Raphael Nudelman
Senior Director Impurity Expert, R&D Operations
Raphael (Raphy) Nudelman, PhD, ERT, is the Senior Director Impurity Expert at Teva Pharmaceutical Industries Ltd., Israel. He is a medicinal chemist by training (PhD) with over 20 years of pharmaceutical industry experience primarily in the chemistry and toxicology interface. Raphy established the Chemical & Computational Toxicology unit in Teva and is an expert in the field of impurity assessment and qualification. Over the past few years, he has specialized in risk assessment of nitrosamine impurities in pharmaceuticals.
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.
