Experience


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      


Education

 

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


Publications


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.