Key Conference Topics

A New World of Post-Approval Research

The Post-Approval Summit is set to discuss the perpetually changing landscape of post-approval research. The Summit’s opening day keynote presentation will discuss and examine how pharmaceutical companies are evolving to address the increasing requirements from multiple stakeholders for real-world and post-approval evidence of the safety and effectiveness of new therapeutics and how they are responding to the impact of real-world and evidence based medicine on the development and commercialization of these products.

Meeting Safety Surveillance and Benefit Risk Management Requirements

Safety and benefit risk management requirements in both the United States and Europe remain among the most pressing topics in post-approval research. Summit sessions address these key topics with presentations from government, industry, and academia. The U.S. FDA will present on the evolving development of new models for device safety reporting and surveillance, new U.S. initiatives, and the role and expectations of the Agency with risk management and safety programs. The European Medicines Agency will present updates to European Pharmacovigilance Guidelines. Sessions from industry and academia will cover an epidemiological perspective on the broader view of methodology in conducting comparative effectiveness research, a case study on using retrospective data to evaluate safety signals and assess risk, and an overview of the role of big database in safety and its applicability to researchers in the post-approval industry.

Different Data Sources: Problems, Limitations, and Methods

The variety and depth of data sources for real-world research continues to grow and with greater opportunities to use different data sources for studies new problems, limitations, and methods arise. The Summit presents two case studies relaying experiences with using different data sources for post-approval programs. One case study will cover a Uterine Fibroid study and the associated problems, limitations, and methods with using two different data sources. The second case study will discuss novel uses of data sources for monitoring the safety and effectiveness of off-label use of drugs in cancer.

Global and Local Considerations in Phase IV

Designing and implementing Phase IV studies in emerging markets present unique challenges and considerations for researchers. This key industry topic will be addressed with sessions on those challenges and special regulatory and operational considerations.

Comparative Effectiveness Research: Challenges, Best Practices and Methods, and Reimbursement

Comparative effectiveness research (CER) is unquestionably a critical area of research in post-approval studies. The Summit dedicates the second day to discussing the challenges, best practices and methods, and reimbursement for CER. Presenters from different industry perspectives will address key CER topics, including the role of effectiveness data from post-approval research, how effectiveness research will be used for reimbursement, patient-centered outcomes research, evaluating different standards of treatment and treatment patterns, how CER affects newly marketed medications, and decision-making.

Quality and Outcomes Measurement and Reporting for Clinical Specialty and Patient Organizations

This special program will include several case presentations addressing how organizations are currently using registries to meet member and stakeholder needs, including the objectives, challenges, and value of implementing these programs.