Negotiating Your Way Through the Vigilance Agreement Maze-is There a Better Way?

The pharmacovigilance agreements (PVA) landscape has evolved over recent decades with rapid growth in the number and complexity of partnerships, mergers, and acquisitions between pharmaceutical companies. Simultaneously there has been increasing scrutiny from regulatory authorities. Detailed regulations and guidance are lacking in this domain; hence companies have developed their own processes, templates, and tools, which have headed in different directions. Where feasible, marketing authorization holders (MAHs) have written contracts based on mutually understood requirements. Currently, MAHs are striving to find optimal solutions that safeguard patients, and in turn, support pharmacovigilance compliance. Through the TransCelerate BioPharma consortium MAHs are seeking simplification and efficiencies, to optimize the process of developing contractual agreements for pharmacovigilance. A survey of MAHs confirmed the perceptions above, and the need for efficient solutions to help navigate through the maze of complexity. The authors have led the development of tools and techniques to enable partnership between MAHs, and ultimately to support patient safety.

The Research of Input-output Efficiency in 50 General Hospitals in Hubei Based on DEA / 中国卫生经济

Objective: To study the input and output efficiency of the general hospitals based on the sampling data, in order to infer the operational efficiency of the general hospital in Hubei Province. Methods: Cobb-Douglas production function is extended and the input-output efficiency of 50 hospitals is analyzed by Data Exchange Agreement ( DEA). Results: Based on C-D production function expansion, through the sampling survey of input and output data, screening the input and output indicators of general hospitals, use DEA to conclude the put-output efficiency of 50 general hospitals in Hubei. Conclusion: The bed utilization rate of 50 general hospitals is low, the general hospital beds should be appropriately reduced, and corresponding policy recommendations are proposed.