PHARMACOVIGILANCE
SURVEILLANCE, QUALITY SYSTEM, QUALIFIED PERSON
“Pharmacovigilance is the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem. It is therefore essential that the safety of all medicines is monitored throughout their use in healthcare practice.”
Pharmacovigilance
Indicative scope of services:
- Quality System (QS) compilation, introduction including preparation of Standard Operating Procedures (SOP)
- Collecting – assessing reports on Adverse Drug Reactions (ADR) – Risk assessments
- Collecting other safety data (studies, follow scientific literature, etc.)
- Detecting safety signals, identified risks, and adopting – implementing safety measures
- Preparation of safety data in Periodic Safety Update Reports (PSUR)
- Risk management plans – risk minimisation measures
- Reporting to EudraVigilance
- Availability for PV audit of MAH, inspections and medicinal agencies
Vigilance
Indicative scope of services:
- Quality System (QS) preparation with its implementation including preparation of Standard Operating Procedures (SOP)
- Responsible Person for vigilance
Device Specific Reports (FSCA Reports, Use Errors, Periodic Summary Reporting, Trend Reporting) - Introduction of any safety measures
- Collection and evaluation of complication reports
- Monitoring of investigation the complication
- Medical technical support
- Coordination – reporting incidemts to the responsible authorities
- Reporting to the medical device vigilance system (EudraMed)
- Regular systematic literature monitoring
Cosmetovigilance
As per Regulation (EC) No 1223/2009 Cosmetovigilance concerns all cosmetic products placed on the market.
Indicative scope of services:
- Responsible Person for cosmetic products
- Collecting undesirable effects
- Gathering the corresponding information on undesirable effects
- Document, investigate, validate and evaluate undesirable cases within a context of prevention
- Reporting on undesirable effects, serious undesirable effects and corrective measures
- Implementation of corrective or preventive measures
- Performing studies and preparing reports concerning the safety use of cosmetic products