Raphael Nudelman - uventia

Raphael Nudelman

Raphael Nudelman

Raphael Nudelman

Chemical Toxicologist

Nudelman ChemTox Consulting
Israel
Nudelman-ChemTox-Consulting

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.

SPEAKED ABOUT:
Genotoxic-Impurities-Nitrosamines-Beyond
December 4, 2024
Meeting with subject matter experts to evaluate different points of view on how to solve the problems associated with mutagenic impurities. Recording of 2 days event sessions [13 video sessions].
Expired

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.

3rd Annual Genotoxic Impurities Nitrosamines & Beyond
November 30, 2023
Learn the best techniques and cutting-edge methods for reducing genotoxic and elemental impurities. Recording of 2 days event sessions [17 video sessions].
Expired

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.

2nd Annual Genotoxic Impurities Nitrosamines & Beyond
December 1, 2022
Learn about best practices and innovative approaches to genotoxic and other mutagenic impurities control. Recording of 2 days event sessions [13 video sessions].
Expired

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.

Genotoxic Impurities Summit Nitrosamines Beyond
December 2, 2021
Review drug impurity profiling strategies in line with regulatory guidelines, new nitrosamine regulations. Recording of 2 days event sessions [14 video sessions].
Expired

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.

Speaker Details
  • Profession
    Chemical Toxicologist
  • Company
    Nudelman ChemTox Consulting
Speaker Details
  • Profession
    Chemical Toxicologist
  • Company
    Nudelman ChemTox Consulting