FORUM · Institut für Management GmbH
Vangerowstraße 18
69115 Heidelberg
Phone: +49 6221 500-500
Fax: +49 6221 500-505
Course: Toxicology Winter School
Summer School
2018-12-21 2019-08-23 Hotel Frankfurt Messe (ehem. QGREENHOTEL by Meliá) Katharinenkreisel 60486 Frankfurt +49 69 70730-0 +49 69 70730-333

Toxicology Summer School

Know-how for employees in R&D, Medical affairs, Regulatory affairs & Pharmacovigilance - no toxicological know-how is expected

During this Summer School you will build a solid toxicological know-how basis and will be informed about the inclusion of toxicological data in the marketing authorisation dossier.
  • Toxicokinetics and drug-drug interaction
  • Mutagenicity and genotoxicity
  • Carcinogenicity
  • Reproductive toxicity and safety pharmacology
  • Immunogenicity
  • Risk assessment and risk communication

This distinguishes our event

Overall impression: 90 % of the participants' feedback was very good or good (January 2018)
Course content: 90 % of the participants' feedback was very good or good (January 2018)
Practical benefit: 100 % of the participants' feedback was very good or good (January 2017)

Aims and objectives

During this summer school:

  • you will build a solid toxicological know-how basis;
  • you will get to know the essential toxicological modes of action and learn how to apply them to your products;
  • you will receive good insights into the toxicological study programme and learn how it must be scheduled in drug development;
  • you will be informed about the inclusion of toxicological data in the marketing authorisation dossier and the associated regulatory affairs duties.

Who should attend
This summer school addresses the need for solid toxicological know-how of employees in the pharmaceutical industry, particularly those in the following departments:

  • Research and development
  • Medical affairs
  • Regulatory affairs
  • Pharmacovigilance

Basic scientific/medical knowledge would be helpful, toxicological know-how is not expected.
Your speakers
Your speaker day 1
Prof. Dr. Michael Arand
University of Zurich, SWITZERLAND

Dr. Susanne Brendler-Schwaab
requested, Senior Expert Regulatory Affairs, Bonn, GERMANY

Your speaker day 2 - Dr. Susanne Brendler Schwaab and
Hans-Joerg Martus, PhD
Preclinical Safety (PCS), Novartis Institutes for BioMedical Research (NIBR), Basel, SWITZERLAND

Your speaker day 3
Dr. Monika Chabicovsky
MC Toxicology Consulting GmbH, Vienna, AUSTRIA

Dr. Niklas Czeloth
Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim, GERMANY

Go forward

Pharma Webcast Forschung und Produktion

Pharma FORUM Webcast Biologics

We would like to invite you to join our live webcasts, where industry and authority experts will provide you with the latest information on the current challenges in analytics, development, quality and regulatory affairs every month. Most webcasts are specifically focused on CMC while addressing topics at the interface Quality and Regulatory Affairs.


Abbreviations, Glossary

List of abbreviations

Many abbreviations for processes, documents and authorities, amongst others, are used in all regulatory areas. We have compiled the most important ones for you. Our list of abbreviations can be freely downloaded here.


More on our quality criteria

Quality guaranteed!

IMI (Innovative Medicines Initiative) defined quality criteria for professional training and education. We follow these criteria and, as a signatory, we are an active partner in further developing and optimising the quality standards.

An aggregate evaluation of participants' feedback on all FORUM's healthcare training courses (evaluation period from 10.2017 - 09.2018 produced a result of 1.6 (based on a school grading system of 1-6).