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Tuesday, June 27 • 10:30am - 11:30am
Benefit-Risk Balance for Medicinal Products: CIOMS Working Group XII Report

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Component Type: Session
Level: Intermediate

will include implementation recommendations, planning for the use of the structured BR approach, and several case studies, using the usual collaborative consensus approach of CIOMS. Speakers will include CIOMS WG members from academia, regulatory authorities and industry.

Learning Objectives

Provide an update on the CIOMS Working Group XII benefit-risk balance for medicinal products; Describe the conduct of high quality, balanced, and comprehensive lifecycle benefit-risk assessments; Discuss strategic guidance on structured framework and benefit-risk methodologies to improve transparency and understanding amongst key stakeholders, including patients.

Chair

Ana-Claudia Ianos, MD

Speakers
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 →

Tuesday June 27, 2023 10:30am - 11:30am CDT
TBD Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  01: ClinSafety-PV, Session