Dear Sopo,

 

As per our communication in the past, the following three activities are part of the GAVI transition plan:

 

1.       Train NRA staff on pharmacovigilance

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

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

 

The QMS in-country training is not part of the transition plan. It has been indicated to the Ministry in 2017 (see the attached email) within the PIP (pandemic influenza framework) and Partnership Contribution (PC) context. I can’t remember any response from the ministry/Regulatory Agency in the past.

 

Based on the initiative of the Deputy Minister, we have raised the issue with the colleagues in the Regional Office and Headquarter.

 

The programme of the QMS is pre-defined and all course materials are already available. The existing methodology is applicable for 3 days’ training and covers the following topics: general description of NRA’s QMS, importance, structure and ways to build it; development of the core draft QMS documents by groups of NRA experts.

 

Recently Dr Werner Gielsdorf, a consultant from Germany, has been engaged for that work in some other countries, but we need to check his availability.

 

We will keep you informed as soon as we get additional information (including possible time frame for implementing that activity) from our colleagues.

 

Best regards,

 

 

 

Dear Marijan,

 

I will clarify the dates for the mission and will send you confirmation.

 

As for vaccine-related pharmacovigilance training: Tuesday, 21 - Friday, 24 August 2018 (3 days basic training and 1 day advanced training for the National Regulatory Authority/Agency)  - as I know this training was already planned and  deputy minister, Ms. Maia Lagvilava asked you about QMS training. Can you specify when the QMS training will be conducted?

 

 

 

Dear Sopo,

 

This is to check the dates for possible missions as follows:

 

-          mission on implementation of System of Health Accounts in Georgia: 31 July – 2 August 2018 (the mission has been provisionally discussed with Ms Keti Goginashvili, but was provisionally planned for early July, which unfortunately is not possible for our technical experts in Geneva)

-          vaccine-related pharmacovigilance training: Tuesday, 21 - Friday, 24 August 2018 (3 days basic training and 1 day advanced training for the National Regulatory Authority/Agency); deputy minister, Ms Maia Lagvilava asked me about the training this Monday;

 

Please, let us know if the above dates are acceptable for the ministry.

 

As per my understanding other scheduled missions have been confirmed already:

-          UHC/SSA: 4-8 June

-          UHC/Patients’ Pathways: 4-6 July

-          Sexual/Reproductive Health Strategy and Action Plan: this is more WHO/UN internal preparatory meeting for the work to be delivered later this year; I also know that Nino Berdzuli is in direct contact with selected staff of the ministry, so in principle a technical meeting with some staff is also possible.

 

I copy also my colleagues from the country office as well as the deputy minister and Ms Keti.

 

Attached please find updated table with the technical missions to Georgia.

 

 

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: ivanusam@who.int

Skype: who-ivanusam

GPN: 74211

Web: www.euro.who.int