{"id":10847,"date":"2023-11-23T08:00:04","date_gmt":"2023-11-23T06:00:04","guid":{"rendered":"https:\/\/www.medengine.fi\/?p=10847"},"modified":"2024-03-22T11:12:41","modified_gmt":"2024-03-22T09:12:41","slug":"medengine-newsletter-post-authorization-safety-studies","status":"publish","type":"post","link":"https:\/\/www.medengine.fi\/news\/medengine-newsletter-post-authorization-safety-studies\/","title":{"rendered":"MedEngine Newsletter: Post-authorization safety studies"},"content":{"rendered":"[vc_row type=”in_container” full_screen_row_position=”middle” column_margin=”default” column_direction=”default” column_direction_tablet=”default” column_direction_phone=”default” scene_position=”center” top_padding=”1%” bottom_padding=”1%” text_color=”dark” text_align=”left” row_border_radius=”none” row_border_radius_applies=”bg” overflow=”visible” overlay_strength=”0.3″ gradient_direction=”left_to_right” shape_divider_position=”bottom” bg_image_animation=”none” shape_type=””][vc_column column_padding=”padding-1-percent” column_padding_tablet=”inherit” column_padding_phone=”inherit” column_padding_position=”right” column_element_direction_desktop=”default” column_element_spacing=”default” desktop_text_alignment=”default” tablet_text_alignment=”default” phone_text_alignment=”default” background_color_opacity=”1″ background_hover_color_opacity=”1″ column_backdrop_filter=”none” column_shadow=”none” column_border_radius=”none” column_link_target=”_self” column_position=”default” gradient_direction=”left_to_right” overlay_strength=”0.3″ width=”1\/1″ tablet_width_inherit=”default” animation_type=”default” bg_image_animation=”none” border_type=”simple” column_border_width=”none” column_border_style=”solid”][vc_video link=”https:\/\/youtu.be\/VfBzXMGdsBw” align=”center”][vc_column_text]Post-authorization safety (PAS) studies play a crucial role in ensuring the ongoing safety and effectiveness profile of pharmaceuticals after regulatory approval.<\/span>[\/vc_column_text][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”accent-color” animate=”yes” custom_height=”30″][divider line_type=”No Line” custom_height=”20″][vc_column_text]The PAS studies monitor products in real-world settings, identifying rare or long-term adverse effects and vulnerable patient populations. Therefore, PAS studies are essential in contributing to a dynamic understanding of a product’s safety profile and optimizing its use.<\/span>[\/vc_column_text][divider line_type=”No Line” custom_height=”20″][vc_column_text]\n

With the availability of versatile health data and extensive longitudinal follow-up, the Nordic registry data offers an optimal setting to conduct PAS studies. In the latest episode of Expert Opinions, MedEngine\u2019s Senior Consultant Simone M\u00f8ller Hede<\/span> shares her insights on PAS studies and explains why the Nordics provide unique opportunities for such research.<\/span><\/p>\n[\/vc_column_text][divider line_type=”No Line” custom_height=”20″][divider line_type=”Small Line” line_alignment=”default” line_thickness=”1″ divider_color=”accent-color” divider_opacity=”50″ animate=”yes” custom_height=”30″ delay=”100″ custom_line_width=”450″][vc_column_text]\n

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\u201cPAS studies are essential in contributing to a dynamic understanding of a product’s safety profile and optimizing its use.\u201d\u00a0<\/span><\/p>\n<\/blockquote>\n[\/vc_column_text][divider line_type=”Small Line” line_alignment=”default” line_thickness=”1″ divider_color=”accent-color” divider_opacity=”50″ animate=”yes” custom_height=”30″ delay=”100″ custom_line_width=”450″][divider line_type=”No Line” custom_height=”20″][vc_column_text]\n

At MedEngine, we have specialized in conducting PAS studies for the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) in the Nordic setting. If you are interested in hearing more, please drop us a note at info@medengine.fi or contact our CEO Tero Ylisaukko-oja<\/span>.<\/span><\/p>\n[\/vc_column_text][divider line_type=”Full Width Line” line_thickness=”1″ divider_color=”accent-color” animate=”yes” custom_height=”30″][divider line_type=”No Line” custom_height=”10″][vc_column_text]\n

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\ud83e\uddb8 Ps. a Pro tip:\u00a0Type your email below and sign up for our newsletter to get the latest news and Expert Opinions directly to your inbox.<\/span><\/p>\n[\/vc_column_text][divider line_type=”No Line” custom_height=”10″][vc_raw_html]JTVCeWlrZXMtbWFpbGNoaW1wJTIwZm9ybSUzRCUyMjElMjIlNUQ=[\/vc_raw_html][\/vc_column][\/vc_row]\n","protected":false},"excerpt":{"rendered":"

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