Drug Safety, Pharmacovigilance and Risk Management Forum
Date
October 22-24, 2012
Location
Philadelphia, PA
Participants
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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