What do you need to know while preparing RMP for EAEU and CIS region?
Preparation of Risk Management Plan (RMP) for a specific medicinal product usually is the responsibility of the Qualified Person Responsible for Pharmacovigilance (QPPV) and its team. Thus, QPPVs and their team’s should be familiar with legislation requirements...
MAH is the Key to the Pharmacovigilance: 10-year Lithuania Statistics
Even though the drug safety and reporting of the adverse effects is the responsibility of all Health Care Providers (HCP), pharmacists and patients, statistics show that the one in charge is Marketing Authorization Holder (MAH). During the National semi-annual...
Biomapas appoints Head of Global Pharmacovigilance
March 2020 – Clinical, regulatory and pharmacovigilance solution provider to the global life science industry, Biomapas, appointed leading pharmacovigilance professional Martijn van de Leur as Head of Global Pharmacovigilance. With offices located in Lithuania,...
What is a Safety Signal?
Occasionally we see the information of a safety signal for medical product, but what does it really mean? We can describe the safety signal as an indication for new and significant safety-related data for a marketed product. The new data could indicate a new...
