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Drug Safety, Pharmacovigilance and Risk Management Forum

October 22-24, 2012
Philadelphia, PA

Risk Management Tools and Processes That Can Provide a Competitive Advantage in Drug Development and Commercialization

  • Up-stream opportunities to better characterize product risk issues early in drug development
  • Simple tools and processes that better position risk management planning and discussions with regulators prior to and during NDA submission
  • Key success factors to monitor
  • REMS learnings to date and an integrated model for proactive product risk management
  • Bringing to market important specialty products with challenging safety profiles
    • focusing on the specialist market from the outset and constructing regulatory and commercial infrastructures accordingly
  • Using REMS when bringing orphan drugs to market
  • REMS as a basis to facilitate and legitimize stronger communications with patients and prescribers
  • Recognizing the role of REMS in obtaining financing and/or venture capital investments
  • Maximizing pricing advantages
  • Understanding lifecycle management issues and strategies
  • Measuring the impact these programs have on key external stakeholders
  • Designing and implementing feasible interventions with clearly measurable outcomes

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