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IPEC Best Practices Guide for the Safety Evaluation of “Novel” Pharmaceutical Excipients

Description

The IPEC Safety Guide for Pharmaceutical Excipients issued in November 2021. The guide was designed to give an overview on recommended toxicological studies for different therapeutic applications, routes of administration and treatment periods.

Contributors

  • Christopher DeMerlis

    CCD Consulting

    Chris DeMerlis currently works for Johnson Matthey, Inc. in regulatory affairs for active pharmaceutical ingredients and controlled substances. Mr. DeMerlis is also a consultant in regulatory affairs for food and pharmaceutical ingredients. Mr. DeMerlis has held the following past positions: Campbell Soup Company Regulatory Affairs-Ingredient Management, Colorcon Inc. Manager of Regulatory Affairs and FMC Corporation Manager of Regulatory Affairs.

    Mr. DeMerlis is a Founding Member of the International Pharmaceutical

    Excipients Council (IPEC) and has served as Chair of the Regulatory Affairs Committee and Chair of the Safety Committee. Mr. DeMerlis has served as a member on the Board of Directors for the International Association of Color Manufacturers (IACM) and the International Food Additives Council (IFAC).

  • Teresa Wegesser

    Principal Scientist, Amgen

    Teresa Wegesser is a Principal Scientist at Amgen Inc. working as a nonclinical Project Team Representative on various cross-functional small and large molecule drug development teams. Teresa received her PhD in Pharmacology and Toxicology from the University of California, Davis where she focused her research on characterizing the pro-inflammatory and toxic potential of specific constituents of coarse particulate matter using in-vivo animal models. Prior to Amgen, Teresa worked at Chevron as a Lead Toxicologist, identifying and classifying human health and environmental hazards, exposures, and assessing potential human health and environmental risks of chemical additives in petroleum products.

  • Jeffrey Pitt

    Lead Toxicologist, IFF

    Jeffrey Pitt is the lead toxicologist for IFF. He graduated with a Ph.D. in toxicology from the University of Michigan in 1997 and completed a Post-Doc at US EPA in RTP North Carolina followed by a few years at Contract Research Labs before joining Sanofi. For the last few years, Jeff worked for Dow, DowDuPont and now IFF in their Pharma Divisions. Jeff has been an active member of IPEC-Americas for many years and has represented IPEC-Americas at several IID and novel excipient meetings with the FDA.

January 20, 2022
Thu 9:00 AM EST

Duration 2H 0M

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