Date: Wed, 17 Jan 2018 19:19:20 +0400
Subject: FW: Training of pharmaceutical inspectors in Georgia
გთხოვთ იხილოთ
თანდართული წერილი და
მომწეროთ თქვენი მოსაზრება
ხვალ, 18 იანვარს
15:00 საათამდე.
სოფო
ბელქანია
ადამიანური რესურსების
მართვისა და საერთაშორისო
ურთიერთობების
დეპარტამენტის უფროსი
საქართველოს
შრომის
,
ჯანმრთელობისა
და
სოციალური
დაცვის
სამინისტრო
აკ.
წერეთლის
გამზირი
144,
თბილისი,
საქართველო,
0159
მობ:
+995 599 223232
From:
IVANUSA, Marijan [mailto:ivanusam@who.int]
Sent: Wednesday,
January 17, 2018 7:15 PM
To: Sopo Belkania
(sbelkania@moh.gov.ge)
Cc: KLIMIASHVILI, Rusudan
Subject:
Training of pharmaceutical inspectors in Georgia
Importance:
High
Dear
Sopo,
Below is the proposal for the training for the
inspectors for the GMP at Pharmakon, Denmark, as discussed during the
mission on GMP in December 2017.
We need to have the approval
soonest possible as time slots may be used differently by Pharmakon.
The
communication focal person from the MoH have to be designated.
This course was developed by WHO EURO and Pharmakon in 2006 and is
constantly evaluated/updated.
It was delivered for the inspectors for several
countries and “produces” competent inspectors at the end.
The course
consists of 3 modules.
Module 1
Theoretical 2 weeks course at
Pharmakon.
Estimated course price is 60k USD excluding
transportation costs.
Arrival of participants on 17 June and departure on 30
June.
WHO EURO will facilitate the module and all its
activities.
Optimal group composition is 20 trainees – as
suggested 8 potential inspectors and 12 industry representatives (who should
be self-financed by the industry).
At the end of the Module 1 the
examination will be carried out to evaluate how trainees gained the
knowledge.
Module 2
Practical modu
le in Georgia – 2 day mock-inspection of the pharmaceutical facility.
Inspectors – Pharmakon trainers.
Trainees (8 NRA staff only)
– supervising the inspection.
On the day 3 of this module – full day work
with trainees on linking observations made during the inspection to EU GMP
guidelines and categorization of the observations.
At the end of the course there
will be a recommendation by trainers whom to select for the Module 3.
Estimated cost is 60k USD without local transportation and admin.
Support.
Module 3
2 day mock-inspection of the
pharmaceutical manufacturer in Georgia conducted by 4 trainees selected in
Module 2.
Trainers will supervise mock-inspection conduct and
make their observations on trainees performance.
Day 3 of Module 3 will be
dedicated to the preparation of the inspection report and personal face2face
appraisal to trainees.
Estimated cost is 60k USD without local transportation
and admin. support
More detailed costing of the course will be made
by Pharmakon upon acceptance of training by the ministry.
At the end of
the course all trainees will receive certificates with clear explanation of
what they have learned.
This mean that by the end of October 2018 Georgia may
have fully functional inspectorate and join WHO Certification scheme and
apply for PIC/S membership.
Please, be informed that WHO
has no resources for the course.
Best regards,
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