raditi kao qp šta sve moramo razumeti qp konferencija 2019... · 2019. 9. 29. · approaches...

Četvrta QP konferencija

Raditi kao QP – šta sve

moramo razumeti

4. i 5. oktobar 2019. Best Western Hotel M,

Bulevar Oslobođenja 56a, Beograd

The Fourth QP conference

Understanding the Implication of Working as QP

Dragana Mileusnić

Đorđe Medarević

Gordana Pejović

Irena Homšek

Katarina Popović

Jelena Rankov

Ljiljana Solomun

Ljubica Tot

Mira Zečević

Nataša Knežević

Nataša Mamula

Slavica Kojić

Snežana Tvrdorijeka

Snežana Večerkov Vukmirović

Svetlana Ibrić

Svjetlana Mihaljica

Sonja Georgieva Jovanović

Valentina Marinković

Zorica Vujić

Organizacioni odbor/Organising committeee

Program konferencije

9 00 – 10 00 Registracija učesnika

10 00 – 10 30 Otvaranje konferencije

10 30 – 11 00 Šta QP treba da zna o audit trail-u i zašto je audit trail važan za QP-a

Nevena Noveski, Hemofarm, Vršac

11 00 – 11 30 Validacija računalnih sustava u GxP kritičnim procesima

Izabela Majić, Dechra Pharmaceutical PLC group, Engleska

11 30 – 12 00 Kafe pauza

12 00 – 12 30

Dobra mikrobiološka praksa - praktičan pristup u farmaceutskoj

industriji Jelena Novaković Jovanović, Galenika, Beograd

12 30 – 13 00 Prevencija unakrsne kontaminacije u proizvodnim pogonima sa većim

brojem proizvoda Tatjana Ilić, Teva, Hrvatska

13 00 – 14 30 Ručak

14 30 – 15 00

Lekovi za naprednu terapiju, razvojni/regulatorni izazovi i

perspektive Miodrag Stamenković, Accelsiors CRO, Beograd

15 00 – 15 30

Sličnosti u pogledu zahteva nacionalne regulative u oblasti kozmetičkih

proizvoda vs. lekova

Tijana Radojičić, Privredna komora Srbije, Beograd

15 30 – 16 00 Kafe pauza

16 00 – 16 30 Uticaj serijalizacije na farmaceutsko poslovanje

Milan Ratković, Bausch Health, Beograd

16 30 – 17 30 Diskusija

Petak, 4.10.2019.

Svečana večera - 20h u restoranu Vizantija, Ušće BB (preko puta Muzeja Savremene Umetnosti)

Conference Program

9 00 – 10 00 Registration

10 00 – 10 30 Opening of the Conference

10 30 – 11 00

What should QP know about audit trail and why audit trail is important for

QP

Nevena Noveski, Hemofarm, Vršac

11 00 – 11 30 Validation of computer systems in GxP critical processes

Izabela Majić, Dechra Pharmaceuticals PLC group, England

11 30 – 12 00 Coffee break

12 00 – 12 30

Good microbiological practice – practical approach in pharmaceutical

industry Jelena Novaković Jovanović, Galenika, Belgrade

12 30 – 13 00 Prevention of cross contamination in multi products facility

Tatjana Ilić, Teva, Croatia

13 00 – 14 30 Lunch time

14 30 – 15 00

Advanced therapy drugs, developmental/regulatory challenges and

perspectives Miodrag Stamenković, Accelsiors CRO, Belgrade

15 00 – 15 30

Similarities regarding the requirements of national regulations in the field

of cosmetic products vs. medicines

Tijana Radojičić, Chamber of Commerce of Serbia, Belgrade


16 00 – 16 30 Impact of serialization on pharmaceutical business

Milan Ratković, Bausch Health, Belgrade

16 30 – 17 30 Discussion

Friday, 4.10.2019.

8pm dinner in Vizantija restaurant, Ušće BB (across the Museum of contemporary art Belgrade)

Subota, 5.10.2019.

9 00 – 9 30 Most frequent deficiencies found during GMP inspections in Bulgaria

Assena Stoimenova - Bulgarian Association of QP, Bugarska

9 30 – 10 00 Bulgarian QP Association - challenges and new horizons

Ketty Tsvetkova - Bulgarian Association of QP, Bugarska

10 00 – 10 30 Kafe pauza

10 30 – 11 30 Radionica 1: Devijacija vs. defekt kvaliteta

Svjetlana Mihaljica, Ljubica Tot

11 30 – 12 30 Radionica 2: Pregled dokumentacije za puštanje serije leka u promet

Katarina Popović, Slavica Kojić

12 30 – 13 30 Ručak

13 30 – 14 30 Radionica 3: Upravljanje promenama

Snežana Tvrdorijeka, Snežana Večerkov Vukmirović

14 30 Zatvaranje konferencije

Saturday, 5.10.2019.

9 00 – 9 30 Most frequent deficiencies found during GMP inspections in Bulgaria

Assena Stoimenova - Bulgarian Association of QP, Bugarska

9 30 – 10 00 Bulgarian QP Association - challenges and new horizons

Ketty Tsvetkova - Bulgarian Association of QP, Bugarska


10 30 – 11 30 Workshop 1: Deviation vs. Quality defect

Svjetlana Mihaljica, Ljubica Tot

11 30 – 12 30 Workshop 2: Batch release documentation review

Katarina Popović, Slavica Kojić

12 30 – 13 30 Lunch time

13 30 – 14 30 Workshop 3: Change management

Snežana Tvrdorijeka, Snežana Večerkov Vukmirović

14 30 Closing remarks

Nevena Noveski je rođena 27.05.1980. u Vršcu, Srbija. Osnovnu školu i gimnaziju završila je u

Vršcu, a 2005. godine diplomirala je na Farmaceutskom fakultetu u Beogradu. Trenutno pohađa

specijalističke studije na Farmaceutskom fakultetu u Beogradu, smer Ispitivanje i kontrola

lekova. Od 2006. godine zaposlena je u Kontroli kvaliteta u Hemofarmu, počevši kao stručni

saradnik odgovoran za HPLC ispitivanja do trenutne pozicije rukovodioca Službe za hemijska

ispitivanja, uzorkovanje i kontrolu kvaliteta pakovnog materijala. Njeno interesovanje i iskustvo

fokusirani su pre svega na hemijska ispitivanja polaznih materijala i gotovih proizvoda, efikasnu

i lean organizaciju laboratorijskog ispitivanja, kao i usaglašenost laboratorijskih procedura sa

cGMP i regulatornim zahtevima.

Aktivni je učesnik eksternih i internih inspekcija laboratorije kontrole kvaliteta, sa velikim

iskustvom iz EU i FDA inspekcija. Poseduje dugogodišnje iskustvo u definisanju laboratorijskih

procedura koje se odnose na data integrity, kao i uspostavljanje risk based pristupa i procedura za

audit trail u laboratorijama Kontrole kvaliteta u Hemofarmu. Posvećena je kontinuiranoj obuci i

podizanju svesti zaposlenih na temu data integrity.

Radi i živi u Vršcu i ponosna je mama dvoje dece školskog uzrasta.

Nevena Noveski

Nevena Noveski is born in Vršac, Serbia, on May 27th,1980. She has finished primary and high

school in Vršac and in 2005th graduated on Faculty of Pharmacy, Belgrade University.

Currently is attending Specialist study programme: Quality Control of Medicinal Products,

Faculty of Pharmacy, University of Belgrade. From 2006th she has been working in Quality

Control of Hemofarm, starting from a position of Expert Associate responsible for HPLC testing

and supervision to current position of Head of Service for Chemical Testing, Sampling and

Packaging Material Control. Main area of interest and experience are focused to chemical testing

of raw materials and pharmaceutical products, efficient and lean organization of laboratory work

and compliance of laboratory procedures with current GMP and regulatory requirements.

Actively participates in external and internal laboratory audits, experienced with both EU and

FDA inspections. Over the years, she was involved in defining laboratory data integrity

strategies, including establishing of risk based approach and procedures for audit trail in QC

laboratories of Hemofarm. Highly devoted to training of laboratory staff for data integrity and

continuous increase of awareness.

She lives and works in Vršac and is a proud and happy mother of two school-children.

What should QP know about audit trail and why audit trail is important for QP

Audit trail can be defined as an independent, computer-generated, time stamped log, which

records time and date of access of users and their activities related to creating, modifying or

deleting of electronic records. Changes to records, as well as originally created data, must

be available and transparent, including the reason of the change during entire lifecycle of

the record. Audit trail funcionalities of software, by itself, cannot assure accuracy and

reliability of regulated GxP records. Therefore, appropriate audit trail reviews should be

integrated and defined within an overall data integrity strategy, which must include well

defined policies, continuous trainings and awareness of employees.

Audit trail review should be included in regular activities of data review and approval

process. There must be evidence on the performed audit trail review. In order to determine

adequate approach and frequency of audit trail review, a risk based analysis should be

applied considering computerized system criticality, criticality of the data generated by the

system and establishment of other controls within pharmaceutical quality system.

Qualified person must be confident that accuracy and integrity of data is secured and that

appropriate controls of records, including audit trail, are in place.

Šta QP treba da zna o audit trail-u i zašto je audit trail važan za QP-a

Audit trail se može definisati kao nezavisan, kompjuterski generisan i vremenski obeleženi

zapis koji sadrži podatke o vremenu i datumu pristupanja korisnika elektronskim

sistemima, kao i njihovim aktivnostima vezanim za kreiranje, izmenu ili brisanje

elektronskih zapisa. Sve izmene zapisa, uključujući i razlog izmene, kao i originalni podaci,

moraju biti sačuvani i dostupni u toku celog životnog ciklusa elektronskih zapisa.

Audit trail funkcionalnost jednog softvera, sama po sebi, ne obezbeđuje tačnost i

pouzdanost regulisanih GxP zapisa. Potrebno je da pregled audit trail-a bude definisan u

okviru sveobuhvatne data integrity strategije koja mora da obuhvati dobro definisane

procedure, kontinuiranu obuku i podizanje svesti zaposlenih. Pregled Audit trail-a treba da

bude sastavni deo redovnih aktivnosti pregleda i odobravanja podataka, a dokaz o

sprovedenom pregledu audit trail-a mora postojati. Pri definisanju procedure i frekvencije

pregleda audi trail-a mogu se primeniti principi analize rizika, uzimajući u obzir kritičnost

kompjuterizovanog sistema, kritičnost i kompleksnost elektronskih podataka, kao i ostale

mere predostrožnosti i provere propisane u okviru sistema kvaliteta.

Kvalifikovani farmaceut mora biti siguran da su tačnost i integritet podataka na kojima se

zasniva odluka o upotrebi obezbeđeni, kao i da su sprovedene sve propisane provere

podataka uključujući pregled audit trail-a.

Izabela Majić

Izabela Majić is a pharmaceutical quality and regulatory management professional and leader

with years of experience in both industry and regulatory. Currently she is a Quality Director for

a whole Dechra Pharmaceutical group having manufacturing sites across the world (Croatia,

Nederlands, UK, US, Brasil, Australia) and using many contract manufacturers across the world.

Before joining Dechra in February she was a head of successful Inspectorate-recognised by the

FDA among first 8 EU Inspectorates, a PIC/S member and was rated with highest grade 5 during

bench marking audit (BEMA) of regulatory agencies in December 2018. She shows high

involvement in international cooperation in the area of GMP and GVP, PIC/S, EMA, MRA,

EDQM.

Before joining Agency she gained strong Quality and Manufacturing background in global

companies such as Teva and in start up pharmaceutical facilities with both managerial

and operational functions. The experience includes implementation of QMS and validation of IT

systems, manufacturing processes (parenterals, API (synthetic, fermented), biotechnological

products, dry oral dosages and topicals) and equipment and analytical methods.

Validation of computer systems in GxP critical processes

In regulated pharmaceutical industries it is crucial that computerized systems used in

critical processes impacting public health and safety are validated.

Regulatory requirements are clear that GxP computerized systems must be kept in

compliance throughout their operational lifetime. Computer System Validation (CSV) is

ensuring that any technology component (software or hardware) is fulfilling its intended

use in line with the regulatory guidelines.

As a former GMP and GVP inspector she will also give overview of inspectors

expectations and concerns reflecting the requirements of the FDA, EU Annex 11 and the

approaches contained in the ISPE/GAMP Good Practice Guide ‘A Risk-Based Approach to

Operation of GxP Computerized Systems – A Companion Volume to GAMP®5’

As someone who has performed and managed validation and implementation of several

computerized systems while working in pharmaceutical industry she will guide you in what

exactly is required and how these requirements can be successfully established and

maintained.

Detailed explanation will be given about processes needed for computer system validation

such as IQ, OQ, PQ, Master Plan and Project Plan.

Jelena Novaković Jovanović je rođena 15.06.1979. godine u Beogradu, gde je 2005. završila

osnovne akademske studije na Biološkom fakultetu Univerziteta u Beogradu, na studijskoj

grupi Ekologija i zaštita životne sredine.

Od 2008. godine je zaposlena u farmaceutskoj kompaniji Galenika a.d. gde je u periodu od

2008-2010. godine radila u Institutu za istraživanje i razvoj, laboratoriji za biotehnologiju. Od

2010. godine radi u Službi za biološka ispitivanja Kontrole kvaliteta na poslovina kontrole

kvaliteta lekova i dijetetskih proizvoda, i praćenju ambijentalnih uslova u proizvodnim

pogonima kompanije Galenika a.d. Doktorske studije je završila 2016. godine na Biološkom

fakultetu Univerziteta u Beogradu, modul Mikrobiologija.

Učestvovala je na više stručnih edukacija i konferencija u zemlji i inostranstvu i objavila

nekoliko naučnih radova u međunarodnim naučnim časopisima. Bila je dobitnik FEMS granta

za mlade istraživače. Više puta je bila predavač po pozivu iz oblasti metoda ispitivanja

mikrobiološkog kvaliteta lekova i bakterijskih endotoksina na međunarodnim skupovima u

organizaciji European Compliance Academy (ECA).

Jelena Novaković Jovanović

Jelena Novaković Jovanović was born on 15.06.1979. in Belgrade, where she gained her

master degree at the Faculty of Biology, University of Belgrade in 2005., module Ecology and

Environmental Protection.

Since 2008. she has been working for the pharmaceutical company Galenika a.d. She worked

at the Institute for Research and Development, Laboratory for biotechnology in the period

2008-2010. Since 2010. she has been working at the Biological Department of Quality Control

performing quality control of drug products and dietary supplements, and environmental

monitoring of production facilities of Galenika a.d.

She completed her PhD studies in 2016. at the Faculty of Biology, University of Belgrade,

module Microbiology.

She has participated in several professional trainings and conferences in the country and

abroad and has published several scientific papers in international scientific journals. She was

the recipient of an FEMS grant for young researchers. She has been a lecturer on several

occasions in the field of methods for testing the microbiological quality of drugs and bacterial

endotoxins at international conferences organized by the European Compliance Academy

(ECA).

Dobra mikrobiološka praksa – praktičan pristup u farmaceutskoj industriji

Mikrobiološka ispitivanja imaju značajnu ulogu u osiguravanju odgovarajućeg kvaliteta lekova i

neophodna su za potvrdu njihove efikasnosti i sigurnosti za pacijente. Mikrobiološka kontaminacija lekova

može da dovede do trenutnih štetnih efekata na zdravlje pacijenata, kao i da promeni hemiju i

farmakologiju lekova.

Savremena farmaceutska industrija teži da ugradi mikrobiološki kvalitet u lekove razumevanjem izvora

kontaminacije, ambijentalnih uslova prevashodno u proizvodnim, ali i u laboratorijskim prostorima i

osobina intermedijarnih proizvoda, komponenti, aktivnih farmaceutskih sastojaka i finalnog proizvoda

koje podržavaju rast mikroorganizama.

Većina mikrobioloških testova koji se koriste u kontroli kvaliteta opisana je u farmakopejama, usled čega

se smatraju validiranim i harmonizovanim. I pored ovoga, svaka laboratorija je obavezna da dokaže da

može da postigne postavljene kriterijume korišćenih metoda ispitivanja, kao i da li je metoda

odgovarajuća za određeni proizvod pre uvođenja iste u rutinska ispitivanja.

Ovaj rad opisuje način na koji funkcioniše mikrobiološka laboratorija u farmaceutskoj industriji u GMP

okruženju, počevši od dizajna i upravljanja, preko izvođenja farmakopejskih testova do adekvatne

interpretacije dobijenih rezultata. Ovi ključni aspekti se analiziraju preko nekoliko kritičnih tačaka i

testova, poput hranljivih podloga, test mikroorganizama, mikrobiološkog ispitivanja nesterilnih proizvoda,

testa sterilnosti, ispitivanja bakterijskih endotoksina i identifikacije mikroorganizama.

Good microbiological practice – practical approach in pharmaceutical industry

Microbiological testing plays a significant role in assuring the appropriate quality of drugs and it is

necessary for their efficacy and patient safety. Microbial contamination of drugs could cause immediate

adverse effects on patient health and can alter the chemistry and pharmacology of drugs.

Modern pharmaceutical industry tends to build microbiological quality into the drugs by understanding the

sources of contamination, environmental conditions, and attributes of intermediate products, components,

active pharmaceutical ingredients and final product that support growth of microorganisms.

Most of the tests performed in microbiological QC are described in Pharmacopoeias, and are considered

validated and harmonized. Nevertheless, each laboratory has to demonstrate that the performance criteria

of the test method can be met and that it is suitable for the specific product before introducing the test for

routine purposes.

This work provides an overview of the function of pharmaceutical microbiology laboratory in the GMP

environment, from laboratory design and management, through performing compendial tests to adequate

interpretation of results. These key aspects will be discussed through a series of dedicated topics covering

culture media, test microorganisms, microbiological examination of non-sterile products, sterility test,

bacterial endotoxin test and microbial identification.

Tatjana Ilic, M.sc Biotechn, leads Quality operations in European Cluster, part of the

European technical operations, Teva Pharmaceutical Industries Ltd. She is responsible for

Quality and Compliance of Teva Sterile manufacturing sites in Europe as well as sites

producing non-sterile products.

Tatjana holds a master degree in biotechnology from the University of Zagreb.

Tatjana joined Teva Global Quality organization in 2017 as Senior Director Quality Europe

Central and West. Prior to this role, she held positions of Site Quality head in Pliva Croatia

Ltd and Gödöllő Site in Hungary. In this role, Tatjana was leading Site Quality teams in

establishing and maintaining quality at the site in accordance with global standards, regulatory

guidelines and cGXP compliance requirements. She was continuously improving the

effectiveness of quality processes and systems, developing, and maintaining a culture of

enhancing quality throughout the entire site operations.

Tatjana has 25 years of pharmaceutical industry experience, holding positions of increasing

responsibility in both Quality and Operations, and working with a wide range of

manufacturing technologies including solid dose, sterile and biologics.

In her current role, Tatjana is responsible for Quality organization for nine sites in Europe

ensuring continuous compliance within the Sites. She executes corporate quality strategy

throughout the Sites ensuring adequate resources and satisfactory costumer service level.

Tatjana is also responsible for establishing program and implementation of process

improvement projects to ensure high operational standards and efficiency and its

improvement.

Tatjana Ilić

Prevention of cross contamination in multi products facility

Cross Contamination is one of the highest risks for patients using pharmaceutical products.

Not only the presence of small amounts of antibiotics or other highly potent compounds in

medicines can cause severe damage but also carryover of products into another

pharmaceutical product is of high risk to the patient. Product contamination is one of the

highest reason for recalls in recent years.

Reasons for cross contamination can be manifold and caused by technical as well as

organisational deficiencies. Insufficient cleaning of equipment, poor facility design or

inappropriate design of the HVAC system may be reasons as well as contamination due via

personnel or primary packing material. In addition, the design of the production process

itself can be the cause for cross contamination. It is therefore extremely important to avoid

or minimise the risk of cross contamination, starting when process and equipment are

designed.

Quality Risk Management (QRM) is a systematic process for the assessment, control,

communication and review of risks to the quality of the drug product and drug substance

across the product lifecycle. The aim of QRM is to improve the effectiveness of

manufacturing processes, preserve the quality of the product and maintain patient safety.

The QRMP-for cross contamination is based on ICH-Q9 "Quality Risk Management" and

the ISPE- “Risk based Manufacture of Pharmaceutical Products” (Risk MaPP) Baseline

Guide.

The QRMP-for cross contamination will identify potential cross contamination risks

between products within a facility, based on the routes of cross contamination as specified

in the ISPE-Risk MaPP Baseline Guide

The Quality Risk Management is performed to manage the risk derived from

manufacturing of each Drug Product and Drug Substance in the facility to other

manufactured Drug Products /Drug Substances, and thus to verify the safety and quality of

the products manufacturing in the multi-product facility.

Miodrag Stamenković je lekar, specijalista medicinske mikrobiologije i doktorirao je iz

oblasti virusologije. Ima više od 15 godina iskustva u različitim oblastima rada Agencije za

lekove i medicinska sredstva Srbije (ALIMS) – laboratorijsko ispitivanje kvaliteta lekova,

procena dokumentacije o kvalitetu leka, kao i pretkliničke i kliničke dokumentacije zahteva

za izdvanje dozvole za lek, kao i odobrenja kliničkih ispitivanja (posebno vakcina i

biotehnoloških lekova). Takođe, učestvovao je u internim proverama QMS, GMP

inspekcijama i sarađivao u projektima sa međunarodnim organizacijama kao što su Ph Eur (5

godina kao spoljnji procenjivač EDQM za sterilne i proizvode fermentacije) i SZO. Odskora

radi u CRO Accelsiors.

Miodrag Stamenković

Miodrag is medical doctor specialized in Medical microbiology, and PhD in Virology. He

has more than 15 years of experience in various fields regarding development of regulatory

framework and several departments within Serbia`s NRA (Medicines and Medical Devices

Agency of Serbia), evaluation, assessment, editing and authorizing of CMC, non-clinical and

clinical documentation for Clinical Trials (CT) and Marketing Authorization (MA)

applications (specialized in vaccines and biotechnology products). He was also involved in

QMS audits, GMP inspections as well as cooperation with international organizations such

as Ph Eur (EDQM-5 years as a sterility and fermentation products external assessor) and

WHO. Few month ago he started working at CRO Accelsiors.

Lekovi za naprednu terapiju, razvojni/regulatorni izazovi i perspektive

Lekovi za naprednu terapiju (engl. Advanced therapy medicinal products-ATMPs) su

lekovi čiji se sastav zasniva na upotrebi gena, tkiva ili ćelija kao aktivne supstance.

Neretko, ovo su lekovi koji dovode do revolucionarnih promena u terapiji određenih

bolesti. Lekovi za naprednu terapiju se uobičajeno dele u više grupa: lekovi za gensku

terapiju, lekovi za somatsku ćelijsku terapiju, lekovi dobijeni iz tkiva bioinženjeringom,

odnosno, kombinovani lekovi za naprednu terapiju. Kako ovu grupu lekova, od ostalih

izdvajaju, način proizvodnje, kontrole i specifična primena, tako i značaj koji mogu da

imaju u lečenju bolesti za koje, do sada nije bilo odgovarajuće terapije, neophodno je

prilagođavanje regulatornih postupaka kod ovih lekova. Ova prilagođavanja bi trebalo da

omoguće brži razvoj ovih lekova uz obezbeđivanje prava, bezbednosti i dobrobiti

pacijenata tokom razvoja, odnosno kvalitet, bezbednost i efikasnost ovih lekova nakon

izdavanja dozvole za lek. Obzirom, da se u budućnosti očekuje dalji razvoj tehnologije

kojom se proizvode lekovi za naprednu terapiju, kao i da će njihova primena biti sve češća,

neophodno je da se adaptacija odgovarajućih regulatornih postupaka namenjenih za

utvrđivanje njihove efikasnosti, bezbednosti i kvaliteta odvija istovremeno, kako bi

omogućio bržu dostupnost lekova za naprednu terapiju pacijentima.

Advanced therapy drugs, developmental/regulatory challenges and perspectives

Advanced therapy medicinal products (ATMPs) are medicines for human use that are based

on genes, tissues or cells as active substance. Very often, these medicines can bring out

revolutionary changes in some diseases therapy. ATMPs can be classified into several main

groups: gene therapy medicines, somatic-cell therapy medicines, tissue-engineered

medicines and combined ATMPs. As this group of medicines is specific by production

method, control and use, also by, sometimes, paramount importance for diseases without

suitable therapeutic answer so far, it is necessary to introduce modifications of regulatory

processes for these medicines approval. These adjustments should provide faster

development of ATMPs and,at the same time provide protection of rights, safety and well

being of patients during development, as well as safety, efficacy and quality of these

medicines during MA procedure. In future, we can expect further technology development

for the ATMPs production, and more frequent use of these medicines, so it is of utmost

importance to adapt procedures for assessment of their safety, efficacy and quality, in order

to provide ATMPs for patients as soon as possible.

Rođena 1963. godine u Beranama, Crna Gora. Farmaceutski fakultet završila 1987. godine u

Beogradu. Akademsku specijalizaciju Menadžment u zdravstvu završila 2005. godine („Primena

benčmarking metode u unapređenju kvaliteta u farmaceutskoj industriji“).

Završila brojne međunarodne obuke i treninge u oblasti inspekcije proizvodnje i prometa lekova,

sistema kvaliteta, Dobre proizvođačke prakse, kao i EU i WHO regulative u oblasti lekova i

medicinskih sredstava idr. Karijeru započela 1988. godine u Apotekarskoj ustanovi Beograd,

nakon čega je radila u proizvodnji lekova. Od 2005. godine je bila zaposlena u Ministarstvu

zdravlja u inspekciji za lekove i medicinska sredstva, kao i na poslovima izrade nacrta zakona i

propisa kojima se uređuje oblast lekova i medicinskih sredstava, kao i propisa kojima se uređuje

sistem cena lekova, ostvarivanja prava na lekove i predlaganja mera za obezbeđivanje

dostupnosti lekova i medicinskih sredstava. Bila je član radne grupe za izradu nacrta zakona o

lekovima i medicinskim sredstvima i pratećih podzakonskih akata, kao i zakona o medicinskim

sredstvima. Od septembra 2018. godine je zaposlena u Privrednoj komori Srbije u Udruženju za

farmaciju i medicinsku delatnost. Kao član radne grupe Ministarstva zdravlja aktivno je

učestvovala u izradi propisa u oblasti kozmetičkih proizvoda.

Tijana Radojičić

Born 1963 in Berane, Montenegro. She graduated the Faculty of Pharmacy in 1987 in

Belgrade. She completed academic specialization in Healthcare Management in 2005

(“Application of the Benchmarking Method in Quality Improvement in the Pharmaceutical

Industry”). She completed numerous international workshops and trainings in the field of

inspection of medicines production and distribution, quality systems, good manufacturing

practice, EU and WHO regulations in the field of medicines and medical devices, etc. She

began career in 1988 at the Apotekarska ustanova Beograd, after which she worked in the

manufacture of medicines. Since 2005 she was employed in the Ministry of Health in

Department for inspection of medicines and medical devices, as well as in Department in

charge for drafting of laws and regulations governing the field of medicines and medical

devices, regulations governing the system of prices of medicines and proposing measures to

ensure the availability of medicines and medical devices. She was a member of the working

group for the drafting of the Law on Medicines and Medical Devices and accompanying by-

laws, as well as the Law on Medical Devices. Since September 2018, she has been employed

by the Serbian Chamber of Commerce in the Association for Pharmacy and Medical Services.

As a member of the working group of the Ministry of Health, she actively participated in

drafting regulations in the field of cosmetic products.

Sličnosti u pogledu zahteva nacionalne regulative u oblasti kozmetičkih proizvoda vs.

lekova

U skladu sa EU propisima, a u cilju zaštite zdravlja potrošača, kozmetički proizvodi koji se

stavljaju na tržište Evropske unije treba da zadovolje visoke standarde u pogledu kvaliteta,

efikasnosti i bezbednosti.

Usklađivanjem nacionalne regulative sa EU regulativom u ovoj oblasti, odnosno

donošenjem Zakona o predmetima opšte upotrebe (“Službeni glasnik RS”, broj 25/19) i

Pravilnika o kozmetičkim proizvodima (“Službeni glasnik RS”, broj 60/19), uvode se

konkretne obaveze odgovornog lica za kozmetički proizvod, kako u pogledu kvaliteta,

dokumentacije kojom se dokazuje bezbednost kozmetičkog proizvoda, tako i u pogledu

ograničenja za određene supstance, kao i informacija za potrošače i izveštavanja o

ozbiljnim neželjenim efektima.

Na navedeni način zahtevi za kozmetičke proizvode postaju značajno strožiji, a u

određenim segmentima se “približavaju” zahtevima EU regulative za medicinske poizvode.

Similarities regarding the requirements of national regulations in the field of cosmetic

products vs. medicines

In accordance with EU regulations, and in order to protect consumer health, cosmetic

products to be placed on the European Union market must meet high standards in terms of

quality, efficiency and safety.

The harmonization of national legislation with EU regulations in this area, ie the adoption

of the Law on General Use Items (“Official Gazette of the RS”, No. 25/19) and the

Rulebook on Cosmetic Products (“Official Gazette of the RS”, No. 60/19), introduces

specific obligations of the responsible person for the cosmetic product, both in terms of

quality, documentation proving the safety of the cosmetic product, as well as restrictions on

certain substances, as well as consumer information and reporting of serious side effects.

In this way, the requirements for cosmetic products are becoming much stricter, and in

certain segments they are "approaching" the requirements of EU regulation for medical

devices.

EMEA Manadžer, Projekti kvaliteta i Unapređenja procesa.

Nakon što je diplomirao na Mašinskom fakultetu u Beogradu, 2001. godine, započeo je

poslovnu karijeru kao projektant u kompaniji Medical System u kojoj je tokom vremena

postao ekspert u oblasti obezbeđenja kvaliteta medicinskih sredstava i primene direktiva

Evropske Unije i harmonizovanih standarda u oblasti medicinskih sredstava. U 2008. godini

pridružuje se kompaniji Visaris, proizvođaču digitalnih rendgena, kao direktor Kvaliteta da bi

nakon 2 godine rada, preuzeo i poziciju Operativnog direktora.

Od 2014. godine, nalazi se u kompaniji Bausch Health, gde je započeno na poziciji EMEA

specijaliste Obezbeđenja kvaliteta a od 2017. godine odgovoran je za implementaciju direktive

o Falsifikovanim lekovima za celokupan Bausch Health portfolio uz podršku različitih

funkcionalnih timova. Nedavno se, polovinom 2019. godine, nakon uspešno završenog

projekta serijalizacije nalazi na poziciji EMEA menadžera odgovornog za projetke u Kvalitetu

I Unapređenju procesa.

Milan Ratković

EMEA Manager, Quality Projects and Operational Excellence.

After graduating at Faculty of Mechanical Engineering in 2001, he starts professional career in

R&D department with Medical system company and during time develop his expertise in

medical devices quality assurance and implementation of EU directives and harmonized

standards in medical devices filed. In 2008, he joins digital x-ray device manufacturer, Visaris

company as Head of Quality and two years after extend role to Head of Operations.

From 2014, he is with Bausch Health starting on position of EMEA Quality Assurance

specialist and from 2017 responsible for implementation of Falsified Medicinal Directive for

Bausch Health products portfolio with cross functional teams of operations, IT, regulatory and

quality. Recently, in mid of 2019, after successful closing of serialization program he is on

position of EMEA manager responsible for projects in Quality and Operation Excellence.

Uticaj serijalizacije na farmaceutsko poslovanje

Poslednjih nekoliko godina napori u borbi protiv falsifikata u farmaceutskom poslovanju

dobili su globalni pristup. Kao rezultat toga, serijalizacija lekova postala je ili će postati

obavezna za sva velika tržišta. Sledeći međunarodno priznati mandat za primenu sistema za

praćenje u lacnu snadbevanja, zemlje su uspostavile svoje sopstvene zahteve radi

usaglašenosti na nacionalnom nivou, što doprinosi dodatnoj kompleksnosti u

implementaciji. Kako se od 9. Februara 2019, svi lekovi na recept u Evropskoj Uniji

moraju biti serijalizovani, nosioci dozvole, proizvođači, distributeri i apoteke susreću se sa

velikim izazazovima, počevši od produženog vremena proizvodnje, upravljanja reklamacija

vezanih za serijalizaciju do nedostatka obuke krajnjih korisnika. Proces puštanja leka u

promet postao je složeniji i integrisan sa zahtevom direktive o uspešnom slanju

serijalizacionih podataka u Evropski sistem za Verifikaciju lekova. U junu, 2019. godine,

objavljenje su smernice za GMP inspekciju proizvođača o usklađenosti sa direktivom i

može se očekivati da će se serijalizacija u Evropskoj Uniji posmatrati kao deo GMP

zahteva. Uticaj serijalizacije na farmaceutsko poslovanje ne može se posmatrati samo sa

akspekta regulative već i sa aspekta kvaliteta, infomacionih tehnologija i proizvodnje.

Impact of serialization on pharmaceutical business

Efforts to fight against counterfeits in pharma business became global approach in last few

years. As result of this approach. serialization of medicinal products is mandatory or will be

mandatory for all major markets. Following an internationally recognized mandate to

implement a system of track and trace into the supply chain, countries established their own

best practices to ensure compliance on national levels which brings additional complexity

in implementation. As since 9th February 2019, all Rx products must be serialized in

European Union, MAHs, manufactures, wholesalers and pharmacies face challenges from

extend lead time, serialization alerts management to lack of end user training. Release

process became more complex and integrated with directive requirement on successful data

upload in to European Medicinal Verification System. In June 2019, guidelines for GMP

inspection of manufacturers compliance with directive requirement was published and it

will be expected that serialization in EU will be consider as part of GMP requirement.

Impact of serialization on pharmaceutical business cannot be looked only from regulatory

perspective but also from quality, IT and manufacturing perspective.

Prof. Assena Stoimenova, Ph.D. graduated from the Faculty of Pharmacy, Medical University-

Sofia in 1996 and defended a dissertation in the field of social medicine and organization of

healthcare in 2007. Master in Health Management and Public Health (Faculty of Public Health,

Medical University-Sofia) and a Master in Health Policy and Pharmacoeconomics (Barcelona

School of Management, Univeristat Pompeu Fabra, Barcelona, Spain). From 11.2008 to

07.2018 she held consecutive positions as Senior Assistant, Chief Assistant and Associate

Professor at the Faculty of Pharmacy, Medical University - Sofia. In 07.2018 Prof. Stoimenova

was appointed at the Faculty of Public Health, Medical University-Sofia, where she delivers

lectures on public health, pharmaceutical strategic management and management of clinical

trials. Author and co-author of more than 150 publications in the field of drug policy, quality

management in healthcare, medicines utilization and health technology assessment. Chair of the

Quality Commission of the Bulgarian Pharmaceutical Union (2007-2010) and Vice President of

the Union for the period 2010-2013. Member of the National Council on Prices and

Reimbursement of Medicinal Products (2013-2104). During the period 07.2014-08.2018 she

served as an Executive Director of the Bulgarian Drug Agency. Former member of the

Management Board of European Medicines Agency and former member of CHMP. Member of

Committee for health technology assessment during the period 2016-2018. Advisor to the

Minister of health as of Aug.2018.

Assena Stoimenova

Most frequent deficiencies found during GMP inspections in Bulgaria

The aim of the publication is to present analysis of the deficiencies reported following

GMP inspections in Bulgaria in two consecutive years (2016-2017) and to compare them

with results from GMP inspections communicated by other EU-member states. A

retrospective study was carried out by reviewing the complete GMP inspection reports of

all manufacturers conducted by the Bulgarian Drug Agency in 2016-2017, according to

GMP requirements and applicable local legislation. The analyzed data included 55

inspections, revealing 460 various deficiencies, of which 2 were critical and 102 – major.

20 GMP inspections were performed in 2016 vs. 35 inspections in 2017. The pattern of

deficiencies was like the findings of other EU regulatory agencies, showing that equivalent

requirements are applied. Our analysis showed that Bulgarian Drug Agency inspectors

rarely raised deficiencies related to Computer Systems, Qualification/Validation, Personnel

and Qualification of Suppliers unlike other EU regulators agents. Our analysis of GMP

inspection findings during 2016-2017 showed that Bulgarian Drug Agency has

demonstrated its ability to detect non-compliances and take necessary regulatory actions.

Quality related issues constitute the main reasons for non-compliances with GMP

requirements. Publishing the results from GMP inspections performed by the national

competent authorities enhances the regulatory transparency that can be useful for industry

to improve its GMP compliance.

Ketty Tsvetkova

Chem. Eng. Ketty Tsvetkova is graduated from Chemico-Technology University in Sofia with

specialization organic synthesis. She started her professional carrier as Analyst in Quality

Control Laboratory in Antibiotic, Razgrad (manufacturing site part of Actavis Group).

She has very wide expertise in pharma industry as Head of Regulatory Affairs in Actavis R&D

Department, Quality Manager and Qualified Person in Roche Bulgaria and Head of Quality

Assurance in Novartis Bulgaria.

Currently she is Chairman of the Executive Board of Bulgarian Association of Qualified

Persons. She is founder and General Manager of KeVaRo Group Ltd, providing QA and EU

QP service.

Bulgarian QP Association - challenges and new horizons

We are going to present our organization, our goals, ambitions, aspirations.

Shared Experience

We will draw how long is the journey to become EU QP – education, experience,

qualification, continuing education. We will share with you our experience how

challenging could be one QP day and how difficult is to keep updated your professional

competence.

Qualification

Our training program – how we are going to support our members in their qualification and

professional competence. GxP Academy - high quality and accessible professional

trainings in Bulgaria on topics suggested by our members.

Collaboration

Our collaboration with national and EU institutions and professional organizations.

The first step is done, what is the next?

Svjetlana Mihaljica je koordinator poslova u Nacionalnoj kontrolnoj laboratoriji u Agencije za

lijekove i medicinska sredstva Srbije (ALIMS). Njena stručnost se ogleda u oblasti kontrole

kvaliteta, proizvodnji, proceni dokumentacije kvaliteta u postupku izdavanja dozvole za lek,

defektu kvaliteta, regulatornim aktivnostima, sistemu obezbeđenja kvaliteta. Njeno početno

iskustvo odnosi se na farmaceutsku industriju - proizvodnju i kontrolu kvaliteta lekova u

Bosnalijeku, Sarajevo i aktivnosti vezanim za ispitivanje i kontrolu lekova u Instrumentalnoj

laboratoriji Zavoda za farmaciju Srbije, Beograd. Od kada je Agencija osnovana (2005.) bila je

rukovodilac odeljenja Farmaceutskog sektora do 2013. godine, a na kraju, od 2013. do danas, je

koordinator poslova u Nacionalnoj kontrolnoj laboratoriji. Praćenje, analiza i razvoj u oblasti

kvaliteta je njen stalni zadatak. Kao ekspert učestvovala je u obrazovnim projektima. U okviru

IPA projekta, bila je posmatrač u Radnoj grupi za kvalitet (QWP) Evropske agencije za lekove

(EMA) (2011-2013).

Od 02.2019. godine je Liason Member of the European QP Association. Od 05.2019. je

sertifikovani Quality Assurance Manager od strane ECA. Svjetlana je diplomirala farmaciju na

Univerzitetu u Sarajevu i završila postdiplomske studije (specijalizacija kontrole kvaliteta

lijekova) na Univerzitetu u Beogradu.

Svjetlana Mihaljica is activity coordinator at National Control Laboratory within Medicines and

Medical Devices Agency of Serbia (ALIMS). Her field of expertise is Quality Control,

Production, Assessment of Quality Documentation for MA, Quality Defect, Regulatory Activity,

Quality System.

Her starting experience relates to pharmaceutical industry – manufacture and medicines quality

control in Bosnalijek, Sarajevo and activities and management at Instrumental laboratory of

Pharmacy Institute of Serbia, Belgrade. Since Agency was established (2005) she served as

Manager of Pharmaceutical Department to 2013, and finally, from 2013 to present, she is activity

coordinator at National Control Laboratory. Monitoring, analysis and development in quality field

is her permanent work.

As expert, she participated in education projects. Within IPA project, she was an observer in

Quality Working Party (QWP) of European Medicines Agency (EMA) (2011-2013).

.

Svjetlana Mihaljica

Ljubica Tot je rođena 27.02.1974. u Beogradu, Srbija. Osnovnu školu i gimnaziju završila je u

Raški, a 1999. godine diplomirala je na Farmaceutskom fakultetu u Beogradu. 2016. je završila

specijalističke studije na Farmaceutskom fakultetu u Beogradu, smer Ispitivanje i kontrola

lekova. Od 1999. godine zaposlena je u Kvalitetu Hemofarm, počevši kao stručni saradnik u

Kontroli kvaliteta odgovoran za ispitivanje i oslobađanje polaznog i pakovnog materijala do

trenutne pozicije rukovodioca QP grupe u okviru Obezbeđenja kvaliteta gde radi kao lice

odgovorno za puštanje serije leka.

Njene aktivnosti u svakodnevnom radu su fokusirane na obezbeđivanju puštanja na tržiste ili

za transport kvalitetnog, efikasnog i bezbednog leka kroz poštovanje cGMP i regulatornih

zahteva. Aktivni je učesnik inspekcija lokalnih i stranih regulatornih tela kao i eksternih

inspekcija proizvođača polaznih materijala.

Poseduje dugogodišnje iskustvo vezano za procese i definisanje procedura: istraga odstupanja,

QW (Quality Warning) i povlačenje proizvoda. Posvećena je kontinuiranom prenosu znanja i

podršci timovima za istragu odstupanja, uvođenju novih proizvođača polaznih materijala.

Radi i živi u Vršcu u dinamičnom poslovnom i porodičnom okruženju.

Ljubica Tot

Ljubica Tot is born in Belgrade, Serbia, on February 27th,1974. She has finished primary and

high school in Raška and in 1999th graduated on Faculty of Pharmacy, Belgrade University. In

2016 she graduated Specialist study programme: Quality Control of Medicinal Products,

Faculty of Pharmacy, Belgrade University. From 1999th she has been working in Hemofarm

Quality, starting from a position of Expert Associate responsible for testing and release of

starting and package material in Quality Control to current position of Head of QP group

within Quality Assurance, as Qualified Person (QP) resposible for batch certification and

release. Daily work activities are focused on release to the market or for transport quality,

efficient and safe batches with respect to cGMP and regulatory requirements.

Actively participates in audits of domestic and foreign regulatory bodies and also in external

audits of starting material manufacturers.

She has many years of experience related to processes of deviation investigation, QW (Quality

Warning) and product recall. She is highly devoted to continuous knowledge transfer and team

supports (for deviation investigation, introducing of new API manufacturers).

She lives and works in Vršac in a business and family dynamic environment.

Katarina Popović je završila Farmaceutski fakultet u Beogradu 2001.godine, a 2010. godine

stekla zvanje specijaliste ispitivanja i kontrole lekova. Akademsku specijalizaciju Puštanje leka u

promet završila je 2014. godine. Karijeru je započela 2002. godine u Zavodu za farmaciju Srbije

kao saradnik u laboratoriji, a zatim u Agenciji za lekove i medicinska sredstva Srbije gde je radila

do 2009 godine, u okviru Sektora za izdavanje dozvola. Od 2010. zaposlena je u farmaceutskoj

kompaniji Pharmanova d.o.o. na poslovima Regulatory Affairs Manager/Qualified Person. Autor

je ili koautor 11 stručnih radova i saopštenja.

Katarina Popović graduated from the Faculty of Pharmacy at the University of Belgrade in 2001.

She finished post graduate specialization in Medicines testing and Quality Control and acquired

the title of specialist in testing and control of medicines in 2010 and she ended academic

specialization Release of finished products to the market in 2014. Katarina began her career in

2002 at the Institute of Pharmacy of Serbia as Associate in Laboratory Sector. Then in Medicines

and Medical Devices Agency of Serbia, where she worked for 8 years on various responsible

jobs within the National Control Laboratory and Licensing Department. Since 2010 she has been

working in the pharmaceutical company Pharmanova d.o.o. as a Regulatory Affairs Manager and

Qualified Person. She is the author or co-author of 11 expert papers and communications.

.

Katarina Popović

Slavica Kojić diplomirala je 1985. na Farmaceutskom fakultetu u Beogradu.

Specijalizaciju iz ispitivanja i kontrole lekova završila je 1999. Specijalizaciju puštanje serije

leka u promet završila je 2014. Od 1989. do 1999. radi u fiziko-hemijskoj laboratoriji Kontrole

kvaliteta u Galenici, na poslovima stručnog i samostalnog saradnika. U periodu od 1999. do

2000. na poziciji rukovodilac fiziko-hemijske laboratorije. 2000. godine prelazi u Obezbeđenje

kvaliteta i do 2008. obavlja poslove kvalifikovanog farmaceuta za odobravanje polaznih

materijala. Od 2008. godine do 2011. radi u Pharmaswiss-u na poslovima rukovodioca

Kontrole kvaliteta. Od 2011. radi na poziciji kvalifikovanog farmaceuta za puštanje lekova u

promet. Najveći deo svoje profesionalne karijere i usavršavanja posvetila je analitičkom radu

za fiziko-hemijsko kontrolisanje polaznih supstanci i lekova, kao i uvođenju i razvoju sistema

kvaliteta u kontroli i obezbeđenju kvaliteta. Učestvovala je u osnivanju fiziko-hemijske

laboratorije Kontrole kvaliteta, kao i izgradnji nove fabrike lekova u PharmaSwissu.

Slavica Kojić

Slavica Kojic graduated from the Faculty of Pharmacy, in Belgrade, in 1985. She finished post

graduate Specialization in Medicines Analysis and Quality Control, in 1999.

She finished post graduate Specialization in Release of finished products to the market, in

2014. From 1989 to 1999 she worked in physics-chemical laboratory of Quality Control

department, in Galenika as associate and independent associate. During 1999 and 2000 she

worked as manager in physics-chemical laboratory of Quality Control Department. From 2000

to 2008 she continued to work in Quality Assurance Department. She was in charge of job of

qualified pharmacist for raw materials release.

From 2008 until 2011 she worked in Pharmaswiss as Quality control manager. In 2011 she

started to work as qualified person for finished products release to the market.

The major part of her professional career she dedicated to analytical work of chemical control

of raw substances and drugs, as well as introduction and development of quality system in

Quality Control and Assurance Departments. She also participated in the foundation of

physics-chemical laboratory of Quality Control, as well as in green fields project building of

new plant in PharmaSwiss.

Snežana Večerkov Vukmirović je pomoćnik direktora za kvalitet za EMEA region u kompaniji

MSD. Snežana poseduje više od 25 godina iskustva u farmaceutskom menadžmentu na

poslovima vezanim za proizvodna mesta tako i u korporativnim kancelarijama širom Evrope.

Oblasti prepoznate expertize uključuju razvoj liderskih veština u oblasti kvaliteta, provere

lanca snabdevanja uključujući integritet podataka, razvoj programa provera zasnovan na

proceni rizika, sistem menadžmenta kvalitetom parenteralnih/biofarmaceutskih proizvoda i

čvrstih farmaceutskih formi u proizvodnji, usaglašen sa legislativnim zahtevima.

Od 2018, odgovorna je za uspostavljanje operativnog kvaliteta kod externih partnera u Rusiji i

CIS zemljama Evroazijske zone. U februaru 2019. na 8TH CSS 2019 - Cool Supply System &

Solutions 2019 održanom u Amsterdamu, Holandija podelila je iskustva vezana za nove

trendove:„Agilnost – Stari pristup u modernom farmaceutskom lancu snabdevanja“.

Snežana Večerkov Vukmirović

Snežana Večerkov Vukmirović is Ass Director External Quality EMEA at Merck Sharp &

Dohme. She has over 25 years of pharmaceutical management experiance in both plant

operation and corporate offices over the Europe. Area of recognized experize include quality

leadership development, supply chain auditing with data integrity aspects and managing audit

program on risk based approach, quality management system parenteral/biopharmaceutical

products and solid dosage forms manufacture and compliance.

Since 2018. she has been appointed to role of Quality Lead responsible to institutionalize

Operationalizing Quality within ExP, Russia and CIS countries (Eurasian Economic Zone). As

a speaker on 8TH CSS 2019 - Cool Supply System & Solutions 2019 held in Amsterdam,

Netherlands shared best practice on new trends „Agility: Old approach in modern pharma

supply chain”.

Snežana Tvrdorijeka, dipl. farmaceut, je direktor Sektora kvaliteta u kompaniji Zdravlje AD u

Leskovcu, koja posluje u okviru kompanije Teva Pharmaceutical Industries Ltd., jedne od

vodećih farmaceutskih kompanija u svetu, posvećena olakšanju pristupa kvalitetnim

zdravstvenim rešenjima. Diplomirala je na Farmaceutskom fakultetu Univerziteta u Beogradu

1995. godine, gde je i završila specijalizaciju za puštanje leka u promet i postala kvalifikovani

farmaceut. Snezana ima preko 20 godina iskustva u farmaceutskoj industriji, koje je stekla u

kompaniji Zdravlje radeći na brojnim izazovnim i odgovornim poslovima, kao što su

formulacija proizvoda i upravljanje u procesu proizvodnje. Istinska posvećenost kvalitetu

farmaceutskih proizvoda opredelila je Snežanu da najznačajniji deo svog dosadašnjeg

individualnog i profesionalnog razvoja usmeri na ovu ključnu ulogu u farmaceutskoj industriji.

Snežana ima i značajno iskustvo u oblasti validacije, obezbedjenja kvaliteta, kontituiranim

poboljšanjima, upravljanju rizicima, uz ogromno iskustvo u internacionalnim inspekcijama,kao

i u auditima dobavljača. Od 2010. godine Snežana je na poziciji direktora Sektora kvaliteta u

kompaniji Zdravlje Actavis, sa koje obezbeđuje GMP usaglašenost i vodi procese

implementacije i upravljanja sistemom kvaliteta u Zdravlju u skladu sa vrhunskim standardima

Teva Pharmaceutical Industries Ltd., kompanije.

Snežana Tvrdorijeka

Snezana Tvrdorijeka, a Msc of Pharmacy, is the Site Quality Director at Zdravlje AD in

Leskovac, operating as a part of Teva Pharmaceutical Industries Ltd., one of the leading

pharma companies in the world, committed to increasing access to quality health solutions, and

an unparalleled impact on patients and healthcare systems worldwide. She graduated from the

Faculty of Pharmacy at the University of Belgrade in 1995, where she successfully completed

the specialist education in drug releasing and became a Qualified Person. Snezana has more

than 20 years of experience in pharmaceutical industry, working with Zdravlje AD on various

challenging and responsible jobs, such as product formulation and management of production

process. Following her true commitment to quality of pharmaceutical products, Snezana

devoted the most significant part of her individual and professional development to this key

role in the pharmaceutical industry. Snezana also has a significant experience in the areas of

validation, quality assurance, continuous improvement and risk management, with valuable

professional expertise acquired through international inspections and regular contractor audits

in compliance with the highest international standards. Since 2010, Snezana has been working

as the Quality Director in Zdravlje Actavis, responsible for GMP Compliance and leading the

processes of implementation and management of the Quality systems in Zdravlje Actavis in

compliance with the highest standards and requirements of Teva Pharmaceuticals Ltd.

Zadaci CIFFF-a su kontinuirano unapredjenje znanja farmaceuta i ostalih

zaposlenih u farmaceutskoj industriji, kroz:

• umrežavanje zaposlenih u farmaceutskoj industriji, na univerzitetima u zemlji

i inostranstvu i u regulatornim telima,

• promociju profesionalnog statusa zaposlenih u farmaceutskoj industriji

registrovanih u okviru Centra,

• saradnju u međunarodnim projektima u oblasti industrijske farmacije,

• organizaciju skupova od interesa za zaposlene u farmaceutskoj industriji,

vezano za razvoj formulacije, obezbeđenje kvaliteta, industrijsku proizvodnju

i registraciju lekova,

• postavljenje internet foruma, na kome će se pravovremeno objavljivati

informacije i razmenjivati iskustva vezana za problematiku od interesa za

farmaceutsku industriju,

• uspostavljanje interdisciplinarne akademske, naučne i stručne saradnje sa

drugim institucijama u zemlji i inostranstvu koje se bave industrijskom

farmacijom,

• razmenu literature i informacija,

• razmatranje propisa koji se odnose na poslove u farmaceutskoj industriji.

Centar za industrijsku farmaciju

Farmaceutskog fakulteta

Članovi Centra za industrijsku farmaciju Farmaceutskog fakulteta (CIFFF)

mogu biti svi stručnjaci na poslovima razvoja i istraživanja, registracije,

proizvodnje i obezbeđenja kvaliteta zaposleni u farmaceutskoj industriji,

zastupništvima i predstavništvima farmaceutskih kompanija i regulatornim telima

zainteresovani za kontinuirano unapređenje znanja i kvaliteta u oblasti

industrijske farmacije.

Članstvo je dobrovoljno i besplatno. Pridružite nam se tako što ćete poslati Vaše

ime i prezime, e-mail adresu i naziv radne ustanove na [email protected]

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Beleške/Notes

Sponzori/Sponsors

Универзитет у Београду Фармацеутски факултет

11000 Београд Војводе Степе 450 Србија

Телефон: +381.11.39.51.380 +381.11.39.51.399

+381.11.39.51.372

Факс: +381.11.39.72.840

Декан: +381.11.24.73.224

E-mail: [email protected]

University of Belgrade Faculty of Pharmacy

11000 Belgrade Vojvode Stepe 450 Serbia

Phone: +381.11.39.51.380 +381.11.39.51.399

+381.11.39.51.372

Fax: +381.11.39.72.840

Dean: +381.11.24.73.224

E-mail: [email protected]

raditi kao qp šta sve moramo razumeti qp konferencija 2019... · 2019. 9. 29. · approaches...

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