Booking an advice slot
There are a limited number of advice slots available, it is advisable for a company to contact us at least 25 weeks before they wish to receive the final advice report. Once the key dates have been established and agreed, we then hold the slot for a project. On occasion we may accommodate requests at short notice but this cannot be guaranteed.
In the event that the product's development programme is delayed, we endeavour to reschedule the project to a later slot provided we are given plenty of advance notice.
To speak with someone about processes and timelines, or to discuss the technical aspects of the project please contact the team.
Agreement of terms and start of project
NICE will send the company a copy of the standard contract to be agreed and signed. This should be agreed and signed by both parties at least one month before the briefing book submission date.
Once signed, the company will receive a signed letter confirming the details of the face-to-face meeting.
NICE will invoice the company for an initial payment.
Project size and total cost
On receipt of the briefing book, NICE will inform the company of the project size and confirm the total cost of the project. This will be based on the number and complexity of the questions asked in the company's briefing book.
You may contact us at firstname.lastname@example.org regarding the general fee information for various types of advice projects we offer.
NICE will send the company any clarification questions about the briefing book within seven weeks of receiving the briefing book. This is to ensure that the scientific advice team has a clear understanding of the issues presented by the company. The company should reply to the clarification questions within two weeks.
A face-to-face meeting will be scheduled to take place approximately 11 weeks after the briefing book submission.
The purpose of the meeting is to generate a greater understanding of the key issues for the development plans from NICE's perspective. The meeting focuses on the identification of and general discussion around the key issues rather than a direct response to the questions in the briefing book.
Opinions expressed in the meeting will not necessarily be reflected in the advice report. There is normally a brief introduction to how the appraisal committees make decisions on new technologies.
Meeting attendees will include company representatives, NICE staff and external experts (for example, clinical experts and health economists). The meeting will be held at the NICE offices in Manchester or in London and will last three hours. The meeting will not be formally minuted by NICE and NICE does not circulate meeting notes.
NICE will send a written advice report to the company approximately seven weeks after the face to face meeting for a medium project, and nine weeks after the face-to-face meeting for a large project. The report will be formally signed off by NICE before it is released to the company.
Follow-up and clarification
The company may ask one set of clarification questions in response to the advice report. These questions should be limited to the advice given and should be intended to clarify the meaning of the advice.
New information or new requests for information will not be considered as part of the current project.
Clarification questions should be received by NICE within three weeks of issuing the advice report. We will reply to the company's clarification questions within four weeks. Any additional questions or a request for a new face-to-face meeting will be considered a new project and an additional fee will be charged.
Binding status of advice
Companies seeking scientific advice should be aware that any scientific advice given is not legally binding with regard to any future appraisal of the product concerned, on the part of NICE or the company. Advice cannot be taken as indicative or suggestive of any future position, and will not be regarded as relevant to any future decision that may be taken by NICE.
The advice given by NICE is based on the questions and documentation submitted, and the scientific knowledge publicly available at the time of the advice. The advice cannot account for future changes and developments in scientific knowledge, regulatory requirements or health technology assessment methodology.
Companies should be aware that the advice provided is without prejudice to applicable legislation relating to the particulars and documents that should be submitted in support of any marketing authorisation (or other) application; it is also without prejudice to any intellectual property rights of third parties.
This page was last updated: 24 August 2012