Compliance & Safety

The Pharmacovigilance Systems Master File (PSMF)

As part of any license submission in Europe, a Company must be able to demonstrate that it has a PSMF in place.  This document is a European requirement which has global implications for the Company, because it must contain how the Company performs Pharmacovigilance activities globally, not just in the European region.

The document, formed out of the Module II EU legislation and in compliance with 2001/83 and 2010/84 legislation, requires the Company to detail not only how Pharmacovigilance is conducted in the company, but how all allied departments linked to the Safety Department operate to ensure safety information is properly communicated within the Company as well as externally to Regulatory Authorities and Prescribers and patients. Hence, the document will have input from Regulatory, Pre-Clinical and Clinical, Marketing and Commercial, Quality Assurance and Compliance, Manufacturing, Medical Information, Information Technology and Training.

For the activities described in the document, the requisite SOPs and working practices need to be recorded, maintained as one of the annexes to the document and as part of Quality Management another annex will detail the compliance activities of the company in reporting cases and PSURs to the Regulatory Agencies.

Another annex details audits, both internal and external for distributors and partners. This is part of the Company Quality Management System (QMS) and is another legal requirement to perform from Module I and helps to test and improve the systems in operation.

This document is an ‘Inspection ready’ document and must be maintained in an up to date state as the Regulators in Europe will use it when conducting their inspections of the Company and is what it will be measured against.

Prior to the new legislation in the EU becoming law in July 2012, Companies had a document in place similar to the PSMF called the Detailed Description of Pharmacovigilance Systems (DDPS).  This document served a similar purpose in describing the Company details of the Pharmacovigilance system in place, including the EU QP PV & Deputy. It described how the Company would manage the Pharmacovigilance of the product if a license was granted in accordance with EU legislation as specified in Vol IXa (now replaced). This DDPS must be retired, along any versions in place. All companies operating within the EU, with marketed products, were required to have a PSMF in place by July 2015.

The DDPS and one of the annexes within the PSMF, also describes information concerning the EU Qualified Person for Pharmacovigilance. This person is integral to license holders in Europe since every company should have one as well as a competent deputy.  Just as the PSMF is the document the Regulators want to see at the Inspection, the EU QP PV and their Deputy are the people they most want to see because they ‘own’ the Pharmacovigilance system and therefore know everything about the PSMF.

Qualified Persons for Pharmacovigilance

PharSafer® can provide the services of a European Qualified Person for Pharmacovigilance (EU QP PV), as well as an appropriately qualified Deputy. It is a pre-requisite of all license holders in the EU and any company submitting a license for approval, that the services for an EU Qualified Person for Pharmacovigilance and suitably qualified and competent Deputy be available to represent the Company on safety matters. As a pre-requisite, the EU QP PV must be ‘trained in all aspects of Pharmacovigilance both theoretical and practical’ as stated in the Regulations – including Module I, and their CV must be submitted to the Regulatory Agencies for approval.

The EU QP PV is critical role within any Pharmaceutical Company.  The experience and knowledge of the EU QP PV is a key part of the safety management of the Company products, systems and compliance to legislation and are the main person to be interviewed during Regulatory Inspections in the EU, expected to explain the Company’s Pharmacovigilance approach.

Additionally, in the EU, there are requirements for nationally resident QPs for Pharmacovigilance, depending on National Law.  PharSafer® can help by providing National QPs for those EU (and non-EU) countries requiring such persons.

A number of our personnel have the experience to be the EU Qualified Person for Pharmacovigilance. We operate an internal mentoring role, training our most experienced and qualified personnel into the position.  Our mentors are themselves, very experienced in this role and have served in this capacity for the last 20 years for major Pharmaceutical Companies.

PharSafer® can provide our clients with Qualified Persons for Pharmacovigilance both for the EU and for non-EU Countries.

Audits and Regulatory Inspections

There are a number of ways of assessing the Company progress towards an acceptable Regulatory level of compliance and Quality. Such measurements can be performed in a number of ways designed to be flexible within the Company but ensure compliance progression and enhanced business processes and Quality outputs.

These are largely achieved by:

• Audits
• Regulatory Inspections (and Pre-Inspection preparation)
• Gap-fill analyses
• Quality Management implementation & maintenance
• Due Diligence – Company/Product acquisitions and mergers