Subject: Fwd: FW: Sovaldi AE report from Armenia
From: Maia Nikoleishvili <[email-masked]>
To: [email-masked], [email-masked]
Cc: [email-masked]
Date: Fri, 20 Oct 2017 08:39:17 +0000

Dear Narine and Naira,

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:
[email-masked]

-----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
<[email-masked]
>
Date: Mon, Jun 26, 2017 at 10:27 AM
Subject: FW: Sovaldi
AE report from Armenia
To:
[email-masked]
Cc: Naira Romanova <[email-masked]>

From: Naira Romanova [mailto:
[email-masked]]

Sent: Friday, June 23, 2017 6:02 PM

To: [email-masked]

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