Who should take this course?
This course will be primarily useful for toxicologists, chemists, and biocompatibility specialists in the medical device and pharmaceutical fields who use computational models (e.g., QSAR, Read Across) to prepare safety or risk assessments of E&L compounds and drug impurities. The course may also be of interest to regulatory affairs professionals and corporate managers who review safety assessments of E&L compounds and drug impurities included in regulatory submission documents.
Photo byMarissa GrootesonUnsplash
Computational Approaches for the Safety Assessment of Extractable and Leachable Compounds and Drug Impurities
Use of QSAR Models and Read Across Approaches
Photo byMarissa GrootesonUnsplash
Why should I take this course?
- The safety assessment of E&L compounds and drug impurities requires data on the dose of the compound received by the patient and the toxicity of the compounds; however, exposure and toxicity data are not available for many of these compounds. Fortunately, in silico computational approaches are available to predict the rate at which compounds leach from polymeric materials and predict the potential toxic hazard posed by patient exposure to these compounds.
- This one-day, in-person course will provide hands on instruction on the use of computational approaches to: 1) predict the rate at which E&L compounds migrate from polymers and 2) estimate the toxicity of data-poor E&L compounds and impurities using QSAR models and Read Across approaches. The course will also explain how to use these model-derived estimates in a safety or risk assessment of E&L compounds and drug impurities.
Registration
The course will include coffee breaks and a lunch break
When?
8.30 - 16.30, 13 June 2023
Where?
The Spark, Medicon Village
Scheeletorget 1, 223 63 Lund
Price?
750 EUR excl. VAT
25 % local VAT will be added.
Do you have any questions regarding the registration?
Please contact Mikaela Mattsson at:
+46 (0) 70 308 06 62
or mikaela.mattsson@limulusbio.com
Register for the course
About the trainer
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices. While at the FDA, he served in a number of leadership roles in standards development organizations. At the international level, he served for many years as convener of ISO TC194 WG11 which is responsible for the development and revision of the ISO 10993-17 standard, Biological evaluation of medical devices-Part 17: Establishment of allowable limits for leachable substances. At the national level, he represented the United States as an expert on ISO TC194 WG11 and served as co-chair of the AAMI Biological Evaluation Committee. Prior to his position at the US FDA, Ron served as a Senior Associate at the ILSI Risk Science Institute. He is founding member and former President of the Medical Device and Combination Products Specialty Section of the Society of Toxicology and former President of the Dose-Response Specialty Section of the Society for Risk Analysis.
