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Read-Across as an Alternative Approach for Assuring the Safety of Excipients

October 30, 2024 - 9:00am to 11:00am DST

George Daston – Victor Mills Society Research Fellow, Procter & Gamble
Ron Filler – President & CEO, Drug Development Consultants, Inc.
Jeffrey Pitt – Lead Toxicologist, IFF
Teresa Wegesser – Scientific Associate Director, Amgen

Read-across is the only accepted alternative to animal testing at present. Cheminformatic approaches to choose and assess the suitability of analogs for read-across have been developed, and high-content biotechnology methods such as global gene expression analysis have been used to prove biological similarity of analogs.

Learning/Awareness Objectives
Attendees will be provided with:
> An introduction read across as a method to use the toxicity data of one material to infer the toxicity of a similar chemical
> Fundamentals of read-across
> Tools for chemical analog selection
> Tools for biological similarity
> Case studies
> Chemical grouping
> Regulatory acceptance, globally

Who should attend?
> Pharmaceutical formulators and development scientists
> Excipient manufacturers
> Regulatory affairs and legal professionals
> Safety evaluation professionals
> Compendial affairs
> Quality affairs

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Note: Did you know this webinar may count toward continuing education credits? Check with your credentialing organization to confirm. A certificate of participation will be available for download upon completion of the webinar.