Subject: RE: Mission to Support the Development of the National Guideline on Surveillance of Adverse Events Following Immunization
From: "IVANUSA, Marijan" <[email-masked]>
To: "Sopo" <Belkania>
Cc: KURTSIKASHVILI, Giorgi
Date: Mon, 2 Apr 2018 07:02:27 +0000

Dear Sopo,

Thank you for the both lists of participants.

We confirm the date and timing of the meeting:

10 April, 11.00; please, book the respective meeting room at the ministry and inform us about the floor.

The meeting will be rather technical, however it would be good if you could join the meeting. This would help us to agree future collaboration. The expected duration of the meeting up to two hours, but your presence is not needed during the entire meeting. The issue of future assistance can be discussed at the beginning of the meeting, afterwards the mission can continue with the NRA staff only. The home work: we just need input to the attached table by Thursday this week if only possible.

In principle the mission doesn’t need to meet the deputy minister.

The training will take place at the NCDC (main building, second floor) on 12 April, it will start at 10.00.

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: 02 April, 2018 10:47
To: IVANUSA, Marijan
Cc: KURTSIKASHVILI, Giorgi
Subject: RE: Mission to Support the Development of the National Guideline on Surveillance of Adverse Events Following Immunization

Dear Marijan,

I have already sent you list of participants for the meeting (April 10) and for the training.

The meeting with the representatives of NRA will be at 11:00 on 10th of April about venue if you don’t mind we can arrange it at the Ministry.  Regarding the training if the participants should prepare “homework” I ask you to send me and I will distribute among them also please send me detailed information regarding training-  time and venue.

After mentioned meeting on 10th of April we can meet with Deputy Minister if the schedule of experts will allow us.

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: Sopo Belkania
Sent: Monday, April 2, 2018 10:28 AM
To: 'IVANUSA, Marijan'
Cc: KURTSIKASHVILI, Giorgi
Subject: RE: Mission to Support the Development of the National Guideline on Surveillance of Adverse Events Following Immunization

Dear Marijan,

Please find below the list of participants for the meeting and for training

Day 1: April 10, 2018 (Tuesday) Meeting with key national stakeholders relevant to AEFI surveillance:

Participants from National Regulatory Agency:

1.       Naili Shengelidze, Head of Registration (MA) Division, Department of Pharmaceutical Activities;

2.       David Japaridze - Head of division of licenses at Department Of Pharmaceutical Activities;

3.       Nana Shanshiashvili -Head of division of inspection at Department Of Pharmaceutical Activities.

Day 3: April 12,2018 (Thursday) Training involving key national level counterparts involved in AEFI detection and Management:

4.       Nino Trokashvili - Chief Specialist of division of registration at Department Of Pharmaceutical Activities;

5.       Mariami Akhvlediani - Chief Specialist of division of registration at Department Of Pharmaceutical Activities.

If you have additional questions do not hesitate to 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: Friday, March 30, 2018 10:03 AM
To: Sopo Belkania
Cc: KURTSIKASHVILI, Giorgi
Subject: Mission to Support the Development of the National Guideline on Surveillance of Adverse Events Following Immunization

Dear Sopo,

Please kindly find bellow the initial proposal for the programme for AEFI (Adverse Events Following Immunization) mission to be conducted during 10-13 April in Georgia.

·         1 day of meetings with key national stakeholders relevant to AEFI surveillance:

o   National Regulatory Agency, incl. a quick assessment at NRA (based on the pre-filled assessment questionnaire in the attachment and the interview during the meeting)

o   NCDC

·         1 day field visit (subnational district and health facility level), followed by work on consolidating findings and proposing a roadmap for strengthening AEFI surveillance

·         1-day training involving key national level counterparts involved in AEFI detection and management

o   Review the consolidating findings of assessment

o   Introduce new WHO concepts and tools related to AEFI surveillance

o   Discuss proposed roadmap and actions to strengthen AEFI surveillance in GEO

·         The last day to meet with National Steering Committee to review latest draft of updated AEFI surveillance guideline, and plan of action to finalize drafted guidelines, and discuss dates of training of updated guidelines in Q3/4.

The programme will be finalized once you confirm timing for the meeting with the NRA, which we propose to take place on day 1, 10 April, to discuss topics as follows:

AEFI reporting in Georgia, as well as the details of activities included in GAVI Transition Plan strengthening functions of the National Regulatory Authority (please see the table below):

6. Strengthening pharmacovigilance function (AEFI surveillance system) of the National Regulatory Authority

3. Strengthening AEFI surveillance system (pharmacovigilance function)

2. Update AEFI guidelines to include AEFI causality assessment scheme

3. Conduct basic vaccine safety trainings

6. Develop immunization communication strategic plan for 2015-16; train TOT on AEFI communication

4. Strengthen functions of the National Regulatory Authority

1. Develop mid and long term strategic plans for the NRA

2. Train NRA staff on market authorization (on review and assessment of dossiers)

3. Train NRA staff on pharmacovigilance

4. Provide hands-on training through visit to a well-functioning NRA

5. Introduce collaborative agreement procedures for registration of WHO pre-qualified vaccines

We kindly ask you, to

-          secure the meeting with the NRA representatives (hopefully including you) as indicated above (10 April; please, define exact time and participants) and

-          secure presence of the NRA representative at the training (12 April).

The meetings with the NCDC, field visit, training and the meeting with the National Steering committee will be organized by us in close collaboration with the NCDC (which includes all respective logistics).

Thank you very much in advance.

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