Local Pharmacovigilance Representation
With its wide Local Safety Officers (LSOs) network, Biomapas can fulfill all and any local Marketing Authorisation Holder’s obligations in EU and non-EU countries and perform all local pharmacovigilance representation activities, including:
- Appointment of Lead LSO and Deputy LSO for each country and their nomination to the local Competent Authority;
- 24/7 availability, where required;
- Weekly monitoring of locally published scientific and medical literature;
- Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable;
- National regulatory intelligence;
- Local support in Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) handling;
- Delivery of pharmacovigilance training to local Marketing Authorisation Holders personnel.
