MAHs are required to establish or have access to a Pharmacovigilance (PV) System which covers all PV activities, including organizational aspects, collection and processing of PV information, reporting to authorities, signal detection and initiating appropriate measures for risk reduction.
- We consult on the development of PV system including standard operating procedures (SOPs) for our client in accordance with local/regional guideline on Good PV Practice (GVP).
- We audit PV system and recommend modification and upgrade if necessary.
- Risk assessment expertise.
- Providing input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
No Records Found.