Scientific Advice Office
Product Development Scientific Support Department
European Medicines Agency
30 Churchill Place
London E14 5EU
United Kingdom / Date:

Letter of intent for request of Qualification of Novel methodologies[i]

Please fill all the predefined fields as accurately as possible

Name of biomarker/method
Description of
biomarker/method
Type of biomarker/method / Genetic Biomarker Protein Biomarker
Imaging Scale
Statistical Other

Comments:

Type of request / Please click here to selectRequest for Qualification AdviceRequest for Qualification Opinion
Context of biomarker/method / Non Clinical
Translational
Clinical
Therapeutic field / Cancer HIV/AIDS Diabetes
Neurodegenerative disorder Infectious disease
Autoimmune disease/dysfunction
CardiovascularOther
Please briefly outline the scope/content of your questions and intended use[ii]

Comments:

Applicant / Company / Customer Account Number[iii]:
Name:
Address:
Contact Person details / Name:
Direct tel: Fax:
Email:
Alternate Contact Person details (if applicable)[iv] / Name:
Direct tel: Fax:
Email:
Invoicing details (if different from Applicant details)[v] / Name:
Address:
Financial contact person details (if applicable or different from procedure contact person)[vi] / Name:
Direct tel: Fax:
Email:
Purchase order number (if applicable or if already available)[vii] / Details:

Comments:

Small and Medium Sized Enterprises (SME) status[viii] / NO – N/A
YES (please fill additional rows)
- SME Number:
- SME fee reduction requested[ix]: YES NO date:
- Additional relevant information:
Consultant on behalf of Applicant (if applicable) / Name of the Company:
Address:
Contact Person details / Name:
Direct tel: Fax:
Email:
Alternate Contact Person details (if applicable) / Name:
Direct tel: Fax:
Email:
Letter of authorisation from applicant / NO (to be provided within 30 days)
YES (please attach)

Comments:

Requirement for preparatory meeting[x] / Specify preferred week for meeting:
Aimed start of the procedure / Please click here to select06 - 09 January 201502 - 05 February 201509 - 12 March 201507 - 10 April 201504 - 07 May 201501 - 04 June 201506 - 09 July 201501 - 04 September 201505 - 08 October 201503 - 06 November 201530 November - 03 December 201511 - 14 January 201608 - 11 February 201607 - 10 March 201611 - 14 April 201610 - 13 May 201606 - 09 June 201604 - 07 July 201630 August - 02 September 201626 - 29 September 201624 - 27 October 201628 November - 01 December 2016

Comments:

Parallel Advice with FDA / NO
YES

Comments:

Previous Qualification/ Scientific Advice received / Other CHMP Qualification/Scientific Advice given to this biomarker/method. Procedure number:
Previous FDA Qualification / Scientific Advice given to this biomarker/method. (please specify):
Previous discussions at Pharmacogenomics Working Party or other CHMP Working Parties (please specify):
Previous discussions with relevant Competent Authorities, EU or non-EU (please specify):

Comments:

Additional EMEA Qualification request planned / NO
YES; planned date:

Comments:

Important: please send this form in Word format as it is to:

-

Do not convert it into PDF.

[i]At the time of submission the Qualification request should be provided in line with the current Qualification of novel methodologies for drug development: guidance to applicants (

[ii]Please only include a brief outline in this box. However, in order to get a better idea of your request and to help the EMEA find the most suitable Coordinator please also attach to the letter of intent a summary of your request in a couple of pages.

[iii]This field is mandatory. Please quote your customer account number with the Agency. To request a customer account number or for any account query please send an e-mail to .

[iv] An additional alternate person is requested in case the main contact point is unavailable. All official correspondence will be sent to both contact persons.

[v]Please note that EMEA fees are payable net of all bank charges, withholding taxes and any other deduction imposed on the customer by legislation of the country of residence.

Only the Applicant will be invoiced, but the invoice can be sent to a different address. If a consultant is dealing with the Qualification request on behalf of the Applicant, nevertheless the payment will be claimed to the Applicant. If purchase order is not yet available at this stage, it will have to be provided at the time of submission of the Scientific Advice request.

[vi] Please provide details of a contact person for matters related to settlement of invoices, statements of account, etc. The Agency will send an invoice to the billing address it has on file at the time of receipt of the present application. For queries on billing addresses please send an e-mail to . Please note that EMA fees are payable net of all bank charges, withholding taxes and any other deduction imposed on the customer by legislation of the country of residence.

[vii] This is a reference number provided by the applicant to the Agency. It will be quoted on the invoice issued by the Agency.

[viii] To be eligible for an SME fee reduction the applicant must be a legal entity with registered office in the European Economic Area (EEA) and have SME status assigned by the EMA.

[ix]If the applicant has an SME status, at the time of submission please provide the fee reduction confirmation document from the EMA SME office. Failure to do so will incur a validation of the request without SME fee reduction and an invoice of the full amount will be sent by our account department.

[x] Please note that the meeting will not take place during CHMP & SAWP meeting dates.