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Structured Evidence Planning, Production, and Evaluation (SEPPE): A “Quality-Based” Framework for Drug Development
Session Chair(s)
Meredith Smith, PhD, MPA, FISPE
Senior Director, Implementation Science Pillar Lead
Evidera, Inc, United States
This forum will convene experts from the regulatory authority, payer, industry, and patient communities to discuss how a new type of strategic “quality by design” framework for drug development.
Learning Objective : Describe a comprehensive framework for evidence generation to support optimal drug development and more efficient pathways to product approval; Identify pragmatic approaches for integrating this framework into regulatory authority and pharmaceutical company organizational structures.
Speaker(s)
SEPPE Framework and Implications for Regulators
Robyn R. Lim, PhD
Health Canada, Canada
Senior Science Advisor, Health Products and Food Branch
Implications for Patients
Marc M. Boutin, JD
Novartis , Switzerland
Global Head of Patient Engagement and Advocacy
Pragmatic Lessons Learned from Implenting Within a Pharmaceutical Company
Meredith Smith, PhD, MPA, FISPE
Evidera, Inc, United States
Senior Director, Implementation Science Pillar Lead
EMA Perspective
Tony Humphreys, MPharm
European Medicines Agency, Netherlands
Head of the Regulatory Science and Innovation Task Force
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