-----Original Message-----
From: Pirgari, Dorina
To: regagency@moh.gov.ge , "Tea Jikia"
Cc: CAKMAK, Osman Niyazi
Date: Mon, 18 Sep 2017 15:28:21 +0000
Subject: Update on the upcoming activities reflected in the PIP plan for 2017

Dear Mr. Gia Tvalavadze,

 

I am writing this e-mail on behalf of Dr. Niyazi Cakmak.

 

I am the consultant that will facilitate the implementation of the upcoming activities reflected in the PIP plan for 2017, listed below.

 

In the Pandemic Influenza Preparedness (PIP) framework and Partnership Contribution (PC) context, Georgia is a priority country in the European region to build regulatory capacity for influenza products including vaccines, antivirals and diagnostics and to accelerate national approval of these commodities in case of influenza pandemic, addressing the gaps in regulatory systems as well as marketing authorization and pharmacovigilance functions. The major responsibility of an NRA is to safeguard public health in an expedient manner under both normal and public health emergency situations by ensuring the quality, safety and efficacy of medical products available in the national market.

 

In this context we would like to inform you that Immunization System Strengthening (ISS) Team, under the Vaccine-preventable Diseases and Immunization Programme (VPI) is 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 would like to kindly ask you to assign one contact person with whom we can discuss and arrange all the steps of the forthcoming activities.

 

Thank you

 

Regards,

Dorina Pirgari
DCE-VPI/WHO EURO

Tel. +45 45 33 7107

Mob. +45 91 98 66 95

E-mail: pirgarid@who.int