WHO Technical Report Series, No. 981 - World Health Organization

WHO Expert Committee on Specifications for Pharmaceutical Preparations Forty-seventh report
WHO Technical Report Series, No. 981, 2013
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Dr M. Kaplan, Director, Institute for Standardization and Control of
Pharmaceuticals, Jerusalem, Israel; Dr M. Karga-Hinds, Director, Barbados Drug
Service, Christchurch, Barbados; Dr A.M. Kaukonen, National Agency for
Medicines, Helsinki, Finland; Ms H. Kavale, Cipla, Mumbai, India; Dr T.
Kawanishi, Deputy Director General, National Institute of Health Sciences,
Tokyo, Japan; Dr S. Keitel, Director, European Directorate for the Quality of
Medicines and Healthcare, Strasbourg, France; Dr K. Keller, Director and
Professor, Federal Ministry of Health, Bonn, Germany; Dr M. Keller, Inspector,
Division of Certificates and Licencing, Swissmedic, Berne, Switzerland; Dr L.
Kerr, Scientific Operations Adviser, Office of Laboratories and Scientific Services,
Therapeutic Goods Administration, Woden, ACT, Australia; Dr M. Khan,
Director, Federal Research Center Life Sciences, US Food and Drug
Administration, Silver Spring, MD, USA; Professor K. Kimura, Drug Management
and Policy, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa
University, Kanazawa-city, Japan; Dr H. Köszegi-Szalai, Head, Department for
Quality Assessment and Control, National Institute of Pharmacy, Budapest,
Hungary; Dr A. Kovacs, Secretariat, Pharmaceutical Inspection Co-operation
Scheme, Geneva, Switzerland; Ms S. Kox, Senior Director Scientific Affairs,
European Generic Medicines Association, Brussels, Belgium; Dr P. Kozarewicz,
Scientific Administrator, Quality of Medicines Sector, Human Unit Pre-
Authorization, European Medicines Agency, London, England; Dr A. Krauss,
Principal Chemist, Office of Laboratories and Scientific Services, Therapeutic
Goods Administration, Woden, ACT, Australia; Professor H.G. Kristensen,
Vedbaek, Denmark; Mr A. Kupferman, Industry Pharmacist, Strasbourg, France;
Professor S. Läer, Institut für Klinische Pharmazie und Pharmakotherapie,
Heinrich-Heine-Universität, Düsseldorf, Germany; Dr J.-M. Legrand,
GlaxoSmithKline Biologicals, Wavre, Belgium; Dr Li H., Head, Chemical
Products Division, Chinese Pharmacopoeia Commission, Beijing, People’s
Republic of China; Dr A. Lodi, Head, Laboratory Department, European
Directorate for the Quality of Medicines and HealthCare, Strasbourg, France;
Mr M. Lok, Head of Office, Office of Manufacturing Quality, Therapeutic Goods
Administration, Woden, ACT, Australia; Ms M.Y. Low, Director, Pharmaceutical
Division, Applied Sciences Group, Health Sciences Authority, Singapore; Dr J.C.
Lyda, Senior Director, Regulatory Affairs, Parenteral Drug Association Europe,
Glienicke/ Berlin, Germany; Mr D. Mader, Compliance Auditor, GlaxoSmithKline,
Cape Town, South Africa; Ms G.N. Mahlangu, Director General, Medicines
Control Authority of Zimbabwe, Harare, Zimbabwe; Mangalam Drugs and
Organics Limited, Mumbai, India; Dr M. Mantri, Bicholim, Goa, India; Dr B.
Matthews, Alcon, Hemel Hempstead, Herts, England; Dr Y. Matthews, Regulatory
Operations Executive, GE Healthcare, Amersham, Bucks, England; Dr G. McGurk,
Executive Inspector, Irish Medicines Board, Dublin, Ireland; Dr A. Mechkovski,
Moscow, Russian Federation; Medicines and Healthcare Products Regulatory