through a special program. Sales of Avandia fell to $680 million last year from $1.8 billion in 2007.
Pharmacovigilance North America is designed to help companies take the lead in creating a proactive and long-term approach to drug management and safety. Over twenty-one in-depth case studies and workshops set out best practices and innovative solutions addressing top industry concerns including:
• Addressing the Importance of Developing & Implementing a Pre-Marketing Plan
• FDA Developments and Future Direction
• Designing Post-Approval Safety Studies
• Best Practices and Methodology of Post-Approval Non-Interventional Studies
• Utilizing a Fully Outsourced Model for Case Processing
• Pharmacovigilance Compliance in a Global Environment
• Difficulties with Investigating Reporting
• Methodological Advances in Post-Approval Studies
• Life-Cycle Management of the Product Safety Profile
• The Future of Drug Safety
• Unintended Consequences on Spontaneous Reporting
Case studies and best practices will be shared from leading industry experts including RTI Health Solutions, Novartis Pharmaceuticals, Genzyme Corporation, Bayer Healthcare LLC, Pfizer Inc., Cephalon and more.
For more information on the IQPC Pharmacovigilance North America Conference, please visit the Pharmacovigilance North America Conference website at http://tinyurl.com/
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