From : IWAMOTO, Kotoji <iwamotok@who.int>
To : Marine Baidauri <mbaidauri@moh.gov.ge>
Subject : RE: [EXT] RE: For your review - study on antimicrobials supplied in community pharmacies
Cc : marine Baidauri <mbaidauri@yahoo.com>; Ekaterine Adamia <eadamia@moh.gov.ge>; ROBERTSON, Jane <robertsonj@who.int>
Received On : 02.10.2020 12:42
Attachments :

Dear Marine,

 

Thank you very much for your message and the information.

We have modified the protocol further with the provided information.

 

We will submit these study documents to WHO ethics committee. (track changes have been kept for submission to them.)

It should take around one week to obtain their approval.

Once approval is obtained, we will send it to you and you could start the study according to your plan.

 

Best regards,

Kotoji

 

From: Marine Baidauri
Sent: Thursday, October 1, 2020 4:53 PM
To: IWAMOTO, Kotoji
Cc: marine Baidauri ; Ekaterine Adamia
Subject: [EXT] RE: For your review - study on antimicrobials supplied in community pharmacies

 

Dear Kotoji,

 

I send you the corrected protocol with comments and also inform you:

 

  1. We plan the Study in 75 pharmacies in Tbilisi and 15 municipalities of 7 regions (There are 9 large regions in our country, which include 75 municipalities)
  2. In addition to me, coordinators from Eastern and Western Georgia will participate in the study:
  1. In our country, only bio-medical studies need the consent of the National Council of Bioethics. These types of studies do not need to be agreed with the Bioethics Council.

Best wishes,

Marine

 

From: IWAMOTO, Kotoji [mailto:iwamotok@who.int]
Sent: 25 September, 2020 19:20
To: marine Baidauri
Cc: Marine Baidauri; KURTSIKASHVILI, Giorgi
Subject: For your review - study on antimicrobials supplied in community pharmacies

 

Dear Marine,

 

We hope this email finds you well.

It is great that we can proceed with the study.

 

By 2 October, could you please provide information for a few parts in the attached protocol for GEO, the information statement?

The information required are

-the number of regions you plan to include,

-name and contact of investigators if there are more investigators than you,

-if you plan to submit the protocol for GEO to a local ethics committee for their approval – this requirement depends on the countries. If not needed, please provide the reason/justification, e.g, according to the national legislation.

 

After your review with the input, we will submit all the documents for GEO to WHO ethics committee for their approval.

 

Thank you very much for our collaboration.

 

Best regards,

Kotoji

 

Kotoji Iwamoto

 

Technical officer

Health Technologies and Pharmaceuticals

Division of Health Systems and Public Health

World Health Organization Regional Office for Europe

 

UN city, Marmovej 51, DK-2100 Copenhagen, Denmark

Email: iwamotok@who.int

Tel: +45 45337018