Overview

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
1.215.442.6131

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.

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

Short Course or Primer

To keep you at the forefront.

Sep 16, 2015

Tutorial:

Stated Preference Methods and the Science of Patient Engagement

Learn more

Sep 16, 2015

Tutorial:

Stated Preference Methods and the Science of Patient Engagement

Learn more

Program Committee

John F. P. Bridges, PhD Professor, Departments of Biomedical Informatics
Ohio State University College of Medicine, United States
Patricia Furlong, BSN Founding President and Chief Executive Officer
Parent Project Muscular Dystrophy, United States
Tarek Hammad, MD, PhD, MS, MSc, FISPE Vice President, Head of Medical Safety, Marketed Products
Takeda, United States
Richard Hermann, DrMed, MD, MPH Safety Science Physician, CMO Organization
AstraZeneca, United States
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 Senior Director, Benefit-Risk Assessment, Global Epidemiology
Janssen Research & Development LLC, United States
Robyn R. Lim, PhD Senior Science Advisor, Health Products and Food Branch
Health Canada, Canada
K. Kimberly McCleary Founder and Chief Executive Officer
The Kith Collective, LLC, United States
Marilyn A. Metcalf, PhD Senior Director, Patient Focused Development, Global Medical
GlaxoSmithKline, United States
Elaine H Morrato, DrPH, MPH Founding Dean, Parkinson School of Health Sciences and Public Health
Loyola University Chicago, United States
Rebecca Noel, DrPH, MPH Executive Director, Benefit-Risk Assessment
Eli Lilly, United States
Cynthia Rice Senior Vice President, Advocacy and Policy
Juvenile Diabetes Research Foundation (JDRF), United States
Meredith Smith, PhD, MPA, FISPE Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States
Anna Floreen Advancement Outreach Manager
T1D Exchange, United States