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    Case reports handling

    According to Pharmacovigilance legislation and GVP guidelines each marketing authorisation holder should take appropriate measures in order to collect and collate all reports of suspected adverse drug reactions (ADRs) associated with medicinal products for human use originating from unsolicited or solicited sources.

    Such Pharmacovigilance activities are required in the long lifecycle of the medicinal product – from the marketing authorization and launch date till termination of the medicinal product’s presence on the market. Fortunately, Pharmacovigilance activities may be conducted by MAHs or delegated to the third party. Depending on  company’s needs, we can provide individual services – such as evaluating and reporting ADRs or a complete Pharmacovigilance package (Check our article on Pharmacovigilance to find out what activities could be delegated).

    Our experience

    Currently, we are monitoring the safety of medicinal products for many companies. On behalf of Clients, we provide comprehensive case safety report handling – at the outset case receipt, going through in-depth analysis and evaluation of the report, MedDRA coding, medical assessment, preparation of necessary documentation and finally case reporting to both: EU and non-EU Agencies. Additionally, we take care of follow-up if applicable.

    For Clients, we could also monitor the EudraVigilance or MHRA database for ADR reports from the market, meaning suspected cases reported by patients and healthcare professionals to national agencies to help in overview of safety issues. We do also cooperate in term of ICSR reporting with PV Local Points from EU and Non-EU countries such as Kingdom of Saudi Arabia (KSA), United Arab Emirates (UAE), Iraq, Albania, Switzerland and others.

    It is worth recalling here, that adverse reactions reports not processed and submitted on time, under-reporting or erroneous reporting, poor quality of adverse reaction reports evaluation, lack of follow-up on adverse reaction reports or follow-up conducted too late are placed among the most common inspection findings (check our article on Pharmacovigilance inspections).

    The right background is the basis

    For the purpose of case reports handling, efficient Pharmacovigilance system with appropriate Standard Operating Procedures (SOPs) and Instructions is needed – we possess it all. Furthermore, our Pharmacovigilance team with medical education undergo many trainings to provide an efficient and workable solution to every case. Every year is a roaring success for us – we handle successfully hundreds of case reports.

    Thanks to our wide experience in case reporting we could offer submission of Individual case safety reports (ICSRs) from any source (e.g. received from published scientific literature during process of literature searches – check our website for more information) not only to the EudraVigilance database, but also to other registration agencies’ databases such as for instance MHRA – due to post Brexit requirements (Yellow card reporting) or Health Canada. We’d be glad to help your company out in submitting ICSRs within required timelines to all needed databases.

    Benefits of cooperation

    Due to clear-cut, prompt communication we hold satisfactory cooperation with many external Clients. Thanks to our steadfast support MAHs could be sure that all adverse reactions or special situations are processed and submitted to required Competent Authorities on time, according to requirements. Our services allow companies to maintain high performance indicators on case reporting and to be inspection-ready. SPh Clients, by appropriate reporting and high quality of adverse reaction reports evaluation, have a helicopter view on products’ safety as well.

    Contact us if you’d like to be sure that all case reports regardless of the source are handled on time and with best quality.

    How can we help You?

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