Subject: RE: Pharmaceuticals - GMO, 12-14 December 2017
From: "Sopo Belkania" <[email-masked]>
To: IVANUSA, Marijan <[email-masked]>
Cc: MAMULASHVILI, Nino <[email-masked]>; KLIMIASHVILI, Rusudan <[email-masked]>; Maia Nikoleishvili ([email-masked]);
Date: Fri, 8 Dec 2017 04:16:26 +0400

Dear Marijan,

Please find attached updated version of agenda.

If you gave any additional comments and requests please contact me.

Best regards,

Sopo Belkania

Head of HR Management and International Relations Department

Ministry of Labor, Health and Social Affairs of Georgia

144 A.Tsereteli Avenue, 0159, Tbilisi, Georgia

Mobile number: +995 599 22 32 32

From: IVANUSA, Marijan [mailto:[email-masked]]
Sent: Monday, December 4, 2017 7:35 PM
To: [email-masked]
Cc: MAMULASHVILI, Nino; KLIMIASHVILI, Rusudan
Subject: Pharmaceuticals - GMO, 12-14 December 2017

Dear Sopo

During the same week (as mission on patients’ pathways – described below), we also have a mission on pharmaceuticals (Good manufacturing Practice) as requested by the letter that the minister has sent to our director.

Olexander Polishchuk will come for a mission and will be available for meetings from Tuesday morning till Thursday early afternoon.

The initial ideas about the programme look like follows:

Tuesday, 12 December 2017

09:20

Transfer from the hotel

10:00 – 10:30

Meeting with Nino Berdzuli, Deputy Minister

11:00 –

Marina Darakhvelidze – Head of Health Care Department; E-mail: [email-masked]

Natia Nogaideli – Health Care Department, Head of Regulation Division; E-mail: [email-masked]

Marine Latsabidze - Health Care Department, Chief Specialist of Regulation Division;  E-mail: [email-masked]

Naili Shengelidze - Head of Division of Marketing Authorization; Department of Pharmaceutical Activities, LEPL State Regulatory Agency for Medical Activities; E-mail:  [email-masked]

Tea Jikia - Deputy Head of the Department of Pharmaceutical Activities, LEPL State Regulatory Agency for Medical Activities; E-mail: [email-masked]

Wednesday, 13 December 2017

Transfer from the hotel

Meeting with the local producer of pharmaceuticals

Meeting with the distributor of the pharmaceuticals

EU Delegation (to be arranged by the WHO Country Office)

Continuation of the meetings with the representatives of the Regulatory Agency (if applicable)

Thursday, 14 December 2017

Transfer from the hotel

10:00 – 11:00

12:00 –

– 15:00

WHO internal discussion on future steps

Continuation of the meetings with the representatives of the Regulatory Agency (if applicable)

Debriefing with the Minister of Health (if only possible)

15:15

Departure to the airport

It would be great if you could help us defining the meetings within the Ministry; additionally it would be great if you could advise us about possible producer, distributer and any other external (private or not-private) institution that we could visit. We plan to meet the EU delegation too, and I can contact them.

Olexander will depart on Wednesday with the late evening flight.

By our opinion it would be good to have a short debriefing meeting with the minister, but this is absolutely on the minister to decide and depends on his availability. We are flexible regarding the timing as long as the meeting takes place within the indicated 3 days.

Thank you once again for all your support and best regards,

Marijan Ivanusa

WHO Representative

Head of WHO Country Office Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

Mobile 1: +995 599 305 207

Mobile 2/EU/private: +386 40 528 639

Email: [email-masked]

Skype: who-ivanusam

GPN: 74211

Web: www.euro.who.int

From: KLIMIASHVILI, Rusudan
Sent: 04 December, 2017 18:58
To: [email-masked]
Cc: IVANUSA, Marijan; KURTSIKASHVILI, Giorgi; [email-masked]
Subject: Mission on patient pathways, 11-13 December 2017

Dear Sopo,

Following to previous discussion and correspondence with Marijan, regarding the forthcoming mission on strategic purchasing and patient pathways, 11-13 December 2017 with participation of :

1.      Dr Jill Farrington WHO, Division of Noncommunicable Diseases and Promoting Health through the Life-course

2.      Alexandre Lourenço , WHO Consultant, Coimbra Hospital and University Centre, Portugal,

we appreciate to have your assistance in organizing meetings for the mission from 11 December:

Day one- Monday, 11 December

14h00 - Meeting with Mrs Nino Berdzuli (Deputy Minister) and SSA officials, MOHLSA

Presentation of Mission Objectives:

Considering the travel of your colleagues during that week , we will appreciate to have meetings on Monday with

Mrs Ketevan Goginashvili Head of the Health Policy Unit, Health Care Department, MOLHSA,

Mrs Ekaterine Adamia, Head of Health Programmes Department and

Mrs Gvantsa Gasviani - Manager of the Diabetes Vertical Program -to revise the patient pathway prepared during last work

Day Two

12:00 - Address bottlenecks, costing and adaptation of the UHC/diabetes vertical program to the patient pathway

Mrs Marina Darakhelidze - Head of Health Care Department, MOLHSA

Mrs Maia Maglakelidze–Khomeriki, Head of UHC Management Department, SSA

Mrs Magda Naskidashvili – Chief specialist, SSA

Mrs Ekaterine Adamia – Head of Health Programmes Department

Mrs Gvantsa Gasviani - Manager of the Diabetes Vertical Program

16:00     Tbilisi Family Medicine Training Centre

Day three

09:00 - Address bottlenecks, costing and adaptation of the UHC/diabetes vertical program to the patient pathway

13:00 De-briefing and Next steps

Thank you for your assistance

Best regards Rusiko

----------------------------------------

Rusudan (Rusiko) Klimiashvili,

Public Health Officer,

WHO Country Office in Georgia,

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street,

0179, Tbilisi , Georgia,

Tel :              +995 32 2 99 80 73

Mobile:        +995 5 99 50 18 79

GPN:               74215

e-mail: [email-masked]

From: IVANUSA, Marijan
Sent: 28 November 2017 16:01
To: Sopo Belkania
Cc: KLIMIASHVILI, Rusudan; NINUA, Irina; KURTSIKASHVILI, Giorgi
Subject: RE: Request

Dear Sopo,

Thank you.

Please, be informed that Rusiko will also send you information on joint mission on patients’ pathways (Alexandre Lourenco, Jill Farrington) as part of the UHC, and ask for your assistance in this regards.

The mission will focus on diabetes and is planned for the same dates 11-13 December, but they will mostly meet different people, so in principle it should be possible to have two missions in parallel.

Best regards,

Marijan Ivanusa

WHO Representative

Head of WHO Country Office Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

Mobile 1: +995 599 305 207

Mobile 2/EU/private: +386 40 528 639

Email: [email-masked]

Skype: who-ivanusam

GPN: 74211

Web: www.euro.who.int

From: Sopo Belkania [mailto:[email-masked]]
Sent: 28 November, 2017 14:39
To: IVANUSA, Marijan
Cc: KLIMIASHVILI, Rusudan; NINUA, Irina
Subject: RE: Request

Dear Marijan,

Sorry for late response.

Please find below the list of representatives of the Ministry of Labour, Health and Social Affairs of Georgia and LEPL State Regulatory Agency for Medical Activities, who will meet the experts and discuss further details regarding the regulatory mechanisms in the area of pharmaceutical.

·         Marina Darakhvelidze – Head of Health Care Department; E-mail: [email-masked]

·         Natia Nogaideli – Health Care Department, Head of Regulation Division; E-mail: [email-masked]

·         Marine Latsabidze - Health Care Department, Chief Specialist of Regulation Division;  E-mail: [email-masked]

·         Naili Shengelidze - Head of Division of Marketing Authorization; Department of Pharmaceutical Activities, LEPL State Regulatory Agency for Medical Activities; E-mail:  [email-masked]

·         Tea Jikia - Deputy Head of the Department of Pharmaceutical Activities, LEPL State Regulatory Agency for Medical Activities; E-mail: [email-masked]

Suggested date from our side for the mission is week of December 11.

I think that first meeting of mission will be with Dr. Nino Berdzuli. Above mentioned date is suitable for her.

Looking forward for your confirmation.

Please do not hesitate to contact me if you have additional requests/comments.

Best regards,

Sopo Belkania

Head of HR Management and International Relations Department

Ministry of Labor, Health and Social Affairs of Georgia

144 A.Tsereteli Avenue, 0159, Tbilisi, Georgia

Mobile number: +995 599 22 32 32

From: IVANUSA, Marijan [mailto:[email-masked]]
Sent: Monday, November 20, 2017 6:55 PM
To: Sopo Belkania ([email-masked])
Cc: KLIMIASHVILI, Rusudan; NINUA, Irina
Subject: FW: Request

Dear Sopo,

As a follow-up of the attached letter we would like our expert to meet representatives of the ministry and its regulatory agency to discuss further details regarding the regulatory mechanisms in the area of pharmaceutical.

We kindly ask you to define the dates for the mission (December) as well as the persons that our expert should meet. This would enable us to organize the travel.

Thank you and best regards,

Marijan Ivanusa

WHO Representative

Head of WHO Country Office Georgia

Office location: 81 Vasil Barnov Street, 0179 Tbilisi, Georgia

Mailing address: UN House, 9 Rapiel Eristavi Street, 0179 Tbilisi, Georgia

Mobile 1: +995 599 305 207

Mobile 2/EU/private: +386 40 528 639

Email: [email-masked]

Skype: who-ivanusam

GPN: 74211

Web: www.euro.who.int

From: Sopo Belkania [mailto:[email-masked]]
Sent: 09 November, 2017 22:03
To: IVANUSA, Marijan
Subject: Request

Dear Marijan,

We received a letter of reply from Dr. Zsuzsanna Jakab, WHO Regional Director for Europe, in which she mentioned that the draft LEPL State Regulations Agency for Medical Activities Road Map to 2020 is attached to this letter. Unfortunately we did not received attached file. Could  you be so kind and send as the draft. I attached letter for your information.

Thank you once more for your support.

Best regards,

Sopo Belkania

Head of HR Management and International Relations Department

Ministry of Labor, Health and Social Affairs of Georgia

144 A.Tsereteli Avenue, 0159, Tbilisi, Georgia

Mobile number: +995 599 22 32 32