We offer a complete and comprehensive pharmacovigilance services to assist you in meeting your legal obligations as Marketing Authorisation Holder (MAH). We are here to help you with some or all of your pharmacovigilance needs.
Do you require a Qualified Person for Pharmacovigilance (QPPV)?
European Pharmacovigilance legislation requires all Marketing Authorisation Holders to have permanently and continuously at their disposal an appropriately Qualified Person for Pharmacovigilance. Acorn Regulatory can help you fulfil this requirement, offering round the clock availability of a Qualified Person for Pharmacovigilance (QPPV) services. Our dedicated Pharmacovigilance team are ready to act as your QPPV or deputy QPPV and manage the ongoing safety evaluation of your products, which is flexible to suit your budget.
Electronic reporting to the Authorities & Eudravigilance
As part of Acorn Regulatory’s pharmacovigilance services, we have established procedures for the collection, management and medical evaluation of all case safety reports, including product complaints and medical information queries. We ensure 100% compliance with reporting timelines in relation to the reporting of adverse reactions as individual case safety reports (ICSR) to Eudravigilance and the Competent Authorities while keeping you informed.
Collating and managing Signal Detection reports
Through the expertise of our pharmacovigilance team and medical experts, our signal management process covers all activities from signal detection and analysis to signal assessment and recommending action where appropriate.
In 2012, Pharmacovigilance audits became a legal requirement in the EU, according to Directive 2010/84/EU. MAHs have an obligation to audit their own PV system. A risk based approach must be taken, and all aspects of the PV system should be within scope, including for example, third party service providers and distributors. Our experienced team of pharmacovigilance auditors can help you achieve compliance with European legislative requirements.
MAHs in Europe must ensure that all personnel involved in the performance of pharmacovigilance activities receive initial and continued training. Training plans and records must be maintained for documenting and developing the competencies of personnel. Our team of experts can provide pharmacovigilance training face-to-face or via webex, thus ensuring you have the fundamental skills to do your job and avoid audit findings.
Routine literature reviews including local medical publications
Routine literature reviews are an essential part of any pharmacovigilance system, providing key data elements necessary in characterising risk and evaluating the benefit/risk profile of any product. Acorn Regulatory can perform a systematic review of widely used reference databases for world wide publications as well as local medical publications on your product portfolio, focusing on new and significant safety findings and identifying potential individual adverse reaction cases.