{"id":49,"date":"2025-02-19T16:08:21","date_gmt":"2025-02-19T16:08:21","guid":{"rendered":"https:\/\/www.convidia.de\/en\/?page_id=49"},"modified":"2025-07-17T14:00:28","modified_gmt":"2025-07-17T14:00:28","slug":"pharmacovigilance","status":"publish","type":"page","link":"https:\/\/www.convidia.de\/en\/pharmacovigilance\/","title":{"rendered":"Pharmacovigilance"},"content":{"rendered":"

[et_pb_section fb_built=”1″ _builder_version=”4.24.0″ _module_preset=”default” background_color=”RGBA(255,255,255,0)” background_image=”https:\/\/www.convidia.de\/en\/wp-content\/uploads\/sites\/2\/2025\/02\/banner-pharmakovigilanz.jpg” min_height=”450px” min_height_tablet=”600px” min_height_phone=”700px” min_height_last_edited=”on|phone” custom_padding=”|0px||||” border_color_all=”#FFFFFF” box_shadow_style=”preset3″ box_shadow_blur=”8px” box_shadow_spread=”-9px” box_shadow_color=”#706F6F” global_colors_info=”{}”][et_pb_row column_structure=”1_3,2_3″ use_custom_gutter=”on” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”30px||||false|false” global_colors_info=”{}”][et_pb_button button_url=”#Literatur” button_text=”Literature Research” button_alignment=”right” _builder_version=”4.27.4″ _module_preset=”default” custom_button=”on” button_text_color=”#FFFFFF” button_bg_color=”rgba(112,134,147,0.6)” box_shadow_style=”preset3″ global_colors_info=”{}”][\/et_pb_button][et_pb_button button_url=”#PSUR” button_text=”PSUR \/ DSUR, RMP” button_alignment=”right” _builder_version=”4.24.0″ _module_preset=”default” custom_button=”on” button_text_color=”#FFFFFF” button_bg_color=”rgba(112,134,147,0.6)” box_shadow_style=”preset3″ global_colors_info=”{}”][\/et_pb_button][et_pb_button button_url=”#Vigilanz” button_text=”Vigilance for Medical Devices” button_alignment=”right” _builder_version=”4.27.4″ _module_preset=”default” custom_button=”on” button_text_color=”#FFFFFF” button_bg_color=”rgba(112,134,147,0.6)” box_shadow_style=”preset3″ global_colors_info=”{}”][\/et_pb_button][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”25px||||false|false” global_colors_info=”{}”][et_pb_blurb title=”Pharmacovigilance” content_max_width=”830px” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h1″ header_font=”|–et_global_body_font_weight|||||||” body_font_size=”24px” body_line_height=”1.4em” background_layout=”dark” custom_margin=”||||false|false” custom_padding=”||||false|false” text_shadow_style=”preset3″ global_colors_info=”{}”]<\/p>\n

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We draw up risk management plans and monitor the safety and risk-benefit profile of medicinal products and the safety of use of medical devices.<\/span><\/div>\n<\/div>\n

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[\/et_pb_blurb][\/et_pb_column][\/et_pb_row][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”|0px||||” global_colors_info=”{}”][et_pb_row module_id=”Literatur” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” header_font=”Open Sans Light|300|||||||” header_text_align=”center” header_text_color=”#EA5B1B” global_colors_info=”{}”]<\/p>\n

Literature Research<\/h1>\n

[\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ use_custom_gutter=”on” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Our services in the context of literature research” content_max_width=”800px” disabled_on=”off|off|off” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h2″ header_font=”|600|||||||” header_text_color=”#706F6F” body_font=”||||||||” global_colors_info=”{}” header_line_height=”1.3em” url_new_window=”on” custom_margin=”3px||||false|false”]<\/p>\n

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  • Definition of the study objectives<\/span><\/li>\n
  • Selection of suitable data sources<\/span><\/li>\n
  • Review and evaluation of available data<\/span><\/li>\n
  • Documentation of the research<\/span><\/li>\n<\/ul>\n

    [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Use of meaningful data from the published literature” content_max_width=”800px” _builder_version=”4.27.4″ _module_preset=”default” header_font=”–et_global_body_font|500|||||||” header_text_color=”#706F6F” header_line_height=”1.3em” body_font=”Open Sans Regular||||||||” custom_padding=”||20px||false|false” global_colors_info=”{}”]<\/p>\n

    The targeted use of a literature search in the context of scientific studies offers an efficient way of accessing a comprehensive and differentiated database. Even before the start of the study, a thorough literature search helps to evaluate the relevant key points of the study design and create a sound basis for decision-making.<\/span><\/p>\n

    Depending on the product and the planned approval strategy, the scope of own clinical studies can be reduced by demonstrating the efficacy of an active substance or a form of therapy by referring to existing data from the scientific literature. <\/span><\/p>\n

    [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”PSUR” _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”||10px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.convidia.de\/en\/wp-content\/uploads\/sites\/2\/2025\/02\/Divider.jpg” title_text=”Divider” align=”center” _builder_version=”4.24.0″ _module_preset=”default” transform_scale=”102%|102%” transform_scale_tablet=”102%|102%” transform_scale_phone=”202%|202%” transform_scale_last_edited=”on|phone” transform_translate_tablet=”” transform_translate_phone=”” transform_translate_last_edited=”on|desktop” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|desktop” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|desktop” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|desktop” transform_styles_last_edited=”on|phone” custom_margin=”||40px||false|false” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.24.0″ _module_preset=”default” header_font=”Open Sans Light|300|||||||” header_text_align=”center” header_text_color=”#EA5B1B” global_colors_info=”{}”]<\/p>\n

    PSUR \/ DSUR, RMP<\/h1>\n

    [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ use_custom_gutter=”on” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Our services in drug safety” content_max_width=”800px” disabled_on=”off|off|off” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h2″ header_font=”|600|||||||” header_text_color=”#706F6F” body_font=”||||||||” global_colors_info=”{}” header_line_height=”1.3em” url_new_window=”on” custom_margin=”3px||||false|false”]<\/p>\n

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    • Development of RMPs<\/span><\/li>\n
    • Medical Monitoring<\/span><\/li>\n
    • Creation of DSURs during the study phases<\/span><\/li>\n
    • Creation of PSURs after successful approval<\/span><\/li>\n
    • Coding according to MedDRA, WHO-DD, WHO.ICD (incl. acquisition of the necessary licenses)<\/span><\/li>\n<\/ul>\n

      [\/et_pb_blurb][\/et_pb_column][et_pb_column type=”2_3″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Drug safety before and after market launch” content_max_width=”800px” _builder_version=”4.27.4″ _module_preset=”default” header_font=”–et_global_body_font|500|||||||” header_text_color=”#706F6F” header_line_height=”1.3em” body_font=”Open Sans Regular||||||||” custom_padding=”||20px||false|false” global_colors_info=”{}”]<\/p>\n

      Already during the preparation of the clinical trial, we work with you to develop risk management plans (RMPs) in accordance with the provisions of the German Medicinal Products Act (AMG). The RMPs define the key aspects of the safety profile and the most important measures to avoid known risks. We draw up detailed RMPs with extensive information, documentation and training material, which also serves as the basis for subsequent pharmacovigilance measures during the course of the study.<\/span><\/p>\n

      We handle the pharmacovigilance notifications to the competent authorities: For medicinal products that are still in the study phase, we evaluate and develop the safety profile and prepare the regular reports for the authorities as part of DSURs (Development Safety Update Reports) in accordance with the ICH guideline.<\/span><\/p>\n

      Following approval, we monitor the safety and risk-benefit profile of medicinal products and report adverse effects and new findings from observational studies as part of PSURs (Periodic Safety Update Reports).<\/span><\/p>\n

      [\/et_pb_blurb][\/et_pb_column][\/et_pb_row][et_pb_row module_id=”Vigilanz” _builder_version=”4.24.0″ _module_preset=”default” custom_padding=”||10px||false|false” locked=”off” global_colors_info=”{}”][et_pb_column type=”4_4″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_image src=”https:\/\/www.convidia.de\/en\/wp-content\/uploads\/sites\/2\/2025\/02\/Divider.jpg” title_text=”Divider” align=”center” _builder_version=”4.24.0″ _module_preset=”default” transform_scale=”102%|102%” transform_scale_tablet=”102%|102%” transform_scale_phone=”202%|202%” transform_scale_last_edited=”on|phone” transform_translate_tablet=”” transform_translate_phone=”” transform_translate_last_edited=”on|desktop” transform_rotate_tablet=”” transform_rotate_phone=”” transform_rotate_last_edited=”on|desktop” transform_skew_tablet=”” transform_skew_phone=”” transform_skew_last_edited=”on|desktop” transform_origin_tablet=”” transform_origin_phone=”” transform_origin_last_edited=”on|desktop” transform_styles_last_edited=”on|phone” custom_margin=”||40px||false|false” transform_styles_tablet=”” transform_styles_phone=”” global_colors_info=”{}”][\/et_pb_image][et_pb_text _builder_version=”4.27.4″ _module_preset=”default” header_font=”Open Sans Light|300|||||||” header_text_align=”center” header_text_color=”#EA5B1B” global_colors_info=”{}”]<\/p>\n

      Vigilance for Medical Devices<\/h1>\n

      [\/et_pb_text][\/et_pb_column][\/et_pb_row][et_pb_row column_structure=”1_3,2_3″ use_custom_gutter=”on” disabled_on=”off|off|off” _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_3″ _builder_version=”4.24.0″ _module_preset=”default” global_colors_info=”{}”][et_pb_blurb title=”Our services to support the vigilance system ” content_max_width=”800px” disabled_on=”off|off|off” _builder_version=”4.27.4″ _module_preset=”default” header_level=”h2″ header_font=”|600|||||||” header_text_color=”#706F6F” body_font=”||||||||” global_colors_info=”{}” header_line_height=”1.3em” url_new_window=”on” custom_margin=”3px||||false|false”]<\/p>\n