Although the scenarios for embedding labeling studies in the clinical development program may depend on prioritization, budgets and sheer practicalities, drug development usually benefits from setting up a well-balanced strategy early on during drug development.
Over the past three years, the Food and Drug Administration (FDA) and/or European Medicines Agency (EMA) have issued either final guidance or updated guidelines for food effect, DDI, ADME, TQT and renal impairment studies. This webinar will summarize these key guidance documents and highlight recent changes drug developers need to know.
From the perspective of current regulatory guidance, this webinar will consider the setup and conduct of selected labeling studies, strategic aspects and best practices.
Join this webinar to gain insights into the latest guidelines from the FDA and EMA on drug labeling in clinical pharmacology.
Join experts from Celerion, Aernout van Haarst, PhD, Director of Scientific Affairs; and Sabina Paglialunga, PhD, Director of Scientific Affairs, for the live webinar on Tuesday, October 24, 2023, at 11am EDT (4pm BST/UK).
For more information, or to register for this event, visit Drug Labeling Studies in Clinical Pharmacology: Recent FDA/EMA Updates.
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