[\/et_pb_text][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
As part of their pharmacovigilance activities, marketing authorization holders are obliged under the German Medicines Act (AMG) and the Guideline on Good Pharmacovigilance Practice (GVP) to provide signal detection and immediate information to the competent higher federal authorities and the EMA about newly discovered risks or a change in the benefit-risk profile of the medicinal product.<\/p>\n
In order to specifically support marketing authorization holders in fulfilling this obligation, we offer the database-based Signal Sentinel\u00ae, a powerful and efficient signal management tool.<\/p>\n
Our signal detection tool Signal Sentinel\u00ae is used to simplify the recording, evaluation and documentation of signal detection processes and is used both for initial reporting and for the creation of routine reports.
\nYou can use an active substance-related subscription to receive pooled or individual signal detection reports as required. <\/p>\n
[\/et_pb_text][et_pb_image src=”https:\/\/www.heacon.de\/wp-content\/uploads\/2024\/07\/shutterstock_1268263864-1-scaled.jpg” title_text=”In,Laboratory,Over,The,Shoulder,View,Of,Scientist,In,Protective” _builder_version=”4.25.1″ _module_preset=”default” global_colors_info=”{}”][\/et_pb_image][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
Pooled report<\/strong><\/p>\n This Signal Sentinel\u00ae report includes an editable digital template:<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” text_font=”|300|||||||” text_font_size=”20px” text_line_height=”1.8em” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n Individual report<\/strong><\/p>\n We create complete signal detection reports for you using the Signal Sentinel\u00ae method with<\/p>\n [\/et_pb_text][et_pb_text _builder_version=”4.24.3″ _module_preset=”default” text_font=”|300|||||||” text_font_size=”20px” text_line_height=”1.8em” custom_margin=”||||false|false” global_colors_info=”{}”]<\/p>\n Signal management SOP<\/strong><\/p>\n The signal management SOP serves to ensure that the signal management for drug risks of a medical nature carried out by MAHs or their contractors, their evaluation and documentation for the fulfillment of pharmacovigilance requirements is carried out according to a uniform procedure and in accordance with regulatory requirements.<\/p>\n By adhering to this SOP, signals that indicate a change in the benefit-risk profile of a medicinal product from a company can be recognized and evaluated in good time and appropriate measures can be initiated.<\/p>\n [\/et_pb_text][\/et_pb_column_inner][\/et_pb_row_inner][\/et_pb_column][\/et_pb_section][et_pb_section fb_built=”1″ _builder_version=”4.24.2″ _module_preset=”default” background_image=”https:\/\/www.heacon.de\/wp-content\/uploads\/2024\/03\/audit-02.jpg” parallax=”on” min_height=”1035.6px” da_disable_devices=”off|off|off” global_colors_info=”{}” da_is_popup=”off” da_exit_intent=”off” da_has_close=”on” da_alt_close=”off” da_dark_close=”off” da_not_modal=”on” da_is_singular=”off” da_with_loader=”off” da_has_shadow=”on”][et_pb_row column_structure=”1_2,1_2″ _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_column type=”1_2″ _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_code _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n <\/div>\n [\/et_pb_code][et_pb_text _builder_version=”4.27.0″ _module_preset=”default” header_2_font=”|700|||||||” header_2_text_align=”left” header_2_font_size=”4rem” header_2_line_height=”1.2em” header_3_font=”|300|||||||” header_3_text_align=”left” header_3_font_size=”20px” header_3_line_height=”1.3em” custom_margin=”||17px|||” hover_enabled=”0″ global_colors_info=”{}” header_2_font_size_last_edited=”on|phone” header_2_font_size_phone=”45px” sticky_enabled=”0″ header_2_font_size_tablet=”4rem”]<\/p>\n [\/et_pb_text][\/et_pb_column][et_pb_column type=”1_2″ _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”][et_pb_code module_class=”formStyleMain” _builder_version=”4.24.2″ _module_preset=”default” global_colors_info=”{}”]<\/p>\n <\/p> \n
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<\/p>\nWe look forward to your message<\/h2>\n
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