Pharmacovigilance

Pharmacovigilance (PV) is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medicines, biological products, herbals and traditional medicines with a view to:

• Identifying information about potential new hazards.
• Preventing harm to patients.

In EU the pharmacovigilance is regulated by the guidelines drawn up by the European Commission in accordance with Article 106 of Directive 2001/83/EC of the European Parliament and the Council are published as Volume 9A of The Rules Governing Medicinal Products in the EU.

JSC Sveikuva provides range of post-marketing pharmacovigilance (PV) services for marketing authorisation holders:

If you are looking for local PV support in Lithuania, Latvia and Estonia:

We are ready to:

• Act as local contacts for PV for authorities
• Monitor local literature for adverse events (or any source of information about your medicines)
• Perform local personnel trainings
• Process suspected ADRs (collection, translation and forwarding of the information, follow-up)

If you are looking for general post-marketing PV support:

We are ready to:

• Appoint QPPV (Qualified Person Responsible for Pharmacovigilance)
• Register your company in EudraVigilance
• Provide management of pharmacovigilance data
• Process of case data
• Report to competent authorities
• Enter data to EudraVigilance
• Perform literature monitoring (world wide and local)
• Prepare PSURs
• Evaluate safety data
• Prepare of reference safety information
• Perform regulatory submissions