QP Facilitation Programme

QP Facilitation Programme

The Almac QP Facilitation Programme is an on-site programme designed to provide the necessary background information on how the QP release process occurs and to gather much of the documentation necessary for import and release of investigational medicinal products into the EU for clinical trial.  An experienced Quality Compliance Manager would work side by side with the client on-site for 2-3 days to accomplish these goals. This process, which normally takes place via email or phone over a prolonged number of weeks, is simplified and expedited with on-site guidance. Achievable goals and contact points will be agreed in advance of the trip with a performance status report issued on leaving the site.

Benefits:

  • Step-by-step review of the QP process
  • Review of why QP release is required
  • Open forum to answer any questions around QP release
  • Collection of relevant documentation
  • Early completion of necessary forms
  • Establish relationships with relevant personnel

Onsite services help to improve the client understanding of the process and supplement a lack of internal resources.  The documentation is completed early and ultimately removes the preparation for QP release from the critical path prior to IMP distribution.

WEBINAR:

Click here to access Almac's QP Facilitiation Programme webinar.

If you would like more information on the QP Facilitation Programme or Almac’s QP Services please contact: clinicalservices@almacgroup.com

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