Subject: RE: FW: Sovaldi AE report from Armenia
From: Maia Nikoleishvili <[email-masked]>
To: Naira Romanova <[email-masked]>
Cc: [email-masked], [email-masked]
Date: Thu, 09 Nov 2017 12:37:37 +0000

Dear
Naira,

By the request of “Gilead Sciences, Inc.”, I
would
like to kindly ask you once again to provide us with clarified information
on
recent AE reports and if there will be observed any other AE events please,
send us within 24 hours.

As you know, under the Paragraph 4 of the
“Contract of
Donation between the Ministry of Labour, Health and Social Affairs of
Georgia
and the Ministry of Health of the Republic of Armenia” signed on May 8,
2017, Ministry
of Health of the Republic of Armenia upon request will provide Ministry of
Labour, Health and Social Affairs of Georgia with all reasonable assistance
in
obtaining any further information regarding clinically approved AE events in
order to identify its reasons.

Thank you once again for your continued support and
cooperation.

Kind regards,

Maia

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

From: Naira Romanova

To: 'Maia Nikoleishvili'

Date: Tue, 7 Nov 2017 12:05:53 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Maya,

We sent requests to all parties, but
unfortunately didn’t’
receive any answer yet. However,  we are keeping to work on it and will
send
you any information as soon as  we received.

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

Sent: Monday, November 06, 2017 7:23 PM

To: Naira Romanova

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

Subject: RE: FW: Sovaldi AE report from Armenia

Have you any progress in clarifying missing information? Please send us
those
forms which are already clarified in order to timely provide Gilead with AE
reports.

Thank you once again for cooperation.

Kind regards,

Maia

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

From: "Maia Nikoleishvili"

To: "Naira Romanova"

Date: Fri, 03 Nov 2017 10:14:00 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Naira,

Thank
you for you prompt reply and continued support.

If
the missing information could be identified, it will be highly appreciated.

Thank
you once again.

Best
regards,

Maia

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

From: Naira Romanova

To: 'Maia Nikoleishvili'

Date: Fri, 3 Nov 2017 10:06:18 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Maia,

Thank you for your email.

As it was mentioned in our first communication
with you, in
early November we will send you some late report, so these reports sent to
you
yesterday were not only reports from September but also some reports which
we
received late from health specialists. Having in regards this, it could be
difficult to retrieve some information on “Safety Information Details”
but
anyhow we will try to find out and write you as soon as possible.

Concerning the cases of deaths and the medicine
stop date, it
was in reports and the stop date also was unknown. But still , we will do
our
best to retrieve the information needed.

Have a nice day!

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

Sent: Thursday, November 02, 2017 9:19 PM

To: Naira Romanova

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

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Naira,

I would like to kindly address
you
regarding the latest reports.

In most of the forms (A3, A5,
A6,
A7, A8, A9, A10, A11, A12, A13, A14, A15, A16, A17, A18) the “Data aware
of
Safety information” is missing. Would you be kind to request service
providers
to fill the missing information as soon as possible?

As we checked from the
“Safety
Information Details” most of the reports (A1, A2, A3, A4, A5, A6, A7, A9,
A10,
A11, A15) are of August, two reports (A8, A13) are of September, one report
is
of June and in three reports (A12, A17, A18) date of AE events is unknown.
In
this regard, it’s highly important to clarify the “Data aware of Safety
information”.

In addition, we would like to
kindly ask you to clarify the “stop date” of receiving drug in the
reports of
A5 and A6. In the paragraph of “stop date” in both cases is indicated
“on-going”, but unfortunately, patients died.

Thank you once again for your
continued support and cooperation.

With best regards,

Maia

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

From: Naira Romanova

To: 'Maia Nikoleishvili'

Date: Thu, 2 Nov 2017 16:24:09 +0400

Subject: RE: FW: Sovaldi AE report from Armenia

Dear Maia,

Please find attached 18 AE reports for September
2017.

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

Sent: Wednesday, November 01, 2017 6:46 PM

To: Naira Romanova

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

Subject: RE: FW: Sovaldi AE report from Armenia

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

To:

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

To: 'Maia Nikoleishvili'

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

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