Post-authorisation pharmacovigilance services for veterinary medicinal products

Pharmacovigilance system set-up and maintenance

With the help of Medfiles’ experienced Pharmacovigilance Team, you can set up your veterinary pharmacovigilance system in the EU or improve your existing system. We will find the ideal solutions for your company and your product’s safety profile, in line with the current pharmacovigilance requirements.

Our experts will assist you in determining the necessary internal and external communication channels and responsibilities of stakeholders related to your product’s safety and animal welfare.

Medfiles can create and maintain your pharmacovigilance system master file (PSMF) and ensure that your PV system remains fully compliant with the applicable EU and UK regulations and guidelines, to be inspection-ready at all times.

Medfiles has its own full PV and quality system in place, and our experts can prepare and review standard operating procedures (SOPs) and other quality-controlled operating instructions needed for creating a pharmacovigilance system or improving an existing system. If you need a comprehensive pharmacovigilance systems for your veterinary products, you can rely on our expertise.

See also:

• Best practices for maintaining a veterinary pharmacovigilance quality system

veterinary Qualified Person for Pharmacovigilance (QPPV)

The veterinary Qualified Person for Pharmacovigilance (QPPV) plays a crucial role in overseeing pharmacovigilance activities for veterinary medicinal products, with specific requirements to ensure compliance and safety. At Medfiles, our QPPV services are tailored to meet these regulatory standards.

Regulation 2019/6 mandates that a QPPV must be a qualified professional with expertise in veterinary pharmacovigilance and a comprehensive understanding of the regulatory framework. Importantly, the QPPV must reside and operate within the European Union to facilitate direct communication with EU authorities.

A comprehensive pharmacovigilance system requires fluent communication between stakeholders, good interface between processes, a robust quality management system with record management and efficient, proactive oversight by an experienced QPPV.

By utilising Medfiles’ veterinary QPPV services, you can ensure adherence to Regulation (EU) 2019/6, effectively manage pharmacovigilance processes, and uphold high safety standards for your veterinary products. Our QPPVs have range of experience as veterinary safety experts with additional training on quality assurance, data integrity and data validation. In addition to QPPV services, you can also outsource the set-up and maintenance of the entire pharmacovigilance system or just some of your pharmacovigilance activities to Medfiles.

See also:

• Veterinary QPPV ensures compliance with EU Regulation 2019/6

Local pharmacovigilance activities

Medfiles’ dedicated and experienced team provides local QPPV and contact person services with in-house resources and expertise, combined with qualified local safety teams that fully understand local regulations.

Our local services include:

• Local contact person for PV
• Intake and local-level processing of suspected adverse event reports
• Local literature reviews
• Local submissions (such as aggregate reports and suspected adverse events)
• Compliance monitoring
• Local PV intelligence
• Fulfilling local PV requirements in relevant procedures and systems
• Providing PV training
• Regulatory authority inspections
• Translations

Literature and social media screening

Literature monitoring is a key element in any pharmacovigilance system. Medfiles can help you by managing your global PubMed database and local literature screening, with text review and assessment of safety information.

Our search is not only limited to identifying suspected adverse event reports, but also covers detection of potential safety issues. Each search includes evaluating the significance of the hit for signal detection. Literature screening influences any decisions made regarding the benefit-risk profile of your product.

Marketing authorisation holders are responsible for social media screening in their company channels. Medfiles can assist you in following the relevant discussions on social media.

Adverse event processing

Medfiles processes safety data received from various sources, such as the public, veterinarians, competent authorities, post-authorisation studies and literature sources. Our experienced team will evaluate the adverse event reports to determine seriousness, enter the data into our pharmacovigilance database, code the reported events according to standardised VedDRA terminology, write narratives and perform veterinary medical evaluation. We will also take care of reporting of the AEs and perform follow-ups on received reports and carry out ongoing surveillance of case reports.

The required translations can be performed by our experienced Translation Team, Pharmacovigilance Team or by our local pharmacovigilance partners.

In addition to the EU systems, Medfiles can also process your reports in the United Kingdom’s veterinary pharmacovigilance system and submit them to the relevant competent authority, the Veterinary Medicines Directorate (VMD).

Our case processing services can be tailored according to your needs, from receiving and forwarding reports to complete case processing, including submissions to the competent authorities.

See also:

• How veterinary adverse event cases are managed in the EU/EEA and UK
• A safety database is a fundamental element of case processing

Safety database AND DOCUMENT MANAGeMENT

Our service portfolio includes a validated cloud-based safety database PV 24/7 and the services of in-house veterinarians. Our Pharmacovigilance Data Management Team can provide cost-effective solutions to manage and process your adverse event reports. Medfiles can provide safety management of your post-authorisation studies, including full case processing, signal detection and cumulative safety analysis.

Benefits of the PV 24/7 database:

• Continuously up to date with the latest regulatory requirements
• Direct gateway connections for EMA, FDA and VMD submissions
• Powerful real-time reporting and dashboards
• Secure, compliant and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic Signatures and EudraLex Annex 11: Computerised Systems

Ease your workload and let Medfiles take care of your safety data processing and storage.

Document management system
For easy sharing of information and reduction of errors, Medfiles can provide a customisable and automated document management system, letting you focus on your direct responsibilities. You can control your documents with the highest possible efficiency and security in their document management processes.

See also:

• A safety database is a fundamental element of case processing

Union product database update and EudraVigilance set-up, maintenance and registration

Marketing authorisation holders of veterinary medicinal products must keep their product information up to date in the Union Product Database (UPD). Furthermore, every MAH and applicant must keep its organisation details, EU QPPV details, PSMF reference number and location of the PSMF up to date in the UPD.

With our help, you can be sure that your UPD information is always up to date and fully compliant. The experienced team at Medfiles will conduct several quality checks during the creation of product report messages for submission to the UPD and keep you informed of successful submissions. Maintenance of the UPD requires close and clear communication, especially with the regulatory team, to ensure timely updating of the submitted information. To guarantee seamless flow of information, Medfiles will ensure regular communication with all relevant company departments.

To be able to use the EudraVigilance Veterinary network and database, including EVWeb, EVVet DWH and IRIS, organization and users needs to be registered in the system. Medfiles can guide you through the EudraVigilance Veterinary set-up process and also manage your users.

Our experts can manage your EudraVigilance obligations and submit adverse event reports to regulatory authorities. Our team follows any system changes and updates to the EudraVigilance Veterinary.

Signal management

For continuous and periodic signal detection and management, Medfiles has in place robust procedures in accordance with VGVP Module: Signal management. Our experienced team continuously reviews existing data to detect and subsequently evaluate safety signals from various sources.

These sources include:

• Global safety database listings and tabulations
• Information from local and global literature screening (such class effects and potential drug interactions)
• Emerging pre-clinical findings (such as teratogenic analyses and effects on pregnancy)
• Blinded and open-label clinical data
• Regulatory agency information from partners
• EudraVigilance data warehouse and information available from other regulatory databases
• Information of product quality defects
• Other external data sources, such as Pharmacovigilance Working Party of the Committee for Veterinary Medicinal Products (PhVWP-V), Committee for Veterinary Medicinal Products (CVMP) and Coordination group for mutual recognition and decentralised procedures for veterinary medicinal products (CMDv)

Medfiles can write your periodic signal detection reports according to a risk-based approach and submit annual reports to the IRIS platform according to EMA’s schedule. and to VMD according VMD schedule.

When needed, Medfiles can arrange safety review meetings with key stakeholders from the MAH’s organisation to discuss these safety findings and decide the appropriate actions.

See also:

• Upcoming revision of the VGVP Signal Management Module: what will change in practice
• What to know about veterinary signal management?
• Blog: Are we really performing signal management – or just think we are doing it?

BENEFIT-RISK REPORTS (BRRS)

When you need continuous monitoring of your veterinary medicinal products’ safety profile and management of your BRR reporting obligations in the UK, Medfiles can help – throughout the lifecycle of your products, from obtaining the marketing authorisation to market. With our extensive experience in signal management, we can prepare all line listings, frequency tabulations and trend reports on your behalf.

When needed, we can also propose additional solutions and customisable reports to suit your specific needs. We can submit Pharmacovigilance Sales Submission (PSS) and Benefit-Risk Submission Report (BRSR) on behalf of your company. Under the previous EU and UK regulatory frameworks, our company has prepared over 110 Veterinary Periodic Safety Update Reports (PSURs), and we are well-equipped to assist you in ensuring compliance also with the current regulatory requirements.

We are continuously keeping up to date with any changes in legislation and making sure that your submissions are always compliant and done within regulatory timelines.

Risk management and risk minimisation activities

Risk management measures and risk minimisation outcomes are the responsibility of the marketing authorisation holder. Medfiles’ risk management experts can help you in planning measures and outcomes, identifying new safety concerns and proposing appropriate and effective risk minimisation measures, keeping you compliant while improving veterinary and human safety.

Our experts can also assist in planning additional risk minimisation measures, their implementation and effectiveness evaluation. With our in-depth regulatory and pharmacovigilance expertise, we can help you to modify your documents according to the applicable local regulatory requirements.

Pharmacovigilance agreements (PVA)

Marketing authorisation holders (MAHs) may outsource or delegate any activities related to distribution, marketing, sales or pharmacovigilance to another party. In such cases and if there is any chance of receiving new safety information, a pharmacovigilance agreement (PVA) must be in place.

The PVA indicates the pharmacovigilance responsibilities of each party. When you need help in allocating the right responsibilities to the responsible parties, Medfiles can help.

A safety data exchange agreement is a legal written agreement that requires different stakeholders (such as manufacturers, distributors and partners) to exchange all safety data for medicinal products with marketing authorisation holders. The MAH must therefore clarify the applicable responsibilities in the agreement to ensure that the Qualified Person for Pharmacovigilance will be kept up to date with all safety issues and emerging safety concerns in real time.

With our extensive experience in creating pharmacovigilance and safety data exchange agreements, we can draft your agreements with the relevant business partners (such as associated manufacturers, marketing partners, local representatives, distribution networks or vendors) to establish clear responsibilities, communication channels and methods for the exchange of safety information.

Pharmacovigilance audits

Pharmacovigilance (PV) audits are designed to verify the appropriateness and effectiveness of the implementation and operation of a PV system, including its quality system. Medfiles has dedicated and knowledgeable auditors to conduct audits that meet the European pharmacovigilance requirements.

Our audits cover the entire PV system, including case intake, adverse event processing and submission, project management, data management, QPPV role and responsibilities, aggregate report writing and signal management. Audits of your affiliates, license partners, service providers, local representatives and distributors, as well as due diligence audits, can be included in our PV audit service.

Implementing a risk-based approach to PV audits and creating an appropriate audit strategy, effective audit program and robust CAPA management system with Medfiles results in a pharmacovigilance system that complies with VGVP Modules “Pharmacovigilance systems, their quality management systems and pharmacovigilance system master files” and “Controls and pharmacovigilance Inspections”.

Satu Kujala
Head of Pharmacovigilance

Satu Kujala has worked at Medfiles since 1999 acting in various leadership positions. She is currently serving as Head of the Pharmacovigilance team consisting of 20 experts in Finland and Baltics.

Satu has a Licentiate’s degree in Philosophy (pharmacy), and she has specialised in pharmacology and industrial pharmacy. She graduated from the University of Helsinki. After a short career in the university and pharmacy, she has worked within the pharmaceutical industry for 30 years and has gained diverse experience through working on marketing, quality, wholesale, clinical trials, safety and regulatory tasks. She is familiar with Good Clinical, Pharmacovigilance and Distribution Practices (GCP, GVP and GDP). Acting as EU QPPV for sixteen years has given her deep knowledge and experience of pharmacovigilance systems.

Saara Mikkola
Head of Operations, Pharmacovigilance, EU QPPV

Saara Mikkola joined Medfiles Pharmacovigilance team in 2020 as a Drug Safety Expert, and in 2022 she was promoted to Safety Manager and later to Head of Operations, Pharmacovigilance. She works as an EU QPPV for Medfiles and has her focus on post-market pharmacovigilance services.

Saara has a master’s degree in pharmacy and graduated from the University of Helsinki, Finland, in 2012. She has worked within the pharmaceutical industry for over 10 years with her focus on pharmacovigilance. Saara has gained her expertise through diverse pharmacovigilance tasks and responsibilities. She is well-versed in the operational aspects of pharmacovigilance, including case processing, quality management, compliance with regulatory requirements (EU regulation), and maintaining pharmacovigilance systems.

She is adept at working in cross-functional teams, collaborating with different stakeholders, and adapting to the ever-evolving pharmacovigilance landscape and technologies.