Pharmacovigilance

Our pharmacovigilance support ranges from full, 24/7 assistance service with global coverage, to tailored services based on client needs.

Therapeutic Expertise in Clinical Trials
Geographical Coverage in Clinical Trials

Clinical safety

Medical Monitoring

Pharmacovigilance System including EU-QPPV

EudraVigilance including XEVMPD Support

Pharmacovigilance Database

Materiovigilance

Local Pharmacovigilance Representation

Medical Information

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.

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

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