Technical Meetings with PQP assessors

Introduction

The assessors of the WHO Prequalification of Medicines Programme (PQP) 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 PQP inspectors in these meetings can be arranged if PQP considers that this is necessary or would be helpful.

The primary purpose of a meeting 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 PQP and its procedures - or specific - for example, concerning PQP guideline requirements relating to pharmaceutical quality or efficacy/safety (particularly bioequivalence).

Applicants may request a meeting in the form of a teleconference, videoconference or as face-to-face meeting.

Notes about contact and meetings with PQP:

• Applicants/potential applicants or manufacturers may forward questions to prequalassessment@who.int at any time and can expect a response from PQP within a few hours or few days, depending on the complexity of the question(s).  Questions regarding the status of dossier assessments are best forwarded to PQP by email.  Similarly, any questions about GMP inspections should be emailed to prequalinspection@who.int.

• 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.

• In some cases, dossier- or site-related questions/issues/deficiencies, especially those relating to dossier compilation or any aspect of GMP, GCP/GLP, GPQCL, are best dealt with through independent technical assistance, rather then through a meeting with PQP staff.  In such instances, the applicant or manufacturer may be referred to the separate unit within PQP that handles technical assistance.  Note that strict criteria apply, and that technical assistance is organized and performed completely independently from assessment and inspection activities.

• With prior agreement, PQP can provide comments on a protocol submitted for review without a meeting being necessary.  This will be done only once per protocol and on the understanding that PQP does not "approve" or "accept" study protocols.  Normally the review of a protocol will take 1-2 weeks, depending on availability of expert reviewers.

How to request a meeting

A face to face, teleconference (TC), or videoconference (VC) meeting may be requested by emailing a completed Meeting Request Form (see below) to prequalassessment@who.int

On receipt of the request for a meeting, the PQP team will review the request and advise the applicant/manufacturer as to whether it considers that a meeting would be worthwhile.  if so, it will also confirm the suggested date of the meeting or propose alternative dates, depending on the availability of any needed experts, and the most appropriate location for the meeting (if face-to-face).  Generally, face-to-face meetings are held in Geneva or Copenhagen.  Meetings in Copenhagen are held in conjunction with dossier assessment sessions, and benefit from the increased availability of experts.

If considered necessary, PQP may request that the applicant provide an information package, to be received at least one week before face-to-face meeting, TC or VC to enable PQP staff to prepare adequately for the meeting.

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.

Related Link:

• Meeting Request Form