Pharmacovigilance

A robust and compliant pharmacovigilance system requires expertise in the following areas: medicine, regulatory, and technology.
Our PV service is covering all types of softwares from inhouse PV system to global PV software of ARGUS, provides you with simple yet transparent approach to undertaking PV electronic reporting, in a manner that meets the needs of regulatory authorities. Our full service provision will service all your needs from a PV system, appropriately qualified personnel to set up and management of PV database. Alternatively we can combine modified elements of the system to match your exact requirements. Robust, cost-effective and compliant manner certified and inspected by many EU/US Authorities.

The scope of a PV System

  • Complete set up of PV system
  • Integrated safety summaries
  • Company core data sheet generation and maintenances
  • Safety and Surveillance Programs for investigational and marketed products
  • Risk mitigation and management plans
  • Risk evaluation and mitigation programs (REMS)
  • Quality control systems for off-shored PV services
  • Mock safety audits
  • Audit Periodic Safety Reports to the FDA
  • Audit preparation
  • Data review, coding and narrative review, plus document verification on Adverse Event case reports
  • Placement of trained PV specialists at client companies

Pharmacovigilance Strategy

What is pharmacovigilance?
Pharmacovigilance, sometimes shortened to “PV,” is the science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications and biologics.

A robust pharmacovigilance strategy requires expertise in the following areas: medicine, regulatory, and technology.

Our PV cloud service, utilising global PV software of ARGUS, provides you with simple yet transparent approach to undertaking PV electronic reporting, in a manner that meets the needs of regulatory authorities. Our full service provision includes a PV system, appropriately qualified personnel and a database. Alternatively we can combine modified elements of the system to match your exact requirements. Robust, cost-effective and compliant manner.

The scope of a PV System

  • Complete set up of PV system
  • Integrated safety summaries
  • Company core data sheet generation and maintenances
  • Safety and Surveillance Programs for investigational and marketed products
  • Risk mitigation and management plans
  • Risk evaluation and mitigation programs (REMS)
  • Quality control systems for off-shored PV services
  • Mock safety audits
  • Audit Periodic Safety Reports to the FDA
  • Audit preparation
  • Data review, coding and narrative review, plus document verification on Adverse Event case reports
  • Placement of trained PV specialists at client companies

Eudravigilance Support

EudraVigilance is a system for monitoring the safety of medicines. Its components facilitate electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the early detection of potential safety issues.

The system contains different components that perform specific tasks in the process of electronic reporting of suspected adverse drug reactions.

PharmAZet Alliance Group has successful records of PV inspections by leading EU/US Authorities thus able to offer excellent PV services, managed by highly experienced PV specialists – our team currently includes 4 fully qualified EU QP PVs with full DIA certifications and medical qualification.

We can provide your company with a complete network for EudraVigilance data processing and a management system for reporting and evaluating suspect adverse reactions during the development of new drugs and for following the marketing authorisation of medicinal products in the European Economic Area (EEA), offering global PV software – ARGUS on a client licence base or as complex PV service support for case processing.

The European EudraVigilance system deals with the electronic exchange of Individual Case Safety Reports (ICSR, based on the ICH E2BM specifications), EudraVigilance Clinical Trial Module (EVCTM) for reporting Suspected Unexpected Serious Adverse Reactions (SUSARs) and EudraVigilance Post-Authorisation Module (EVPM) for post-authorisation ICSRs.

Our PV Specialists/EU QP PVs have over 10 years’ experience within PV, so our services are always highly professional, efficient and cost effective, especially as this is an area where only experienced experts are the correct choice.

xEVMPD

EU pharmacovigilance legislation now requires all Marketing Authorisation Holders in Europe to electronically submit detailed, XML-based product records to the European Medicine Agency’s EudraVigilance Medicinal Product Dictionary (EVMPD). For MAHs that fail to comply, the consequences are punitive a potential fine of up to 5% of gross profit in the European market.

The EVMPD has been developed by the EMA in collaboration with the EudraVigilance implementation to help the pharmacovigilance activities in the European Economic Area. The EVMPD was designed to support the collection, reporting, coding and evaluation of authorised and investigational medicinal product information in a standardised and structured way.

Extended Medicinal Product Dictionary (XEVMPD) is a re-branding of the EVMPD to reflect the new format for the Electronic Submission of Information on Medicines published by the EMA in July 2011. XEVMPD has been developed to allow the EMA to create a list of all medicines authorised and registered in the EU, to identify medicines accurately (especially those included in reports of suspected adverse reactions), and to co-ordinate the regulation and safety monitoring of medicines across the EU.

EU QPPV

A Qualified Person Responsible for Pharmacovigilance, or QPPV, is an individual named by a pharmaceutical company as the main person responsible for ensuring that the company (the product’s Marketing Authorisation Holder or MAH) meets its legal obligations for the monitoring of the safety of a medicinal product on the market.

When a company submits an application for permission to bring a medicinal product onto the market, the company submits a description of its system for monitoring the safety of the product in actual use (a pharmacovigilance system) and proof that the services of a QPPV are in place.

Our PV Specialists/EU QP PVs have over 10 years’ experience in the PV area so our services are always highly professional, efficient and cost effective, especially as this is an area where only experienced experts are the correct choice.

PharmAZet QPPV acts as the primary and single point of contact to EMA, and other national competent authorities, and on behalf of MAH communicate new and emerging safety concerns in a timely manner PharmAZet provides oversight of the MAH’s or client’s safety systems, processes and procedures and a benefit-risk analysis.

PharmAZet provides the required knowledge and expertise for interpreting and applying local and global safety regulations ensuring:

  • Performance and maintenance of MAH’s pharmacovigilance Systems and risk management, and oversee pharmacovigilance audits to assess regulatory compliance.
  • Timely submission, and quality of aggregated data reports (e.g. PSURs, Post authorization study reports, risk management findings) and other documents required by European Health Authorities.
  • Adequate quality assurance, control, performance, and measurement to include SOPs and work instructions to cover all processes relevant to Pharmacovigilance.
  • All personnel involved in the pharmacovigilance system receive adequate training on all aspects of an EU regulatory mandate affecting pharmacovigilance.

Literature Searching

Information obtained from medical and scientific literature is an important source of patient safety data and can contribute enormously to the safety profile of a medicinal product. It is a regulatory requirement for the marketing authorisation holder (MAH) of a medicinal product to perform regular searches of the scientific literature, including any unpublished manuscripts and abstracts presented at medical or scientific conferences.

Due to the complexity and variety of the data sources available, scientific literature management for pharmacovigilance is a complex process. However, scientific literature is an important source of adverse drug reaction (ADRs).

PharmAZet is able to perform a far more effective literature search than the majority of other consultancies, the reason behind this is our experienced PV experts have access to dozens of online databases (such as PubMed, UpToDate, Ovid MEDLINE, Micromedex, MD Consult, CINAHL,EMBASE, Web) and while all literature searches are comprehensive and in depth, we are most proud of the high efficiency that we can guarantee.

PV System

  • Special issue work-up
  • Integrated safety summaries
  • Company core data sheet generation and maintenances
  • Safety and Surveillance Programs for investigational and marketed products
  • Risk mitigation and management plans
  • Risk evaluation and mitigation programs (REMS)
  • Quality control systems for off-shored PV services
  • Mock safety audits
  • Audit Periodic Safety Reports to the FDA
  • Audit preparation
  • Data review, coding and narrative review, plus document verification on Adverse Event case reports
  • Placement of trained PV specialists at client companies

PSUR’s

According to the company’s specific requirements and needs, PharmAZet offers both the compilation of complete PSURs, and the provision of cross-company pooled PSURs in the form of PSUR templates.

When a customized PSUR is ordered, a complete PSUR in compliance with all regulatory requirements is written. The finished PSUR includes an Executive Summary, Introduction, Worldwide Market Authorisation Status, Update of regulatory authority or MAH actions taken for safety reasons, changes to reference safety information, patient exposure presentation of individual case history, studies, overall safety evaluation conclusion, and appendices (line listings, SmPC). The PSUR is delivered as one print copy and on digital copy (for editing).

Access to national and global safety databases is also essential so we always ensure that all possible sources are evaluated prior finalising such essential safety document as PSUR.