RFI

MENU

Szukaj

    RFI

    Drop in a message and we will reach out to you

    Local literature monitoring

    According to Pharmacovigilance legislation and GVP guidelines each Marketing Authorisation Holder (MAH) is obliged to perform literature monitoring in countries where their medicinal products are authorized (check our article on Pharmacovigilance). It is preferred to designate a local safety team that will supervise local literature and transfer safety data to central unit. Literature should be monitored as valuable information regarding safety and efficacy profile of the medicinal product could be found.

    A woman who is an expert in a lab coat reviews and monitors literature for pharmacovigilance, following GVP guidelines to detect adverse reactions, prepare safety reports like PSURs, and ensure medicinal product safety. SciencePharma offers tailored global and local literature monitoring with over 15 years of experience, emphasizing good communication, punctuality, and high-quality service.

    Literature monitoring is crucial for:

    • detection & report of adverse reactions on behalf of our clients.
    • preparing safety analysis and reports required by registration agencies such as Periodic Update Safety Reports (PSUR) or Addendum to the Clinical Overview (AddCO). For more information regarding PSUR  and AddCO check our website.
    • finding important information regarding the safety of the medicinal products that we supervise – reports related to quality defects or falsified medicinal products, drug exposure during pregnancy and breast-feeding, lack of efficacy and any other special situations.
    Pharmaceutical items with the text 'Do you know that we prepare a personalized literature review strategy for each medicinal product?' SciencePharma offers tailored literature monitoring for MAH, detecting adverse reactions, preparing PSURs, and ensuring product safety according to GVP guidelines.

    Global and local literature monitoring in SciencePharna is an individually tailored service. For each searched medicinal product unique strategy is established. Based on the type of medicinal product, taking into consideration countries with Marketing Authorisation, depending on further client’s needs, appropriate journals and databases are chosen.

    Additionally, we constantly screen medical databases, such as PubMed and Reactions Weekly, on a weekly basis as well as currently available Polish databases and about 90 meaningful Polish journals – electronic or that available only in paper according to their issuing frequency.

    Why us?

    SciencePharma sets high standards of offered services and ensures proper communication. Thanks to our 15 year of hands-on, invaluable experience and transparency, SciencePharma holds satisfactory cooperation with many external clients. We have been engaged both in Polish and foreign PV inspections with positive feedback and favorable outcome covering literature monitoring process described in our Standard Operating Procedures (SOPs) and Instructions (check our article on Pharmacovigilance inspections). We do not allow to cut corners, we rely on impeccable quality. Constantly trained, experienced in local literature monitoring Pharmacovigilance team with medical education ensure a meticulous overview of available literature.

    SciencePharma employees performing local literature screening, highlighting key company features: over 15 years of experience, good communication, punctuality, and high-quality service.

    Why is it worth it?

    Thanks to our wide experience in literature monitoring process, especially collecting adverse reaction and special situations reports from literature review, SPh clients have oversight on products’ safety. Clear-cut, prompt communication provide SPh clients with enough time to react, process reports and submit them to required Competent Authorities on time, according to requirements. This timely cooperation allows companies to maintain high performance indicators on case reporting. MAH could also be sure that any signals coming from literature are properly captured and assessed. Furthermore, collected articles regarding safety issue will be valuable while preparing detailed, up-to-date reports i.e. Periodic Safety Update Reports.

    All safety information regarding your products will be detected if you entrust us with literature review.
    If you are interested in cooperation, please contact us. Our experts will answer all your pharmacovigilance questions and more.

    How can we help You?

      Please be advised that the administrator of personal data entered in the above form is SciencePharma Sp. z o.o. with its registered office in Warsaw, Chełmska 30/34. These data are processed in order to receive incoming correspondence and respond to it. Providing personal data is voluntary, but necessary to send the form. Each person has the right to access their data and correct it.

      You can read the details on the protection of personal data here.