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Wednesday June 18, 2025 8:30am - 9:30pm EDT
TBD
Component Type: Session
Level: Intermediate

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 Objectives

Provide an update on Benefit-Risk Balance for Medicinal Products issued by CIOMS WG XII; Learn about the conduct of high quality, balanced and comprehensive lifecycle benefit-risk assessments using the structured benefit-risk framework; Provide strategic guidance patient-centric benefit-risk assessment methodologies to improve transparency and understanding amongst key stakeholders.

Chair

Claudia Ana Ianos, MD

Speaker

speaker
James Buchanan, PharmD


Speakers
avatar for James Buchanan

James Buchanan

President, Covilance LLC, United States
Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and... Read More →
avatar for Ana-Claudia Ianos

Ana-Claudia Ianos

Senior Director, Safety Risk, Pfizer Inc, Switzerland
Ana-Claudia Ianos, MD is Senior Director, Safety Risk Lead in Worldwide Safety at Pfizer, responsible for proactive safety surveillance and lifecycle benefit-risk management for drugs and vaccines in various stages of development. Claudia is a medical doctor with over 12 years of... Read More →
Wednesday June 18, 2025 8:30am - 9:30pm EDT
TBD Walter E. Washington Convention Center 801 Allen Y. Lew Place, NW Washington, DC 20001-3614 USA
  01: ClinSafety-PV, Session

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