The work of the Ethics Committee inTokuda Hospital Sofia is designed to protect the rights, safety and welfare of all participants in clinical trials.

 

Chairman

Dr. Ivo Petrov, M.D

/Head of Cardiology Department/

 

Vice-chairman

Dr. Ivan Staikov, Assoc. Prof.

/Head of Neurology Department/

Secretary

Srebrina Taseva - +359 2 403 4837

Members

Dr. Veselina Koleva – Head of Clinical Laboratory

Dr. Rositsa Dencheva – Head of Dermatology & Venereology Department

Dr. Kiril Draganov, Assoc. Prof. – Head of General Surgery Department

Dr. Vasil Yablanski – Head of Orthopaedics & Traumatology Department

Dr. Rozalina Balabanska – Gastroenterologist

Dr. Asen Petrov – Head of Internal Medicine Department

Lidia Kiovtorova – nurse at the Cardiology Department

Elena Nacheva-Lafazanova – an actress, producer and writer

George Bakalov – Lawyer

 

The Ethics Committee has been established early in 2008. The Committee holds regular meetings twice a month. Notifications and/or Applications with the full set of accompanying documents filed a week prior to the date of the regular meeting, were being dealt with.

The required documents at filing an Application for a single-centre clinical trial are enclosed under Regulation No. 31 of 12 August 2007 on Good Clinical Practice (Promulgated in the Official Gazette, copy 67 of 17 August 2007).

The required documents at filing a Notification for planned multi-centre clinical trial are filled at the Ethics Committee prior to applying for the declaration under article 87, paragraph 3 of the Pharmaceuticals Serving Human Medicine Act. The documents to be submitted in hard copy. It is required to submit the documents itemized below (2-5) on electronic media, namely:

1.       Notification made to pattern – 2 originals;

2.       Summary of the protocol in Bulgarian language;

3.       Information about the participants and an informed consent form in Bulgarian language;

4.       Any other information which will be provided to the participants, incl. promotional materials;

5.       Investigator’s brochure / Summary of Product Characteristics (in case of clinical trial of investigational medicinal product);

All required documents to be submitted to the Secretary of the Ethics Committee Srebrina Taseva, Sofia city, 51 B “Nikola Vaptsarov” Blvd. Further information may be obtained through the e-mail tasevasrebrina@yahoo.com.