Dr. Reinhard Stidl
Senior Toxicologist – Managing Director
Reinhard has more than 16 years of experience as Toxicological Risk Assessor in the pharmaceutical and medical device context. He works as an independent toxicology consultant and founded Safetree Consulting e.U. (since 2018). Reinhard holds a Master and PhD in Chemistry, a Master of Advanced Studies Toxicology, is Certified European Risk Assessor (TRISK) and EUROTOX registered toxicologist (ERT). He started his career as Toxicological Risk Assessor and team leader at Baxter, later Baxalta and Shire, where his last assignment was Associate Director Toxicological Risk Assessments, responsible for the global design and toxicological risk assessment strategy in a global context. Reinhard is specialized in chemical safety assessment, with focus on impurities (including extractables and leachables), active ingredients (carry-over PDEs, OELs), excipients and quality defects. Today, he provides his expertise to clients around the world, assisting to make pharmaceutical and medical products safe for patients.
DAY 2: December 5th, 2024
SESSION: Safety assessment of non-genotoxic and Genotoxic/Carcinogenic Extractables and Leachables
◆ Regulatory environment concerning E&L.
◆ E&L safety assessment – Similarities and differences to assessment of drug substance impurities.
◆ Approaches for hazard assessment and safety threshold derivation.
◆ Cohort of concern impurities observed as E&L.
DAY 2: December 1st, 2023
SESSION: Extractables and leachables – potential genotoxic impurities?
◆ Different regulatory expectations on toxicological risk assessments for different classes of impurities.
◆ Potential E&L genotoxicity – impact of route of administration on Threshold of Toxicological Concern.
◆ Hazard characterization of identified and not identified extractables and leachables.
◆ Assessment of data poor substances: (Q)SARs and read-across.
DAY 1: March 30th, 2022
SESSION: Derivation of permitted daily exposure limits for individual or groups of E&L substances
◆ Standardized approach for PDE derivation.
◆ Use of surrogate data for data poor substances.
◆ In silico tools to cover essential endpoints.
◆ Case studies.
DAY 1: December 3rd, 2021
SESSION: Setting safety based limits for genotoxic and non-genotoxic impurities
◆ General approaches for GI and NGI safety threshold derivation.
◆ Acceptable exposure calculations based on TD50 and their limitations.
◆ Route-to-route considerations for safety thresholds.
◆ Calculation of concentration limits in drug substances and drug products.
