Beyond harmonization: Regulatory innovation for the next generation of drug development

5^th International Conference and Exhibition on Pharmaceutical Regulatory Affairs

August 03-05, 2015 Orlando, USA

Greg Koski

ACRES, USA

Posters-Accepted Abstracts: Pharmaceut Reg Affairs

Abstract :

For more than 50 years, the drug development process has been subject to processes for oversight and regulation that are well intended, but cumbersome, expensive and ineffective. Regulatory agencies do not have, nor will they ever have, the financial and human resources to fulfill their responsibilities. Ethical review and over-sight are considered an impediment innovation not only by investigators, but by the oversight offices and review committees themselves. Application of systems thinking, human factors research and safety engineering principles afford many innovative solutions, but without systemic change in the highly fragmented and dysfunctional ecosystem, their realization is impossible. In this presentation, Greg Koski, former director of the US Office for Human Research Protections and current CEO of the Alliance for Clinical Research Excellence and Safety illustrates, and discusses what the future holds for true regulatory and ethical innovation and outlines the pathway to fulfillment through regulatory science, systems engineering, real-time statistical analytics of â�?�?big dataâ�? through high-performance computing and the creation of a shared, interoperable informatics infrastructure within a federated trust-framework for identity management and secure digital work-flow processes.

Biography :

Email: gkoski@acresglobal.net