Dr. Clemens Guenther
Former Senior Expert Nonclinical Safety at Bayer AG
Dr. Clemens Guenther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany. He started his professional career in 1990 at Schering AG, Berlin-Germany. From 2007 to 2013, he was Director and Head of Global Preclinical Development at Intendis GmbH, branded later-on as Bayer Dermatology. In this position, he was responsible for Nonclinical Safety for the marketed product portfolio of Bayer Dermatology as well as the global preclinical development strategy including human DMPK for development and life cycle management projects.
After integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care and later-on Senior Expert Nonclinical Safety within the Division of Bayer Pharmaceuticals. He held this position until June 2024 and is acting now as independent lecturer.
Dr. Clemens Günther gained about 35 years of experience in drug development. He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products including Transdermal Therapeutic Systems. His expertise includes also the Toxicological Risk Assessment of impurities as well as extractables and leachables.
DAY 1: February 27th, 2025
SESSION: Toxicological Risk Assessment on Extractables and Leachables
◆ Introduction: why do we need to care about E&L?
◆ How to perform a Toxicological Risk Assessment.
◆ The concept of Permitted Daily Exposure (PDE).
◆ The concept of Threshold of Toxicological Concern (TTC).
◆ Compounds of specific concern: Nitrosamines.
DAY 1: March 7th, 2024
SESSION: Toxicological assessments in E&L
◆ PQRI’s recommendations for analytical and safety thresholds.
◆ The QSAR application and qualification standards.
◆ Analyzing toxicological risk and toxicity data.
DAY 1: March 9th, 2023
SESSION: Toxicological assessments in E&L
◆ PQRI’s guidance on safety and analytical thresholds.
◆ Qualification criteria and QSAR application.
◆ Examining toxicological risk and toxicity data.
DAY 1: March 30th, 2022
SESSION: The toxicological risk assessment for extractables & leachables
◆ Step 1: The planning phase.
◆ Analytical and safety thresholds.
◆ Assessing toxicological risk and evaluating toxicological information.
DAY 1: May 19th, 2021
SESSION: Toxicological assessment for E&L
◆ Assessing toxicological risk and toxicity data.
◆ PQRI recommendations on analytical and safety thresholds.
◆ Qualification thresholds and use of QSAR.
◆ Considerations on quality and safety.
