expert panels

Service description

This service provides access to qualified experts in a controlled setting to enable companies to rehearse their strategies in a variety of contexts, such as with NICE submissions, Ethics Committees, Safety Monitoring Committee, GCP audits, product recalls, systems validation, presentations to regulatory authorities and working with PCTs. These forums can be used for contingency planning purposes (eg simulating a product recall) or training (eg rehearsing a product license application hearing)

Our approach is to ensure that our consultants understand your objectives in commissioning an expert panel. Typically this would take the form of a documented brief for the assignment, listing objectives, participants, timescales, intended outcome. This will enable us to ensure that we resource the panel only with appropriately qualified content experts.

Panel meetings may be once-off (eg Product License Application) or recurrent (eg. Ethics Committee decsions) depending on the client need. In either event, our consultants will handle the meeting logistics and facilitation to ensure the best use of participants time. Meeting outcome will be documented, either as minutes or recommendations and actions, as appropriate to the context. Our consultants may be able to assist with the follow-up actions (eg writing SOPs following a GCP audit)

Case Study

The company wished to rehearse for a regulatory audit of its clinical practices for a product that was to be filed for registration. The purpose was to ensure that when the real audit took place they were as well prepared as possible.

The product development had been conducted in a highly focussed manner, across several European countries on an aggressive timescale. The company wanted to check whether any compromises had been made between time and quality, especially in following GCP.

The scope and objectives were agreed prospectively and a small team visited the site for several days, role playing regulatory inspectors throughout the period. Their findings were presented back in the management team and contained a prioritised list of recommendations for action to improve overall preparedness.

The client benefits of the simulated audit were:

Gaining access to independent industry expertise to review their internal practices

Prospectively, to provide a focus and timeline for preparation of the necessary documentation and record keeping

After the fact, to highlight priorities for remediation which became the agenda for the follow-up program