Technical Advice

WHO prequalification requirements for in vitro diagnostics and male circumcision devices are based on international norms and standards. Meeting these can be challenging for manufacturers. WHO prequalification staff can, however, provide technical and scientific advice to manufacturers  either in response to questions forwarded by email, or at a meeting (be this face-to-face or via tele- or videoconference).

Technical advice: in writing

Potential applicants or applicants may forward a request for technical advice to prequalification assessors (by emailing diagnostics@who.int) or prequalification inspectors (by emailing prequalinspection@who.int) at any time, and can expect a response within a few hours or a few days, depending on the complexity of the question(s).  

Technical advice: in person

WHO prequalification assessors are available to meet with applicants either before ("pre-submission" meeting), or at any stage following submission of a dossier. Meetings can thus be organized with reference to a new or to an ongoing application. Participation of WHO prequalification inspectors in these meetings can be arranged if this is considered necessary or would be helpful.

The primary purpose of such meetings is to resolve or clarify technical issues that cannot be addressed easily by other means, such as email exchange. These issues may be general — for example, relating to WHO prequalification procedures — or specific — for example, concerning compilation of a dossier for a specific product. Applicants may request a face-to-face meeting or a meeting in the form of a teleconference or videoconference.

How to request a meeting

A face-to-face meeting, teleconference, or videoconference may be requested by email (see aforementioned email addresses). The request will be reviewed and if a meeting is considered to be worthwhile, WHO will confirm the suggested date of the meeting, or propose alternative dates, depending on the availability of any needed experts, as well as the most appropriate location if the meeting will be face-to-face. Face-to-face meetings are generally held in Geneva, Switzerland or in Copenhagen, Denmark during the annual meeting with manufacturers.

The applicant may be requested to provide an information package, to be received at least one week before the face-to-face meeting, tele- or videoconference, so that WHO staff can prepare adequately.

Applicants are requested to draft meeting minutes that summarize the important discussion points, decisions, recommendations, agreements, disagreements, issues for further discussion and action items. These must be emailed for review and comment to all those who attended, before they can be considered as final.

Note

In accordance with WHO Staff Regulations and Rules, gifts or favours offered in connection with duties will be refused. To avoid embarrassment, applicants and manufacturers are therefore requested not to offer any gifts or favours.