Loading…
This event has ended. Visit the official site or create your own event on Sched.

View analytic
Monday, June 27 • 10:45am - 12:00pm
#139: Measuring the Impact and Influence of Patient Input on Regulatory and Health Technology Assessment Decision Making: What Are the Key Considerations?

Sign up or log in to save this to your schedule and see who's attending!

Limited Capacity seats available

Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-16-568-L04-P; CME 1.25; IACET 1.25; RN 1.25

This interdisciplinary session will explain how, with increased patient engagement, both regulatory and health technology assessment agencies need to be able to assess and report on how patient input is being utilized and how it is informing the decision process.

Learning Objectives

Discuss how health technology assessment agencies and regulators engage with patients so that the assessment and decision making is utilizing patients’ viewpoints; Identify the challenges that agencies face to ensure that the patient’s viewpoints are embedded into their decision processes; Assess the types of parameters agencies are using to measure the impact patient engagement is having on their processes and decision making.

Chair

Neil McAuslane, PhD, MSc

Speaker

FDA Perspective
Theresa M. Mullin, PhD

Empowering Patients as Organizational Change Agents
Durhane Wong-Rieger, PhD, MA

HTA Perspective
Victoria Thomas, MSc



Chair
avatar for Neil McAuslane

Neil McAuslane

Director, Centre For Innovation In Regulatory Science (CIRS)
Neil McAuslane is Director of the Centre for Innovation in Regulatory Science (previously CMR International) and works in the area of regulatory strategy and R&D performance. Prior to joining CMR International in 1988, Neil completed his PhD degree in Clinical Pharmacology from the University of Edinburgh.

Speakers
avatar for Theresa Mullin

Theresa Mullin

Director, Office of Strategic Programs, CDER, FDA
She leads a number of CDERs strategic initiatives including human drugs international program, data standardization, business informatics, lean management, development of benefit-risk and other decision support tools, program analysis and major user fee negotiations. Currently serving as FDAs lead negotiator for PDUFA 2017 reauthorization and the lead negotiator for the BsUFA 2017 reauthorization. She leads the FDA Patient Focused Drug... Read More →
avatar for Victoria Thomas

Victoria Thomas

Head of Public Involvement, Public Involvement Programme, National Institute For Health and Care Excellence (NICE)
Victoria Thomas has run the Public Involvement Programme at NICE since 2009, and has been with the Programme since 2001. Following a degree in Art History, Victoria has worked exclusively in the public and voluntary sector, specialising in healthcare quality improvement activities and in patient and public involvement. Victoria’s MSc, in Science and Society, concentrated on issues of science communication and science and the public. Victoria... Read More →
avatar for Durhane Wong-Rieger

Durhane Wong-Rieger

President and Chief Executive Officer, Canadian Organization For Rare Disorders (CORD)
Durhane Wong-Rieger, PhD, is President, Institute for Optimizing Health Outcomes; President; Canadian Organization for Rare Disorders; Chair, Consumer Advocare Network; Past-Chair, International Alliance of Patient Organizations; Co-Chair, HTAi Patient / Citizen Involvement IG; Board, DIA International; Advisory Board, Canadian Institutes of Health Research Institute of Genetics. Durhane has a PhD in psychology from McGill and was professor at... Read More →


Monday June 27, 2016 10:45am - 12:00pm
105AB Pennsylvania Convention Center 1101 Arch Street, Philadelphia, PA 19107 USA