Paving the Way to the FAIR Submission of In Vitro Pharmacololgy Results to Regulatory Bodies

Agenda

• Introduction to In Vitro Pharmacology (IVP) and problematics faced during submission of IVP data for an IND application
• How to pave the way to the FAIRification of IVP data? Two key steps:
  • Standardised data structure for submission of results – IVP module/GSRS
  • Repository of safety and secondary in vitro pharmacology assays: using a single, centralised protocol repository with an integrated ontology and providing a unique Identifier for each assay

• Q&A session

Speakers

• Kevin Snyder (FDA)
• Larry Callahan (FDA)
• Jane Lomax (Scibite)
• Chris Butler (Abbvie)