Raphael Nudelman, Ph.D., ERT, Teva Pharmaceutical  Industries Ltd. - Qepler Summits And Conferences

Raphael Nudelman, Ph.D., ERT

Senior Director Impurity Expert
Teva Pharmaceutical Industries Ltd.
Israel
At Teva Pharmaceuticals, our mission is to be a global leader in generics and biopharmaceutical medicines, improving the lives of patients around the world.

Raphael 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 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals.

In 2010 he established the Chemical & Computational Toxicology group in Teva, and now he is Senior Director Impurity Expert in R&D Operations. Raphael’s main topics of expertise are impurity and excipient qualification in drug substances and drug products. Over the past few years he has specialized in risk assessment of nitrosamine impurities in pharmaceuticals.

Related Sessions:

Genotoxic Impurities in
Pharmaceuticals Summit 2019

GTI strategies & new methodologies: analysis, in silico & regulations. Challenges & opportunities.
  • 11 Apr 2019
  • Berlin, DE
  • Pharma
Day 2: Friday, 12 April 2019
CASE STUDY: Best practice for dealing with conflicting computational predictions for mutagenicity.
  • Must we always take the conservative approach when dealing with conflicting predictions?
  • When can we overrule a predictions
  • Case studies showing methods to come to a consensus predictions
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2nd Annual Genotoxic Impurities in
Pharmaceuticals Summit 2021

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 15 Jul 2021
  • Virtual,
  • Pharma
Day 1: Thursday, 15 July 2021
CASE STUDY: Setting limits for nitrosamines that lack carcinogenicity data.
View Details

3rd Annual Genotoxic Impurities
in Pharmaceuticals Summit 2023

Genotoxic Impurities in Pharmaceuticals strategies & new methodologies: analysis, in silico & regulations.
  • 09 Mar 2023
  • Virtual,
  • Pharma
Day 1: Thursday, 09 March 2023
CASE STUDY: Setting Limits for Complex Nitrosamines (NDSRIs)
  • Differences between ICH M7 and nitrosamine guidances
  • Setting AIs for NDSRIs using SAR/read-across
  • Case studies - De-risking of NDSRIs of drug classes (Ca channel blockers, β-blockers, ACE inhibitors)
View Details