Raphael Nudelman
Senior Director Impurity Expert, R&D Operations
Raphael Nudelman has over 20 years of pharmaceutical industry experience. He has a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, a post-doctorate at the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and another post-doctorate at Duke University Medical Center, North Carolina. In 2001 he joined a startup biotech company in Israel that performed rational drug design by molecular modeling, and in 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals. In 2010 he established the Chemical & Computational Toxicology group in Teva, which he headed until mid-2021. Raphael now holds the position of Senior Director Impurity Expert in the R&D Operations and Biosimilars department. Raphael’s main topics of expertise are impurity and excipient qualification in drug substances and drug products.
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.
