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Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Session Chair(s)
Claudia Ana Ianos, MD
Senior Director, Safety Risk Management Lead
Pfizer Inc, United States
The session reports the CIOMS WG XII Benefit-Risk Balance for Medicinal Products that formulates key principles for lifecycle benefit-risk assessments to inform decision-making and further the development of medicines that patients need.
Learning Objective : Discuss the Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Explain the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Identify strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.
Speaker(s)
Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Claudia Ana Ianos, MD
Pfizer Inc, United States
Senior Director, Safety Risk Management Lead
Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Carmit Strauss, PharmD
Takeda, United States
Executive Director, Head of Risk Management, Organ Toxicity and Benefit Risk
Newly Released Benefit-Risk Balance for Medicinal Products: A CIOMS Working Group XII Report
Scott Evans, PhD, MS
George Washington University Milken Institute of Public Health, United States
Professor and Founding Chair, Department of Biostatistics and Bioinformatics
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