{"id":13591,"date":"2024-09-26T15:10:23","date_gmt":"2024-09-26T15:10:23","guid":{"rendered":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/?page_id=13591"},"modified":"2024-10-03T10:09:35","modified_gmt":"2024-10-03T10:09:35","slug":"regulatory-affairs-quality-and-safety","status":"publish","type":"page","link":"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/info-resources\/exploration\/regulatory-affairs-quality-and-safety\/","title":{"rendered":"Career area: Regulatory affairs, quality and safety"},"content":{"rendered":"\n<div class=\"vf-grid | vf-grid__col-3\"><div class=\"vf-grid__col--span-2\"><!--[vf\/content]-->\n<div class=\"vf-content\">\n\n<h2 class=\"wp-block-heading\">A &#8216;regulatory affairs, science policy&#8217; career<\/h2>\n\n\n\n<p>Many life science products are subject to national or international regulations to ensure that the products are safe and effective.&nbsp;The career area of regulatory affairs, quality control and safety centres around understanding, communicating and applying product\/safety regulations, documenting relevant information, applying for required approvals, and coordinating related processes. These roles can be found in pharmaceutical companies, contract research\/manufacturing organizations, and medical device companies; there are also roles in other sectors (e.g. food or national testing laboratories) that might be relevant for some scientific backgrounds. Every academic institution also has a safety office focused on biosafety and good working practices for safe research.<\/p>\n\n\n\n<div style=\"height:20px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"vf-tabs\"><ul class=\"vf-tabs__list\" data-vf-js-tabs=\"true\"><li class=\"vf-tabs__item\"><a class=\"vf-tabs__link\" href=\"#vf-tabs__section-ad9d22e7-f2ff-4f69-8d17-6906474a25b3\" data-vf-js-location-nearest-activation-target=\"\">Roles and responsibilities<\/a><\/li><li class=\"vf-tabs__item\"><a class=\"vf-tabs__link\" href=\"#vf-tabs__section-0e516856-67d5-40f7-8a48-9fb56f3d4d9c\" data-vf-js-location-nearest-activation-target=\"\">Career entry and progression<\/a><\/li><li class=\"vf-tabs__item\"><a class=\"vf-tabs__link\" href=\"#vf-tabs__section-2b831503-f499-4f03-ae98-402b00c99e2e\" data-vf-js-location-nearest-activation-target=\"\">Knowledge and skills<\/a><\/li><\/ul><div class=\"vf-tabs-content\" data-vf-js-tabs-content=\"true\">\n<section class=\"vf-tabs__section\" id=\"vf-tabs__section-ad9d22e7-f2ff-4f69-8d17-6906474a25b3\"><h2>Roles and responsibilities<\/h2>\n<p><strong>Regulatory affairs<\/strong><em> <\/em>professionals oversee and manage the regulatory approval process for new products (e.g. medicines, and medical devices), and ensure that necessary processes are followed during product development. They can be employed directly by the company producing the product, or by consultancies who provide regulatory support on a contract basis. Additionally, a small number of positions also exist within the regulatory authorities themselves.<\/p>\n\n\n\n<p>Depending on the role, tasks may include a subset of:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>keep up to date with national and\/or international regulations.<\/li>\n\n\n\n<li>providing strategic advice to research and development teams on processes and requirements, with the aim of ensuring that the product will be developed in a way that is compatible with the regulatory process \u2013 for example, that records and documentation are completed.&nbsp;<\/li>\n\n\n\n<li>coordinating collation, formatting and submission of relevant documentation for approval of new products, clinical trials, licence renewals and changes in the wording of packing\/product inserts; for example, interacting with the scientists and medical writers compiling different sections of the reports. Regulatory affairs professionals may also be involved in writing some parts of the dossier.<\/li>\n\n\n\n<li>making presentations to regulatory authorities like the US Food and Drug Administration (FDA)\/European Medicines Agency (EMA), communicating with the agencies regarding current submissions or within regulatory authorities.<\/li>\n\n\n\n<li>coordinating assessment of submissions.<\/li>\n\n\n\n<li>managing any regulatory inspections.&nbsp;<\/li>\n<\/ul>\n\n\n\n<p><strong>Quality positions <\/strong>include roles linked to quality control or assurance (QC or QA), and regulatory compliance for existing products. These roles involve ensuring that processes, systems and products comply with required standards (for example, \u2018good manufacturing practices (GMP)), that each batch of product is checked for contaminants or other quality issues according to defined procedures, and developing related procedures and processes where needed. Specific tasks for QC roles may involve:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>overseeing (senior roles) or carrying out (junior roles) lab-based sample testing to ensure e.g. homogeneity and purity with relevant techniques (e.g. HPLC, LC\/GC-MS, ELISA, Octet<sup>\u00ae<\/sup>) and absence of microbial contamination.<\/li>\n\n\n\n<li>project management around the quality control process\/related work.<\/li>\n\n\n\n<li>completing reports and other documentation e.g. standard operating procedures (SOPs) and reports on trends; presenting data.<\/li>\n\n\n\n<li>approving the release of product batches (more senior roles).<\/li>\n\n\n\n<li>identify potential improvements in systems.<\/li>\n\n\n\n<li>investigating root causes and proposing \u2018corrective and preventative actions\u2019 when a potential quality issue is identified (e.g. \u2018deviations\u2019 from procedure due to human error or equipment failure, or deviations from expected values in the laboratory tests).<\/li>\n<\/ul>\n\n\n\n<p>Assurance and compliance roles tend to focus at a broader level on the processes and documentation involved in the whole manufacturing process, including preparing for quality audits.<\/p>\n\n\n\n<p><strong>Safety<\/strong><\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>drug safety\/pharmacovigilance investigates possible safety issues with products in development or already on the market. They receive and evaluate reports of adverse events, and write periodic safety reports. Entry-level roles may also involve coding reports and entering them into a central database.<\/li>\n\n\n\n<li>lab safety: role in institutes (and presumably industry) \u2013 for example biosafety \u2013 advising researchers\/management on legal requirements and risks around lab and research safety (e.g. containment levels for different infectious disease research), promoting good practice and responding to\/documenting lab accidents etc.<\/li>\n<\/ul>\n<\/section>\n\n\n\n<section class=\"vf-tabs__section\" id=\"vf-tabs__section-0e516856-67d5-40f7-8a48-9fb56f3d4d9c\"><h2>Career entry and progression<\/h2>\n<p>A PhD is generally not required to enter this career area, but a scientific background is helpful in most roles \u2013 for example, to understand the context of the information being handled in the submissions; and a PhD may be required for some more technical positions.<\/p>\n\n\n\n<p>Some pharma companies offer traineeships and\/or internships in regulatory affairs for those entering directly from a scientific (higher) degree or postdoc, and there are also training courses available that can help you to get familiar with the field before applying for positions within companies or agencies.<\/p>\n\n\n\n<p>For \u2018Quality\u2019 positions, some training (e.g. in GMP) is available. However, while obtaining qualifications in the area may help you show your interest in a career change, additional qualifications are not strictly necessary \u2013 speakers in a quality control career webinar we held reported that recent PhD-hires to their company did not have GMP certification.<\/p>\n<\/section>\n\n\n\n<section class=\"vf-tabs__section\" id=\"vf-tabs__section-2b831503-f499-4f03-ae98-402b00c99e2e\"><h2>Knowledge and skills<\/h2>\n<p>Generally, these roles require good attention to detail, a structured working style, strong communication skills and good interpersonal skills (e.g. to ensure that people from different departments submit their information on time, or follow processes they find cumbersome).<\/p>\n\n\n\n<p>In our <a href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/2022\/03\/skills-for-a-scientific-career\/\" target=\"_blank\" rel=\"noreferrer noopener\">careers and skills survey<\/a>, 6 regulatory and quality professionals told us the competencies they use most in their daily work&nbsp; The most frequently selected competencies were::<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>teamwork (selected by 100% of respondents)<\/li>\n\n\n\n<li>organization (selected&nbsp;by 100%)<\/li>\n\n\n\n<li>writing (selected&nbsp;by 67%)<\/li>\n\n\n\n<li>effective communication (selected&nbsp;by 67%)<\/li>\n\n\n\n<li>resilient problem solving&nbsp; (selected&nbsp;by 67%)<\/li>\n<\/ul>\n\n\n\n<h4 class=\"wp-block-heading\">Language requirements<\/h4>\n\n\n\n<p>The small number of responses to our careers and skills survey suggested that fluency in the local language is required for many, but not all, regulatory and quality roles. Those most likely to be possible without fluency in the local language are regulatory roles focused on FDA or European-level regulations in international companies. Roles involving national regulations, or where you will manage\/communicate with quality control lab technicians, are likely to require the local language.<\/p>\n\n\n\n<p>&nbsp;<\/p>\n<\/section>\n<\/div><\/div>\n\n<\/div>\n<\/div>\n\n\n<div class=\"\"><!--[vf\/content]-->\n<div class=\"vf-content\">\n\n<figure class=\"vf-figure wp-block-image size-full\"><img loading=\"lazy\" decoding=\"async\" width=\"1920\" height=\"1282\" class=\"vf-figure__image\" src=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/pexels-kampus-6829535.jpg\" alt=\"\" class=\"wp-image-13341\" srcset=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/pexels-kampus-6829535.jpg 1920w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/pexels-kampus-6829535-300x200.jpg 300w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/pexels-kampus-6829535-1024x684.jpg 1024w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/pexels-kampus-6829535-768x513.jpg 768w, https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/wp-content\/uploads\/pexels-kampus-6829535-1536x1026.jpg 1536w\" sizes=\"auto, (max-width: 1920px) 100vw, 1920px\" \/><\/figure>\n\n\n\n<div style=\"height:25px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<article class=\"vf-card vf-card--brand vf-card--bordered vf-u-margin__bottom--800\" default>\n  \n  <div class=\"vf-card__content | vf-stack vf-stack--400\">\n          <h3 class=\"vf-card__heading\">\n        \n        What do people value about this career?\n              <\/h3>\n    \n    \n          <p class=\"vf-card__text\"><!-- wp:paragraph -->\r\n\r\nIn our<a class=\"vf-card_link\" href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/2022\/03\/skills-for-a-scientific-career\/\" target=\"_blank\" rel=\"noreferrer noopener\"> careers and skills survey,<\/a> scientists working in regulatory affairs and quality told us that they appreciate that their work:\r\n<ul>\r\n \t<li>involves collaboration\/ working in a team<\/li>\r\n \t<li>has high task variet<\/li>\r\n<\/ul>\r\n<!-- wp:list -->\r\n<ul>\r\n \t<li style=\"list-style-type: none;\">\r\n<ul><!-- wp:list-item --><\/ul>\r\n<\/li>\r\n<\/ul>\r\n<!-- \/wp:list-item -->\r\n\r\n<!-- \/wp:list --><\/p>\n      <\/div>\n<\/article>\n\n<\/div>\n<\/div>\n<\/div>\n\n\n<style>\n    <\/style>\n\n<section id=\"wp-block-1\">\n  <div class=\"vf-card-container  | vf-u-fullbleed  \n  | vf-u-background-color-ui--grey--light \">\n          <div class=\"vf-section-header | vf-u-margin__bottom--600 | vf-u-sr-only\">\n        <h2 class=\"vf-section-header__heading\" >\n        header    <\/h2>\n              <\/div>\n      \n\n<div class=\"vf-grid | vf-grid__col-3\"><div class=\"vf-grid__col--span-2\"><!--[vf\/content]-->\n<div class=\"vf-content\">\n\n<h2 class=\"wp-block-heading\">Want to learn more about these career areas?<\/h2>\n\n\n\n<details  class=\"vf-details\" id=\"\"  >\n<summary class=\"vf-details--summary\">\nRegulatory Affairs <\/summary>\n<div class=\"acf-innerblocks-container\">\n<div class=\"vf-links vf-links--tight vf-links__list--s vf-links__list--very-easy\">\n    <ul class=\"vf-links__list vf-list vf-links__list--secondary\">\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.prospects.ac.uk\/job-profiles\/regulatory-affairs-officer\">\n        Regulatory affairs officer \u2013 PROSPECTS Job profile      <\/a>\n          <span class=\"vf-badge vf-badge--primary\">\n        **Recommended**      <\/span>\n      <\/li>\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"http:\/\/blogs.nature.com\/naturejobs\/2015\/06\/03\/finding-job-satisfaction-in-regulatory-affairs\/\">\n        Finding job satisfaction in regulatory affairs \u2013 Nature Jobs      <\/a>\n      <\/li>\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.sciencemag.org\/careers\/2003\/11\/research-regulatory-affairs-long-journey-complete-life-cycle\">\n        From Research to Regulatory Affairs: Long Journey to a Complete Life Cycle \u2013 Science Careers      <\/a>\n      <\/li>\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.northeastern.edu\/graduate\/blog\/working-in-regulatory-affairs-careers-and-trends\/\">\n        Working in regulatory affairs: careers and trends \u2013 Northeastern University      <\/a>\n      <\/li>\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.topra.org\/TOPRA_Member\/Professional_Development\/Regulatory_Careers_Live_\/RA_careers_information_pack\/TOPRA\/TOPRA_Member\/Careers\/Careers_Information_Pack.aspx?hkey=27d05f9b-ddf7-4718-8cae-ab517b07738f\">\n        Careers information pack \u2013 TOPRA (The organisation for professionals in regulatory affairs)      <\/a>\n      <\/li>\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/intersectjobsims.com\/library\/performing-a-competitive-analysis\/\">\n        InterSECT Job Sim simulation library -Perform a Competitive Analysis      <\/a>\n      <\/li>\n  <\/ul>\n\n<\/div>\n\n<\/div>\n<\/details>\n\n\n\n<details  class=\"vf-details\" id=\"\"  >\n<summary class=\"vf-details--summary\">\nQuality assurance and control<\/summary>\n<div class=\"acf-innerblocks-container\">\n<div class=\"vf-links vf-links--tight vf-links__list--s vf-links__list--very-easy\">\n    <ul class=\"vf-links__list vf-list vf-links__list--secondary\">\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.acs.org\/content\/acs\/en\/careers\/chemical-sciences\/fields\/quality-assurance-and-control.html\">\n        Quality Assurance &amp; Control &#8211; ACS      <\/a>\n      <\/li>\n  <\/ul>\n\n<\/div>\n\n<\/div>\n<\/details>\n\n\n\n<details  class=\"vf-details\" id=\"\"  >\n<summary class=\"vf-details--summary\">\nDrug safety<\/summary>\n<div class=\"acf-innerblocks-container\">\n<div class=\"vf-links vf-links--tight vf-links__list--s vf-links__list--very-easy\">\n    <ul class=\"vf-links__list vf-list vf-links__list--secondary\">\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.abpi.org.uk\/careers\/job-roles\/drug-safety-pharmacovigilance\/\">\n        Drug safety  \u2013 Association of the British Pharmaceutical Industry      <\/a>\n      <\/li>\n  <\/ul>\n\n<\/div>\n\n<\/div>\n<\/details>\n\n\n\n<details  class=\"vf-details\" id=\"\"  >\n<summary class=\"vf-details--summary\">\nLab safety<\/summary>\n<div class=\"acf-innerblocks-container\">\n<div class=\"vf-links vf-links--tight vf-links__list--s vf-links__list--very-easy\">\n    <ul class=\"vf-links__list vf-list vf-links__list--secondary\">\n    <li class=\"vf-list__item\">\n          <a class=\"vf-list__link\" href=\"https:\/\/www.nature.com\/articles\/d41586-020-00593-5\">\n        Behind the scenes in the biosafety office \u2013 nature careers      <\/a>\n      <\/li>\n  <\/ul>\n\n<\/div>\n\n<\/div>\n<\/details>\n\n\n\n<div style=\"height:12px\" aria-hidden=\"true\" class=\"wp-block-spacer\"><\/div>\n\n\n\n<div class=\"vf-box vf-box--normal vf-box-theme--quinary | vf-u-margin__bottom--400\">\n                            <p class=\"vf-box__text\">We highly recommend learning more about the careers using the resources above, then conducting <a href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/info-resources\/making-connections\/#vf-tabs__section-c9d226ee-2bad-45ed-bf4a-7d49cd01ad03\">informational interviews<\/a> to gain further insights directly from former PhDs working in career areas that interest you.<\/p>\n<\/div>\n<\/div>\n<\/div>\n\n\n<div class=\"\"><!--[vf\/content]-->\n<div class=\"vf-content\">\n\n<article class=\"vf-card vf-card--brand vf-card--bordered vf-u-margin__bottom--800\" default>\n  \n  <div class=\"vf-card__content | vf-stack vf-stack--400\">\n          <h3 class=\"vf-card__heading\">\n                  <a class=\"vf-card__link\" href=\"https:\/\/www.embl.org\/internal-information\/eicat\/embl-fellows-career-service\/career-exploration\/\" target=\"\">\n        \n        For EMBL fellows\n                  <svg aria-hidden=\"true\" class=\"vf-card__heading__icon | vf-icon vf-icon-arrow--inline-end\" width=\"1em\" height=\"1em\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n            <path d=\"M0 12c0 6.627 5.373 12 12 12s12-5.373 12-12S18.627 0 12 0C5.376.008.008 5.376 0 12zm13.707-5.209l4.5 4.5a1 1 0 010 1.414l-4.5 4.5a1 1 0 01-1.414-1.414l2.366-2.367a.25.25 0 00-.177-.424H6a1 1 0 010-2h8.482a.25.25 0 00.177-.427l-2.366-2.368a1 1 0 011.414-1.414z\" fill=\"currentColor\" fill-rule=\"nonzero\"><\/path>\n          <\/svg>\n        <\/a>\n              <\/h3>\n    \n    \n          <p class=\"vf-card__text\">Further internal resources (e.g. library of recorded career talks) can be found on our intranet pages.<\/p>\n      <\/div>\n<\/article>\n\n<\/div>\n<\/div>\n<\/div>\n\n\n        <\/div>\n<\/section>\n\n\n<hr class=\"vf-divider\">\n\n\n\n\n        <div class=\"vf-section-header\">\n        <h2 class=\"vf-section-header__heading\">\n            <a class=\"vf-section-header__heading vf-section-header__heading--is-link\"\n               target=\"\"\n               href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/category\/career-profiles\/profiles_reg_pol\/regulation\/\">\n                Read relevant posts from our blog                <svg aria-hidden=\"true\" class=\"vf-section-header__icon | vf-icon vf-icon-arrow--inline-end\" width=\"24\" height=\"24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n                    <path d=\"M0 12c0 6.627 5.373 12 12 12s12-5.373 12-12S18.627 0 12 0C5.376.008.008 5.376 0 12zm13.707-5.209l4.5 4.5a1 1 0 010 1.414l-4.5 4.5a1 1 0 01-1.414-1.414l2.366-2.367a.25.25 0 00-.177-.424H6a1 1 0 010-2h8.482a.25.25 0 00.177-.427l-2.366-2.368a1 1 0 011.414-1.414z\" fill=\"\" fill-rule=\"nonzero\"><\/path>\n                <\/svg>\n            <\/a>\n        <\/h2>\n            <\/div>\n    \n<div class=\"vf-grid vf-grid__col-3 | vf-content\">\n\n    \n            \n<article class=\"vf-summary vf-summary--news\" style=\"display: block; display: unset;\">\n  \n  <span class=\"vf-summary__date\" title=\"2022-06-10T13:43:26+00:00\"\n    datetime=\"2022-06-10T13:43:26+00:00\">10 June 2022  <\/span>\n    \n  <h3 class=\"vf-summary__title\">\n    <a href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/2022\/06\/career-profile-yave-lozano-medical-writer-icon\/\" class=\"vf-summary__link\">Career profile: Yav\u00e9 Lozano,  Medical Writer, ICON<\/a>\n  <\/h3>\n    <p class=\"vf-summary__text\">\n    Yav\u00e9 Lozano shares his experience of moving into regulatory writing, a specialist medical communications role.  <\/p>\n    <\/span>\n      \n<\/article>\n\n<!--\/vf-summary-->\n\n<article class=\"vf-summary vf-summary--news\" style=\"display: block; display: unset;\">\n  \n  <span class=\"vf-summary__date\" title=\"2019-12-20T14:57:09+00:00\"\n    datetime=\"2019-12-20T14:57:09+00:00\">20 December 2019  <\/span>\n    \n  <h3 class=\"vf-summary__title\">\n    <a href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/blog\/2019\/12\/vicente-tur-director-of-regulatory-affairs-at-asphalion-spain\/\" class=\"vf-summary__link\">Career profile: Vicente Tur, Director of Regulatory Affairs at Asphalion, Spain<\/a>\n  <\/h3>\n    <p class=\"vf-summary__text\">\n    Vicente Tur tells us about his career in regulatory affairs, one of many non-research professions tightly linked with pharma and biotech industries.  <\/p>\n    <\/span>\n      \n<\/article>\n\n<!--\/vf-summary-->\n    \n<\/div>\n\n<\/div>\n\n\n\n\n<hr class=\"vf-divider\">\n\n\n\n<div class=\"vf-grid | vf-grid__col-3\"><div class=\"vf-grid__col--span-3\"><!--[vf\/content]-->\n<div class=\"vf-content\">\n\n<div class=\"vf-section-header | vf-u-margin__bottom--400\">\n  <h2 class=\"vf-section-header__heading\" \n      >\n      \n          <a class=\"vf-section-header__heading vf-section-header__heading--is-link\"\n                  target=\"_blank\"\n         href=\"https:\/\/www.embl.org\/about\/info\/embl-fellows-career-service\/info-resources\/exploration\/\">\n        Return to our Career information and exploration page        <svg aria-hidden=\"true\" class=\"vf-section-header__icon | vf-icon vf-icon-arrow--inline-end\" width=\"24\" height=\"24\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\">\n          <path d=\"M0 12c0 6.627 5.373 12 12 12s12-5.373 12-12S18.627 0 12 0C5.376.008.008 5.376 0 12zm13.707-5.209l4.5 4.5a1 1 0 010 1.414l-4.5 4.5a1 1 0 01-1.414-1.414l2.366-2.367a.25.25 0 00-.177-.424H6a1 1 0 010-2h8.482a.25.25 0 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