When Omics Meet Regulations
ECETOC Workshop Session at EUROTOX 2017, 11 September 2017, Bratislava, Slovakia.
Programme of the Session
- 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
- Towards Establishing Criteria and Best Practices for Analysing Omic Data for Regulatory Decision Making
Weida TongNCTR/FDA, Jefferson, United States
- Towards establishing a consistent set of criteria to assess the use of non-animal methods in regulatory decision making
Alan Boobis1, Stan Parish2, Douglas Wolf3
1Centre 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
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.