Subject: RE: FW: Sovaldi AE report from Armenia
From: "Maia Nikoleishvili" <[email-masked]>
To: Naira Romanova <[email-masked]>
Cc: [email-masked]; Mariana Mkurnali
Date: Thu, 9 Nov 2017 16:37:27 +0400

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