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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 Roache, MS
Deputy Vice President, 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
Associate Center Director - CDER, FDA, United States
ICH E22 Patient Preference Studies
Brett Hauber, PhD, MA
Patient Preference Evidence Generation Team Lead, Pfizer, United States
ICH Patient Engagement
Francesco Pignatti, MD
Scientific Adviser for Oncology, European Medicines Agency, Netherlands
Patient Perspective on Engagement to Inform Drug Development
Nicholas Brooke, MBA
CEO, The Synergist, Belgium
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