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Tuesday, June 29 • 2:00pm - 3:00pm
#236 L: Systems Thinking: A Better Way of Safety Management Planning

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Component Type: Workshop
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-572-L04-P; CME 1.00; IACET 1.00; RN 1.00

Workshop attendees will use systems thinking to sketch their safety management system, and will use the sketch to identify assumptions, risks, and design requirements, and to better manage quality.

Learning Objectives

Create a systems model of a pharmacovigilance process; Identify assumptions, gaps, risks, requirements and design constraints from the model; Describe how to utilize the model to improve the quality management system.


Alan M Hochberg


Systems Thinking: A Better Way of Safety Management Planning
Brian Edwards, DrMed

avatar for Brian Edwards

Brian Edwards

Principal Consultant, Pharmacovigilance and Drug Safety, Vice-President ACRES, NDA Group, United Kingdom
After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining... Read More →
avatar for Alan Hochberg

Alan Hochberg

Principal Scientific Enablement Director, F. Hoffmann-La Roche, Switzerland
Alan Hochberg is a Scientific Enablement Leader at Roche in Basel, involved in bringing innovations into the pharmacovigilance system. He was formerly with ProSanos, where he developed and evaluated signal-detection algorithms. He has worked in bioinformatics and biomedical engineering... Read More →

Tuesday June 29, 2021 2:00pm - 3:00pm EDT
TBD Virtual Event Horsham, PA 19044
  01: ClinSafety-PV, Workshop