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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) including... Read More →

Speakers
avatar for Dinah Duarte

Dinah Duarte

Scientific Evaluation Unit, Directorate of Medicinal Products, INFARMED, Portugal
Dr. Dinah Duarte is a senior assessor at the Scientific Evaluation Unit at the Directorate of Medicinal Products, in the Portuguese regulatory authority for medicines and health products (INFARMED). She is an expert member at the European Medicines Agency (EMA); the current Committee... Read More →
avatar for Helen Edelberg

Helen Edelberg

Head of Medical Safety Assessment, Innovative Medicines & Global Safety Risk Mgt, Bristol-Myers Squibb
Dr Helen Edelberg is Head of Med Safety Assmt for Innovative Med & Gbl Safety Risk Mgmt, which provides authoritative expertise on development & execution of rigorous & innovative risk mgmt strategies at BMS. A strategic & innovative biopharmaceutical exec & physician with ~20 years... 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) including... Read More →

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