Qualified Person (QP) Facilitation Program
Our Qualified Person (QP) Facilitation Program is designed to provide the necessary background information on how the QP release process occurs. The program happens on-site and enables us to gather much of the documentation required for the import and release of investigational medicinal products into the EU.
An experienced Quality Compliance Manager will work side by side with you for approximately 2-3 days. This process, which normally takes place via email or phone over an extended number of weeks, is simplified and expedited with our on-site guidance. Achievable goals and contact points will be agreed upon in advance of the trip, with a performance status report issued upon leaving the site.
Onsite services help to improve understanding of your processes, as well as allows us to supplement any lack of internal resources. Your documentation is completed early, ultimately removing the preparation for QP release from the critical path prior to IMP distribution.
This on demand webinar will focus on this QP Facilitation Program and will offer a step-by-step review, including:
- Review of why QP release is required
- Collection of relevant documentation
- Early completion of necessary forms
- Establish relationships with relevant personnel
Almac Clinical Services
Guided by our extensive clinical supply experience and expertise, Almac Clinical Services is recognised as an innovative, global solution provider within the specialised and complex market of clinical trial supply.
Our integrated and adaptable solutions offer the most flexible approach to support the delivery of global clinical trials from protocol right through to patient delivery.
Our core purpose is to be the partner of choice, to deliver the next generation of health care solutions effectively and to focus on winning for you and your patients.