FARMAKOVIGILANCA

FARMAKOVIGILANCA

V podjetju PharmReg d.o.o. nudimo farmakovigilančno podporo. Delujemo kot prva kontaktna točka za nacionalni pristojni organ.

V podjetju PharmReg nudimo na področju farmakovigilance zdravil naslednje pogodbene storitve:

  • strokovne nasvete na področju farmakovigilance;
  • izvajanje storitev v skladu z dobro farmakovigilančno prakso (GvP);
  • nudenje storitev izobraženega in usposobljenega osebja za farmakovigilanco v vlogi lokalne odgovorne osebe za farmakovigilanco (LPPV) z 24-urno dosegljivostjo;
  • izvajanje vseh nalog na področju farmakovigilance, kot je pregled nacionalne literature, zaznavanje varnostnih signalov, priprava standardnih operativnih postopkov (SOP), oblikovanje lokalnih dokumentov kakovosti za farmakovigilanco;
  • zbiranje in poročanje o vseh neželenih učinkih/dogodkih in poročil o drugih varnostnih spremembah;
  • priprava načrta PSUR/PBRER/PADER za zdravila;
  • preverjanje spletne strani lokalno pristojnega organa in spremljanje lokalne zakonodaje o farmakovigilanci;
  • upravljanje in spremljanje vseh neskladnosti/odstopanj in CAPA, povezanih z lokalnimi postopki in procesi farmakovigilance;
  • nudimo načrt vzpostave postopka za odpoklic zdravila.

At PharmReg d.o.o. we provide pharmacovigilance support. We act as the first point of contact for the national competent authority.

PharmReg offers the following contractual services in the field of pharmacovigilance of medicinal products:

  • Expert advice on pharmacovigilance;
  • Provision of services in accordance with Good Pharmacovigilance Practice (GvP);
  • Provision of services by trained and qualified pharmacovigilance staff in the role of Local Contact Person for Pharmacovigilance (LPPV) with 24-hour availability;
  • Performing all pharmacovigilance tasks such as national literature review, detection of safety signals, development of standard operating procedures (SOPs), development of local quality documents for pharmacovigilance;
  • Collection and reporting of all adverse reactions/events and reports of other safety changes;
  • Preparation of a PSUR/PBRER/PADER plan for medicinal products;
  • Monitoring National Competent Authorities website and local pharmacovigilance legislation;
  • Management and follow-up of all non-compliances/ deviations and CAPAs related to local pharmacovigilance procedures and processes;
  • provide a roadmap for the implementation of the product recall procedure.