Webinar Topic
Webinar Date & Time
17 January from 02:00 PM to 03:30 PM (CET)
Webinar Overview
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).
Presenters
Jana Brajdih Čendak, MD
Medical and Pharmacovigilance Lead
Billev Pharma East (Slovenia)
Jana started her professional career as a practicing physician, specializing in Emergency Medicine. After almost 10 years in clinical practice, she joined Sanofi’s Medical Affairs team, covering Southeast and Central European countries. Following a short transition to Novo Nordisk, she moved to Billev Pharma East, a consultancy company based in Slovenia. In her current position, Jana is 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.
She is currently more involved in toxicology, finalizing an MSc program in Toxicology at the Vienna Medical University and in the process of obtaining the European Registered Toxicologist certification. She is also an active member of various industry associations, including EUCROF and Medicines for Europe.
Attendance Fee
€ 90,- for non-EUCROF members
€ 60,- for EUCROF members
Deadline for registration
16 January 2024 at 6 p.m.
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