6th Annual Pharmacovigilance

Drug safety has long been an issue however the concern has risen again in recent years following high profile scares. In 2009, FDA reported more than 1,742 recall in comparison to 426 in 2008 and fast pace of drug recalls seems to be continuing in 2010 totalled 296 from January through June of this year¹.

According to peer-reviewed published studies, FDA-approved prescription drugs injure 2.2 million and kill approximately 100,000 Americans each year and more realistic estimates put the number of deaths at over 200,000 people annually in the United States alone. 

On the other hand pharmaceutical companies continues to face pressure to develop novel drugs as the patents of many blockbuster drugs are rapidly approaching expiry with at least $150bn worth of blockbuster revenues due to be lost by 2015².

Visiongain’s 6th Annual Pharmacovigilance Conference is designed to bring together exclusive panel of experts who will discuss various aspects of pharmacovigilance practices in clinical trails, risk management and drug safety. The conference will feature keynote addresses on reporting, auditing & inspection, technical advances for the betterment of pharmacovigilance practices, live-licensing and pharmacovigilance in Europe, US and Asia.

¹Gold Sheet, a trade publication on drug quality that analyzes FDA data.
²Visiongain report: Live-Licensing & In-life testing: R&D Processes and Regulation for New Drugs, 2008-2020

Whether your interests lie in drug safety, risk management or pharmacovigilance, attending this conference will enable you to
• Gain insight about the global pharmacovigilance landscape today and perspectives on the future
• Understand pharmacovigilance during the pre-approval phases
• Develop pharmacovigilance in clinical trials
• Explore risk management plans: are they a tool for improving drug safety?
• Assess post marketing safety strategy
• Implement new statistical tools for monitoring the safety of marketed drugs
• Examine advances in inspection, reporting and auditing
• Learn signal detection methodologies to support effective safety management
• Make the most of inspections and best practices in maintaining constant vigilance
• Review current principles and practices of regulatory pharmacovigilace in Europe and US
• Improve pharmacovigilance in Asia
• Hear about role of Live-Licensing/In-Life Testing in drug development
• Evaluate role of electronic data capture in clinical trails
• Stay ahead by learning advances in computing and electronic communications in pharmacovigilance
• Overcome challenges in pharmacovigilance for orphan, rare indications and biosimilars
• Be part of a major networking opportunity

Who will attend?

VP’s, Directors, Heads, Managers, Scientific Advisors, Consultants of: 
• Pharmacovigilance
• Pharmacoepidemiology
• Pharmacogenomics
• Drug/Product Safety
• Drug Development
• Information and Clinical Data Management
• Clinical Pharmacology
• Clinical Safety
• Periodical safety update report
• Risk Management
• Research & Development
• Quality Assurance
• Patient Safety
• Signal Detection
• Safety Surveillance
• Outcomes Research
• Data Analysis
• Epidemiology
• Medical Affairs
• Regulatory Affairs and Compliance
• Information technology
• Sales and Marketing