Dr. Dvir Doron, Teva Pharmaceutical Industries Ltd. - Qepler Summits And Conferences

Dr. Dvir Doron

Sr. Chemical Toxicologist
Teva Pharmaceutical Industries Ltd.
At Teva Pharmaceutical Industries,  we improve people's health through our products, integrated R&D, generic medicines and global businesses

Over the past 5 years at Teva Pharmaceutical Industries Ltd., Dvir Doron serves as a Senior Chemical Toxicologist in the Non-Clinical Safety Department of the Global R&D Division.

He is responsible for providing toxicological assessments and qualifications of unintended chemicals in drug substances and drug products, including process-related impurities, degradation products, residual solvents, elemental impurities, extractable and leachable substances originating from container closure systems and manufacturing equipment, and various types of contaminants and foreign materials.

Dvir has a Ph.D. in Computational Chemistry from Bar-Ilan University, Israel (2013), where he studied enzyme-catalyzed hydrogen-transfer reactions using Quantum Mechanics/Molecular Mechanics (QM/MM) simulations and explored the temperature dependence of kinetic isotope effects in these systems.

Prior to his doctoral studies, Dvir received a B.Sc. (summa cum laude) in Medicinal Chemistry (2006) and an M.Sc. (summa cum laude) in Medicinal and Organic Chemistry (2008), both from Bar-Ilan University. His Master’s research focused on the synthesis of prodrugs of 5-aminolevulinic acid (5-ALA) as potential phototherapeutic and chemotherapeutic agents for cancer treatment.

Related Sessions:

2nd Annual Pre-Filled
Syringes Summit 2019

Enhance expertise sharing in developing pre-filled syringes and provide attendees with ample networking opportunities.
  • 04 Jun 2019
  • Barcelona, ES
  • Pharma
Day 2: Wednesday, 05 June 2019
CASE STUDY: The relationship between ICH guidelines for impurities (M7 & Q3) and extractable & leachable thresholds
  • Extractables & Leachables (E&L) in scope of ICH Guidelines for impurities
  • Why Not ICH Q3B thresholds for E&L?
  • PQRI recommendations for E&L in Orally Inhaled & Nasal Drug Products (OINDP) and in Parenteral Drug Products (PDP)
  • E&L thresholds vs. impurity thresholds (ICH Q3A/B and ICH M7)
  • FDA/CDER approach to the SCT and AET
  • E&L safety evaluation process
  • The Use of ICH M7 principles for E&L risk assessment
  • The Use of ICH Q3D principles for E&L analyses
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