Menu Back to Patient-Engagement-in-Benefit-Risk-Assessment-throughout-the-Life-Cycle-of-Medical-Products


Patient Organizations/Patients are invited to attend the Patient Engagement In Benefit-Risk Assessment Throughout The Life Cycle Of Medical Products at a reduced registration fee of $200.

Questions? Contact:

Send Email

Download registration form

Tutorial: September 16*
Conference:  September 17-18

*Tutorials require registration and are an additional fee

Historically, patients have been targeted with education and promotion after product approval, but continuous engagement in benefit-risk assessment throughout the research and approval process is key to assuring that medical products will meet patient needs.

During this two-day conference, patient partners, academic and industry medical product researchers, and regulators will address the important challenge of how and when to best engage patients to more actively incorporate their voices into benefit-risk assessment throughout the life cycle of medical products. Multiple stakeholders will reach consensus on appropriate engagement of patient partners in benefit-risk assessment throughout the medical product life cycle; share effective approaches and assess methodological, operational, and regulatory challenges to implementation of effective patient engagement; and identify next steps for developing and adopting needed tools and practices that will result in better outcomes for patients.

Featured topics

  • Key decision-making stages and patient engagement in the context of medical product development and benefit-risk assessment
  • Setting the baseline for benefit-risk assessment and the current environmental context making patient perspective crucial to decision-making
  • Regulatory, operational, and methodological challenges to patient engagement in a regulated environment
  • Effective approaches to patient engagement in benefit-risk assessment throughout the product life cycle, including what can be learned from other aspects of clinical research and other types of health research
  • Enabling patient partners to provide input on benefit and risk considerations
  • Patient-initiated models for collecting patient perspectives

Who should attend?

This program is being developed for:

  • Patients
  • Caregivers
  • Patient organizations and advocates
  • Regulatory agency policy and review staff
  • Industry scientists involved in the evaluation and communication of the benefit-risk assessment of products in development or post-approval

As well as Professionals involved in:

  • Risk Management/REMS
  • Clinical Safety/Pharmacovigilance
  • Pharmacoepidemiology
  • Regulatory Affairs
  • Legal Affairs
  • Medical Affairs
  • Medical product safety assessment
  • Marketing
  • Clinical Research
  • Medical Communications
  • Statistics
  • Comparative Effectiveness/HTAs/Health Outcomes
  • Brand Commercial Team
  • Statistics

Learning objectives

At the conclusion of this meeting, participants should be able to :

  • Discuss the importance, context, and approaches to appropriate engagement of stakeholders in benefit-risk assessments throughout the medical product life cycle
  • Evaluate and propose solutions to regulatory, methodological, and operational challenges for all aspects of engagement in benefit-risk assessment
  • Identify gaps in current knowledge in the practice of stakeholder collaboration in benefit-risk assessment and propose improvements that will result in better outcomes for patients
  • Propose ways to increase engagement of other stakeholders in their own work within the medical product life cycle

Program Committee

  • John F. P. Bridges, PhD
    John F. P. Bridges, PhD Associate Professor, Center for Health Services and Outcomes Research
    Johns Hopkins Bloomberg School of Public Health, United States
  • Patricia  Furlong, BSN
    Patricia Furlong, BSN Founding President and CEO
    Parent Project Muscular Dystrophy, United States
  • Tarek  Hammad, MD, PhD, MS, MSc, FISPE
    Tarek Hammad, MD, PhD, MS, MSc, FISPE Head, Signal Detection, Benefit-Risk Assessment, Global Drug Safety Innovation
    EMD Serono, Inc., United States
  • Richard  Hermann, MD, MPH
    Richard Hermann, MD, MPH Safety Science Physician, Global Patient Safety
    AstraZeneca, United States
  • F. Reed  Johnson, PhD, MA
    F. Reed Johnson, PhD, MA Senior Research Scholar, Center for Clinical and Genetic Economics
    Duke Clinical Research Institute, Duke University, United States
  • Bennett  Levitan, MD, PhD
    Bennett Levitan, MD, PhD Senior Director, Benefit-Risk Assessment, Department of Epidemiology
    Janssen Research & Development, LLC, United States
  • Robyn R. Lim, PhD, PMP
    Robyn R. Lim, PhD, PMP Senior Science Advisor, Office of Legislative and Regulatory Modernization, HPFB
    Health Canada, Canada
  • K. Kimberly  McCleary
    K. Kimberly McCleary Managing Director
    FasterCures, A Center of the Milken Institute, United States
  • Marilyn A. Metcalf, PhD
    Marilyn A. Metcalf, PhD Patient Engagement Lead
    GlaxoSmithKline, United States
  • Elaine H Morrato, DrPH, MPH
    Elaine H Morrato, DrPH, MPH Associate Dean for Public Health Practice
    Colorado School of Public Health, United States
  • Rebecca A. Noel, DrPH
    Rebecca A. Noel, DrPH Global Benefit-Risk Lead, Global Patient Safety
    Eli Lilly and Company, United States
  • Cynthia  Rice
    Cynthia Rice Senior Vice President, Advocacy and Policy
    Juvenile Diabetes Research Foundation (JDRF), United States
  • Meredith Y. Smith, PhD, MPA
    Meredith Y. Smith, PhD, MPA Global Risk Management Officer, Global Patient Safety
    Amgen Inc., United States
  • Anna  Floreen
    Anna Floreen Advancement Outreach Manager
    T1D Exchange, United States
Load More

Contact us

Registration Questions?

Send Email

Agenda Details

Send Email

Event Logistics

Send Email

Digital Learning Catalog

eLearning Catalog Cover