Pharmacovigilance Contact Person at National Level (LCPPV)
Competent authorities in EU Member States are legally provided with the option to request the nomination of a pharmacovigilance contact person at national level reporting to the QPPV.
Ensure compliance with each country requirements within the EU. Check the Information on the Member States requirement for the nomination of a pharmacovigilance (PhV) contact person at national level – Human medicines requirements (EMA)
We currently provide the legally required figure of the local PV contact person in Spain and Portugal.
Check our blog entry about the LCPPV role in Spain
Local Contact Person for Pharmacovigilance (LCPPV)
LCPPV / Deputy LCPPV
Alone or in combination with other activities, we provide the legally required figure of the contact person for Pharmacovigilance at national level.
Local Literature Monitoring
We develop customized local literature search strategies, utilizing relevant local sources. Weekly reviews and assessment of literature hits.
Regulatory Intelligence
The NCA websites are monitored by our experts in pharmacovigilance to identify any changes in legislation or publications with impact on client's product portfolio.
ICSR Management
Collection, translation, submission to the global PV unit and follow-up at local level. Point of contact to solve NCA queries about ICSR.