Pharmacovigilance

Qplus consult is your full-service partner for vigilance

 

Pharmacovigilance (PV)

Materiovigilance – Cosmetovigilance – Nutrivigilance

Working for both EU Corporate organisations & local affiliates, Qplus consult understands international as well as company-specific requirements. Even more, our focus on quality and customer satisfaction has resulted in a proven record of exceeding the clients’ expectations. As experts in the field, we are frequently invited to keep in-company workshops highlighting the implementation of regulatory requirements.

Marketing Authorisation Holders (MAH) must comply to specific pharmacovigilance requirements. Our pharmacovigilance and Quality Management System are regularly inspected by the Belgian regulatory authority (federal agency for medicines and health products or FAMPH). This ensures that all our activities are in line with applicable standards.

Need a PV expert? Contact us for a free appointment!

Call +32 (0)2 889 05 68

or

Send an email

“Understanding and correctly implementing relevant vigilance regulations & requirements, full service and a senior expertise convince us to trust our vigilance to Qplus consult.”

say life science companies who select Qplus consult as their preferred partner

Our vigilance services

Adverse Event Management and expedited reporting to EudraVigilance

Receipt & recording
Follow-up
Quality control
Medical assessment
Expedited reporting (entry in EudraVigilance)
Reconciliation
24/7 availability and testing

Our adverse event (case) management team supports (bio)pharmaceutical companies of all sizes and therapeutic groups with compliance to applicable pharmacovigilance requirements. From adverse event receipt to medical assessment and follow-up, including ‘special situation’ handling, evaluation and follow-up. We report the cases to the Competent Authorities via EudraVigilance or record it into your company specific database. Depending on your needs, we follow Qplus consult’s or your internal procedures. We assist with the set-up and implementation of the necessary ‘interfacing’ procedure for exchange of safety data between your company and Qplus consult.
Contact us today for a free appointment to find out how we can assist you.


Pharmacovigilance System & Pharmacovigilance System Master File (PSMF)

Development of a suitable system for your organisation and products
Setting up processes and writing procedures
Establishment and maintenance of the Pharmacovigilance System Master File (PSMF)
Including the possibility to act as ‘your location’ of the PSMF
Defining KPI’s & metrics and reporting
Gap Analysis and mapping for implementation of General Data Protection Regulation (GDPR) for pharmacovigilance departments

The Pharmacovigilance System Master File (PSMF) provides a detailed description of the pharmacovigilance system with respect to one or more authorised medicinal products. Qplus consult guides you with the creation and shaping of your pharmacovigilance system (complete or partial) and the establishment of a PSMF.
Contact us today for a free appointment to find out how we can assist you.


Global and local literature screening

Global literature screening: advice on how to perform online literature searches, screen and record the search results, and report the findings
Local literature screening: advice on how to select and screen local journals and websites, and record and report any relevant information
Medical Literature Monitoring (MLM) follow-up
Recording and reporting
Medical assessment

Marketing Authorisation Holders (MAH) are obliged to screen medical and scientific literature to ensure that (new) safety information of their products and active substances is duly noted and, if required, reported to the Competent Authorities. Our dedicated and qualified pharmacovigilance team is experienced in carrying out this activity on your behalf and can manage all your literature-screening requirements.
Contact us today for a free appointment to find out how we can assist you.


EU Qualified Person for Pharmacovigilance (QPPV)

Contracted EU Qualified Person responsible for Pharmacovigilance (QPPV) and/or Deputy
Fully qualified and compliant with European and national regulations, laws and legislation
24/7 availability and testing

The Qualified Person responsible for Pharmacovigilance (QPPV) is personally responsible for the safety of the human pharmaceutical products marketed by a company in the European Union (EU). (Bio)pharmaceutical companies must provide proof that a QPPV was appointed when they submit an application for permission to bring a product on the market. Our experienced QPPV and/or Deputy QPPV help you fulfil all applicable European and national requirements, thereby avoiding additional employment capacity.
Contact us today for a free appointment to find out how we can assist you.


Local Contact Person (LCP) for Pharmacovigilance in Belgium, Luxembourg and the Netherlands

Contracted Local Contact Person for pharmacovigilance in Belgium, Luxembourg, the Netherlands
Fully qualified and compliant with European and national regulations, laws and legislation
24/7 availability and testing

The Local Contact Person (LCP) performs daily pharmacovigilance (PV) tasks and activities per national legislation. He or she ensures among other things communication with and reporting to the EU Qualified Person for Pharmacovigilance (QPPV), registration and contact with local competent authorities, the monitoring of relevant legislation, guidelines and procedures, a well-designed PV system capable of handling notifications in all national languages, and access to medical expertise. Our experienced LCP helps you with these daily PV tasks and activities, thereby avoiding additional employment capacity.
Contact us today for a free appointment to find out how we can assist you.


Signal Management & EudraVigilance data analysis system (EVDAS) database

Complete system for benefit/risk assessment and signal management
Statistical analysis of EudraVigilance data and Individual Case Safety Report (ICSR) review
Medical assessment and reporting
Advice on reference safety information updates (Patient Information Leaflet [PIL], Summary of Product Characteristics [SmPC], Company Core Data sheet [CCDS])
Clinical Expert Overview to support safety variations

Signal management is one of the most crucial steps in pharmacovigilance. However, monitoring and identifying safety signals is an intricate and data-intensive process. Thanks to our experience and approach, we can simplify this process and ultimately reduce your costs without affecting the quality.
Contact us today for a free appointment to find out how we can assist you.


Risk Management Plan (RMP) and Risk Minimisation Measures (RMM)

Development of a Risk Management Plan (RMP) for a new application or revision of the existing RMP
Medical assessment
Advice on reference safety information updates (Patient Information Leaflet [PIL], Summary of Product Characteristics [SmPC], Company Core Data sheet [CCDS])
Advice on Risk Minimization Measures (RMMs)

The scope, form and documentation used in pharmaceutical risk management should be tailored to suit the specific risks in question. Qplus consult has years of experience in developing Risk Management Plans (RMP) and measures for products from various therapeutic areas.
Contact us today for a free appointment to find out how we can assist you.


Periodic Safety Update Report (PSUR)

Preparing and writing a Periodic Safety Update Report (PSUR) for medicinal products for human use for any therapeutic area (including submission and follow-up on feedback of authorities)
Advice on reference safety information updates (Patient Information Leafelet [PIL], Summary of Product Characteristics [SmPC], Company Core Data sheet [CCDS])
Clinical Expert Overview to support safety variations

The goal of the PSUR is to present an exhausting and critical analysis of the risk-benefit balance of your medicinal product, taking into account newly emerging and historical safety information. Hence, the PSUR is updated on an ongoing basis and at defined time points after product’s authorisation. This document is mandatory for both centrally and nationally authorised products. Our medical writers and PV experts assist you with the preparation and writing of your PSUR making sure you comply with all European standards and requirements as defined in the Good Pharmacovigilance Practice (GVP) guidelines. Contact us today for a free appointment to find out how we can assist you.


Art. 57 database: eXtended EudraVigilance Medicinal Product Dictionary (XEVMPD)

Entry of new and updated authorised medicinal products within the legally required timelines
Regular review and maintenance

XEVMPD stands for eXtended EudraVigilance Medicinal Product Dictionary, a database where all Marketing Authorisation Holders (MAH) must submit and update their product details to the European Medicines Agency (EMA). We make sure you comply with the latest guidelines by reviewing and updating your product information on a regular basis.
Contact us today for a free appointment to find out how we can assist you.


Audits

Perform internal audits, self-inspections and reporting
Audit your pharmacovigilance service providers and reporting
Inspection readiness preparations

Pharmacovigilance (PV) audits are an essential component of any (bio)pharmaceutical company’s Quality Management System (QMS). Our experts can perform an objective analysis of your PV system, examining its compliancy with all European and national requirements. It’s the perfect way to detect any shortcomings, thereby preparing your company for an audit by Competent Authorities.
Contact us today for a free appointment to find out how we can assist you.


Pharmacovigilance training

Development and performance of an annual awareness training for all personnel
Pharmacovigilance training on specific topics depending on your interests and needs
Reporting

Quastion, our learning department, offers tailor made courses on Good Pharmacovigilance Practice (GVP), Case management & reporting, Periodic Safety Reporting, the establishment of a Product System Master File (PSMF) & Pharmacovigilance (PV) system, and on many other topics. All courses can be given in our or your facilities, via e-learning or webinars. Learn more about our training offer and facilities on quastioncourses.com.


Vigilance and General Data Protection Regulation (GDPR)

The privacy requirements included in the General Data Protection Regulation (GDPR) lead to a higher amount of work for vigilance in the processing of assignments, the documentation of processes and the reporting of events. Qplus consult supports (bio)pharmaceutical companies of all sizesin getting their vigilance activities GDPR-complaint.
Contact us today for a free appointment to find out how we can assist you.


Materiovigilance

Receipt, evaluation and reporting of events
Reconciliation
Quality Control
Risk Management
Medical assessment
Clinical Evaluation Reports
Literature search
Study set-up and follow-up
Report writing

The purpose of materiovigilance is to study and follow incidents that might result from using medical devices. It eliminates faults in medical devices with the goal to improve the quality and to provide patients and users with increased safety. Qplus consult supports manufacturers and/or distributors of medical devices with accurate safety management.
Contact us today for a free appointment to find out how we can assist you.


Cosmetovigilance

Receipt, evaluation and reporting of Undesirable Events (UEs)
Reconciliation
Quality Control
Medical assessment

Cosmetovigilance is defined as the collection, evaluation and monitoring of spontaneous reports of undesirable events (including serious ones) observed during or after normal or reasonably foreseeable use of a cosmetic product. Qplus consult provides a comprehensive and customizable set of services to assist cosmetic companies in complying with the regulatory directives.
Contact us today for a free appointment to find out how we can assist you.


Nutrivigilance

Receipt, evaluation and reporting of events
Reconciliation
Quality Control
Medical assessment

The consumption and availability of food supplements have grown exponentially during the last decades. The nutritional vigilance scheme is a monitoring system that aims to improve consumer safety by rapidly identifying potential adverse effects associated with the consumption of food supplements.
Contact us today for a free appointment to find out how we can assist you.

Need a PV expert? Contact us for a free appointment!

Call +32 (0)2 889 05 68

or

Send an email