Local Pharmacovigilance Representation

With its wide Local Safety Officers (LSOs) network, Biomapas can fulfil 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 trainings to local Marketing Authorisation Holders personnel.

 

For any inquiry regarding our services, please contact Biomapas Business Development team.

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