Raphael Nudelman
Chemical Toxicologist
Raphael (Raphy) Nudelman is an accomplished chemical toxicologist with more than 20 years of experience in the pharmaceutical industry. He earned his PhD in organic chemistry from the Weizmann Institute of Science in Israel and completed postdoctoral fellowships at the US Air Force Research Laboratory and Duke University Medical Center. During his two decades at Teva Pharmaceuticals, Raphy held a variety of positions, including roles in medicinal chemistry, patents, non-clinical safety, and ultimately served as the company’s Impurity Expert. His areas of expertise include the qualification of impurities and excipients in both drug substances and drug products, with a particular emphasis in recent years on the risk assessment of nitrosamine impurities. After retiring from Teva in September 2024, Raphy established Nudelman ChemTox Consulting, where he now offers consulting services to the pharmaceutical sector.
DAY 1: December 5th, 2025
SESSION: Updates on Setting Limits for NDSRIs
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DAY 1: December 4th, 2024
SESSION: Setting limits for NDSRIs
◆ Methods for setting acceptable intakes (AIs) for NDSRIs.
◆ Good read across vs bad read across.
◆ Use of in vivo mutagenicity (negative and positive) to set AIs for NDSRIs.
DAY 1: November 30th, 2023
SESSION: Setting limits for NDSRIs
◆ Misalignments between ICH M7 and regulatory requirements for nitrosamines.
◆ Difficulty in setting acceptable intake (AI) levels for nitrosamine drug substance related impurities (NDSRIs).
◆ Proposals for AIs of nitrosamines of classes of drugs – position papers for nitrosamines of calcium channel blockers, beta-blockers and beta-agonist, and ACE inhibitors.
◆ Use of in vivo mutagenicity data to categorize the potency of NDSRIs.
DAY 1: December 1st, 2022
SESSION: Setting limits for complex nitrosamines
◆ Read-across in guidelines.
◆ Examples & challenging regulators read-across.
◆ Read-across for complex nitrosamines.
◆ Mechanistic de-risking.
DAY 1: December 2nd, 2021
SESSION: Setting limits for nitrosamines
◆ Setting accptable intake levels for nitrosamines by using read-across methods.
◆ Setting limits for complex nitrosamines.
◆ Mechanistic de-risking of nitrosamines.
