Veterinarska zdravila

illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.

Veterinarska zdravila

Nova uredba o veterinarskih zdravilih (Uredba (EU) 2019/6), ki je začela veljati 28. januarja 2022, je posodobila obstoječa pravila o odobritvi in uporabi veterinarskih zdravil v Evropski uniji (EU).

STORITVE

  • Učinkovita uvedba nove uredbe o veterinarskih zdravilih (Uredba (EU) 2019/6)
  • Skladnost z dobro farmakovigilančno prakso v zvezi z zdravili za uporabo v veterinarski medicini (VGVP)
  • Storitev osebe, odgovorne za farmakovigilanco (24/7), z dostopom do veterinarja
  • Vzpostavitev in vzdrževanje glavnega dosjeja o sistemu farmakovigilance (PSMF)
  • Vzpostavitev in vzdrževanje sistema farmakovigilance in sistema kakovosti, vključno z usposabljanjem osebja
  • Zbiranje, evidentiranje ter poročanje o domnevnih neželenih dogodkih 
  • Redno ocenjevanje razmerja med koristmi in tveganji
  • Redna obravnava signalov
  • Vzpostavitev ustreznih pogodbenih dogovorov ter nadzor
  • Presoje in svetovanje pred inšpekcijskimi nadzori
illev Pharma East has a highly educated and dedicated team of international experts with many years of experience in Pharmaceutical industry.
medicine

I think it is quite remarkable how we as humans have improved in the pharmaceutical and medical fields in the last 100 years. I am sure that we will remain courageous and continue to innovate!

Martina

Božíková

MASTER'S in PHARMACY REGULATORY AFFAIRS & PHARMACOVIGILANCE OFFICER