Pharmacovigilance & medical device vigilance

End-to-end local pharmacovigilance and medical device vigilance services in Israel that include:

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• Local Israeli qualified persons for pharmacovigilance (QPPV) – appointment of Lead LQPPV and Deputy LQPPV for each client and their nomination in the Israeli Competent Authority.

• Case Processing – Local processing of Individual Case Safety Reports (ICSRs), including reporting to the local Competent Authority, where applicable

• Regulatory Intelligence – Local regulatory intelligence

• RMP – Local support in the creation and implementation of Risk Management Plans (RMPs).

• Periodic Safety Update Reports (PSURs) – handling, reviewing, and locally submitting of periodic reports, such as Periodic Safety Update Reports (PSUR)

• Pharmacovigilance training – delivery of pharmacovigilance training to local Marketing Authorization Holders and other stakeholders’ personnel

• Local literature search – monitoring scientific and medical literature that is published locally.

• PV Consulting – direct access to strategic advisors and SMEs