From : Mariam darakhvelidze <mdarakhvelidze@moh.gov.ge>
To : POLISHCHUK, Olexandr <polishchuko@who.int>; IVANUSA, Marijan <ivanusam@who.int>
Subject : RE: GMP Terms of Reference for the mission in March 2018
Cc : KLIMIASHVILI, Rusudan <klimiashvilir@who.int>; KURTSIKASHVILI, Giorgi <kurtsikashvilig@who.int>; Sopo Belkania <sbelkania@moh.gov.ge>; mmkurnali@moh.gov.ge; PEDERSEN, Hanne Bak <pedersenh@who.int>
Received On : 21.02.2018 16:16
Thank you, dear Olexandr! With best, Marina -----Original Message----- From: POLISHCHUK, Olexandr [mailto:polishchuko@who.int] Sent: 21 February, 2018 13:01 To: Marina Darakhvelidze ; IVANUSA, Marijan Cc: KLIMIASHVILI, Rusudan ; KURTSIKASHVILI, Giorgi ; Sopo Belkania (sbelkania@moh.gov.ge) ; Mariana Mkurnali (mmkurnali@moh.gov.ge) (mmkurnali@moh.gov.ge) ; PEDERSEN, Hanne Bak Subject: RE: GMP Terms of Reference for the mission in March 2018 Dear Marina, We were discussing with Marijan the need to have a written test for the candidates. This is a standard procedure at WHO selection process. Applicants can make a presentation on interrelation of inspection function with other regulatory functions, e.g. Marketing Authorization, Pharmacovigilance, Market surveillance, Licensing of facilities, Laboratory access and testing, Clinical trials. This is a simple exercise, however may bring the level of regulatory awareness. It is quite clear that use of GMP in written test is too premature. First we receive a long list of applicants and make it short by evaluating qualification criteria according to the vacancy notice. After a shortlisting we give written test and evaluate results. Sometimes we ask applicants to make a presentation and score it accordingly. The next step is an interview with candidates which is also scored. At the end selection panel make an advice to the Top management and decision is made by them. This is in brief and hope is useful. Best regards Olexandr -----Original Message----- From: Marina Darakhvelidze [mailto:mdarakhvelidze@moh.gov.ge] Sent: 21 February 2018 09:45 To: POLISHCHUK@gva11suichigo01.who.int; POLISHCHUK, Olexandr; IVANUSA@gva11suichigo01.who.int; IVANUSA, Marijan Cc: KLIMIASHVILI@gva11suichigo01.who.int; KLIMIASHVILI, Rusudan; KURTSIKASHVILI@gva11suichigo01.who.int; KURTSIKASHVILI, Giorgi; Sopo Belkania (sbelkania@moh.gov.ge); Mariana Mkurnali (mmkurnali@moh.gov.ge) (mmkurnali@moh.gov.ge); PEDERSEN@gva11suichigo01.who.int; PEDERSEN, Hanne Bak Subject: RE: GMP Terms of Reference for the mission in March 2018 Dear Olexandr, Thank you for your cooperation and assistance. Today we are going to get first meeting regarding selection of candidates for GMP inspectorate. We will discuss all requirements and related issues. According our needs, we will contact you, and of course, will send you appropriate time and telefone number for teleconference. With best, Marina -----Original Message----- From: POLISHCHUK, Olexandr To: IVANUSA, Marijan , mdarakhvelidze@moh.gov.ge Cc: KLIMIASHVILI, Rusudan , KURTSIKASHVILI, Giorgi , Sopo Belkania (sbelkania@moh.gov.ge) , Mariana Mkurnali (mmkurnali@moh.gov.ge) (mmkurnali@moh.gov.ge) , PEDERSEN, Hanne Bak Date: Wed, 21 Feb 2018 08:15:12 +0000 Subject: RE: GMP Terms of Reference for the mission in March 2018 > Dear Marijan, > > Thank you for support and CC me. > > Dear Marina, > > I am available any time for the teleconference with explanations. > Please do not hesitate to contact me. I will need your phone number > ant time when we can talk. > > Kind regards > Olexandr > > -----Original Message----- > From: IVANUSA, Marijan > Sent: 20 February 2018 18:26 > To: mdarakhvelidze@moh.gov.ge > Cc: POLISHCHUK, Olexandr; KLIMIASHVILI, Rusudan; KURTSIKASHVILI, > Giorgi; Sopo Belkania (sbelkania@moh.gov.ge); Mariana Mkurnali > (mmkurnali@moh.gov.ge) (mmkurnali@moh.gov.ge) > Subject: FW: GMP Terms of Reference for the mission in March 2018 > > Dear Marina, > > Below you can find further guidance from Olexander. > If needed you can agree for the teleconference with him (in cc) and > see if he can provide any further assistance regarding the selection > process. > > 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 > > -----Original Message----- > From: POLISHCHUK, Olexandr > Sent: 20 February, 2018 17:59 > To: IVANUSA, Marijan; PEDERSEN, Hanne Bak > Subject: RE: GMP Terms of Reference for the mission in March 2018 > > Dear Marijan, > > Thank you for the good news. > > I do not see any risk of inviting local industry. > However preferably they should be Qualified persons from 2 - 3 largest > producers. > Declaration of interests is the must to sign and confidentiality > agreement as well. > They may not share information of this selection by any means. > > Composition of the panel is very important. > MoH representatives should be there as an interested party NRA - > technical party representative I would recommend Tea Jikia, as a > competent expert, trained by WHO in GMP inspection theory and > practice, and work within WHO Prequalification programme, with good > command of English MoH HR representative as a neutral party to > facilitate a selection panel work. > > Our advice is to use core UN competences for the selection and scoring > methodology as we use in our selection process. > > UN core values/competencies > > Core values > - Integrity > - Professionalism > - Respect for Diversity > > Core UN competencies > - Communication > - Teamwork > - Planning & Organizing > - Accountability > - Creativity > - Client Orientation > - Commitment to Continuous Learning > - Technological Awareness > > I think that for inspector's work these four are more specific: > Teamwork > Communication > Planning & Organizing > Commitment to Continuous Learning > > Competency based questions might be taken from the attached file. > It also include indicators to be considered by the panel members. > Advice is to get a panel together and give clear instructions in > advance. > Attached is also a generic MS Word document from UNEP which gives more > explanations on UN competencies. > > NB it is very important to have somebody "trustful" from the current > agency staff to start the process of administration. > This person will take part in education and most probably will become > a good Head of inspection. > > Please let us know if you need further explanation > > With best wishes > Olexandr > > >