Pharmacovigilance Contact Person at National Level (NPRP)
We provide an extensive network of EU local representatives or pharmacovigilance officers (NPRP – also known as local QPPV or local contact persons). These are the primary contacts for local competent authorities and work closely with EEAQPPV. It also assists in understanding the requirements of local representatives / NPRPs of relevant EU member states.
SIGNAL MANAGEMENT
Pharmacovigilance and risk management are important in the development and commercialization of medication and cover many highly regulatory activity around the world signal management can be used not only in clinical development but also in the post marketing stages of the product life cycles.
Our team has deep expertise in all signal management activities, including detection, verification, prioritization and evaluation. The team conducts a cumulative review of the data using a variety of sources e.g. Safety data from spontaneous cases, clinical trials and non-intervention studies, and literature reviews to identify and assess potential new signals. We also have sufficient training and experience in using the EudraVigilance data analysis system. It is functional and ensures that the certificate holder (MAH) meets the requirements for signal detection and management.
Our procedures for signal detection and management are written in accordance to GVP Module IX. We shall make available you with Signal Detection report to estimate effect on benefit-risk profile.
Risk Management
A product is contemplate to be “safe” if it has an suitable benefit-risk balance for conscious population and use. Risk management is the regulation within pharmacovigilance that is accountable for signal detection and the monitoring of the risk-benefit contour of medicines
A Risk Management plan (RMP) is a detailed and complex document that reflects current knowledge about safety and effectiveness of a drug risk mitigation measures are described in the risk management plan (RMP) for a particular product. Marketing authorization holders are required to obtain an RMP for any new medicinal products intended for human use. For nationally licensed products an RMP must be submitted to the HPRA for review and approval