Subject: RE: FW: Sovaldi AE report from Armenia
From: "Maia Nikoleishvili" <[email-masked]>
To: Naira Romanova <[email-masked]>
Cc: [email-masked]; Mariana Mkurnali
Date: Wed, 1 Nov 2017 18:45:38 +0400

Dear
Naira,

Thank you for your e-mail. Looking forward
to receiving AE reporting forms of September as soon as possible.

Kind regards,

Maia

-----Original Message-----

From: Naira Romanova <[email-masked]>

To: <[email-masked]>

Date: Wed, 1 Nov 2017 17:46:09 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Maia,

Thank you for your email.

Please note that according to
“Agreement
of Donation and Cooperation Between the Government of Georgia and the
Government of the Republic of Armenia”, point 2.2.7.1  AE
report must be
submitted monthly  by Armenian part to Georgian part:

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) .

Taking into account the agreement points we were
sending all AE
reports on monthly bases.

During the treatment we are getting notified y
health facilities
about AEs  but receiving the gathered information from health
facilities again
in monthly bases.

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

From:
Narine
Hovhannisyan
[mailto:[email-masked]]

Sent: Wednesday, November 01, 2017 5:32 PM

To: [email-masked]

Subject: FW: FW: Sovaldi AE report from Armenia

From:
Maia
Nikoleishvili
[mailto:[email-masked]]

Sent: Wednesday, November 01, 2017 2:34 PM

To: Narine Hovhannisyan

Cc: [email-masked]; [email-masked]

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Narine,

For timely reporting to
Gilead on adverse events, we would like to kindly ask you to send us the
rest
of AE forms as soon as adverse events are observed.

Kind
regards,

Maia

-----Original
Message-----

From: Narine Hovhannisyan <[email-masked]>

To: 'Maia Nikoleishvili' <[email-masked]>

Date: Mon, 23 Oct 2017 12:50:46 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear
Maia,

Thank you for your email.

Attached you can find 38 AEs for July and
17AEs
for August which were send to Irina Tskhomelidze.

Please note, that we are still receiving
some
late AEs which will be send you early in November.

Feel free to contact if you have any
questions.

Kind regards,

Narine

Narine Hovhannisyan

Expert 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

From: Maia
Nikoleishvili [mailto:[email-masked]]

Sent: Friday, October 20, 2017 12:35 PM

To: [email-masked]; [email-masked]

Cc: [email-masked]

Subject: Fwd: FW: Sovaldi AE report from Armenia

Importance: High

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 <[email-masked]>

To: Maia Nikoleishvili <[email-masked]>

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