18 - 20 February, 2020 | Leonardo Royal Hotel Berlin Alexanderplatz, Berlin, Germany
Clemens Guenther, Director Non-Clinical Safety at Bayer

Clemens Guenther


Director Non-Clinical Safety
Bayer

Check out the incredible speaker line-up to see who will be joining Clemens.

Download The Latest Agenda

Day 1 - System Implementation

Tuesday, February 18th, 2020


1:40 PM Mini-Workshop

Safety Assessment of Extractables & Leachables

All biopharmaceutical processing materials have to be evaluated to determine whether they impact the safety and efficacy of the final drug product. However, it can be extremely difficult to get reliable data, and with the stakes so high, would you want to take this risk? Join this session to: 

•Understand the importance of E&L structure identification 
•Discuss the concept of the Threshold of Toxicological Concern (TTC)
•Gain insight of the limits applied to genotoxic E&L incl. the “staged” TTC concept 
•Understand the limits applied to non-genotoxic E&L incl. the Cramer substance classification system
•Learn the limits applied to elemental Impurities 
•Perform a toxicological risk assessment to meet the expectations of Health Authorities