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Wednesday, June 21 • 2:00pm - 3:15pm
#347: Integrated Life Cycle Approaches to Benefit -Risk Assessment, Communication, and Evaluation

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-535-L04-P; CME 1.25; IACET 1.25; RN 1.25

Effective benefit-risk (B-R) communication is important in ensuring that key stakeholders understand how to use medicines appropriately. It requires the creation of processes to deliver communications that are relevant to their audiences, robust dissemination mechanisms, and evaluations to show they promote behaviors optimizing B-R. This session will address these areas.

Learning Objectives

Identify the importance of effective benefit-risk communication.

Chair

Simon Ingate, PhD, MBA

Speaker

Digital Strategies for Communicating Benefit-Risk and Gathering Effectiveness and Other Data Used to Optimize the Benefit-Risk Ratio
Simon Ingate, PhD, MBA

Learnings from Implementing Risk Minimization Measure Effectiveness Evaluation PASS Studies
Helen Kathryn Edelberg

Benefit-Risk Communication Strategies: The Patient as a Partner
Dinah Duarte, PharmD, MSc



Moderators
avatar for Simon Ingate

Simon Ingate

Principal Consultant, Safety Gauge Product Manager, Pope Woodhead & Associates Ltd
Simon Ingate is a Principal Consultant at Pope Woodhead (a Huron Solution) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures (RMMs) in... Read More →

Speakers
avatar for Dinah Duarte

Dinah Duarte

Head, Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED
Head of Scientific Evaluation Unit at INFARMED, I.P. Portuguese regulatory authority for medicines; Committee for Orphan Medicinal Products member at European Medicines Agency; Associate Professor (Lisbon University); member of European Network of Centres for Pharmacoepidemiology... Read More →
avatar for Helen Edelberg

Helen Edelberg

Head, Global Safety Risk Management, Bristol-Myers Squibb
Dr Helen Edelberg is Head of Global Safety Risk Management, which provides authoritative expertise on the development & execution of rigorous & innovative risk management strategies at BMS. A strategic & innovative biopharmaceutical executive and physician with Regulatory/PV & ac... Read More →
avatar for Simon Ingate

Simon Ingate

Principal Consultant, Safety Gauge Product Manager, Pope Woodhead & Associates Ltd
Simon Ingate is a Principal Consultant at Pope Woodhead (a Huron Solution) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures (RMMs) in... Read More →
avatar for Simon Ingate

Simon Ingate

Principal Consultant, Safety Gauge Product Manager, Pope Woodhead & Associates Ltd
Simon Ingate is a Principal Consultant at Pope Woodhead (a Huron Solution) where he develops and implements risk management/minimisation (RM) strategy and programmes. Simon leads teams developing new approaches for disseminating and evaluating risk minimisation measures (RMMs) in... Read More →


Wednesday June 21, 2017 2:00pm - 3:15pm
S401d McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616