About the course

This course will provide valuable insights and practical tips on designng biological evaluation plans for FDA submission. Participants will learn about the best practices for Chemical Characterization and Biologicak tests, as well as common pitfalls to avoid when submitting data to the FDA. By the end of the course, participants will have an understanding of the FDA requirements for biocompatibility and be better quipped tp navigate this complex regulatory landscape.

Topics

The following topics are some of the ones that will be touched upon in this ON-site course: 

• ISO 10993 Series and FDA requirements
• Chemical Characterization (10993-18)
• Biological Tests
• Sample Preparation

Who should attend?

This ON-site course is intended for:

• RA professionals responsible for preparing and submitting regulatory documents to the FDA
• QC personnel responsible for implementing and validating biological tests in compliance with FDA regulations 

When?

June 28th 2023
09:00 - 13:00 (CET)

Where?

ON-site course at Eurofins BioPharma Product Testing Glostrup DK

Speaker

ERT with a MSc in Applied Toxicology and Biomedical Engineering, Paolo has over 15 years of experience in biological evaluation of medical devices and toxicological risk assessment for pharmaceutical products. He is a former Healthcare Engineering HAS consultant for EU Commission and is now a Senior Scientific Director at Eurofins Medical Device Testing Europe, member of ISO TC 194 and CEN TC 206 and adjunct professor at the University of Milan.