Head of Veterinary Medicines Department - EMA
2009 - 2015
Responsible for all aspects of the registration of centralised veterinary medicinal products: scientific advice, marketing authorisation applications, pre- and post-, MRL applications, pharmacovigilance for veterinary medicinal products, MUMS designation, referrals, organisation of CVMP, regulatory affairs. Responsibility for the management of the three sections on marketing authorisation procedures, safety and regulatory/post-authorisation.
Head of Sector Safety of Veterinary Medicines - EMA
1999 - 2009
Responsible for MRL applications, PSURs/pharmacovigilance for veterinary medicinal products, availability/MUMS, safety aspects of marketing authorisation applications and scientific advice requests, organisation of CVMP.
Head of Sector Safety of Residues (MRLs) - European Agency for the Evaluation of Medicinal Products (EMEA)
1996 - 1999
Responsible for MRL applications, completion of the assessment of MRL applications for “old’ substances, secretarial support to VMRFG.
EU co-ordinator for VICH
2002 - 2015
Co-ordinating the EU position to VICH guidelines, negotiation at VICH Steering Committee meetings.
EMA representative in EC delegation to CCRVDF
1998 - 2012
Co-ordinating the technical input to the EU position at Codex Alimentarius (CCRVDF) regarding MRLs and its presentation at CCRVDF.
Senior Scientific Administrator - Ministry for the Environment, Conservation and Nuclear Safety, Bonn, Germany
1995 - 1996
Implementation of EU legislation on ‘Existing Chemicals’, international harmonisation activities.
National Expert on secondment/Auxiliary agent at the European Commission, Directorate General XI (Environment), Unit for Environmental control of chemical products and biotechnology, Brussels
1992 - 1995
Implementation of the new Regulation on ‘Existing Chemicals’, responsible for the EU Technical guidance document on risk assessment of chemical substances, international harmonisation activities.
(Senior) Scientific Administrator Environmental Agency (UBA), Germany
1987 - 1992
Environmental risk assessment of chemicals, member of the expert working group to the Advisory Committee on Existing Chemicals (BUA), representative at EU technical meetings on classification of chemicals. International co-operation.
Dispensing pharmacist, Berlin, Germany
1983 - 1987
Research and teaching - Institute for Chemistry, Freie Universität Berlin, Germany
1976 - 1981
Graduation in Pharmacy and Licence to practice as pharmacist
Freie Universität Berlin and Landesprüfungsamt für Gesundheitsberufe Berlin, Germany
1978 - 1983
Dr. rer. nat. (Organic Chemistry)
Freie Universität Berlin, Germany
1976 - 1981
Master's degree (Diploma) in Chemistry
Freie Universität Berlin, Goethe Universität Frankfurt am Main, Germany
1971 - 1976
Catry, B., Cavaleri, M., Baptiste, K., Grave, K., Grein, K., Holm, A., ... Torren Edo, J. (2015). Use of colistin-containing products within the European Union and European Economic Area (EU/EEA): development of resistance in animals and possible impact on human and animal health. Int J Antimicrob Agents. 46(3), 297-306.
Grein K., Duarte I. (2014). Establishing maximum Residue Limits in Europe. Strategies for Reducing Drug and Chemical Residues in Food Animals. In: Baynes, R.E., Riviera, J.E. (eds.). International Approaches to Residue Avoidance, Management, and Testing. Hoboken, New Jersey: John Wiley & Sons, Inc.
Grein, K. (2012). Responsibilities of regulatory agencies in the marketing of antimicrobials. In: Acar, J.F., Moulin, G. (eds.). Antimicrobial resistance in animal and public health. Rev. sci. tech. Off. int. Epiz., 31(1), 289-298.
Grein, K., (2009). Pharmacovigilance and the European Medicines Agency: conduct of pharmacovigilance activities. In: Woodward, K.N. (ed.). Veterinary Pharmacovigilance, Adverse Reactions to Veterinary Medicinal Products. Chichester: Blackwell Publishing Ltd.
Valois, A.A., Endoh Y.S., Grein, K., Tollefsen, L. (2008). Geographical differences in market availability, regulation and use of veterinary antimicrobial products. In: Guardabassi, L., Jensen, L.B., Kruse, H. (eds.). Guide to Antimicrobial Use in Animals, Oxford: Blackwell Publishing Ltd.
Grein, K., Papadopolous O., Tollis M. (2007). Safe use of vaccines and vaccine compliance with food safety requirements. Rev. sci. tech. Off. int. Epiz., 26(2), 339-350.