Session 4

• S04-01
  Towards Establishing Criteria in a GLP Like Context for Collecting, Storing and Retieving Omic Data for Regulatory Decision Making 
  Bennard van Ravenzwaay 
  Experimental Toxicology and Ecology, BASF SE, Ludwigshafen, Germany
• S04-02
  Towards Establishing Criteria and Best Practices for Analysing Omic Data for Regulatory Decision Making 
  Weida Tong

  NCTR/FDA, Jefferson, United States

• S04-03
  Towards establishing a consistent set of criteria to assess the use of non-animal methods in regulatory decision making
  Alan Boobis¹, Stan Parish², Douglas Wolf^{3
  1}Centre for Pharmacology & Therapeutics, Imperial College London, London, United Kingdom; ²ILSI Health and Environmental Sciences Institute (HESI), Washington, DC, United States; ³Syngenta Crop Protection, LLC, Greensboro, NC, United Kingdom

• S04-04
  Towards establishing a QWoE approach for integrating omics data with experimental animal and human data for regulatory decision purposes 
  Jim Bridges
  Research for Sustainability, Guildford, United Kingdom 

Session Abstract

The robust and reproducibe production, storage, analysis and application of omic data in regulatory decision making will require the validation and standardisation of best laboratory practices and use of standardised frameworks.This Workshop will look to begin establishing guidelines and best practices for attaining, analysing and applying omic data in regulatory decision making. The acceptance and establishment of standardised practices and guidelines will provide confidence for regulators and registrants to interpret and apply omic data in regulatory decision making.