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This document (Information and Administrative Forms) describes the background and procedures for applications to the OIE for recognition and registration of kits for veterinary diagnosis and studies and gives the forms for confidentiality agreements and declarations of interests. The 'Application Form for Validation and Certification of Diagnostic Tests by OIE' is available for downloading on the OIE website. Registration will allow the use of the OIE logo on associated kit materials, recognising the status of a test as valid for the defined fitness for purpose, or purposes, according to OIE parameters. Registered tests will be published on the OIE web pages and in hard copy. Successful OIE recognition and registration will depend on supplying quality controlled validation data to demonstrate the fitness of the test or test system to fulfill a defined task or tasks. Fitness for purpose criteria are further explained in this document. The Application Form for Validation and Certification of Diagnostic Tests by OIE allows applicants to submit data in a logical way so that scientific reviewers, appointed by the OIE, can assess tests against criteria of validation and fitness for purpose. Tests may include immunological or molecular-based systems relevant to the veterinary area including zoonotic diseases. Where a test system is submitted that involves multiple test procedures, then validation of all tests in that system is required (for example Test A as a screening test, with positive samples submitted to Test B as a confirmatory procedure). Anyone can apply for OIE recognition if they supply the necessary proof of fitness for purpose and can justify to end users, with validation data, the potential applications of the kits . The OIE aims to produce a register of recognised assays fit for one or more purpose(s). OIE Members wish to move towards improvement in quality and enhanced confidence in assays and greater assurance that they correctly classify animal disease status. Therefore they need assays that are validated according to OIE criteria.
OIE 2009
Table of Contents
SECTION 1. BACKGROUND INFORMATION AND PROCEDURAL PROCESS ................................................4 1.1. LEGAL BASIS .............................................................................................................................................................4 1.2. PURPOSES..................................................................................................................................................................4 1.3. PROCEDURE FOR THE SUBMISSION OF A DOSSIER ......................................................................................................5 1.3.1. General outline of the procedure ......................................................................................................................5 1.3.2. Role of the OIESVCRDA ...................................................................................................................................6 1.3.3. Before submission .............................................................................................................................................7 1.3.4. Submission of the dossier and payment of fees .................................................................................................7 1.3.5. Dossier to be submitted .....................................................................................................................................7 1.3.6. Validation of the dossier by the OIESVCRDA ..................................................................................................7 1.3.7. Positive outcome of the validation of the dossier ..............................................................................................8 1.3.8. Selection of the CRP/Reviewer(s)......................................................................................................................8 1.3.9. Negative outcome of the validation of the dossier.............................................................................................8 1.3.10. Management of applications ...........................................................................................................................8 1.3.11. Need for samples and sample analysis............................................................................................................8 1.4. SCIENTIFIC EVALUATION ...........................................................................................................................................9 1.4.1. Timetable for the evaluation .............................................................................................................................9 1.4.2. Liaison between the applicant and the OIE ....................................................................................................10 1.4.3. Request for additional information .................................................................................................................10 1.4.4. Opinion of the BSC..........................................................................................................................................10 1.4.5. Favorable opinion...........................................................................................................................................10 1.4.6. Specific obligations .........................................................................................................................................11 1.4.7. Non-fulfillment of specific obligations ............................................................................................................11 1.4.8. Unfavorable opinions......................................................................................................................................11 1.5. FOLLOW-UP TO THE BSCS OPINION .......................................................................................................................11 1.5.1. Transmission of the BSCs opinion .................................................................................................................11 1.5.2. Appeal .............................................................................................................................................................11 1.5.3. Negative decision ............................................................................................................................................11 1.6. CHANGES TO A DIAGNOSTIC TEST PREVIOUSLY INCLUDED IN THE REGISTER ...........................................................11 1.7. ANNUAL REVIEW AND ANNUAL FEE ........................................................................................................................12 1.8. RENEWAL OF A REGISTRATION ................................................................................................................................12 SECTION 2. VALIDATION STUDIES OVERVIEW ................................................................................................13 2.1. STAGE 1 VALIDATION ..............................................................................................................................................13 2.1.1. Calibration ......................................................................................................................................................13 2.1.2. Repeatability data ...........................................................................................................................................13 2.1.3. Analytical specificity data ...............................................................................................................................13 2.1.4. Analytical sensitivity data ...............................................................................................................................13 2.2. STAGE 2 VALIDATION ..............................................................................................................................................13 2.2.1. Negative reference animals/samples (Complete description) .........................................................................13 2.2.2. Positive reference animals (Complete description).........................................................................................13 2.2.3. Experimental animals......................................................................................................................................14 2.2.4. Threshold determination .................................................................................................................................14 2.2.5. Performance estimates ....................................................................................................................................14 2.2.6. Diagnostic sensitivity and specificity estimates with defined reference animals .........................................14 2.2.7. Diagnostic sensitivity and specificity estimates without defined reference animals ....................................14 2.2.8. Agreement between tests .................................................................................................................................14 2.3. STAGE 3 VALIDATION ..............................................................................................................................................14 2.3.1. Laboratory identification ................................................................................................................................14 2.3.2. Evaluation panel .............................................................................................................................................15 2.3.3. Reproducibility................................................................................................................................................15 2.4. STAGE 4 VALIDATION ..............................................................................................................................................15 2.4.1. Laboratories....................................................................................................................................................15 2.4.2. Test Applications.............................................................................................................................................15 2.4.3. International reference standards ...................................................................................................................15 2.4.4. Inter-laboratory testing programmes..............................................................................................................15
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2.4.5. International recognition ................................................................................................................................15 SECTION 3. GUIDANCE ON CONFIDENTIALITY AND DISCRETION ............................................................16 3.1. DUTY OF CONFIDENTIALITY ....................................................................................................................................16 3.2. CONTINUING DUTY OF CONFIDENTIALITY ...............................................................................................................16 SECTION 4. GUIDANCE ON CONFLICTS OF INTERESTS .................................................................................17 4.1. INTRODUCTION .......................................................................................................................................................17 4.2. WHO SHOULD DECLARE? ........................................................................................................................................17 4.3. WHAT TO DECLARE? ...............................................................................................................................................17 4.3.1. What is an interest?.........................................................................................................................................17 4.3.2. What are direct and indirect interests? ...........................................................................................................18 4.4. WHEN TO DECLARE? ...............................................................................................................................................18 4.4.1. Initial declaration............................................................................................................................................18 4.4.2. Appointment as CPR or reviewer....................................................................................................................18 4.4.3. Spontaneous declarations ...............................................................................................................................18 4.4.4. Updates ...........................................................................................................................................................19 4.5. OPERATIONAL ASPECTS ..........................................................................................................................................19 4.5.1. Tasks of OIESVCRDA .....................................................................................................................................19 4.5.2. Obligations of individuals concerned..............................................................................................................19 4.5.3. Meeting proceedings .......................................................................................................................................19 SECTION 5. FEES FOR APPLICATIONS FOR THE OIE VALIDATION AND CERTIFICATION OF DIAGNOSTIC ASSAYS.................................................................................................................................................20 5.1. BASIC FEES..............................................................................................................................................................20 5.2. RENEWAL FEE .........................................................................................................................................................20 5.3. METHOD OF PAYMENT ............................................................................................................................................20 SECTION 6. OIE REGISTRATION OF A DIAGNOSTIC TEST AS VALIDATED AND CERTIFIED - RULES OF RECOGNITION.......................................................................................................................................................21 APPENDIX: DECLARATION FORMS .....................................................................................................................22 FORM A1. CONFIDENTIALITY UNDERTAKING FOR THE EXPERT ADVISERS ..................................................................23 FORM A2. CONFIDENTIALITY UNDERTAKING FOR THE STAFF OF THE OIE AND THE OIE COLLABORATING CENTRE AND BIOLOGICAL STANDARDS COMMISSION MEMBERS .................................................................................................24 FORM A3. PUBLIC DECLARATION OF INTERESTS OF RELEVANT STAFF MEMBERS OF THE OIE ...................................25 FORM A4. PUBLIC DECLARATION OF INTERESTS OF THE RELEVANT MEMBERS OF COMMITTEES AND REVIEWERS.....26
SOP for OIE Validation and Certification of Diagnostic Assays Version 2.1 (06/2009)
The Resolution states that the Director General of the OIE should make provisions to establish a registry of assays with levels of validation specified. He is given the mandate to review the procedures involved in the timely approval of assays and is authorised to recover, if necessary, any costs incurred in the process of validation, certification and registry of such assays. Resolution No. XXIX establishes that OIE Reference Laboratories should be intimately involved with the validation procedures and that they should establish serum/sample reference collections to be used for validation in line with their mandates.
1.2. Purposes
The aim of the procedure for diagnostic kits is to produce a register of recognised assays for OIE Members and for test manufacturers. OIE Member need assays that are known to be validated according to OIE criteria in order to improve the quality of assays, to ensure that the test can be used to correctly establish animal disease status and to enhance confidence in assays. This process of producing a register of recognised assays will provide greater transparency and clarity of the validation process and also a means for recognising manufacturers that produce validated and certified tests in a kit format. In order to render the process transparent, all results of the test validation procedure by the OIE will be included in detailed form on the OIE web site. The submission form, the Application Form for Validation and Certification of Diagnostic Tests by OIE, is used to apply for certification by the OIE of a diagnostic test as 'fit for purpose'. The form guides an applicant through the application process by indicating important features of test validation to enable the reviewers to come to a rapid conclusion about any test's validation status (the extent to which data supports the claims for a particular purpose). 'Fit for purpose' means that the test has to be validated to such a level to show that the tests results can be interpreted to have a defined meaning in terms of diagnosis or another biological property being examined. It is no use reporting that a test will detect antibodies to foot and mouth disease (FMD) or any other disease agent or that a polymerase chain reaction (PCR) can detect a genome to a particular analytical level. There must be proof for the purpose of the test in a diagnostic / detection setting. Enough information has to be given to show that this is a valid statement. There is a need to define the purpose of the test and demonstrate that sufficient data have been obtained to ascribe some confidence to its use, in statistical terms, to answer a defined question.
SOP for OIE Validation and Certification of Diagnostic Assays Version 2.1 (06/2009)
Examples: 1. Fitness for purpose to detect antibodies against non-structural proteins for FMD is no useful. 2. Fitness for purpose to detect antibodies against non - structural proteins for FMD in pigs, cattle, sheep and goats to allow differentiation of infected and vaccinated animals on a herd basis following an outbreak to declare a country free from disease, is better.
An undertaking of confidentiality will be signed by all the persons involved in the assessment. Throughout the procedure, the OIESVCRDA is the contact point for the applicant. Exchanges between the chairperson of the review panel (CRP) and the applicant are possible during the assessment of the dossier provided that the OIEVCRDA is duly informed. The total duration of the procedure will be 135 days. Once the clock starts, the reviewers should provide an initial report within 30 days to the CRP. The CRP should prepare a consolidated report and liaise with the other reviewers. If questions are to be sent to the applicant, the clock is stopped until answers are received. An assessment report should be sent by the CRP to the OIESVCRDA before day 60. If any questions arise, the OIESVCRDA will send them to the applicant. After receipt of the answer to the questions and acceptable clarification, the CRP, in consultation with the reviewer(s), should provide a final assessment report with a clear proposition within 15 days. At the next meeting of the BSC, the CRP, if necessary, will present the assessment report and conclusions. If successful, the BSC will then propose to the OIE Director General to place the diagnostic test on the register. The OIE Director General will take the final decision. The OIESVCRDA will notify the applicant within 15 days of a successful application and the information will be published on the OIE web site stating that the test has been approved by the OIE Director General and is proposed for inclusion in the register. The final inclusion in the OIE register will be discussed and voted on by the OIE International Committee (comprising the Delegates of the OIE Members) during the General Session through the presentation of a Resolution drafted by the BSC containing a list of recommended validated and certified assays to be registered by the OIE. The final inclusion is effective within 7 days of the vote of the OIE International Committee. In cases where the BSC recommends that the test not be included in the register, the applicant may appeal the decision in writing; at his request, the applicant could appear before the BSC to give an oral appeal. If the appeal is rejected by the BSC, the final decision of the Director General will be notified to the applicant by the OIESVCRDA. Once a diagnostic test is placed on the register, any changes to the test must be declared and justified in advance before approval for implementation. The OIE Central Bureau, through the OIESVCRDA, will require an annual declaration from the applicant stating that the test remains valid and should be retained on the registry. Every 5 years, the OIE will insure that the diagnostic test remains within the current state of the art.
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SOP for OIE Validation and Certification of Diagnostic Assays Version 2.1 (06/2009)
samples, number of batches, testing to be performed, and specify, in consultation with the OIE Central Bureau, which laboratory will carry out the required testing. The cost of this testing will be charged to the applicant. Such information may be useful where a submission is regarded as bordering between the outlined validation stages or where there is disagreement about the fitness for purpose of a test. The results of the tests will be reported to the Scientific and Technical Department, the CRP, reviewer(s) and the BSC for consideration in finalising the BSC Assessment Report.
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Should the BSC want to record any follow-up measures, these will be included in the assessment report and referenced in a letter of undertaking signed by the applicant that will be appended to the assessment report. The diagnostic kit is validated and certified for only the fitness for purpose mentioned in the opinion of the BSC. In order to prevent any off-label use of the kit, the OIE will remove any diagnostic test from the OIE register that mention other fitness for purpose than those validated and certified by the OIE. In this case, the applicant or his authorised representative shall no longer state that his diagnostic test is validated and certified by the OIE. Any violation of this rule is liable to legal action by the OIE against the applicant.
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1.5.2. Appeal
The applicant may notify the OIE Central Bureau of his/her intention to appeal within 10 days of receipt of the decision. If the applicant does not appeal in this time, he/she shall be deemed to have agreed with the decision and it becomes final. The grounds for appeal must be forwarded to the OIESVCRDA within 30 days of receipt of the decision. If the applicant wishes to meet the BSC for an oral appeal, the request should also be sent at this stage. The OIE Central Bureau, through the OIESVCRDA, may decide to appoint a new CRP and/or reviewer(s), to assess the appeal procedure. The BSC will consider whether its opinion is to be revised at its next meeting. Once the BSC issues a final decision, it is forwarded (with the required appendices) to the OIE Director General for action.
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This Validation and Certification procedure for Diagnostic Assays establishes the fitness for purpose of a diagnostic test. This procedure does not establish the manufacturing quality of the test. The OIE reserves the right to remove from its validated and certified diagnostic test register, any test that does not perform according to the previously validated fitness for purpose.
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Selection criteria including historical, epidemiological and/or clinical data. Pathognomonic and/or surrogate tests used to define status of animals or prevalence within population. Sampling plan and procedures. 2.2.3. Experimental animals Complete description Age, sex, breed, etc. Immunological status. Relatedness to intended target population. Exposure. Inoculum, source, dose, etc. Type of exposure inoculation, aerosol, contact, etc. Sampling plan and procedures. 2.2.4. Threshold determination Complete description of method used: empirical, ROC, mean SD, etc. Descriptive statistics, frequency distribution diagrams, etc. 2.2.5. Performance estimates Irrespective of the method chosen, the standard method(s) of comparison should be run in parallel on all samples, i.e. the test methods in current use. 2.2.6. Diagnostic sensitivity and specificity estimates with defined reference animals Conventional method using reference animals. Assuming a minimum sensitivity and specificity of 75% with an allowable error of 5% in the estimate at a level of confidence of 95%, number of reference animals required is 300 for each population. Individual animals must be selected from negative and positive reference populations. Include 2x2 table, calculations for diagnostic sensitivity and specificity including error and confidence. Include same calculations for other tests if being compared to the test in question. 2.2.7. Diagnostic sensitivity and specificity estimates without defined reference animals Complete description of model used. Bayesian inference, latent class analysis, etc. Describe rationale, priors, supporting data. Population selection criteria, including prevalence estimates. Other test methods in evaluated should also include the standard method of comparison. Using best available priors, choose test populations with appropriate prevalence and select animals in sufficient numbers to generate estimates of sensitivity and specificity with an allowable error of 5% at a level of confidence of 95%. 2.2.8. Agreement between tests Complete description of test methods in comparison. Presumptive vs confirmatory tests. Relatedness of analytes. Potential biases. Complete description of samples tested. Source of samples may include experimental animals sequentially sampled over time. May also include animals or herds defined by reactivity in confirmatory tests or multiple presumptive tests and sampled over a period of time. Describe measures of agreement and explanations for results not in agreement.
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SOP, INFORMATION AND ADMINISTRATIVE FORMS Accreditation status. Number of laboratories included. Minimum of three laboratories should also include OIE Reference Laboratory, if possible. 2.3.2. Evaluation panel Description of test panel. Selection criteria, number of samples (minimum of 20). Sample volume, allowable number of repeats. Panel composition, i.e. number of replicates, range of analyte concentrations/ reactivities. Sample processing requirements, i.e. extractions, spiking, serial dilutions, preservatives, sterilisation. Coding of unknown (blind) samples. Frequency of testing. 2.3.3. Reproducibility Description of type of data/interpretation. Qualitative (categorical). Quantitative or semi-quantitative data. Single dilution vs titration. Description of type of analysis. Pre-determined limits, consensus, Youden plots. Descriptive statistics. Include mean, SD, range of results. Should include controls, as well as, blind samples. Number and proportion of accepted/rejected runs should be included.
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4.1. Introduction
In order to respect the confidentiality between the OIE and diagnostic test productor (DTP), the Members of the BSC, CRP and reviewer(s) shall not have financial or other interests with the DTP that could affect their impartiality. All indirect interests that could relate to this process shall be entered into a register held by the OIE. This requirement is extended to all OIE staff and persons involved in the process of OIE Validation, Certification and Registration.
1. Spouse or partner and dependent children living in the same household. 2. When declaring financial interests, e.g. stocks and shares, only the kind, number and company name need be stated. 3. Company or public laboratory name, position held and activities performed should be set out clearly and precisely. Where activities relate to specific product(s), declarations must indicate product name and nature of the work.
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c) Other links with industry During the preceding 5 years, all assistance and support received from industry, whether associated with direct or indirect pecuniary or material benefits, including: Grants for study or research allocated by the industry; Fellowships or sponsorships endowed by DTPs.
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4.4.4. Updates
Declarations of interests must be updated at least annually or as soon as an update is required for any new situation arising. As part of the new reviewers database, electronic updates are available to facilitate exchange of information.
The OIESVCRDA ensures, under the responsibility of the OIE Central Bureau, the availability of all declarations and updates for public consultation in the OIE headquarters.
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Section 5. Fees for applications for the OIE validation and certification of diagnostic assays
All diagnostic tests for diseases, including zoonoses, caused by pathogens (viruses, bacteria, prions and parasites) present in terrestrial and aquatic animals can be validated and certified by the OIE procedure.
2.
For the first year only, the annual fee is calculated for 7 months. This is because diagnostic tests are definitively validated and certified during the OIE General Session in May (after a vote by the International Committee). Every year, between 1 and 15 January, the manufacturer or his authorised representative shall pay the annual fee and send a profit justification for the diagnostic test. If the fee is not received on time, the OIE will remove the diagnostic test from the OIE web site and the manufacturer or his authorised representative shall no longer state that his diagnostic test is validated and certified by the OIE. Any violation of this rule is liable to legal action by the OIE against the manufacturer.
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Section 6. OIE registration of a diagnostic test as validated and certified - rules of recognition
The OIE logo is a part of the Organisations intellectual property and may not be used without the express permission of the Director General of the OIE. The OIE logo, name and abbreviation are also protected from being registered as a trade mark under article 6 of the Paris Convention for the Protection of Industrial Property. The use of the OIE logo (marking) signifies the recognition and registration of a test by the OIE through the validation application process. The logo can only be used when the test has been reviewed and accepted through the registration process. It could appear on any device associated with the test, on the instructions for use and on the sales packaging. For the device and sales packaging, it shall be stated under the logo: "Validated and certified by the OIE as fit for the purposes defined in the <leaflet/kit insert/document> provided with this kit" [use appropriate term] and accompanied by the Registration number. For the instructions for use, it shall be stated under the logo: "Validated and certified by the OIE as fit for the purposes defined in this <leaflet/kit insert/document>" [use appropriate term] and accompanied by the Registration number. Within the main text (introduction) of the leaflet/kit insert/document, a more detailed paragraph should be provided, saying: "The validation data for this kit have been certified by the OIE, based on expert review, as fit for the following purposes: <give details of the certified purposes> (As stated in the resolution adopted by the OIE International Committee)." The summary of the validation data (Section 4 of the application form), that will be on the OIE Register website, shall be included in this leaflet/kit insert/document. The OIE agreement will be withdrawn if it appears that the aims and objectives of the certification no longer justify maintaining such an agreement. The OIE validated and certified logo shall consist of the initials OIE taking the following form (the OIESVCRDA will provide a jpg or ai file of the OIE logo on request):
Validated and certified by the OIE as fit for the purposes defined in [this <leaflet/kit insert/document>] or [the <leaflet/kit insert/document> provided with this kit]* Register number: - - - - - - -
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I hereby accept and agree to the conditions and provisions contained in this document. Signature
Name_________________________________________________________
Date____________________
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FORM A2. Confidentiality Undertaking for the staff of the OIE and the OIE Collaborating Centre and Biological Standards Commission members
The respect of confidentiality during the OIE procedure for validation and certification of diagnostic assays is an essential part of the relationship between the OIE, industry and other parties. The OIE recognises that its staff, the BSC members and the OIE collaborating centre staff could have access to confidential information related to intellectual property or of commercial concern. Staff, BSC members and reviewers are required to respect their obligations of confidentiality in all cases, whether in the work place or in a public place.
Each member of the OIE, OIE collaborating centre and Biological Standards Commission participating in the procedure is conscious that he shall exercise the utmost discretion in regard to all matters of confidential information to which he could have access during the process of this procedure. He shall not communicate to any person unpublished information known to him by reason of his official position, except in the course of his duties or by authorisation of the Director General. These obligations remain binding after termination of his functions.
I hereby accept and agree to the conditions and provisions contained in this document. Signature
Name_________________________________________________________
Date____________________
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FORM A3. Public Declaration of Interests of Relevant Staff Members of the OIE
Surname: (family name) Fore names
Position
1
Grade:
Name of company
Share type
Number of shares:
List the work that you have previously carried out including paid/unpaid traineeships on behalf of the DTP in the 5 preceding years:
Other interests or facts that you consider should be made known to the Agency and the Public including matters 2 relating to members of your household
Declaration I, __________________________________________________________________________________ Do hereby declare on my honour that, to the best of my knowledge, the only direct or indirect interests I and my household members have in the DTP are those listed above.
I further declare that should any changes occur and should it appear that I have or acquire additional interests that should be made known to the OIE, I shall forthwith declare them and complete a new public declaration of interests.
1 2
If you have no interests, please indicate none in the relevant section. Household members means spouse, partner and dependent children living at the same address as the staff member. The names of these persons need not be declared.
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FORM A4. Public Declaration of Interests of the Relevant Members of Committees and Reviewers
Surname: (family name) Fore names
Qualifications
Professional Address
1
Name of company
Share type
Number of shares:
Work you previously carried out in return for payment including paid/unpaid traineeships on behalf of a DTP in the 5 preceding years:
Other interests or facts that you consider should be made known to the OIE and the Public including matters relating to 2 members of your household
Declaration I, ___________________________________________ do hereby declare on my honour that, to the best of my knowledge, the only direct or indirect interests I or my household members have in the DTP are those listed above.
I further declare that should any changes occur and should it appear that I have or acquire additional interests that should be made known to the OIE, I shall forthwith declare them and complete a new public declaration of interests. Done at: _____________________ Signature_______________________________________________Date_____________________
1 2
If you have no interests, please indicate none in the relevant section. If you lack space on this form, please use and attach additional pages. Household members means spouse, partner and dependent children living at the same address as the committee member/reviewer. The names of these persons need not be declared.
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