RxLogix PV Digital Transformation Seminar Series 2024-Tokyo

High Level Agenda

  1. Guest Speaker Presentations and Case Studies
  2. RxLogix Corporate Update and Roadmap
  3. Client NextGen Safety Program Update
  4. RxLogix Solutions Overview and Demo
    • Safety-In-A-Box (PV Case Management)
    • Reporting and Analytics (PV Reports and PV Analytics)
    • Compliance and Quality Monitoring (PV Central & PV Quality)
    • Signal Detection and Management (PV Signal)
    • AI, ML and NLP Capabilities in RxLogix PV SaaS Platform
  5. RxLogix Innovation Lab Update
  6. Exchange of Ideas with Peers from Other Companies

Guest Speaker

E. Stewart Geary, MD

Global Safety Officer,  Eisai

Topic: CIOMS XII- A New Era for Structured Benefit Risk Assessments

This presentation will describe some key concepts in the report, including:

  • The current landscape for benefit-risk assessments
  • The importance of using a structured benefit-risk framework
  • The CIOMS XII Structured Benefit Risk Framework
  • The new concepts of Key Benefits and Key Risks which are compared in the benefit-risk framework
  • Evaluating benefits and risks from the perspective of the clinical trial subject using Desirability of Outcome Ranking (DOOR)

Ken Kubota

Senior Vice President PV Operations, Astellas

Jens Nordahl

Senior Project Manager, GPS Projects and Partnering, Lundbeck