Application Form for TAIEX Expertise

Application form for TAIEX Expertise

N.B.: only type-written applications will be accepted
Beneficiary: / TURKEY
Date of submission: / 20.03.2006
Objective of the expertise:
Our Department is the official control laboratories of drugs, cosmetics and medical devices, responsible from all quality control test of officially sent , locally manufactured and imported samples for preregistration and postmarketing controls.A draft legislation of "Turkish Drug Agency" is prepared by the Ministry of Health, which our department is going to take part as "Laboratories" For the reorganisation studies in our laboratories we need to get information from an expert has experience on EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories .

Please complete and return to:

European Commission

InstitutionBuilding unit (TAIEX)

Rue de la Loi 200, B-1049 Brussels

Fax: +32-2-296 68 40

E-mail:

1. Details of applicant acting as main co-ordinator for the execution of Expert Mission
Title (Mr., Mrs.) :[1] / Mr.
First Name: / Koray
Surname: / Sakar
Ministry or Institution: / Ministry of Health-Refik Saydam Central Institute of Hygiene
Department: / Drugs and Cosmetics Research Department
Function: / Director - Professor Pharmacist
Office address (street/number/office number): / Cemal Gürsel Cad. No:18 Sıhhiye
Post code: / 06100
City: / Ankara
Office Tel: / +90(312)431 28 87
Office Fax: / +90(312)435 35 46
E-mail: /
Will also participate to the expert mission? / Yes No
2. Details of the participant(s) wishing to meet the expert
a)
Title (Mr., Mrs.) : / Mr.
First Name: / Sebahattin
Surname: / Yıldırım
Ministry or Institution: / Ministry of Health-Refik Saydam Central Institute of Hygiene
Department: / Drugs and Cosmetics Research Department
Function: / Deputy Director (Biologist)
Office address (street/number/office number): / Cemal Gürsel Cad. No:18 Sıhhiye
Post code: / 06100
City: / Ankara
Office Tel: / +90(312)435 56 80 ext. 1412 or 1331
Office Fax: / +90(312)435 35 46
E-mail: /
b)
Title (Mr., Mrs.) : / Ms.
First Name: / Ayşe Nur
Surname: / Bölükbaşı
Ministry or Institution: / Refik Saydam Central Institute of Hygiene Center
Department: / Drugs and Cosmetics Research Department
Function: / Laboratory chief of pharmaceutical analysis (Chemist)
Office address (street/number/office number): / Cemal Gürsel Cad. No:18 Sıhhiye
Post code: / 06100
City: / Ankara
Office Tel: / +90(312) 435 56 80 ext. 1412
Office Fax: / +90(312)435 35 46
E-mail: /
c)
Title (Mr., Mrs.) : / Ms.
First Name: / Nihal
Surname: / Alper
Ministry or Institution: / Refik Saydam Central Institute of Hygiene Center
Department: / Drugs and Cosmetics Research Department
Function: / Labaratory Chief of pharmaceutical analysis (Pharmacist)
Office address (street/number/office number): / Cemal Gürsel Cad. No:18 Sıhhiye
Post code: / 06100
City: / Ankara
Office Tel: / +90(312)435 56 80 ext. 1321
Office Fax: / +90(312)435 35 46
E-mail: /
d)
Title (Mr., Mrs.) : / Ms
First Name: / Zerrin
Surname: / Acar
Ministry or Institution: / Refik Saydam Central Institute of Hygiene Center
Department: / Drugs and Cosmetics Research Department
Function: / Pharmacist
Office address (street/number/office number): / Cemal Gürsel Cad. No:18 Sıhhiye
Post code: / 06100
City: / Ankara
Office Tel: / +90(312)435 56 80 ext.1397
Office Fax: / +90(312)435 35 46
E-mail: /
e)
Title (Mr., Mrs.) : / Ms.
First Name: / Hülya
Surname: / Şenel
Ministry or Institution: / Refik Saydam Central Institute of Hygiene Center
Department: / Drugs and Cosmetics Research Department
Function: / M.Sc.Chemical Engineer
Office address (street/number/office number): / Cemal Gürsel Cad. No:18 Sıhhiye
Post code: / 06100
City: / Ankara
Office Tel: / +90(312)435 56 80 ext.1309
Office Fax: / +90(312)435 35 46
E-mail: /
3. Institution/Organisation from which you wish to receive the expertise :
(this information is mandatory for applicants from beneficiary Member States)
Preferred Country (choice cannot always be guaranteed)
Hosting Member State Authority/Institution (if known)
Name(s) of individual(s) from whom you / wish to receive expertise (if known)
Title: / Mr.
First Name: / Felix
Surname: / Gutierrez
Ministry or Institution:
Department:
Function:
Office address (street/number/office number)
Post code:
City:
Office Tel:
Office Fax:
E-mail: /
Have you had previous contact with your selected host Institution/Organisation/Expert? Yes No
4. Details of the required Expertise:
a) EU legislation concerned (please give reference to regulations, directives etc.) and chapter of the Acquis
CELEX N°/Natural number: / EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories
Type of legislation: / - Implementing Standard on EN ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories, harmonizing standard for Drug and Cosmetics Research Departmant
Screening chapter: / Related standards (EN ISO/IEC 17025 and EN ISO/IEC 17020)
b) What will the task of the expert concern? / Legislation Implementation
Is there any planned or currently running PHARE/CARDS/TWINNING project that is dealing with the issues covered by the request? Yes No
If yes, please indicate details:
If the task of the expert concerns legislation:
Do you already have draft legislation you wish to discuss? Yes No
Please give details of the stage of preparation of the legislation (e.g. not yet sent to Parliament):
Please outline the timetable for the adoption of the legislation:
A copy of the draft legislation in your own language and in English or French should be made available to TAIEX before the Expert visit can take place.
If the task of the expert concerns implementation:
Please list in detail the issues you would like to discuss with the visiting expert, such as implementing regulations, infrastructure, strategies, training and any other elements of relevance:
We need to establish a quality system for our laboratories. Several times we attended training programs of EN ISO 17025 (General requirements for the competence of testing and calibration laboratories ) only in theorotical aspect. The reason we need an expert is to show us applications in practise and in situ observation of pharmaceutical, cosmetics, microbiological, farmacology and medical devices laboratories . This will be an on the job training . So that we will have the opportinity of improve our knowladge and gain experience regarding the applications of EN ISO 17025 for our laboratories.
5. Other background information relating to the current situation in the beneficiary country:
Please give an outline of your current situation concerning the sector of the acquis communautaire indicated and indicate any recent developments that may be relevant in this regard:
Drug and Cosmetics Research Department of Refik Saydam Central Institute of Hygiene is the unique official control unit in Turkey responsible from all quality control tests of officially sent samples of locally manufactured and imported human drugs, medical devices and cosmetics for the preregistration and postmarketing controls. All the tests (physical, chemical, pharmaceutical, microbiological and biological) are performed according to the international standards (EP, USP, BP, ICH, WHO, EU Guide Lines and Standards, Regulations etc...) to guarantee efficacy, safety and quality of drugs, cosmetics and medical devices in the market to protect public health. In a short time a legislation will be sent to the Parliament for establishing "Turkish Drug Agency" which our laboratories are going to take place.
6. Draft programme for the Expertise:
1st Day: In situ observations
2nd Day: Practical applications of pharmaceutical analyses laboratories
3rd Day: Practical applications of pharmaceutical analyses laboratories
4th Day : Practical application of microbiolgy laboratories
5th Day : Practical application of cosmetic laboratories
7. Further details:
Preferred date of the mission (indicate week number and proposed duration of the visit):
Year: / 2006
Calendar week: / June 2 nd week
Duration (days): / 5
Language knowledge (please state the language(s) and indicate your level of competence)
1st language: English / Very Good Good Fair Poor
2nd language: other please specify / Very Good Good Fair Poor
3rd language: other please specify / Very Good Good Fair Poor
8. Authorisation from Hierarchy (Head of EU integration department or technical dept.)
Title: / Mr
First name: / Koray
Surname: / Sakar
Function: / Director of Drug and Cosmetics Research Dept.
Office Tel.: / +90(312) 431 28 87
Office Fax: / +90(312) 435 35 46
E-mail: /
Date of consultation: / 21/11/2005
Supporting comments:
Signature (if applicable):
Please note: The information contained in this form will be made
available on-line to the Mission and Embassy of your country in Brussels.
All applications received directly from the Western Balkans will be forwarded to the
EU Delegation in the country concerned, and in the case of Kosovo to the EC-Liaison Office, for a preliminary evaluation.

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Telephone: switchboard +32-2-296 73 07 Fax: +32-2-296 68 40

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