PV Regulatory Intelligence

Insuvia provides PV Regulatory Intelligence services and ensures that our clients maintain compliance with the latest regulatory requirements and guidelines. We provide central oversight of regional/global requirements (EMA, ICH, etc.) as well as utilize our Local PV infrastructure and LPPVs (Local Persons for Pharmacovigilance) to gather local PV regulatory intelligence from National Competent Authorities.

We promptly communicate PV regulatory Intelligence updates to clients, providing a summary, an impact assessment and any necessary actions. Our PV regulatory intelligence service can be tailored to the clients’ needs in terms of territories, content, frequency and other aspects.

Services Offered:

PV Regulatory Intelligence on new PV requirements, changes, and developments to watch

Regional Pharmacovigilance Regulatory Intelligence (EMA, MHRA, FDA, ICH, WHO, etc.)

Local Regulatory Intelligence (national / country specific updates on PV requirements)

Intelligence on local reporting requirements (ICSRs, SUSARs/SAEs, PSURs, DSURs, etc.)

Countries covered
Local PV experts
We communicate urgent updates within 24h

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Feb 25, 2022

Requirements for Nomination of a PV Contact Person

Under the requirements for the EU pharmacovigilance system, the Marketing Authorization Holders…

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Dec 16, 2020

BREXIT – Key Changes in the UK Pharmacovigilance System

The United Kingdom (UK) has left the European Union (EU), and the…

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Feb 24, 2020

The Deadline to Appoint Your UK QPPV Post BREXIT

As confirmed by Senior Inspector, Kiernan Trevett, at the MHRA GPvP Symposium,…