Dear Sopo,

 

In the WHO Country Office we understand that the topics listed by you correspond to the following activities in the GAVI transition plan (highlighted in red color in the table below):

 

Strengthen functions of the National Regulatory Authority:

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

 

As per our understanding details need to be agreed during the mission.

Unfortunately we cannot double-check the details with the technical unit due to the Easter holidays.

In any case Eugene Lam is available for the meeting on 10th of April and all issues can be discussed and agreed.

 

This means that we are confirming the meeting at which the topics listed by you shall be raised.

Best regards,

 

 

 

 

 

Dear Marijan,

 

As I understand the training which was mentioned in your email and  these activities are different. Am I right?

 

•             In-country QMS workshop – WHO is looking for an expert that will provide support to the LEPL State Regulations Agency for Medical Activities.

•             Study visit to a Stringent Regulatory Authority (SRA) – WHO will facilitate and prepare the visit with LEPL State Regulations Agency for Medical Activities.

•             Collaborative registration procedure – A meeting is planned from the WHO that will invite participants from all the regions, where NRA officers from LEPL State Regulations Agency for Medical Activities, will be invited.

 

 

 

 

 

 

Dear Sopo.

 

I have shortly meet deputy minister Ms Maia Lagvilava today (together with Rusiko Klimiashvili). From my side there is no need to meet her again on 2 or 3 April, but if she thinks we need to meet again, this is of course possible.

 

I can confirm the meeting for the 10 April. Most probably Rusiko Klimiashvili will accompany me.

 

Additionally I can confirm the meeting with Eugene Lam on 10th of April (our emails have crossed, as I have sent another email regarding that meeting).

Please, inform us about exact timings when you will define them.

 

Thank you and best regards,

 

 

 

Dear Marijan,

 

Me and Marina Darakhvelidze will be out of city on 2ND and 3RD April. I can suggest meeting with deputy minister on 2nd or 3rd of April and second meeting on 10th of April (me and marina will attend).

 

I also want to disscuse with you another issue. As I was informed in 2017 Immunization System Strengthening (ISS) Team, under the Vaccine-preventable Diseases and Immunization Programme (VPI) was planning to organize the following activities to strengthening the LEPL State Regulations Agency for Medical Activities:

 

•             In-country QMS workshop – WHO is looking for an expert that will provide support to the LEPL State Regulations Agency for Medical Activities.

•             Study visit to a Stringent Regulatory Authority (SRA) – WHO will facilitate and prepare the visit with LEPL State Regulations Agency for Medical Activities.

•             Collaborative registration procedure – A meeting is planned from the WHO that will invite participants from all the regions, where NRA officers from LEPL State Regulations Agency for Medical Activities, will be invited.

I was also told that it’s possible to transfer above mentioned activities in 2018. Giorgi KURTSIKASHVILI was in touch with the NRA representatives.  Therefore, we will be greatful if you can help us arrange meeting with Dr. Eugene Lam on 10th of April.

 

Looking forward for your feedback.

 

 

 

Dear Sopo,

 

I apologize for a mistake in my email:

I am available from 10-14 April, and not on 4 April.

 

There are several options:

1.       We have an individual meeting with the deputy minister in the following days (30 March – 3 April) followed by

2.       a group meeting in the period of 10-14 April

or we only have a group meeting in the period of 10-14 April.

 

Above days are the only days when I am available. The next possible date is after 23 April.

 

I really apologize for that.

 

Thank you for understanding,

 

 

 

Dear Marijan,

 

I can propose following time for the meeting , 4^th of April 12:00.

 

Looking forward for your confirmation.

 

 

 

Dear Sopo,

 

At an event today I have shortly met Ms Maia Lagvilava and Ms Marina Darakhvelidze.

We agreed to have a meeting in the following days.

 

There are several options:

1.       We have an individual meeting with the deputy minister in the following days (30 March – 3 April) followed by

2.       a group meeting in the period of 4-10 April

or we only have a group meeting in the period of 4-10 April.

 

Above days are the only days when I am available. The next possible date is after 23 April.

 

Thank you and best regards,

 

Marijan Ivanusa

WHO Representative

Head of WHO Country Office Georgia

 

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

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