EU QPPV and Deputy QPPV

The Guideline on good pharmacovigilance practices (GVP) Module 1 – Pharmacovigilance systems and their quality systems, states that as part of the pharmacovigilance system, the market authorisation holder must have permanently and continuously at its disposal, an appropriately qualified person responsible for pharmacovigilance in the EU (EU QPPV).

Local QPPV/ Named Safety Contacts
(NSC) across global territories

Competent authorities in Member States are legally provided with an option to request the nomination of a pharmacovigilance contact person at national level reporting to the EU QPPV. A contact person at national level may also be nominated as the local QPPV. Member States that do not stipulate a local QPPV would require an NSC to cover local surveillance activities. Local QPPVs are also mandated in national legislation within certain third countries.

Scientific Literature Monitoring

Utilising our ‘state-of-the art’, deep mining tool, we have an established literature monitoring process that covers over 12 literature databases including PubMed and Embase, providing de-duplicated, unique results in an exceptionally time-efficient and coherent manner.

Pharmacovigilance
System Oversight

The PSMF is described in GVP Module II. It is a modular document that outlines the various aspects of the pharmacovigilance system of a Marketing Authorisation Holder (MAH). The document must be maintained in an up to date state and can be requested by a competent authority within a 7 calendar day deadline for delivery.

Pharmacovigilance
and Drug Safety Operations

An integrated (E2B), case processing and expedited reporting service utilising our own dedicated safety database or our clients’ systems.

Our legacy-data transfer service involves dedicated IT subject matter experts to manage all of the pre-and post-migration activities in compliance with regulations.

Standard Operating Procedures

Standard Operating Procedures are a mandatory requirement within any self-respectng Quality Management System. Our subject matter experts conduct gap analyses, whilst producing and maintaining our clients’ SOP suites. Training on SOPs and managing training curriculae forms part of the package.

Audits and Inspections

Partner audits are an integral and mandatory requirement for a Market Authorisation Holder. We provide trained experts to plan your audits, conduct and report findings in a cost-effective manner. Our Inspection-readiness programme applies tested methods to help produce effective Inspection outcomes.

Training

IntuVigilance offers one-off, on-going and new training to ensure that our customers are consistently on top of changing PV requirements. We offer customisable training packages and assist with developing training material to suit all levels.

Regulatory Intelligence Database

Global country requirements form the basis of everything we do within drug safety and pharmacovigilance. Knowing the legislation in concerned countries, ensuring that you use the most current information and keeping on top of changing legislative requirements is a challenge across the Industry.

Peripheral Services

Our qualified partners across the world provide a number of peripheral services to complement our offerings.

Regulatory Affairs

Pre-marketing Activities
Post-marketing maintenance
Regulatory Project Management

Medical Writing

Non-Clinical and Clinical Writing
Regulatory Writing
Scientific and Technical Writing

24/7 Medical Monitoring Services

Dedicated team of physicians
State-of-the-art technology
Call-handling and document management system

QA Services

Specialist GCP and GMP services
Audits, Gap Analysis, Due Diligence
Training and QP Services