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Implementing an Internationally Acceptable Framework for the Benefit-risk Assessment of Medicines: How Close Are We to This?
Program Code:
253
Date:
Tuesday, June 25, 2013
Time:
1:45 PM to 3:15 PM
EST
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
James was a board-certified pharmacist before his current role at the regulatory agency of Singapore as a senior reviewer, focusing on cardiology and post-approval regulatory actions. His research interests include frameworks for benefit-risk decisions and innovation in regulatory affairs.
|
Nate C. Blevins,
MS (SPKNON), Director, Global Regulatory Affairs and Patient Safety,
AstraZeneca Pharmaceuticals LP, United States
Nate has 18 years of experience working in information technology in pharma industry. Nate's current role is director for AstraZeneca pharmacovigilance and regulatory information systems. He has a continuing journey to improve benefit/risk assessment of medicines, where "science meets technology".
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Lawrence Phillips,
PhD (SPKSUP), Emeritus Professor of Decision Sciences, Department of Management,
London School of Economics, United Kingdom
Emeritus Professor of Decision Sciences at the London School of Economics. Awarded the Frank P. Ramsey medal in 2005 for "distinguished contributions to decision analysis" by the Decision Analysis Society of INFORMS. From 2009-11 led a research project on benefit-risk modeling for the EMA.
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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.