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ICH Efforts to Incorporate Patient’s Perspective to Enhance Quality, Relevance, Safety and Efficacy of Drug Development
Session Chair(s)
Amanda Marie Roache, MS
Senior Director, Science and Regulatory Advocacy
Phrma, United States
Discussion of ICH work to harmonize recommendations for inclusion of patient’s perspective in drug development. Patient group representatives will also highlight key considerations for clinical research and development of international standards.
Learning Objective : Discuss ICH’s portfolio for inclusion of patient’s perspective in drug development and outline specific case examples; Describe the patient perspective in clinical research and identify key considerations that may be relevant for the international community in developing standards; Evaluate linkages between ICH’s mission and key interests of patient, health care professional, and life science communities.
Speaker(s)
Moderator
Theresa Mullin, PhD
FDA, United States
Associate Center Director - Strategic Initiatives, CDER
ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA
Pfizer Inc, United States
Senior Director, Patient Preference Elicitation
ICH Patient Engagement
Francesco Pignatti, MD
European Medicines Agency, Netherlands
Scientific Adviser for Oncology
Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA
PFMD, Belgium
Executive Director, Patient Focused Medicines Development (PFMD)
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