A large number of people at the moment are taking a medication. Each time the medicine is taken a certain risk of side effects is present, but at the same time with each medicine taken our knowledge of its effectiveness and safety is further complemented.

It is known that the safety information collected during clinical trials do not provide sufficient data on rare, and especially not on a very rare side effects of the medicine that occur in less than 1 in 10,000 patients taking the medicine, which means that at least 30,000-60,000 patients should be exposed to the same, in order to observe such a very rare side effect. There are very few medicines that have been tested on so many patients before they were marketed and therefore the continuous collection of side effects and safety monitoring of medicines during their practical application remains of utmost importance for patient safety and for their successful treatment.

Timely detection, assessment and understanding of the side effects or unwanted side effects of medicines, is crucial for appropriate treatment in the event of their occurrence, but it also allows us to take a whole range of measures, whose compliance can largely prevent their formation, which is the main objective of pharmacovigilance as a discipline that by collection, assessment, identifying and minimizing risks continuously strives to ensure that the benefit outweighs the potential risks of medicinal products.

Thus, we can conclude that the ultimate purpose of pharmacovigilance is to ensure the availability of safe and effective medicines which greatly contribute to the improvement of public health.

Given its importance, each and single serious pharmaceutical company aims to establish a good and effective pharmacovigilance system without which it is very difficult to maintain the continuity of its medications on the market. However, as pharmacovigilance by its nature is more demanding than other disciplines, given its multidisciplinary nature and extreme dynamism, very often it is not easy, especially for smaller pharmaceutical companies, to build and maintain such a high quality and efficient pharmacovigilance system.

With its skilled and experienced team Bonifarm provides its clients with just such a quality and functional pharmacovigilance system. Our services can be individual, as support to the central office holder of the authorization to the organization of a complete pharmacovigilance system of individual holders.

PHARMACOVIGILANCE SERVICES

Pharmacovigilance services at the global level

• Organization services and maintenance of a comprehensive pharmacovigilance system,

• • Services of qualified person responsible for pharmacovigilance at the global level (EU QPPV),
  • Internal inspection (audit) of the pharmacovigilance system,
  • Development of the plan of implementation of the pharmacovigilance system,
  • Development of SOP related to pharmacovigilance,
  • Training of personnel involved in the pharmacovigilance system,
  • The collection and compilation of information on all suspected adverse reactions to medicines of the authorization holder
  • Collection and integration of other security information relevant to the safety profile of medicines authorization holder (overdose without visible symptoms, errors in the treatment including errors in the issuance of a medicine, inadvertent exposing to the medicine and misapplication, use outside the approved indications, abuse, inefficiency, merciful giving, occupational exposure, exposure in pregnancy and pregnancy outcome including the outcome of no consequence, the use of the medicine in the paediatric population, important pre-clinical tests),
  • Search of expert literature indexed in databases Medline and Embase,
  • Signal detection and evaluation of risk for a particular medicine,
  • Processing of side effects reports, preparation of Electronic Individual Case Safety Reporting (ICSR) in terms of making narratives, coding in MedDRA and expert medical assessment of the case, the application of ICSRs to the regulatory authorities through the EudraVigilance system,
  • Preparation and delivery of reports on Emerging Safety Issue,
  • Preparation and centralized submition of Periodic Safety Update Reports (PSURs) and the Risk Management Plan (RMP) to the regulatory bodies,
  • the registration of medicines in XEVMPD and their update them,
  • participation in the process of user complaints processing and the process of recall of the medicine in terms of identifying the side effects and safety issues at the local level,
  • communication with relevant local regulatory authorities,
  • systematic storage of documents related to pharmacovigilance activities, and
  • development and maintenance of the Pharmacovigilance system master file (PSMF).

• Individual services in terms of support to the existing operating pharmacovigilance system which applies to any service or combination of services listed in the list of services provided within the organization and implementation of a comprehensive pharmacovigilance system globally.

Pharmacovigilance services at the local level

• Organization services and implementation of the local Pharmacovigilance System,

• • Services of qualified local persons responsible for pharmacovigilance in accordance with local regulations
  • The organization and implementation of the pharmacovigilance system in accordance with SOP related to pharmacovigilance at the global level
  • Training of personnel involved in the pharmacovigilance system
  • Gathering information about all suspected adverse reactions to medicines of the authorization holder that originate from the local territory,
  • Collection and integration of other security information relevant to the safety profile of medicines authorization holder (overdose without visible symptoms, errors in the treatment including errors in the issuance of a medicine, inadvertent exposing to the medicine and misapplication, use outside the approved indications, abuse, inefficiency, merciful giving, occupational exposure , exposure in pregnancy and pregnancy outcome including the outcome of no consequence, the use of the medicine in the paediatric population, important pre-clinical tests) that originate from the local territory,
  • Search of local literature that is not indexed in databases Medline and Embase,
  • Login of ICSR to local regulatory authorities through the EudraVigilance system
  • processing and delivery of Periodic Safety Update Reports (PSURs) and the Risk Management Plan (RMP) to local regulatory authorities,
  • participation in the process of user complaints processing and the process of recall of the medicine in terms of identifying the side effects and safety issues at the local level,
  • communication with relevant local regulatory authorities,
  • systematic storage of documents related to pharmacovigilance activities, and
  • participation in internal inspections of the pharmacovigilance system.

• Individual services in terms of support to the existing operating system of the local pharmacovigilance system which applies to any service or combination of services listed in the list of services provided within the organization and implementation of the pharmacovigilance system at the local level.

Professional team of BONIFARM bases its expertise in regulatory affairs on long experience in the development, preparation and harmonization of comprehensive documentation required for registration of medicines, medical products, food supplements and cosmetic products in accordance with Croatian and European legislation.

Our work is based on a consideration of the overall scientific, legal and business aspects, with the aim to ensure fast and reliable compliance with current legislation for our partners who develop, produce or distribute their products, and thus shorten and simplify putting their products on the market.

Scope of Regulatory Affairs

Bonifarm offers professional management of all regulatory activities related to medicines, medical devices, dietary supplements and cosmetic products, which include:

• strategic planning of the medicine registration process (pre-registration activities)
• registration of medicines in the area of Croatia and the EU
• post-registration regulatory activities (modifications, renewals, approval of transfers etc.).
• expert translations of Summaries of product characteristics, patient information leaflets and labelling, and other documentation on the medicine
• conducting readability users tests (RUT)
• obtaining a license for medicines and medical products wholesale
• obtaining consent for entry / import of medicines and approval for exemption from labelling and patient information leaflets
• registration of the manufacturer of the medical product in the register of medical products
• registration of medicinal product in the register of medical products
• the inclusion of dietary supplements in the monitoring program / obtaining notification number
• obtaining electronic notification of cosmetic products through CPNP

Contact us with confidence at Ova e-mail adresa je zaštićena od spambota. Potrebno je omogućiti JavaScript da je vidite.!

Medicines

• Registration of medicines (National procedure and MRP/DCP procedure)

- Registration of new medicine

• • Collecting and preparation of documentation for registration
  • Professional translations of SPC, PIL and other documentation on medicine
  • Preparation of forms for application
  • Submition of complete request with the Regulatory agency
  • Permanent communication with the Agency until the final decision on registration

- Registration of homeopathic medicine

• • Collecting and preparation of documentation for registration
  • Professional translations of SPC, PIL and other documentation on medicine
  • Preparation of forms for application
  • Submition of complete request with the Regulatory agency
  • Permanent communication with the Agency until the final decision on registration

- Registration of allergens

• • Collecting and preparation of documentation for registration
  • Professional translations of SPC, PIL and other documentation on medicine
  • Preparation of forms for application
  • Submition of complete request with the Regulatory agency
  • Permanent communication with the Agency until the final decision on registration

- Registration of a traditional herbal medicine

• • Collecting and preparation of documentation for registration
  • Search in the professional literature and preparation of expert opinion
  • Preparation of necessary documentation
  • Preparation of forms for application
  • Submition of complete request with the Regulatory agency

• Permanent communication with the Agency until the final decision on registration
• Post-registration regulatory activities (changes, renewals, approval of transfers etc.)

- Registration renewal
- Changes in the approval for putting the medicine on the market (all chances included
- Approval of transfer

• Strategic planning of the medicine registration procedure (pre-registration activities)
• Possibility of working also in eCTD format

MEDICAL PRODUCTS

• Manufacturer registration in the Register of producers of medical products
• Registration of medical product in the Register of medical products

FOOD AUPPLEMENTS

• Inclusion of food supplements in the monitoring program /obtaining the notification number

COSMETIC PRODICTS

• Electronic notification of cosmetic products via CPNP

Testiranje čitljivosti upute o lijeku provodi se u svrhu provjere u kojoj mjeri su bolesnici u mogućnosti pronaći, ali isto tako i razumjeti sigurnosne informacije navedene u priloženoj uputi za lijek. Ovo testiranje, dakle, nema nikakvog utjecaja na sadržaj i kvalitetu informacija već se provodi isključivo radi utvrđivanja eventualnih poteškoća u čitljivosti, odnosno razumljivosti teksta napisanog u Uputi o lijeku ili Uputstvu za uporabu tijekom njihovog uobičajenog korištenja. Testiranjem čitljivosti izdvojit će se pojedini termini ili čitava poglavlja unutar Upute o lijeku koji bolesnicima nisu jasni i koji mogu dovesti do pogrešaka u korištenju pojedinog lijeka, i na taj način će se omogućiti bolja prilagodba Upute bolesnicima.

Sukldano Direktivi 2001/83/EC dopunjenoj u Directivi 2004/27/EC, čitljivost upute priložene uz lijekove i medicinske proizvode za primjenu u ljudi obavezno je na teritoriju čitave Europske Unije i zahtjeva se njeno ispitivanje na ciljanoj populaciji (potencijalnim korisnicima) kako bi se utvrdilo da su bolesnici kao potencijslni korisnici, sposobni ispravno koristiti lijekove, odnosno koristiti ih u skladu s naputcima navedenim u Uputi.

Za više informacija o zakonskim okvirima i ostalim detaljima ispitivanja čitljivosti upute o lijeku kliknite ovdje.

Prva iskustva u ispitivanju čitljivosti datiraju još iz ranih 90-ih. Ona su pokazala da je kvalitetno proveden intervju najbolja i najčešće korištena metoda testiranja čitljivosti Upute i kao takva ta metoda je prihvaćena od regulatornih tijela. U tom smislu su izdane i službene Smjernice "Guideline on the readability of the label and package leaflet of medicinal products for human use" (EC, Revision 1, January 2009), koje propisuju detalje provođenja testiranja čitljivosti Upute, a sve u svrhu osiguranja reprezentativnosti dobivenih rezultata.

BONIFARM je izgradio standardiziranu metodu provedbe testiranja čitljivosti Upute o lijeku, vodeći posebnu brigu o standardima kvalitete, temeljem koje svojim klijentima nudimo brzu, profesionalnu i kompletnu uslugu.

• PROVJERA RAZUMLJIVOSTI UPUTE O LIJEKU (Readability user testing)
  - analiza postojeće upute o lijeku
  - sugestije i pomoć oko potrebnih izmjena PIL-a
  - pilot testiranje (3-6 ispitanika)
  - 2/3 kruga testiranja (ukupno 20/30 ispitanika)
  - izrada završnog izvješća
  - eventualna naknadna pojašnjenja u slučaju traženja od strane Agencije
• PRIPREMA I IZRADA IZVJEŠTAJA/TESTERANJA ZA PREMOŠTAVANJE REZULTATA
• CILJANA PROVJERA RAZUMLJIVOSTI UPUTE O LIJEKU (focus testing)

Obratite nam se s povjerenjem Ova e-mail adresa je zaštićena od spambota. Potrebno je omogućiti JavaScript da je vidite.!

Velik broj ljudi u ovom trenutku uzima neki lijek. Prilikom svakog uzimanja lijeka prisutan je određen rizik nastanka nuspojave, ali istovremeno sa svakim uzimanjem nekog lijeka nadopunjujemo i našu spoznaju o njegovoj učinkovitosti i sigurnosti.

Poznato je da sigurnosne informacije prikupljene tijekom kliničkih ispitivanja ne daju dovoljno podataka o rijetkim, a posebno ne o vrlo rijetkim nuspojavama nekog lijeka koje se javljaju u manje od 1 na 10.000 bolesnika koji uzimaju taj lijek, što znači da bi minimalno 30.000-60.000 bolesnika trebalo biti izloženo istom, da bi se uočila takva vrlo rijetka nuspojava. Izuzetno malo je lijekova koji su ispitivani na tolikom broju bolesnika prije stavljanja u promet i stoga je kontinuirano prikupljanje nuspojava i praćenje sigurnosti svih lijekova tijekom njihove primjene u praksi od neizmjerne važnosti za sigurnost bolesnika i za njihovo uspješno liječenje.

Pravovremeno otkrivanje, procjena i razumijevanje nuspojava, odnosno neželjenih djelovanja lijekova, ključno je za primjereno postupanja u slučaju pojave istih, ali isto tako nam omogućava poduzimanja čitavog niza mjera, čijim pridržavanjem možemo u velikoj mjeri prevenirati njihov nastanak, što je ujedno i glavni cilj farmakovigilancije kao discipline koja prikupljanjem, procjenom, identificiranjem i minimaliziranjem rizika nastoji kontinuirano osigurati da korist nadmašuje moguće rizike primjene lijekova.

Prema tome, možemo zaključiti kako je krajnja svrha farmakovigilancije osigurati dostupnost sigurnih i djelotvornih lijekova što uvelike doprinosi unaprijeđenju javnog zdravlja.

S obzirom na svoju važnost, svaka iole ozbiljnija farmaceutska kompanija nastoji uspostaviti dobar i učinkovit farmakovigilancijski sustav bez kojeg vrlo teško može održati kontinuitet svojih lijekova na tržištu. Međutim, kako je farmakovigilancija po svojoj prirodi zahtjevnija od drugih disciplina s obzirom na svoju multidisciplinarnost i izrazitu dinamičnost, vrlo često nije lako, posebno manjim farmaceutskim tvrtkama, izgraditi i održavati takav kvalitetan i učinkovit farmakovigilancijski sustav.

Svojim stručnim i iskusnim timom Bonifarm svojim klijentima osigurava upravo takav kvalitetan i funkcionalan farmakovigilancijski sustav. Naše usluge mogu biti pojedinačne, u vidu podrške središnjem uredu nositelja odobrenja pa sve do organizacije kompletnog sustava farmakovigilancije pojedinog nositelja.

FARMAKOVIGILANCIJSKE USLUGE

Farmakovigilancijske usluge na globalnoj razini

• Usluge organizacije i održavanja cjelovitog farmakovigilancijskog sustava,

• • Usluga kvalificirane odgovorne osobe za farmakovigilanciju na globalnoj razini (EU QPPV),
  • Unutarnja inspekcija (audit) farmakovigilancijskog sustava,
  • Izrada plana implementacije farmakovigilancijskog sustava,
  • Izrada SOP-a vezanih za farmakovigilanciju,
  • Edukacija osoblja uključenog u farmakovigilancijski sustav,
  • Prikupljanje i objedinjavanje informacija o svim sumnjama na nuspojave lijekova nositelja odobrenja,
  • Prikupljanje i objedinjavanje ostalih sigurnosnih informacija važnih za sigurnosni profil lijekova nositelja odobrenja (predoziranje bez vidljivih simptoma, pogreške u liječenju uključujući pogreške u izdavanju lijeka, nenamjerno izlaganje lijeku i pogrešnu primjenu, upotreba izvan odobrenih indikacija, zloupotreba, neučinkovitost, milosrdno davanje, profesionalna izloženost, izloženost u trudnoći i ishod trudnoće uključujući ishod bez posljedica, upotreba lijeka u pedijatrijskoj populaciji, važni nalazi nekliničkih ispitivanja),
  • Pretraga stručne literature indeksirane u bazama Embase i Medline,
  • Detekcija signala i evaluacija rizika za pojedini lijek,
  • Obrada prijava nuspojava, izrada Sigurnosnog izvješća o pojedinačnom slučaju (ICSR) u smislu izrade narativa, kodiranja u MedDRA-i i stručne medicinske procjene slučaja, prijava ICSR-a regulatornim tijelima putem EudraVigilance sustava,
  • Priprema i predaja izvješća o novom sigurnosnom pitanju (engl. Emerging Safety Issue),
  • Priprema i centralizirana predaja Periodičkog izvješća o neškodljivosti lijeka (PSUR) i Plana upravljanja rizicima (RMP) regulatornim tijelima,
  • unošenje podataka o lijekovima u XEVMPD i ažuriranje istih,
  • sudjelovanje u procesu zbrinjavanja pritužbi korisnika (engl. complaint) i postupku povlačenja lijeka (engl. recall) u smislu identificiranja nuspojava i sigurnosnih pitanja
  • komunikacija s nadležnim regulatornim tijelima,
  • sustavno pohranjivanje dokumentacije vezane uz poslove farmakovigilancije, te
  • izrada i održavanje glavnog spisa o farmakovigilancijskom sustavu (PSMF).

• Pojedinačne usluge u smislu potpore postojećem operativnom farmakovigilancijskom sustavu što se odnosi na bilo koju uslugu ili kombinaciju više usluga navedenih na popisu usluga koje se pružaju u sklopu organizacije i provođenja cjelovitog farmakovigilancijskog sustava na globalnoj razini.

Farmakovigilancijske usluge na lokalnoj razini

• Usluge organizacije i provođenja lokalnog farmakovigilancijskog sustava,

• • Usluga kvalificirane lokalne odgovorne osobe za farmakovigilanciju u skladu s lokalnom regulativom,
  • Ustroj i provođenje farmakovigilancijskog sustava u skladu s SOP-ima vezanim za farmakovigilanciju na globalnoj razini,
  • Edukacija osoblja uključenog u farmakovigilancijski sustav,
  • Prikupljanje informacija o svim sumnjama na nuspojave lijekova nositelja odobrenja koje potječu s lokalnog teritorija,
  • Prikupljanje i objedinjavanje ostalih sigurnosnih informacija važnih za sigurnosni profil lijekova nositelja odobrenja (predoziranje bez vidljivih simptoma, pogreške u liječenju uključujući pogreške u izdavanju lijeka, nenamjerno izlaganje lijeku i pogrešnu primjenu, upotreba izvan odobrenih indikacija, zloupotreba, neučinkovitost, milosrdno davanje, profesionalna izloženost, izloženost u trudnoći i ishod trudnoće uključujući ishod bez posljedica, upotreba lijeka u pedijatrijskoj populaciji, važni nalazi nekliničkih ispitivanja) koje potječu s lokalnog teritorija,
  • Pretraga lokalne stručne literature koja nije indeksirana u bazama Embase i Medline,
  • Prijava ICSR-a lokalnim regulatornim tijelima putem EudraVigilance sustava,
  • Obrada i predaja Periodičkog izvješća o neškodljivosti lijeka (PSUR) i Plana upravljanja rizicima (RMP) lokalnim regulatornim tijelima,
  • sudjelovanje u procesu zbrinjavanja pritužbi korisnika (engl. complaint) i postupku povlačenja lijeka (engl. recall) u smislu identificiranja nuspojava i sigurnosnih pitanja na lokalnoj razini,
  • komunikacija s nadležnim lokalnim regulatornim tijelima,
  • sustavno pohranjivanje dokumentacije vezane uz poslove farmakovigilancije, te
  • sudjelovanje u unutranjim inspekcijama farmakovigilancijskog sustava.

• Pojedinačne usluge u smislu potpore postojećem operativnom lokalnom farmakovigilancijskom sustavu sustavu što se odnosi na bilo koju uslugu ili kombinaciju više usluga navedenih na popisu usluga koje se pružaju u sklopu organizacije i provođenja farmakovigilancijskog sustava na lokalnoj razini.