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European Pharmacovigilance Reform

Strategic Implications of Ongoing Benefit-Risk Assessment Across the Product Lifecycle

Globally, there is a heightened focus on the risk-benefit profile of medicines. In Europe, the new pharmacovigilance legislation— enacted in 2010 and implemented in July 2012—has ushered in a new framework for the risk management of pharmaceuticals, with additional responsibilities now facing the industry.

European Pharmacovigilance Reform: Strategic Implications of Ongoing Benefit-Risk Assessment Across the Product Lifecycle provides a detailed analysis of what the new pharmacovigilance legislation means in terms of PAES/PASS and assesses how this framework is likely to evolve, taking into account growing activity at the payer-regulatory interface. The study is based on extensive secondary research, as well as primary research through interviews with key stakeholders and provides answers to these key questions:

  • What are the implications for pricing and reimbursement?
  • What are the potential cost implications of PASS/PAES, and what lessons can be drawn in terms of investment strategy?
  • What will a successful market launch look like in the new pharmacovigilance landscape, and will current launch strategies need to be modified?
  • What do the current legislation and related guidance tell us about the future of PASS/PAES?

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