Raphael Nudelman, PhD, ERT
Senior Director Impurity Expert, R&D Operations at Teva Pharmaceuticals
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 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.
Title: Extractables & Leachables Qualification in Pre-Filled Syringes
The presentation will focus on:
- What are extractables & leachabels (E&L)
- Guidelines for E&L (or the lack of them)
- Toxicological qualification of E&L