Subject: Fwd: [EXT] FW: update on Solidarity trial progress
From: Tamar Gabunia </O=EXCHORGANIZATION/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=E6CA04F38EC94D0CADAB9CBDF90FCDDE-TAMAR G>
To: info </o=ExchOrganization/ou=Exchange Administrative Group (FYDIBOHF23SPDLT)/cn=Recipients/cn=2069f7f4886b493dbd84f07150d67a52-info>
Date: Thu, 30 Apr 2020 15:44:27 +0000

გთხოვთ დაარეგისტრიროთ!

Sent from my Samsung Galaxy smartphone.

-------- Original message --------

From: "DARA, Masoud" <[email-masked]>

Date: 4/30/20 6:29 PM (GMT+04:00)

To: Tamar Gabunia <[email-masked]>

Cc: "DOMENTE, Silviu" <[email-masked]>, "MAMULASHVILI, Nino" <[email-masked]>, Ekaterine Adamia <[email-masked]>, Alisa Tsuladze <[email-masked]>, "LYDON, Patrick" <[email-masked]>, "HENAO RESTREPO, Ana Maria" <[email-masked]>,
"SATHIYAMOORTHY, Vaseeharan" <[email-masked]>, "KONE, Souleymane" <[email-masked]>, "PREZIOSI, Marie-pierre" <[email-masked]>, "LYDON, Patrick" <[email-masked]>, EURO Clinical Trial Solidarity <[email-masked]>

Subject: RE: [EXT] FW: update on Solidarity trial progress

Dear Dr Gabunia,

Congratulations with the timely clearances and your Government commitment.

We will be in touch with professor Tsertsvadze and Dr Adamia to work on the next practical steps.

All the best,

Dr Masoud Dara

EURO Solidarity Trial Surge Team

From: Tamar Gabunia <[email-masked]>

Sent: Thursday, April 30, 2020 3:55 PM

To: DARA, Masoud <[email-masked]>; LYDON, Patrick <[email-masked]>

Cc: DOMENTE, Silviu <[email-masked]>; MAMULASHVILI, Nino <[email-masked]>; Ekaterine Adamia <[email-masked]>; Alisa Tsuladze <[email-masked]>

Subject: [EXT] FW: update on Solidarity trial progress

Dear Dr Dara,

First of all I would like to express my gratitude for the opportunity for Georgia to be included in SOLIDARITY Trial.  Secondly, I would like to update you on the progress we have made so far:

·         Ministry of Health has obtained both ethical and regulatory clearances and signed the protocol (see attached)

·         The  main PI (Tengiz Tsertsvadze - General Director of Infectious Diseases, AIDS and Clinical Immunology Research Center) and MoH representative (Ekaterine Adamia- the head of the Health
Care Policy Division) have been chosen as well as clinicians from the hospitals chosen for the trial;

·         The required information on the clinicians is attached and they are ready to start a rapid training on data entry;

·         As for the medicinal products, we would like to request WHO to supply all of the needed, except for Hydroxychloroquine;

·         Remdesivir is the only drug from the list that is not registered in Georgia, although according to the national legislation, unregistered medicinal products could be imported, for noncommercial
purposes in the following case: under particular circumstances (a natural disaster, mass injury of the population, epidemic, rare disease) for humanitarian purposes, as well as in case of a special state interest, with the consent of the Ministry. On the basis
of intermediate decisions by the Drug Agency and Department of Health the consent or refusal for importing unregistered medicines into Georgia will be issued by the Minister.

·         LEPL “Social Service Agency” will be the receiver and carry out further controlled distribution of the drug to medical institutions for the patients enrolled in the trial.

We will provide the shipping address later and put you in contact with the representatives of the agency when other details are finalized.

·         The protocol was approved by the National Bioethics Committee, although the members of the committee had few minor comments about the ICF. First of all they are asking to allow possibility
for the legal representative of the subject/patient to sign the consent.

·         Please find attached file with other changes that were requested by the committee and let us know if they are acceptable.

Many thanks and look forward to receiving your guidance on next steps.

პატივისცემით,

თამარ გაბუნია

მინისტრის პირველი მოადგილე

Sincerely,

Tamar Gabunia,
MD, MPH

First Deputy Minister