Date: Wed, 1 Nov 2017 17:46:09 +0400
Subject: RE: FW: Sovaldi AE report from Armenia
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
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:narineh@pharm.am]
Sent: Wednesday, November 01, 2017 5:32 PM
To: naira@pharm.am
Subject: FW: FW: Sovaldi AE report from Armenia
From:
Maia
Nikoleishvili
[mailto:mnikoleishvili@moh.gov.ge]
Sent: Wednesday, November 01, 2017 2:34 PM
To: Narine Hovhannisyan
Cc: sbelkania@moh.gov.ge; mmkurnali@moh.gov.ge
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.
-----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
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:mnikoleishvili@moh.gov.ge]
Sent: Friday, October 20, 2017 12:35 PM
To: narineh@pharm.am; naira@pharm.am
Cc: mmkurnali@moh.gov.ge
Subject: Fwd: FW: Sovaldi AE report from Armenia
Importance: High
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.
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
--
Ministry of
Labour,
Health and Social Affairs of Georgia