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Pharmacovigilance (PV) is defined as the science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other drug-related problem. The aims of PV are to enhance patient care and patient safety in relation to the use of medicines; and to support public health programmes by providing reliable, balanced information for the effective assessment of the risk-benefit profile of medicines. (WHO information)
The pharmacovigilance system in the European Union (EU) operates with the management and involvement of regulatory authorities in Member States, the European Commission and the European Medicines Agency. In some Member States, regional centres are in place under the coordination of the national competent authority. (EMEA information)
We can help you if you are looking for local pharmacovigilance person in Estonia, Latvia or Lithuania.
Moreover we can:
• Perform local and word wide literature screening for adverse events.
• Perform literature screening of any information source you are requested.
• Perform personnel pharmacovigilance trainings.
• Process if any adverse reaction will be reported.
• Provide management of pharmacovigilance data.
If you need general pharmacovigilance support we can:
• Prepare risk Management Plan.
• Prepare periodic safety update report.
• Register your company in EudraVigilance.
• Enter data to EudraVigilance.
• Prepare adverse reaction reports.
• Perform adverse events / reactions reporting to competent authorities
• Dedicate Qualified Person Responsible for Pharmacovigilance (QPPV)
If you need further information please don‘t hesitate to contact:
Regulatory Affairs Manager/Responsible Person
+370 601 24040