Drug Safety, Pharmacovigilance and Risk Management Forum

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