We offer complete and comprehensive end-to-end pharmacovigilance services to assist you in meeting your pharmacovigilance obligations according to the latest regulations and guidance. Our team of experienced pharmacovigilance experts and safety physicians will support and guide you in all pharmacovigilance activities required to support your Marketing Authorisations.
Case Processing and Reporting
The collection and processing of Individual Case Safety Reports (ICSRs) is a fundamental component of the pharmacovigilance system. Acorn Regulatory can provide comprehensive management of cases, arising from all sources, from receipt, data entry, coding, medical assessment and follow-up, through to reporting to the relevant Competent Authorities.
A signal management process is a set of activities performed to determine whether there are new risks associated with an active substance or a medicinal product or whether known risks have changed, and includes any related recommendations, decisions, communications and tracking. Our pharmacovigilance team handle signal detection, signal validation, signal confirmation, signal analysis and prioritisation, signal assessment and recommendation for action.
The aim of risk management is to address uncertainties in the safety profile at different points in the product lifecycle, and to plan accordingly. Marketing authorisation applicants are required to submit risk management plans (RMPs), which include information on a medicine’ safety profile and plans for pharmacovigilance activities designed to gain greater knowledge. They also explain how risks will be minimised in patients and how those efforts will be measured. Acorn Regulatory can create and maintain your RMP and offer additional risk management and risk minimisation activitites required for safety concerns.
The periodic safety update report (PSUR) is a pharmacovigilance document intended to provide an evaluation of the risk-benefit balance of the product, taking into account new or emerging safety information in the context of cumulative information on risk and benefits. Our team are highly experienced in the compilation of PSURs.
Medical literature is an important source of information for the identification of suspected adverse reactions to authorised medicines. Marketing authorisation holders of medicines are responsible for monitoring the medical literature on their medicines, and reporting individual cases of suspected adverse reactions to the competent authorities. Acorn Regulatory’s literature team can work with you to develop search strategies, run literature searches and review the results to support on-going screening of global and local literature as required by legislation.
The QPPV acts as the 24 hour contact point for competent authorities, supported by a backup QPPV to cover for any absences. The QPPV, along with the backup QPPV, oversees the implementation of the PV system, provides direct oversight on smooth running of the PV system, and monitors the risk-benefit status of the medicinal products to ensure safe use of the authorized products. Acorn Regulatory can provide an experienced QPPV to support and oversee a client’s portfolio.
The Pharmacovigilance System Master File (PSMF) is a legal requirement for any medicinal product authorised in the European Union (EU). The PSMF provides a detailed description of the entire pharmacovigilance system for the organisation and documents the performance and compliance with the requirements as described by Good Pharmacovigilance Practices (GVP). The PSMF must be made available to the Competent Authorities on request at any time. Acorn Regulatory can prepare and maintain your PSMF on an on-going basis.
Independent audits are an essential component of any PV system. We can assist with a one-off audit or the management of your full audit program. Our experienced team of pharmacovigilance auditors can address the specific demands of the PV legislation by conducting risk– based systems audits of the PV system, 3rd party service providers and distributors.
``I believe that using Acorn Regulatory to perform our PV was good value for money``