Human and Veterinary Medicinal Products Post Marketing Pharmacovigilance

Pharmacovigilance System set-up and maintenance

With Medfiles experienced pharmacovigilance team we can set up your pharmacovigilance system, as well as improve your existing system. Medfiles will search solutions adequate for your company and product’s safety profiles which in line with current pharmacovigilance requirements. We will assist you in determining the necessary internal and external communication channels and responsibilities of those stakeholders that will need to interact with the pharmacovigilance. Medfiles will create and maintain your PSMF and ensure that your PV system remains fully compliant with European regulations and guidelines and inspection-ready at all times.

Medfiles has own full PV-system in place and can prepare and/or review of standard operating procedures (SOPs) and other quality controlled operating instructions to create of a pharmacovigilance system or improvement of a pre-existing system. Medfiles has built comprehensive pharmacovigilance systems for human and veterinary products and herbal medicines.

Local Pharmacovigilance activities

Medfiles dedicated and knowledgeable team provide the services of a Local contact person at the individual country level with in-house resource and expertise, combined with local qualified safety teams who fully understand local regulations. The local services include but is not limited to:

  • ICSR intake and local level processing
  • Local literature review
  • Local submissions (aggregate reports, RMPs, ICSRs, etc.)
  • Compliance monitoring
  • The implementation of aRMM
  • Local PV inteligence
  • Fulfilling local PV requirements in relevant procedures and systems
  • Providing PV training
  • Health Authority inspections
  • Medical information [K3]services

Literature and social media screening

Literature Monitoring is a key element of a pharmacovigilance system and Medfiles can manage your global and local literature screening monitoring of the EMA’s Medical Literature Monitoring (MLM) service, with text review and assessment of safety information.

Our search is not only limited to identification of individual case safety reports, but also includes detection of potential safety issues. Each search will include the evaluation of the hit for periodic safety reports. Literature screening also supports the signal management process, and influences decisions on the benefit-risk profile of your product.

Medfiles can assist you on following the discussions in social media you as a marketing authorization holder are responsible.

Case processing

Medfiles is processing safety data i.e from the public, from health professionals, competent authorities, clinical trials and literature sources. The experienced team at Medfiles will conduct triage of case reports to determine seriousness and causality, enter the data into our pharmacovigilance database, code the medical information according to standardised MedDRA/VedDRA terminology and provide medical review, the follow up of received reports and ongoing surveillance of case reports. Translations will be done either Medfiles own experienced translator [K4]team or pharmacovigilance team or our local pharmacovigilance partners.

In addition, Medfiles is processing your reports to United Kingdom pharmacovigilance system when required.

Case processing activities are tailor made according to your needs from receiving and forwarding the reports to complete case processing including submission to the competent authorities.

Safety Database

Medfiles is providing you a cloud-based validated safety database PV 24/7 for both human and veterinary products. With Medfiles pharmacovigilance data management team you have cost effective way to process and submit your adverse event reports. Listings for i.e. periodic safety update reports, signal detection and reconciliations can be effectively provided from the database.

PV 24/7 is providing:

  • Continuously updated to the latest regulatory requirements
  • Direct gateway connections for EMA submissions, FDA and [K5]later MHRA
  • Powerful real-time reporting and dashboards
  • ICH E2B (R3) structure alignment.
  • Secure, compliant, and validated in accordance with FDA 21 CFR Part 11 Electronic Records, Electronic
  • Signatures, and EudraLex Annex 11: Computerized Systems regulations
  • What else

Make it easier for you and let Medfiles take care of your safety data storage.

EudraVigilance set-up, maintenance & registration, product information (XEVMPD)

Pharmaceutical companies holding or applying for a MA and sponsors of clinical trials in the EEA must be registered in the EudraVigilance database system. Medfiles can create your EudraVigilance account, update your organization’s data as needed, create and manage your affiliates and virtual affiliates, and manage your EudraVigilance users. Medfiles can guide you through the whole EudraVigilance set-up process and manage the transfer of the QPPV and/ or Responsible Person functions.

Our experienced experts can manage Eudravigilance and submit adverse event reports to authorities on behalf of you. Medfiles has for a system a EMA? certified user which is required. Our team follows the changes regularly and is working routinely on submission decreasing your technical burden.

MAHs and Applicants for medicines in the EU must submit information on authorized medicines to the eXtended EudraVigilance Medicinal Product Dictionary (xEVMPD), also known as the Article 57 database, and keep this information up-to-date. In addition, every MAH and Applicant must keep its organization details, EU QPPV details, and location of the PSMF updated in the xEVMPD. With Medfiles team your xEVMPD is updated and fully compliant. The experienced team at Medfiles will conduct several quality checks during the creation of product report messages (XEVPRM) for submission to the XEVMPD and keep you informed of successful submission. Maintenance of the XEVMPD will require close and clear communication especially with regulatory team to ensure timely updating of the submitted information. Medfiles is having regular communication with company departments to ensure the information flow.

Signal management

Medfiles procedures on continuous and periodic signal detection and management in accordance with GVP Module IX: Signal management on your behalf. Experienced team with medically qualified experts, continuously review existing data for the detection and subsequent evaluation of safety signals includes from sources, but may not be limited to, the following:

  • Global safety database listings and tabulations
  • Information from literature screening (e.g. class effects, potential drug interactions etc.)
  • Emerging pre-clinical findings (e.g. teratogenic analysis, effects on pregnancy)
  • Blinded/open label clinical data (e.g. Data and Safety Monitoring Board (DSMB) summaries, clinical
    study reports)
  • Regulatory agency information (e.g.
  • Pharmacovigilance Risk Assessment Committee (PRAC) findings, FDA notices)
  • Information from partners
  • Eudravigilance Data Analysis System (EVDAS) and information available from other regulatory databases
  • Competitor product labeling information

When needed Medfiles may take a lead of safety review meetings with key stakeholders from the MAH’s
organisation, to discuss these safety findings and decide on appropriate actions.

Periodic safety update reports (PSURs)

Medfiles can ensure continuous monitoring of the safety profile of medicinal products and handle your Aggregate Safety Reporting obligations throughout the life cycle of your products, from development to market by writing:

  • Development Safety Update Report ([K6]DSUR)
  • Periodic safetu update reports (PSURs)/ Periodic Benefit-Risk Evaluation Reports (PBRERs)
  • Addendum to the Clinical Overviews (ACOs)

with comprehensive experience of writing over 240 PSURS. Medfiles prepares all line listings, frequency
tabulations, and trend reports, as applicable. We can also propose additional solutions and customizable reports to fit your requirements.

We are continuously following the changes in legislation and are taking care that submissions are compliant an done per timelines.

Risk management / risk minimisation activities

The RMP describes the risk management system and contains information regarding identified risks, potential risks and missing information. It outlines any risk minimisation measures adopted and includes information about monitoring the effectiveness of these measures. Effective Risk Management System is a critical part of pharmacovigilance and patient safety. All new applications for products within the European Union (EU) require submission of a Risk Management Plan (RMP) to the European Medicines Agency (EMA).

Medfiles risk management experts can identify new safety concerns and propose appropriate and effective risk minimization measures, keeping you compliant whilst improving patient safety.

Medfiles can in cooperation with MAH write and submit product specific Risk management plans to the competent authorities at the time of marketing authorization application or when information is updated. Medfiles can assist keeping RMP up to date corresponding requirements and information gathered from the product.

Medfiles can assist on planning additional risk minimisation measures, their implementations end effectiveness evaluation. With the regulatory/pharmacovigilance network we can assist in modifying the documents according to the local requirements.

Post authorization studies (PASS)

PASS is an important tool to actively evaluate safety concerns in the real-world setting. A study is classified as PASS when the main aim for initiating the study is to quantify potential or identified risks, evaluate the risks of a medicinal product used by a patient population for which safety information is limited or missing, evaluate the risks of a medicinal product after long-term use, provide evidence about the absence of risks, assess patterns of drug utilization that add knowledge regarding the safety of the medicinal product or the effectiveness of an RMP. PASS can either be clinical trials or non-interventional studies.

Medfiles pharmacovigilance experts can you provide service with Medfiles clinical team for both clinical and non-interventional studies with the set-up, management and design of the PASS, writing of the study protocol, progress report and final study report.

For more information please contact

  • Pharmacovigilance Services

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