Dear Maia,

 

Thank you for the clarification. I have completed the review of the reconciliation report and can confirm the reconciliation for October 2017 is complete.

 

I understand that additional AEs have been reported from Armenia and will be included in the reconciliation for November 2017.

 

Please, do not hesitate to contact me should you have any questions or concerns.

 

Kind regards

Farhana

 

Farhana Haque

Drug Safety Specialist

Drug Safety & Public Health

Tel.  +44 (0)1223 824693

 

From: Maia Nikoleishvili [mailto:mnikoleishvili@moh.gov.ge]
Sent: 09 November 2017 12:40
To: Standards & Collaborations DSPH
Cc: sbelkania@moh.gov.ge; mmkurnali@moh.gov.ge
Subject: RE: AE reports from Armenia_provided in November

 

Dear Farhana,

Yes, our contact point in Armenia is Ms. Naira Romanova. As it was mentioned in our previous e-mail, we have requested to clarify the details on recent AE reports and in addition, we asked her to provide other/rest AE events within 24 hours, if such events will be observed.

Kind regards,

Maia

-----Original Message-----
From: Standards & Collaborations DSPH <Standards.&CollaborationsDSPH@gilead.com>
To: Maia Nikoleishvili
Cc: "sbelkania@moh.gov.ge" , "mmkurnali@moh.gov.ge"
Date: Wed, 8 Nov 2017 10:11:31 +0000
Subject: RE: AE reports from Armenia_provided in November

Dear Maia,

Thanks for this information.

May I ask who your contact is in Armenia? Is it Naira Romanova? Also, once the details have been clarified we need to ensure that they send you the reports within 24 hrs such that there are no more delays in forwarding these reports to Gilead. If it helps we can set up a call with you, myself and the team in Armenia.

Kind regards

Farhana

From: Maia Nikoleishvili [mailto:mnikoleishvili@moh.gov.ge]
Sent: 08 November 2017 06:32
To: Standards & Collaborations DSPH
Cc: sbelkania@moh.gov.ge; mmkurnali@moh.gov.ge
Subject: AE reports from Armenia_provided in November

Our Armenian colleagues collected AE reports from different service providers on monthly basis. Unfortunately, in most cases the reports were sent to us with delay.

In addition, I am sending some late AE reports from Armenia. As we checked, according to 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 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. Therefore, we asked our contact point in Armenia to clarify the details and as soon as we get any additional information from them we will send it to you immediately.

Please, accept once again our sincere apologies for the inconvenience.

Hope for your kind consideration and understanding.

Kind regards,

Maia

-----Original Message-----
From: Standards & Collaborations DSPH < Standards.&CollaborationsDSPH@gilead.com>
To: Maia Nikoleishvili < mnikoleishvili@moh.gov.ge>
Cc: "sbelkania@moh.gov.ge" <sbelkania@moh.gov.ge>, "mmkurnali@moh.gov.ge" <mmkurnali@moh.gov.ge>
Date: Mon, 6 Nov 2017 10:15:32 +0000
Subject: RE: reconciliation reports_Georgia(October) and Armenia (July and August)

Thank you for your response. Can you please elaborate, what technical problems did you have and how was it identified? I am just trying to understand the situation such that we can prevent this from happening again.

Kind regards

Farhana

From: Maia Nikoleishvili [ mailto:mnikoleishvili@moh.gov.ge]
Sent: 02 November 2017 17:47
To: Standards & Collaborations DSPH
Cc: sbelkania@moh.gov.ge; mmkurnali@moh.gov.ge
Subject: RE: reconciliation reports_Georgia(October) and Armenia (July and August)

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: Standards & Collaborations DSPH < Standards.&CollaborationsDSPH@gilead.com>
To: Maia Nikoleishvili < mnikoleishvili@moh.gov.ge>
Cc: "sbelkania@moh.gov.ge" <sbelkania@moh.gov.ge>
Date: Thu, 2 Nov 2017 17:17:50 +0000
Subject: RE: reconciliation reports_Georgia(October) and Armenia (July and August)

Can you please confirm on my query below?

Many thanks

Farhana

Dear Maia,

Thank you for sending the reports. May I ask you to clarify why the reports from Armenia which were from July were only reported to Gilead now in October, what is the reason for that?

Kind regards

Farhana

From: Maia Nikoleishvili [ mailto:mnikoleishvili@moh.gov.ge]
Sent: 31 October 2017 07:31
To: Standards & Collaborations DSPH
Cc: sbelkania@moh.gov.ge
Subject: reconciliation reports_Georgia(October) and Armenia (July and August)

Dear Colleagues,

On behalf of the Ministry of Labour, Health and Social Affairs of Georgia I would like to provide you with completed reconciliation report for the period of October 2017 within the Hepatitis C Elimination Program in Georgia and reconciliation reports of Armenia for the period of July and August 2017, within the Treatment of HCV Patients with Donated “SOVALDI” Medicine in the Republic of Armenia.

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