Prof. Clemens Allgaier, PhD

Managing Dirctor/Professor of Pharmacology and Toxicology

Over 20 years expert on pharmacological and toxicological issues in the fields of medicinal products, medical devices, chemicals and biocides. Lecturer of Pharmacology and Toxicology at the University of Freiburg i. Br.; Professor of Pharmacology and Toxicology at the University of Leipzig.

Since October 2006, Managing Director of ACA-pharma concept GmbH.

Head of the ‘Regulatory Toxicology and Risk Assessment’ module of the PGS ‘Toxicology and Environmental Protection’. Speaker at the DGK/IKW course for safety assessors.

Stephanie Franz, PhD

Senior Regulatory Affairs Manager

Studied Geoecology at the Technical University Bergakademie Freiberg and received her doctorate at the Helmholtz Centre for Environmental Research GmbH – UFZ, Leipzig. Her work at the Department of Bioanalytical Ecotoxicology focused on the behaviour and effects of chemicals in the aquatic environment.

Since 2011, working as scientific expert/Senior Regulatory Affairs Manager at ACA-pharma concept. She is responsible for the preparation of environmental risk assessments (ERAs) of medicinal products for human use, the preparation of authorization documents according to Medical Device Regulation (MDR) and the authorization of substances according to REACH-regulation.

Bianca Leubner

Regulatory Affairs Manager

Since 2019, assistant to the management/regulatory affairs manager at ACA-pharma concept. She has been familiar with REACH/CLP/national chemicals legislation since 2011.

Her tasks include project management, the organisation of ACA Campus seminars and the preparation of dossiers in accordance with the REACH and CLP regulations.

Boris Klein PhD

Senior Regulatory Expert

Since 1995 at the Bremen Trade Inspectorate, head of the ‘Hazardous Substances and Radiation’ department and permanent deputy to the head of the office. Since 2007, lecturer at the University of Bremen in the Department of Biology/Chemistry (‘Legal Studies for Chemistry Students’), at Bremerhaven University of Applied Sciences (in the ‘Integrated Safety and Security Management’ degree programme), since 2018 at the University of Leipzig Postgraduate Studies (PGS) ‘Toxicology and Environmental Protection’.

Holger Kittner, MD

Senior Clinical Expert

He is Specialist of Pharmacology and Toxicology since 1993. He gained his clinical experiences in internal medicine, surgery, paediatrics and general medicine at the University of Leipzig; since 1993 he has also served in the Toxicological Advisory Service of the University. He is very experienced in supporting industrial and consultancy organisations with his toxicological and clinical expertise.