Pharmacovigilance is the set of activities undertaken in order to ensure a safe and appropriate use of medicines. It is an essential tool for monitoring safety in the use of drugs, to protect public health, and consequently it imposes specific obligations on the health authorities and the companies that market pharmaceuticals.
It also requires close collaboration between all professionals involved, supranational, national and local health authorities as well as pharmaceutical companies. Moreover a conscious involvement of end-users, i.e. citizens-patients, is highly desirable.
In compliance with current regulations and European and national guidelines, Di Renzo Regulatory Affairs has, for some time, set up a unit (consisting of three QPPVs, two doctors, a chemist, two pharmacists, three graduates in pharmaceutical chemistry, two biotechnical doctors, two IT specialists, a language graduate and three administrative personnel) able to offer clients a complete outsourcing of pharmacovigilance service.
Di Renzo Regulatory Affairs has a validated Pharmacovigilance database that facilitates the recording and safe keeping of all Individual Case Safety Reports (ICSRs) relating to suspected adverse reactions, in accordance with the provisions of the current legislation.
The services offered are as follows:
- Assume the role of the European Qualified Person for Pharmacovigilance (EU-QPPV)
- Assume the role of Local contact point
- Validated Pharmacovigilance database
- Daily checks of the National Network of Pharmacovigilance (RNF)
- Periodic inspection of national and international scientific literature for medicinal products and active substances
- Inclusion of cases of Italian literature in the National Network of Pharmacovigilance (RNF)
- Information requests for follow-ups
- Translation into English of ADRs in CIOMS format and / or in xml format in accordance with the E2B standard
- Inserting ICSRs in EudraVigilance
- Insertion and update of medicinal products in the European database Extended EudraVigilance Medicinal Product Dictionary (XEVMPD)
- Audits and preparation for inspections by regulatory authorities
- Pharmacovigilance Training for pharmaceutical sales representatives and / or company personnel
- Preparation of Periodic Safety Update Reports (PSURs)
- Preparation of Standard Operating Procedures (SOPs)
- Preparation of the Risk Management Plan (RMP)
- Preparation, maintenance and updating the Pharmacovigilance System Master File (PSMF)
- Drafting, reviewing and updating the Safety Data Exchange Agreements (SDEA)
- Data Entry