pim f schreef:
[quote=Koffiebroodje]
The dates for the assessment during 2006 are:
* 25 September - 29 September
* 27 November - 1 December
[/quote]
Koffiebroodje, heb jij hier een link van?
groet pim f
[/quote]
Het doet er eigenlijk niet zoveel toe, want als de WHO zegt dat ze volgende week een beslissing neemt over Quinvaxem is dat het enige dat er toe doet, maar vooruit,......
...naar mijn mening zijn de bovengenoemde data voor de assesment niet relevant voor vaccins. Ze doen al een tijd rondgang over dit forum, maar dat maakt ze niet juister. Ik kan de verwarring goed begrijpen, want ze komen van een WHO website genoemd:
"WHO prequalification of medicines":
mednet3.who.int/prequal/default.htmAls je vanaf hier op "Product dossiers" klikt kom je op:
mednet3.who.int/prequal/dossiers.htmmet daarop de volgende tekst:
[quote=WHO]
How often are dossiers assessed?
Each product dossier is evaluated by a team of evaluators for quality aspects, and for efficacy and safety (or bio-equivalence).
Due to the particular properties of several substances used in some pharmaceutical finished dosage forms (e.g. chiral activity, isomerism, sensitivity to relative humidity etc.) and the current status where there are no pharmacopoeia monographs and standards available for several substances and finished products, WHO appointed experts perform a comprehensive and rigorous evaluation of the submitted product data and information with a view to assess product compliance with international standards.
Assessments are done every second month at the offices of UNICEF Supply Division, Copenhagen (Denmark).
The dates for the assessment during 2006 are:
30 January - 3 February
27 March - 31 March
29 May - 2 June
17 July - 21 July
25 September - 29 September
27 November - 1 December
Product dossiers received in the period before the date mentioned, are assessed during that week. Manufacturers are then informed of the outcome of the evaluation and are given the opportunity to submit additional data and information requested by the evaluators. The additional data submitted will be assessed when received.
[/quote]
maar belangrijker:
[quote=WHO]
Which products do we prequalify?
A transparent procedure was established to invite all manufacturers of selected pharmaceutical products to take part in the prequalification procedure. The products were selected taking into consideration products recommended for use in the Essential Medicines List (web site link)
Interested manufacturers (or through their suppliers) are requested to submit an Expression Of Interest (EOI) to participate in the prequalification. The invitations for submitting EOI are published on the web pages of the participating United Nations procurement organizations as well as in the international press.
The products that are assessed in the Prequalification Programme, are listed in the respective EOIs for HIV/AIDS, TB and Malaria
[/quote]
Het gaat hier om de laatste zin. Dit Prequalificatieprogramma is UITSLUITEND gericht op medicijnen tegen HIV/AIDS, TB en malaria. Dit vindt je overal terug op deze website. Het ENIGE verband met vaccins dat ik heb kunnen vinden is
[quote=WHO]
The products were selected taking into consideration products recommended for use in the Essential Medicines List (web site link)