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yogesh1004 ☆ India, 2012-10-09 20:47 (5011 d 14:54 ago) Posting: # 9360 Views: 3,260 |
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Dear All, Can anyone please guide with the procedure for registration of CRO with Ministry of Health, Turkey. Unable to find the checklist. Also is it advisable to submit the application directly to MOH office or proceed with the consultant. Regards, S.Yogesh |
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drgunasakaran1 ★★  2012-10-09 22:20 (5011 d 13:21 ago) @ yogesh1004 Posting: # 9365 Views: 2,884 |
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Dear Mr Yogesh, You can get the application form for CRO Facility Inspection of MoH, Turkey by sending mail to the following address [email protected] For more details on the documents and the SOP followed by MoH, Turkey during their Inspection of the CRO, see the below links Guidance For The Conduct Of Good Clinical Practice Inspections To Bioanalytical Part, Pharmacokinetic And Statistical Analyses Of Bioequivalence Trials Guidance For Conduction Of Good Clinical Practice Inspections Of Sponsor And Contract Research Organization — Dr Gunasakaran Sambandan MD Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn |
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suds4u ☆ India, 2012-10-10 15:06 (5010 d 20:35 ago) @ drgunasakaran1 Posting: # 9373 Views: 2,755 |
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Dear Yogesh Having worked for the compilation of documents for MoH Turkey, you also need to have somebody to represent your CRO from Turkey to act as coordinator and for audit of the facility. Regards Suds |
Ing. Helmut Schütz