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Introduction A series of high profile safety concerns, such as the withdrawal of Vioxx (rofecoxib) and the link between antidepressants and suicidal thoughts in children over the last two years has made drug safety a major issue for governments, regulatory authorities and the pharma industry. This has triggered a period of change across the board, and the industry is now entering a new era of drug safety. Scope - Evaluation of the US and EU pharmacovigilance systems, including major regulatory changes implemented since the beginning of 2004
- Examination of the future of pharmacovigilance in the US and EU, including analysis of major technological advances and proposed legislation
- Recommendations on how companies can optimize their pharmacovigilance activities
- Discussion of the changing pharmacovigilance environment with key stakeholders, including pharmaceutical company executives and physicians
Highlights Although the US has been considered to have a stronger pharmacovigilance system than the EU, new legislation implemented in the EU over the last two years has transformed pharmacovigilance regulations, with the EU finally catching up with the US system and even taking the lead in a number of ways. It is necessary to take a more proactive approach to pharmacovigilance in the future. Over the last few years there has been a noticeable shift towards this driven by regulatory authorities, such as through their policy on risk management plans, and pharma companies, such as through the incorporation of pharmacogenomics in development programs. It has become a essential for companies to increase the transparency of their activities and the communication of information about drugs, which was triggered by the lawsuit that Spitzer filed against GlaxoSmithKline in 2004, alleging that it withheld negative information about the use of Paxil (paroxetine) in children. Reasons to Purchase - Get up to speed with recent developments in the pharmacovigilance systems in the EU and US
- Assess the implications of regulatory and environmental changes that will shape the future of pharmacovigilance on your business
- Understand the key steps necessary to optimize your pharmacovigilance activities
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