emas pharmacovigilance

Pharmacovigilance

Pharmacovigilance Overview

Whether it’s for short term-projects such as preparation of a periodic safety update report (PSUR), through to long-term projects such as establishment and operation of a Pharmacovigilance system we have experts on hand to support you. Our experience extends from oncology to endocrinology and from medical devices to CNS therapies. In addition to our dedicated Case Management Team you will also be assigned to one of our experienced pharmacovigilance Project Managers.

Our clients range from virtual biotech companies though small pharma to some of the world’s largest healthcare companies.  Our in-house safety database, PV Works, is highly cost effective for clients with small case numbers. Alternatively, our Case Management Team have experience in a variety of safety databases including all the major commercially available global safety databases. With remote access, we can work within your systems entering data directly into your safety database.

We understand that pharmacovigilance regulations are complex and constantly evolving and will ensure that you are fully compliant with all requirements. We pride ourselves on providing a personal service to our clients. We support our clients every step of the way.

Summary of Services:

  • AE database entry and tracking
  • ICSR / SUSAR reporting
  • Literature review
  • Aggregate report (DSUR / PSUR) preparation and submission
  • PSMF preparation
  • EU QPPV
  • EudraVigilance and XEVMPD registration
  • Signal detection
  • Review of regulatory documents e.g. RMP, CCDS, IB, Protocol etc.
emas pharmacovigilance

Our Global Safety Database

Our chosen global safety database (PV Works) sits on a secure server, and is suitably backed-up locally, off-site and at cloud level. PV Works is a cost effective safety database which provides great value for money for our clients. We have a wealth of SOPs that cover us for both disaster recovery and business continuity, meaning our service, remains uninterrupted.

Good pharmacovigilance practice relies on a database that balances usability and compliance – PV Works ticks both boxes.

PV Works meets all international regulatory requirements, including ICH E2B electronic submission and is an entirely scalable solution. PV Works also works with your business process ensuring SOP compliance and on-time reporting.

The functionality of PV Works ensures that you can capture and report safety data in full compliance with ICH Guidelines, creating PSURs, DSURs, XML e-reports as well as CIOMS I and MedWatch 3500 report forms.

Quality is built in with full FDA 21CFR PartII compliance and a fully integrated audit trail. Similarly, all data is secure in its Oracle database with access permissions set according to role.


Eudravigilance Database and Expedited Reporting

Within our Pharmacovigilance team we have users who are certified by the EMA to use and train other members of staff on EudraVigilance and the extended EudraVigilance Medicinal Product Dictionary (XEVMPD). We are highly experienced in all aspects of the EudraVigilance database and can help you from the start at the registration process, upload product information into XEVMPD, act as your Responsible Person for EudraVigilance (during clinical trials) as well as reporting ICSRs to competent authorities (regardless of whether we are performing full case entry). We can also support regulatory reporting outside of the EU, either directly or via our network of local representatives. Many global territories have made it mandatory to conduct the Electronic Reporting of ICSRs and SUSARS. We can assist with the registration and testing for electronic submissions to EEA national competent authorities. Once set up we can then manage electronic reporting for your pharmacovigilance system, ensuring that expedited reporting meets the local regulatory requirements in each country.


Post Marketing Pharmacovigilance

After achieving a marketing authorization for your pharmaceutical product, the safety requirements set out by regulatory authorities’ changes considerably. We can walk you through this process. We provide additional resource by assisting with specific activities such as; creation of the PSMF (Pharmacovigilance System Master File), case processing, expedited reporting, writing and submitting periodic safety update reports (PSURs), scientific literature monitoring, signal detection and much more.

With a number of highly skilled and experienced Pharmacovigilance experts within our team, we can offer the role of EEA Qualified Person for Pharmacovigilance to our clients and the additional management of LQPPVs. As well as fulfilling this crucial role, their expertise and experience will prove to be invaluable in providing specialist medical and scientific assistance such as the production of the PSMF, risk management plans (RMPs), Safety Data Exchange agreements (SDEAs), responding to regulatory requests, and assisting in responding to safety concerns.


Clinical Trial Pharmacovigilance

The success or failure of a clinical trial relies heavily on accurate data. Our years of clinical trial experience mean that our Pharmacovigilance Team work to ensure that you are fully compliant with Good Clinical Practices (GCP) and pharmacovigilance regulations to ensure your data is of sound quality.

We can provide input right from the very start of your trial with review of study documentation like the protocol and IB and throughout the trial with the preparation and authoring of Development Safety Update Reports (DSUR). We offer effective management in the collection, data entry and review of Serious Adverse Events (SAEs), as well as compliant regulatory reporting of SUSARs and aggregate data. We can manage all required submissions in multiple territories; to regulatory authorities, ethics committees and investigators. Our experienced personnel will ensure that expedited reporting meets the individual regulatory requirements in each territory where the trials are conducted. After trials close we manage reconciliation processes to ensure safety and clinical databases are in agreement.

We frequently manage the assembly of DSMBs (Drug Safety Monitoring Boards) on behalf of our clients. We also work closely with our Clinical Operations Team to deliver a full service clinical trial solution for your investigational medicinal product all the way through Phase I – IV. Alternatively, we can provide stand-alone Pharmacovigilance support for your studies.


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