Dr. Clemens Günther, Bayer AG - Qepler Summits And Conferences

Dr. Clemens Günther

Director Nonclinical Safety Consumer Care
Bayer AG
Berlin, Germany
We exist to help people thrive - Advancing health and nutrition is what we do best and care about most.

Dr. Clemens Günther received his diploma in biology and doctorate for natural sciences from the Free University, Berlin-Germany.

From 1990 to 2006 he started his professional career at Schering AG, Berlin-Germany.

From 2007 to 2013, Dr. Clemens Günther 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.

Since integration of Intendis into Bayer in 2013, he became Director Nonclinical Safety Consumer Care within the Division of Bayer Pharmaceuticals.

Meanwhile Dr. Clemens Günther has gained 29 years experience in nonclinical safety.

He has been involved in nonclinical development and regulatory toxicology of small molecules, biologics, medical devices and drug device combination products.

Related Sessions:

Extractables & Leachables
Summit 2019

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 15 Oct 2019
  • Berlin, DE
  • Pharma
Day 1: Tuesday, 15 October 2019
CASE STUDY: Toxicological assessment of non-genotoxic E&L.
  • Regulatory Guidance
  • Searching for toxicological information
  • No data available - The Threshold of Toxicological Concern (TTC) approach
  • Point of departure available - How to define the Permitted Daily Exposure
View Details

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 2: Thursday, 05 December 2019
CASE STUDY: Development of Drug Device Combination Products: Nonclinical safety requirements.
  • Understanding the complexity of nonclinical safety requirements
  • How to select an appropriate test strategy
  • How to perform biocompatibility testing according to ISO-10993
  • How to avoid potential pitfalls
View Details

Medical Device
Regulations Summit 2021

Exploring EU MDR and IVDR updates and preparing company for new requirements implementation.
  • 08 Jul 2021
  • Virtual,
  • Pharma
Day 2: Friday, 09 July 2021
CASE STUDY: Biocompatibility testing to meet the requirements of the EU Medical Device Regulation.
  • Understanding the principles of nonclinical safety evaluation of medical devices
  • Clarifying the requirements for biocompatibility testing according to ISO-10993
  • Selecting an appropriate test strategy
  • How to practically apply biocompatibility testing
  • Examples and potential pitfalls
View Details

3rd Annual Extractables &
Leachables Summit 2023

Get the latest updates in regulation, analytical testing, risk & safety assessment, biocompatibility.
  • 13 Jun 2023
  • Virtual,
  • Pharma
Day 1: Tuesday, 13 June 2023
CASE STUDY: Toxicological Risk Assessment on Extractables and Leachables
  • Introduction: why do we need to care about E&L?
  • In silico assessment using computer expert systems
  • Concept of Threshold of Toxicological Concern
  • Concept of Permitted Daily Exposure
  • Compounds of specific concern: nitrosamines
View Details
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