State of the Industry – Safety, Quality, and Effectiveness

The 6th Annual Post-Approval Summit will lead off with discussions on the current state of the post-approval industry and envisioning the future of monitoring the safety and measuring the effectiveness of marketed medical products and services. In this section, presenters will address the impact that evolving global post-approval safety and effectiveness regulations and increasing data collection requirements have or will have on the life sciences industry and how industry can adjust to continue to be successful amid all the change.

Safety and Risk Management

This section will cover the most pressing issues and developments in monitoring safety and minimizing the risk of medical products through post-approval programs. Sessions will cover the evolving role and expectations for REMS, risk management, and safety programs globally; real-world examples of registries for safety and REMS studies; considerations for designing interventional versus observational studies; new initiatives in safety surveillance; and the challenges of device tracking and adverse event reporting in post-approval studies. The final presentation will discuss the increasing number of personalized medicines, how regulatory agencies may have to adapt, and the ways in which post-approval studies can support more effective and safe delivery of the right medicine to the right patient at the right time.

Comparative Effectiveness and Evidence Development

The second day will begin with discussions on ARRA and the growing movement for comparative effectiveness research in the new U.S. Healthcare System. Sessions will discuss the industry perspective on how pharmaceutical companies must retool to meet evolving global post-approva safety and effectiveness requirements in an era of evidence based decision making. Speakers will present different perspectives of how effectiveness research will be used for reimbursement, coverage determination and value-based reimbursement in the new U.S. Healthcare System.

Multi-Stakeholder Collaboration in Evidence Development

This section will cover collaborative models for priority setting and program support, with an update from the Center for Medical Technology Policy. A case study from the Cystic Fibrosis Foundation will follow to discuss the use of a disease registry to meet multi-stakeholder needs, including those of manufacturers with post-approval requirements.

Registries Workshop: Planning, Operational, and Analytical Challenges

Closing the Summit, a registries workshop will address practical issues and solutions with  designing, operating and evaluating patient registries. Workshop leaders will also discuss governance and communication strategies as well as global challenges. Case studies will present real-world examples of getting value from a registry.