Adverse Outcome Pathways are a structural representation of a sequence of biological events that lead to an adverse outcome, considered important for risk assessment. The construct assembles existing knowledge about biological events and pragmatically describes the action of a substance and subsequent linked molecular and cellular mechanisms, by which an adverse event can be fully described and characterized. Initially developed for and implemented by the OECD as a tool in the evaluation of industrial chemicals, the concept is fast gaining importance also in early phases of drug development, as it is envisioned that regulators may use AOPs as a point of reference when mechanistic knowledge is used as the basis for the development of testing strategies.  With the emerging field of in silico toxicology, AOPs are becoming an essential tool, as it allows for evaluation and modelling even before the molecule is synthetized. The concept puts all techniques into a broader context and can elucidate predictions by mechanistic insights. Altogether, AOPs are expected to become a point of reference for regulatory drug toxicology and will become an integrative part of the 3R approach (reduce, replace, refine the use of laboratory animals).

Presenter

Jana Brajdih Čendak started her professional career as a practicing physician, specializing in Emergency Medicine. Currently she is part of Billev Pharma East team, a consultancy company based in Slovenia, responsible for a team of pharmacovigilance specialists, medical advisors, and veterinary medical advisors, covering human and veterinary pharmacovigilance and providing medical regulatory support to clients.

Webinar Date & Time

20 September from 02:00 PM to 03:30 PM (CEST)

Deadline for registration

19 September 2023 at 6 p.m.

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