DIA 2013 49th Annual Meeting
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Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?
Track : Track 08:Regulatory Affairs and Submissions
Program Code: 253
Date: Tuesday, June 25, 2013
Time: 1:45 PM to 3:15 PM  EST
Location: 257AB
CHAIR :
Stuart Walker, PhD (SCHNON), Founder, Centre For Innovation In Regulatory Science (CIRS), United Kingdom
SPEAKER (S):
 James Leong, MPharm (SPKAGY), Regulatory Specialist, Health Sciences Authority, Singapore
 Nate C. Blevins, MS (SPKNON), Director, Global Regulatory Affairs and Patient Safety, AstraZeneca Pharmaceuticals LP, United States
 Lawrence Phillips, PhD (SPKSUP), Emeritus Professor of Decision Sciences, Department of Management, London School of Economics, United Kingdom
Description
Major changes of benefit-risk methodologies have been undertaken by agencies and companies which have enabled the development of an overarching eight step framework. This session will bring together the various stakeholders to review progress.