Tokuda Hospital Sofia

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Ethics Comittee

The work of the Ethics Committee in Acibadem City Clinic Tokuda Hospital is designed to protect the rights, safety and welfare of all participants in clinical trials.

Chairman 

Dr. Rozalina Balabanska, Gastroenterologist, Gasroenterology Clinic

Vice-chairman

Dr. Krasimir Oreshkov, Oncologist, Medical Oncology Department

Secretary

Rumyana Gorelska, Clinical Trials Coordinator, Tokuda Clinical Research Center

Members

1. Assoc. Prof. Natalia Stoeva, Head of Pneumology Clinic

2. Dr. Valeri Gelev, Head of Cardiology Clinic

3. Dr. Lachezar Tanchev, Oncogynecologist

4. Dr. Anelia Simeonova, Neurologist

5. Dr. Nikolay Katev – Surgeon

6. Mrs. Botayna Yordanova – Markreting Specialist

7. Mr. Petar Antonov – 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 Rumyana Gorelska (rumyana.gorelska@acibademcityclinic.bg), Sofia city, 51 B “Nikola Vaptsarov” Blvd.

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Hospital location

51B "Nikola I. Vaptsarov" blvd. (if you drive, the entrance is from "At. Dukov" str.), "Hladilnika" distr., 1407 "Lozenets".

The hospital has a parking lot. The first 30 min. are free of charge, then a fee of 3 bgn/hours applies.

Public transport:
Buses: №88, 120
Shuttle bus: 32

Subway: Getting off at "James Bourchier" station, after that walking through "Lozenets" distr., or tram №10, taking off at "Nikola I. Vaptsarov" stop. or a bus №88, taking ff at "Tokuda Hospital" stop.

Map 

From the Central Railway Station

Bus line №305 getting off at "Romanian embassy" stop
From "Romanian embassy" stop – Bus line №120 getting off at "Tokuda Hospital" stop.
(after the traffic lights at "Atanas Dukov" str.

With a subway, from "Central Railway Station" station, getting off at "James Bourchier" station, after that walking through "Lozenets" distr., or tram №10, taking off at "Nikola I. Vaptsarov" stop. or a bus №88, taking ff at "Tokuda Hospital" stop.