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Wednesday, June 22 • 4:15pm - 5:15pm
#365: Field of Dreams: If We Build it, Will they Come? Using Implementation Science to Improve Digital Risk-Minimization Tools

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-22-633-L04-P ; CME 1.00; RN 1.00

This session will explore how digital aRMMs can be designed and implemented to improve their quality and effectiveness and will seek to share perspectives from both industry and regulatory authorities.

Learning Objectives

Identify how to design high quality digital 'additional risk minimization measures' (aRMMs); Describe how to apply implementation science strategies to improve the uptake and effectiveness of digital aRMMs; Discuss regulators’ perspectives (including barriers faced) regarding digital aRMMs.

Chair

Meredith Smith, PhD, MPA, FISPE

Speaker

What is the Quality of Existing Digital Tools for Risk Minimization Purposes? An Assessment of Risk Minimization Websites
Meredith Smith, PhD, MPA, FISPE

Digital Additional Risk Minimization Measures: Are Stakeholders on Board for a Digital Approach and How Do We Get There?
Barbara Da Silva-Tillmann, DrMed, FRCPC

PDUFA VII: How FDA is Planning to Increase its Expertise in the Use of Digital Technology for Improving REMS and REMS Assessments
Edward D. Millikan, PharmD, RPh

Digital Support to Risk Minimization: EU Thinking on Opportunities and Challenges
Priya Bahri, PhD, RPh

Panelist
Claudia Manzo, PharmD



Speakers
avatar for Priya Bahri

Priya Bahri

Lead Pharmacovigilance and Risk Management Guidance and Policy, European Medicines Agency, Netherlands
Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation... Read More →
CM

Claudia Manzo

Director, Office of Medication Error Prevention and Risk Management, OSE, CDER, FDA, United States
Claudia Manzo, PharmD is the Director of the Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology (OSE), FDA. She has over 20 years of drug safety experience and in her current role she directs review staffs (~100 FTEs) that advise and... Read More →
avatar for Edward Millikan

Edward Millikan

Senior Informatics Pharmacist, OMEPRM, OSE, CDER, FDA, United States
Ed Millikan, PharmD, is the Senior Informatics Pharmacist in the Division of Mitigation Assessment and Medication Error Surveillance, Office of Surveillance and Epidemiology (OSE), in FDA’s Center for Drug Evaluation and Research. With over 20 years of experience as an Informatics... Read More →
avatar for Barbara Da Silva-Tillmann

Barbara Da Silva-Tillmann

Group Medical Director, AbbVie, United States
Barbara obtained her MD from McGill University in Montreal, Canada, and completed general Internal Medicine with specialty in Endocrinology and Metabolism at the University of Toronto. Barbara continued her training in Boston and Chicago doing basic science research and clinical endocrinology... Read More →
avatar for Meredith Smith

Meredith Smith

Sr Director, Risk Management, Global Patient Safety, Alexion Astra Zeneca Rare Disease, United States
Meredith Smith is Risk Management Director at AstraZeneca where she is responsible for medicinal product benefit-risk management for the Alexion Rare Disease Business Unit portfolio. She is a behavioral scientist and health services researcher by training with over 15 years of experience... Read More →


Wednesday June 22, 2022 4:15pm - 5:15pm CDT
Room 175 McCormick Place 2301 South Indiana Avenue Gate 40 Chicago, IL 60616
  01: ClinSafety-PV, Session