{"id":3481,"date":"2024-04-13T20:46:39","date_gmt":"2024-04-13T18:46:39","guid":{"rendered":"https:\/\/www.heacon.de\/pharmacovigilance\/e2b-database-pheda"},"modified":"2024-12-04T22:34:04","modified_gmt":"2024-12-04T21:34:04","slug":"e2b-database-pheda","status":"publish","type":"page","link":"https:\/\/www.heacon.de\/en\/pharmacovigilance\/e2b-database-pheda","title":{"rendered":"E2B database Pheda"},"content":{"rendered":"

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Powerful – User-friendly – E2B-compliant<\/strong><\/h2>\n

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Pheda provides you with a modern software solution to fulfill your legal requirements in the area of pharmacovigilance.<\/p>\n

[\/et_pb_text][et_pb_button button_url=”https:\/\/www.bpi-pheda.de\/” url_new_window=”on” button_text=”Pheda database” _builder_version=”4.27.0″ _module_preset=”default” custom_button=”on” button_text_size=”20px” button_text_color=”#FFFFFF” button_bg_color=”#5e7ad5″ button_border_width=”0px” button_border_radius=”0px” button_font=”Inter|300|||||||” button_use_icon=”off” custom_padding=”0.8rem|4.5rem|0.8rem|4.5rem|true|true” box_shadow_style=”preset3″ global_colors_info=”{}”][\/et_pb_button][\/et_pb_column_inner][\/et_pb_row_inner][et_pb_row_inner _builder_version=”4.24.2″ _module_preset=”default” z_index=”1″ custom_padding=”15px|||||” global_colors_info=”{}”][et_pb_column_inner saved_specialty_column_type=”3_4″ _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.25.1″ _module_preset=”default” text_font=”|300|||||||” text_font_size=”20px” text_line_height=”1.8em” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n

Our pharmacovigilance database enables structured, online-based management of adverse reaction reports – including the creation of listings and extensive query options – and you can also use the gateway to exchange reports with authorities and partners.<\/p>\n

Pheda is a modern, GAMP 5 validated, E2B(R2) and E2B(R3) compliant system based on a shared SQL database.<\/p>\n

Each participant manages their data in a company-owned, locked database area.
\nThe database is accessed via a web browser, so that no software installation is necessary for the user. <\/p>\n

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Your advantages at a glance:<\/p>\n

    \n
  • E2B-compliant database in R2 and R3 standard<\/li>\n
  • Versatile database functionalities<\/li>\n
  • User-friendly software tool<\/li>\n
  • No software installation at the user (“Software-as-a-Service”)<\/li>\n
  • Password protection of company data<\/li>\n
  • Independent management of reportable and non-reportable adverse reaction reports by users<\/li>\n
  • Cost reduction and transparency through pooling effect<\/li>\n
  • Individually bookable service tools<\/li>\n
  • Comprehensive quality management – validated system in accordance with the GAMP 5 standard<\/li>\n
  • Continuous further development<\/li>\n
  • Interdisciplinary project team (pharmacovigilance and IT)<\/li>\n
  • Support hotline<\/li>\n<\/ul>\n

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    Demand-oriented database use: basic and professional version<\/strong><\/p>\n

    In addition to current regulatory requirements, the continuous development of the database focuses in particular on usability.
    \nDepending on the different user habits, Pheda is available to users as either a basic or professional version, which contain different functionalities. <\/p>\n

    The functional tools include the reporting of side effects, the creation of tables and listings as well as extensive query options.
    \nBPI-Pheda is connected to the European adverse drug reaction reporting system (EudraVigilance) via a gateway, thus enabling reporting to authorities throughout Europe and data exchange with partners. <\/p>\n

    Basic version: Powerful and practical<\/strong><\/p>\n

    <\/strong><\/p>\n

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    The basic version of Pheda includes the following functionalities:<\/p>\n

      \n
    • Clearly structured, user-friendly interface<\/li>\n
    • Color coding to differentiate between mandatory fields, other E2B fields and administrative \/ additional database-internal fields<\/li>\n
    • Recording, administration and storage of reports – adverse drug reaction reports, incl.
      \nnon-reportable reports – in the company’s own area of the shared database <\/li>\n
    • Coding of side effects with an integrated MedDRA browser<\/li>\n
    • Generation of ICSR-XMLs for electronic reporting from entered data<\/li>\n
    • Sending ICSRs via gateway software<\/li>\n
    • Extensive query, evaluation and export options<\/li>\n
    • Workflow functionality linked to a role\/rights system for quality assurance and proof of the dual control principle<\/li>\n
    • Tracking function of the reporting obligation (7-, 15-, 90-day reports)<\/li>\n
    • Possibility to transfer a report to another user (Transfer Safety Report)<\/li>\n
    • Document upload option for each entry<\/li>\n
    • Mapping of workflows – incl.
      \nAssignment function of reports <\/li>\n
    • Creation of PSUR tables<\/li>\n
    • Display \/ use on mobile devices – including tablets and smartphones<\/li>\n
    • Two-factor authentication to increase access security<\/li>\n<\/ul>\n

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      Professional version: make full use of Pheda<\/strong><\/p>\n

      In addition to the applications of the basic version, you can use a variety of advanced functionalities with the professional version, including<\/p>\n

        \n
      • Flexibly configurable tracking timelines<\/li>\n
      • Sending email notifications as a reminder when the registration deadline is reached<\/li>\n
      • Sending email notifications for incoming ACKs and ICSRs in the gateway<\/li>\n
      • Fully flexible searches – any database field can be searched<\/li>\n
      • Possibility to query cases according to a keyword (case classification)<\/li>\n
      • Saving option for searches (Saved Searches)<\/li>\n
      • Configurable line listings<\/li>\n
      • Configurable results table<\/li>\n
      • Bulk export of various export formats<\/li>\n
      • Display of reaction severity and racial group in the line listing<\/li>\n
      • Key performance indicators for the PSMF can be queried and exported<\/li>\n<\/ul>\n

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        Individual additional services<\/strong><\/p>\n

        We offer you individually bookable additional services around the Pheda.<\/p>\n

        These include<\/p>\n

          \n
        • German and English-language system training courses (beginner \/ advanced course)<\/li>\n
        • Recording and coding cases<\/li>\n
        • Support with EudraVigilance registration<\/li>\n
        • Testing with authorities of other member states for electronic reporting to these authorities<\/li>\n
        • Electronic reporting to authorities<\/li>\n
        • Participation in the MedDRA group license<\/li>\n
        • Free service hotline<\/li>\n
        • System training courses – either in German or English<\/li>\n
        • Audit report (collective audit)<\/li>\n<\/ul>\n

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          <\/p>\n
          Do you still have questions?<\/strong><\/div>\n

          <\/div>\n

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          We look forward to your message<\/h2>\n

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