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Procedure for assessing the acceptability, in principle, of vaccines ...

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Geneva, Switzerland; Dr U Rosskopf, World Health Organization, Geneva,<br />

Switzerland.<br />

The proposals were discussed at <strong>the</strong> "In<strong>for</strong>mal consultation with <strong>the</strong> ad hoc committee<br />

on vacc<strong>in</strong>es prequalification <strong>for</strong> <strong>the</strong> revision <strong>of</strong> <strong>the</strong> procedure <strong>for</strong> <strong>assess<strong>in</strong>g</strong> <strong>the</strong><br />

<strong>acceptability</strong>, <strong>in</strong> pr<strong>in</strong>ciple, <strong>of</strong> vacc<strong>in</strong>es <strong>for</strong> purchase by UN agencies" and<br />

recommendations were received from <strong>the</strong> ad hoc committee members – Ms LG<br />

Castanheira, ANVISA, Brasilia, Brazil; Dr P Chagnaud, Agence Française de Sécurite<br />

Sanitaire de Produits de Santé, Lyon, France; Ms X Chen, State Food and Drug<br />

Adm<strong>in</strong>istration, Beij<strong>in</strong>g, People's Republic <strong>of</strong> Ch<strong>in</strong>a; Dr E Cooke, European<br />

Medic<strong>in</strong>es Agency, London, England; Dr R Dobbelaer, Lokeren, Belgium; Mr RD<br />

Morales, Centro Control Estatal de la Calidad de los Medicamentos, Havana, Cuba;<br />

Dr M Eisenhawer, Swiss Agency <strong>for</strong> Therapeutic Products Inspectorates, Bern,<br />

Switzerland; Dr I Feavers, National Institute <strong>for</strong> Biological Standards and Control,<br />

Potters Bar, England; Dr M Ferguson, Independent, Norfolk, England; Ms T<br />

Jivapaisarnpong, M<strong>in</strong>istry <strong>of</strong> Public Health, Bangkok, Thailand; Dr J Joung, Korea<br />

Food and Drug Adm<strong>in</strong>istration, Seoul, Republic <strong>of</strong> Korea; Dr R Nibbel<strong>in</strong>g, National<br />

Institute <strong>of</strong> Public Health and Environment Protection, Bilthoven, Ne<strong>the</strong>rlands; Dr M-<br />

H P<strong>in</strong>heiro, European Medic<strong>in</strong>es Agency, London, England; Pr<strong>of</strong> H Rees, University<br />

<strong>of</strong> <strong>the</strong> Witwatersrand, Johannesburg, South Africa; Dr. C Rolls, Therapeutic Goods<br />

Adm<strong>in</strong>istration, Woden ACT, Australia; Dr VG Somani, M<strong>in</strong>istry <strong>of</strong> Health and<br />

Central Drugs Standard Control Organisation, New Delhi, India; Dr L Slamet,<br />

National Agency <strong>of</strong> Food and Drug Control, Jakarta, Indonesia; Dr J Sou<strong>the</strong>rn,<br />

Temporary Adviser, Pretoria, South Africa; Dr JM Spieser, European Pharmacopoeia<br />

Commission Secretariat, Strasbourg, France; Dr L Tesol<strong>in</strong>, Scientific Institute <strong>of</strong><br />

Public Health, Brussels, Belgium; Dr W Vergeer, National Control Laboratory,<br />

Bloemfonte<strong>in</strong>, South Africa; Dr JW Blair, US Food and Drug Adm<strong>in</strong>istration,<br />

Rockville, MD, USA; Dr K Midthun, Center <strong>for</strong> Biologics Evaluation and Research,<br />

Rockville, MD, USA and o<strong>the</strong>r meet<strong>in</strong>g participants.<br />

The first draft <strong>of</strong> <strong>the</strong> revised procedure was prepared by <strong>the</strong> draft<strong>in</strong>g group: Ms E<br />

Uramis, Consultant, World Health Organization, Geneva, Switzerland; Dr N<br />

Dellepiane, World Health Organization, Geneva, Switzerland; Dr D Meek, World<br />

Health Organization, Geneva, Switzerland; Ms C Rodriguez, World Health<br />

41

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