I would like to kindly address you from the Ministry of Labour, Health and Social Affairs of Georgia regarding treatment of HCV patients with donated “Sovaldi” medicine in the Republic of Armenia.

Please, be informed that Irinka Tskhomelidze is no longer employee of the Ministry. Currently, I am a contact point from the Ministry of Labour, Health and Social Affairs of Georgia to collect information on Adverse Events.

In this regard, I would like to kindly ask you to send us filled reporting forms which include information on all adverse events (“AE”), serious adverse events (“SAE”), or Special Situation Reports. After June 26, 2017 we have not received such forms.

Looking forward to receiving the requested information as soon as possible.

Thank you for cooperation.

Kind regards,

Maia
 

Maia Nikoleishvili MPA

Chief Specialist of International Relations Division

HR Management and International Relations Department
Ministry of Labour, Health and Social Affairs of Georgia
144 Tsereteli ave., 0159 Tbilisi, Georgia
Tel.: +995 32 2510034 (0803)
Cell phone: +995 577272713
E-mail: mnikoleishvili@moh.gov.ge

-----Original Message-----
From: Irinka Tskhomelidze
To: Maia Nikoleishvili
Date: Fri, 20 Oct 2017 11:57:27 +0400
Subject: Fwd: FW: Sovaldi AE report from Armenia

ეს არის მაიკო ერთხელ აქვთ მხოლოდ გადმოგზავნილი.

პატივისცემით,

ირინა

---------- Forwarded message ----------
From: Narine Hovhannisyan <narineh@pharm.am >
Date: Mon, Jun 26, 2017 at 10:27 AM
Subject: FW: Sovaldi AE report from Armenia
To: itskhomelidze@moh.gov.ge
Cc: Naira Romanova <naira@pharm.am>

 

 

From: Naira Romanova [mailto: naira@pharm.am]
Sent: Friday, June 23, 2017 6:02 PM
To: narineh@pharm.am
Subject: Sovaldi AE report from Armenia

 

Dear Irinka,

 

Hope my this letter finds you well.

 

I am Naira Romanova, head of drug safety monitoring department at Scientific centre of drug and medical technology expertise after academician Emil Gabrilyan MoH of the Republic of Armenia.

As you know Armenia received  Sovaldi (manufactured by Gilead) medicine from Georgian government .  For this purpose an agreement was  signed by both parties. One of the points concerning the pharmacovigilance in the agreement is the following “2.2.7.1 Ministry of Labour, Health and Social Affairs of Georgia should receive submitted monthly drug safety report in English in accordance with provided special reporting form which includes all adverse events (“AE”), serious adverse events (“SAE”), or Special Situation Reports. (According to the attachment 1).

In order to complete this point in agreement I am sending you attached received ESs for July.

 

Staying at your disposal.

Kind regards,

Naira

 

 

Naira Romanova

Head of Pharmacovigilance department
Scientific Center of Drug and Medical
Technology Expertise after Academic E. Gabrielyan

 

Address: 49/4 Komitas av.
               0051 Yerevan,  Armenia
Tel.:        (+374 10) 232133 # 123
Fax:        (+374 10) 232942

 

 

--

Best regards,

Irina Tskhomelidze,

Health Care Department

Ministry of Labour, Health and Social Affairs of Georgia