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CBI’s 15th Annual Registries and Post-Approval Studies Congress

Achieve Scientific and Commercial Data Objectives by Optimizing Study Design and Implementation

September 19-21, 2012
  • Chicago, Illinois

Available for $298.00

A number of forces are coming together to create a perfect storm for healthcare and the pharmaceutical industry, impacting the way post-approval studies are designed and operationalized!   

Post-approval studies continue to be an area of significant importance given the payer’s increasingly powerful role and heightened regulatory requirements.  Recently, the FDA’s Center for Drug Evaluation and Research identified the need to improve access to post-market data sources, determine its accuracy as well as explore the feasibility of using post-market data in safety analyses.  Evidence Based Medicine and Comparative Effectiveness Research proponents disagree on the best way to achieve this need for reliable and relevant information. This Congress provides the opportunity to learn from a distinguished senior faculty and network with the best medical, clinical, regulatory, scientific, HEOR, risk and safety minds in post-approval studies.

Customize your experience with relevant sessions and breakouts tailored to your role:

  • CER trials
  • Observational studies
  • Registries
  • Global phase IV studies
  • Longitudinal studies
  • Pragmatic clinical trials
  • Safety studies

 


 

About our Educational Sponsor and Silver CRO/ Consulting Leadership Circle Sponsor:

The PAREXEL PACE (Peri-approval Clinical Excellence) group is the only resource you need to seamlessly transition from development to market. As dedicated group within PAREXEL®, one of the world’s largest CROs, PACE provide a comprehensive suite of strategy, data collection and analysis services, as well as direct service capabilities to conduct the crucial studies to best position your product in a competitive marketplace. We provide:

  • Specialized peri- and post-approval expertise
  •  Industry leading patient recruitment and forecasting tools
  • An established global infrastructure
  • Unique solutions for the design and execution of interventional and non-interventional studies
  • Proprietary technologies included a dedicated web platform
  • Full scope of post-marketed safety surveillance and reporting services
  • Fully integrated commercialization consultancy