MPS WORLD SUMMIT VIRTUAL PRE-CONFERENCE 1: Towards Regulatory Acceptance
MPS WORLD SUMMIT VIRTUAL PRE-CONFERENCE 1: Towards Regulatory Acceptance
Virtual conference
Welcome
Thomas Hartung, CAAT, Johns Hopkins University, United States
Keynote Address: Advancing Alternative Methods at FDA
Suzanne Fitzpatrick, Food and Drug Administration (FDA), United States
Short talks: Standardization, scaling-up, and quality control of platforms and cell sources
- Multi-organ microphysiological system coupled with mechanistic mathematical modelling for studying cardio-metabolic disorders
Peter Gennemark, AstraZeneca, Sweden - A robotized 1546 compound screen in a perfused 3D microfluidic angiogenesis assays
Camilla Soragni, MIMETAS, the Netherlands - PSIS workshop: the many roles of standards for organ-on-chip
Monica Piergiovanni, European Commission, Joint Research Center (JRC), Belgium, Italy - Supporting the adoption of microphysiological systems for COVID research
Anthony Holmes, National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs), United Kingdom
Short talks: Obstacles to accomplishing regulatory acceptance
- MPS initiatives for industrial implementation and regulatory acceptance in Japan
Seiichi Ishida, National Institute of Health Sciences, Sojo University, Japan - A roadmap to overcoming obstacles to MPS regulatory acceptance: perspectives from technology providers
Megan LaFollette, North American 3Rs Collaborative, United States - Applicability of organ-on-chip systems in toxicology and pharmacology
Rob Vanderbriel, National Institute for Public Health and the Environment (RIVM), The Netherlands
Panel Discussion: Perspectives on Regulatory Acceptance
Moderator – Danilo Tagle, National Center for Advancing Translational Sciences (NCATS), United States
- Anne Gourmelon, Organization for Economic Co-operation and Development (OECD) Test Guidelines Programme, France
- Sonja Beken, European Medicines Agency (EMA), Belgium
- Seiichi Ishida, National Institute of Health Sciences (NIHS), Japan
- Jean Lou Dorne, European Food Safety Authority (EFSA), Italy
- Donna Mendrick, Food and Drug Administration (FDA), United States
- Elizabeth Mendez, Environmental Protection Agency (EPA), United States
Q&A Session with Panelists
