Reinhard Stidl - uventia

Reinhard Stidl

Reinhard Stidl

Dr. Reinhard Stidl

Senior Toxicologist – Managing Director

Safetree-Consulting

Dr. Reinhard Stidl, MAS(Toxicology), ERT
Reinhard has more than 14 years of experience as Toxicological Risk Assessor in the pharmaceutical context and is Senior Toxicologist at and founder of Safetree Consulting (since 2018). Reinhard holds a Master and PhD in Chemistry (University of Vienna), a Master of Advanced Studies Toxicology (Medical University of Vienna), 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. During the assignments in the pharmaceutical industry, he was responsible for the global design and toxicological risk assessment strategy within Baxter, Baxalta and Shire. Reinhard is specialized in chemical safety assessment, with focus on impurities (including extractables and leachables), active ingredients (carry-over PDEs, OELs) and excipients. Today, he provides his expertise to clients around the world, assisting to make pharmaceutical and medical products safe for patients.

SPEAKED ABOUT:
December 4, 2024
We are planning to hold an online meeting with subject matter experts to evaluate different points of view on how to solve the problems associated with mutagenic impurities.
Upcoming

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.

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 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.

2nd Annual Extractables Leachables Summit
March 30, 2022
What is next in testing and analyzing for extractables and leachables in biopharmaceutical development and release? Recording of 2 days event sessions [12 video sessions].
Expired

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.

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 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.

Speaker Details
  • Profession
    Senior Toxicologist - Managing Director
  • Company
    Safetree Consulting e.U.
Speaker Details
  • Profession
    Senior Toxicologist - Managing Director
  • Company
    Safetree Consulting e.U.