Rolf Bass is MD and holds Professorships in Berlin and Basel. He created the ICH Guideline on Reproductive Toxicity and headed EMEA's Human Medicines from 1995-2000. He then became CPMP member for Germany and counseled Poland in Twinning Projects. He chairs the RA Master Program development in IMI16

Gerd Bode holds board certified specializations in Pathology, Neuropathology, Legal Medicine, Pharmacology and Toxicology. He works now as a lecturer and independent consultant in Toxicology and Pathology. Gerd was long term ICH Topic Leader for Safety Guidelines.

2004-2013: Non-Clinical Safety, F. Hoffmann-La Roche, Switzerland•Lead Late Stage Projects – Toxicology representative to the ICH Guideline Expert Working Groups (Genotoxicity – S2 and Genotoxic Impurities – M7) Over 100 original publications

Klaus Olejniczak is head for the “Geno – and Reproductive Toxicity” Unit in the German Federal Institute for Drugs and Medical Devices (BfArM). At ICH, he serves as EU Topic Leader for several topics (e.g. Safety Pharmacology, CTD – Safety, and Non-clinical Anticancer Drug Development).

i) Coordinates the Group of Pharmacological Sciences of the iMed.ULisboa, ii) for 20 years acted as expert in nonclinical and regulatory science at Infarmed, Portugal and EMEA, UK iii) has been (end July 2012) member of CHMP, CAT and SAWP and Chair of Safety Working Party and EU Co-Deputy in ICH M3R2, S6R1 and S1 guidelines. She consults on nonclinical drug development and is member of the NDA Advisory Board. She Chairs the Scientific Committee of the Innovative Medicines Initiative. Beatriz integrates the implementation Group of EUPATI (European Patient Academy) Portugal, and is a member of the Steering Committee and the Executive Committee of EUPATI National Platform.

Per Spindler, DVM, MSc (Applied Toxicology), Executive-MBA; on top of various senior positions in biotech & pharma, and in the public-private health care system, he now leads the GCP, GVP and GLP inspection teams at the Danish Medicines Agency in support of national activities and European / international collaborations. He has been active in IMI, ICH and EMA/CHMP activities. Dr. Spindler received DIA’s Outstanding Service Award in 2002, was DIA Board Member 2007-2016 and served as President 2014-2015.

In 1980 Jan Willem van der Laan joint the National Institute for Public Health and the Environment (RIVM, Bilthoven) as a biochemist and pharmacologist on CNS targets. In 1990 is he assessor Pharmacology and Toxicology of Human Pharmaceuticals at the and later, since 2011 directly for the Medicines Evaluation Board, located in Utrecht, the Netherlands. He is chair of the EMA/CHMP Safety Working Party since 2012. His contributions to the International Council on Harmonization started in 1993 on Carcinogenicity Testing. In 2012 the discussions on this topic have been restarted to reduce the number of 2-yr studies in rodents, and Jan Willem is Regulatory Chair on this process.