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wpb_top-to-bottom"> <div class="wpb_wrapper"> <h1 style="letter-spacing: 1px; line-height: 0; padding: 3px 20px; display: inline; background-color: #f7c51e; text-align: left; font-size: 50px; text-transform: uppercase;">PROMOTING <strong>GOOD</strong> PRACTICE</h1> <p> </p> <h1 style="letter-spacing: 1px; line-height: 0; padding: 3px 20px; display: inline; background-color: #f7c51e; text-align: left; font-size: 50px; text-transform: uppercase;">FOR THE OFF-LABEL</h1> <p> </p> <h1 style="letter-spacing: 1px; line-height: 0; padding: 3px 20px; display: inline; background-color: #f7c51e; text-align: left; font-size: 50px; text-transform: uppercase;"><strong>USE</strong> OF MEDICINES:</h1> </div> </div> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_right-to-left"> <div class="wpb_wrapper"> <h3 style="letter-spacing: 0px; line-height: 2.3; padding: 3px 20px; display: inline; background-color: #fff; text-align: left;">A harmonised European approach to prioritise patient safety</h3> </div> </div> <hr class="vertical-space2"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_bottom-to-top"> <div class="wpb_wrapper"> <h2 style="color: #fff; letter-spacing: 1px; line-height: 0; padding: 10px 20px; display: inline; background-color: #000; text-align: left; font-size: 35px; text-transform: uppercase;"><img decoding="async" class="alignnone size-full wp-image-8249" src="http://www.braincouncil.eu/golup/wp-content/uploads/2015/05/arrow_before_button.png" alt="arrow_before_button" width="11" height="22" /> <a style="color: #fff;" href="http://www.braincouncil.eu/golup/wp-content/uploads/2017/11/GOLUP_Declaration.pdf" target="_blank" rel="noopener"><span style="text-decoration: underline;">DOWNLOAD <strong>THE DECLARATION</strong></span></a></h2> </div> </div> <div class="vc_empty_space" style="height: 40px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_video_widget wpb_content_element vc_clearfix vc_video-aspect-ratio-169 vc_video-el-width-100 vc_video-align-center"> <div class="wpb_wrapper"> <div class="wpb_video_wrapper"><iframe title="The Declaration on Good Off-Label Use Practice - An harmonised approach to prioritise patient safety" width="940" height="529" src="https://www.youtube.com/embed/zlqo80UP18Q?start=7&feature=oembed" frameborder="0" allow="accelerometer; autoplay; clipboard-write; encrypted-media; gyroscope; picture-in-picture" allowfullscreen></iframe></div> </div> </div> <div class="vc_empty_space" style="height: 32px" ><span class="vc_empty_space_inner"></span></div> </div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"></div></section><section id="box_follow_the_campaign" class="blox aligncenter " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f7c51e;"><div class="max-overlay" style="background-color:"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_row wpb_row vc_inner vc_row-fluid vc_row-o-content-middle vc_row-flex"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 40px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2 style="text-align: center;">WHAT IS <strong>OFF-LABEL USE?</strong></h2> </div> </div> <div class="vc_empty_space" style="height: 30px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_single_image wpb_content_element vc_align_center wpb_animate_when_almost_visible wpb_top-to-bottom vc_custom_1467803947540"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="38" height="20" src="https://www.braincouncil.eu/golup/wp-content/uploads/2016/07/arrow-yellow-bottom.png" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div></div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space3"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_bottom-to-top"> <div class="wpb_wrapper"> <p style="text-align: center;">Before being placed on the market, medicines obtain an authorisation and a label for the indication for which they are tested. This testing follows very rigorous regulatory standards and procedures to scientifically demonstrate that the medicine is efficacious and of high quality but also minimises as much as possible risks to patient safety.</p> <p style="text-align: center;">Off-label use is the practice of using a medicine outside its authorised indication. It plays an important part in some medical areas, since it can be of benefit to patients when no other treatment option is available, such as it is often the case in rare diseases or in the case of child and adolescent care.</p> </div> </div> <hr class="vertical-space1"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f7c51e;"><div class="max-overlay" style="background-color:"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space3"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3 style="text-align: center;"><strong>WHAT SHOULD YOU KNOW ABOUT OFF-LABEL USE?</strong></h3> </div> </div> <div class="vc_empty_space" style="height: 10px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: center;">Some European Union Member States are imposing prescribing guidelines that effectively promote off-label use for the sole purpose of reducing healthcare spending. We are concerned that this trend is creating unnecessary and avoidable risks for patients and often puts healthcare professionals in the position of being liable for a decision that they have not taken in full autonomy, and is potentially disrespecting the medical needs of the patients.</p> </div> </div> <hr class="vertical-space1"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space3"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-8 vc_col-has-fill"><div class="vc_column-inner vc_custom_1470229115456"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_top-to-bottom vc_custom_1503302426920 li_white"> <div class="wpb_wrapper"> <h2 style="text-align: left;"><span style="color: #ffffff;">WHAT IS <strong>GOOD PRACTICE?</strong></span></h2> <h3><span style="color: #ffffff;">We believe that off-label use of medicinal products <strong>should only occur if the following criteria are met</strong>:</span></h3> <ul> <li><span style="color: #ffffff; font-size: 23px;">Presence of a medical therapeutic need based on a current examination of the patient by a suitably qualified health care professional;</span></li> <li><span style="color: #ffffff; font-size: 23px;">Absence of authorised treatment and licensed alternatives tolerated by the patient or repeated treatment failure;</span></li> <li><span style="color: #ffffff; font-size: 23px;">A documented review and critical appraisal of available scientific evidence favours off-label use to respond to the unmet medical need of the individual patient</span></li> <li><span style="color: #ffffff; font-size: 23px;">Patients (or their legal representative) must be given sufficient information about the medicines that are prescribed to allow them to make an informed decision; </span></li> <li><span style="color: #ffffff; font-size: 23px;">Presence of established reporting routes for outcomes and adverse events linked to off-label use.</span></li> </ul> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_left-to-right"> <div class="wpb_wrapper"> <p> These criteria, drawn together by <span style="color: #006db2;"><strong>an independent expert</strong></span>, stem from decades of research and clinical practice and serve to provide a <span style="color: #006db2;"><strong>clear framework</strong></span> on when and how the off-label use of medicinal products could safely take place. </p> </div> </div> <hr class="vertical-space1"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_left-to-right"> <div class="wpb_wrapper"> <p> <span style="color: #006db2;">They do not aim to limit off-label use, but seek to promote a harmonised approach for its occurrence in order to maintain the highest levels of patient safety and minimise adverse events.</span> </p> </div> </div> </div></div></div></section></div></section><section class="parallax-sec blox aligncenter " style=" padding-top:px; padding-bottom:px; background: url('https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/background-pills.jpg') no-repeat center; min-height:300px; " data-stellar-background-ratio="0.6"><div class="max-overlay" style="background-color:"></div><div data-stellar-ratio="1" class="wpb_row vc_row-fluid "><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2 style="text-align: center;"><strong>CALL TO ACTION!</strong></h2> </div> </div> <div class="vc_empty_space" style="height: 10px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3 style="text-align: center;">We believe health professionals should be supported by the public bodies and authorities responsible for the approval and use of medicines whose role is to protect public health. Physicians need to be given the freedom to uphold their pledge towards their patients to act ethically and put the patient’s interest first.</h3> </div> </div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: center;">A clear, Europe-wide approach on the issue is becoming increasingly urgent to preserve the European regulatory framework and ensure the safety of patients.</p> </div> </div> <hr class="vertical-space1"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section id="newsletter" class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3 style="text-align: center;"><strong>NEWSLETTER</strong></h3> </div> </div> <div class="wpb_raw_code wpb_content_element wpb_raw_html"> <div class="wpb_wrapper"> <script charset="utf-8" type="text/javascript" src="//js-eu1.hsforms.net/forms/embed/v2.js"></script> <script> hbspt.forms.create({ region: "eu1", portalId: "143680132", formId: "5201a112-3027-4f50-8ece-3a5718ca4e9e" }); </script> </div> </div> <div class="vc_empty_space" style="height: 35px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_appear"> <div class="wpb_wrapper"> <p style="text-align: center;">We thus call on the <strong>European Medicines Agency</strong> and other national regulatory bodies to adopt strict guidelines to support healthcare practioners to take their decision on the basis of the medical need of their patients and ensure economic benefit does not prevail over public health.</p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-6 vc_col-has-fill"><div class="vc_column-inner vc_custom_1470227130552"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3 style="text-align: center;"><strong>Endorse the Declaration on Good Off-Label Use Practice</strong></h3> </div> </div> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_appear"> <div class="wpb_wrapper"> <p style="text-align: center;">The Declaration on Good Off-Label Use Practices is open to any national and European organisation which supports its principles and objectives.</p> <h3 style="text-align: center;"><a style="color: #000;" href="http://www.braincouncil.eu/golup/wp-content/uploads/2017/11/GOLUP_Declaration.pdf" target="_blank" rel="noopener"><span style="text-decoration: underline;">Download the declaration</span></a></h3> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6 vc_col-has-fill"><div class="vc_column-inner vc_custom_1470227137898"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3 style="text-align: center;"><strong>Share your experience</strong></h3> <h3 style="text-align: center;"><strong> </strong></h3> </div> </div> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_appear"> <div class="wpb_wrapper"> <p class="p1" style="text-align: center;"><span class="s1">We are interested in knowing your experience with off-label use. If you are interested in sharing it,</span></p> <ul> <li class="inlinelb" style="text-align: center; font-size: 28px; line-height: 14px; list-style: none;"><span style="text-decoration: underline;"><a style="color: #000;" href="#w-contact">please contact us</a></span></li> </ul> </div> </div> </div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section></div></section><section id="box_logos" class="blox aligncenter " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:280px; background-color:#eaeaea;"><div class="max-overlay" style="background-color:"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-12 vc_col-has-fill"><div class="vc_column-inner vc_custom_1467800655963"><div class="wpb_wrapper"><hr 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class="vertical-space1"></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"></div></section><section id="box_follow_the_campaign" class="blox aligncenter " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f7c51e;"><div class="max-overlay" style="background-color:"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_row wpb_row vc_inner vc_row-fluid vc_row-o-content-middle vc_row-flex"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 40px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2 style="text-align: center;"><strong>FOLLOW</strong> THE CAMPAIGN</h2> </div> </div> <div class="vc_empty_space" style="height: 30px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_single_image wpb_content_element vc_align_center wpb_animate_when_almost_visible wpb_top-to-bottom vc_custom_1467803947540"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="38" height="20" src="https://www.braincouncil.eu/golup/wp-content/uploads/2016/07/arrow-yellow-bottom.png" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div></div></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_empty_space" style="height: 32px" ><span class="vc_empty_space_inner"></span></div> </div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 style="text-align: center;"><strong> EVENTS</strong></h4> </div> </div> </div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2021/05/17june.png" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p><span style="font-size: 20px;"><strong>Patient safety and informed consent:<br /> The importance of good off-label use practices</strong></span></p> <p><span style="font-size: 20px;">The purpose of this event is to allow an exchange of ideas and experience among stakeholders and local actors, to understand which paths to take in individual Member States and to allow a continuous exchange of ideas and information on the off-label use of medicines.</span></p> <p><em><span style="font-size: 20px;">17th June 2021</span></em></p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.braincouncil.eu/event/golup-off-label-use-event/" class="button green large " target="_blank"><i class="none"></i>EVENT DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/25-April-1-1.png" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p> <span style="font-size: 20px;"><strong>National Workshop on Off-label Use of Medicines </strong></span> <span style="font-size: 20px;">Declaración sobre buenas prácticas del uso fuera de guía de medicamentos en España – 25th April 2018</span> </p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.braincouncil.eu/event/national-workshop-on-off-label-use-of-medicines-declaracion-sobre-buenas-practicas-del-uso-fuera-de-guia-de-medicamentos-en-espana-25th-april-2018/" class="button green large " target="_blank"><i class="none"></i>EVENT DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/13-dec.png" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p> <span style="font-size: 20px;"><strong>Good Off-Label Use Practice (GOLUP) National Roundtable – Italy </strong></span> <span style="font-size: 20px;">On 13th December 2017, the European Brain Council (EBC) participated in a roundtable on the use of off-label medicines in Rome, Italy. This was the first of a series of national roundtables to be organised by the Good Off-Label Use Practice (GOLUP) coalition.</span> </p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.braincouncil.eu/good-off-label-use-practice-golup-national-roundtable-italy/" class="button green large " target="_blank"><i class="none"></i>EVENT DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/10-July.png" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p> <span style="font-size: 20px;"><strong>EBC Hosts Roundtable on Off-Label Use of Medicines </strong></span> <span style="font-size: 20px;">On the 10th of July, the European Brain Council (EBC) hosted an extremely insightful roundtable on “Ensuring the safe prescription of medicines off-label in Europe: what role for the European Union?”.</span> </p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.braincouncil.eu/ebc-hosts-roundtable-on-off-label-use-of-medicines/" class="button green large " target="_blank"><i class="none"></i>EVENT DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/27_sept.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>Kick-off debate on off-label use of medicines in Europe</strong></h4> <h4 class="event-title">Safeguarding patient safety and quality of care in europe Tuesday, 27 September 2016, European Parliament</h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.braincouncil.eu/european-brain-council-kicks-off-the-debate-on-off-label-use-in-europe/" class="button green large " target="_blank"><i class="none"></i>EVENT DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 style="text-align: center;"><strong>NEWS</strong></h4> </div> </div> </div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h1><span style="font-size: 20px;"><strong>A harmonised EU approach to the off-label use of medicines?</strong></span></h1> <p style="text-align: left;"><span style="font-size: 20px;">The European Brain Council’s Frédéric Destrebecq and MEP Cyrus Engerer explain how European patients can benefit from a properly regulated off-label medicine framework.</span></p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.theparliamentmagazine.eu/news/article/a-harmonised-eu-approach-to-the-offlabel-use-of-medicines" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: left;"><span style="font-size: 20px;"><strong>Professor Marc Dooms presents the GOLUP declaration at the ECRD</strong></span></p> <p style="text-align: left;"><span style="font-size: 20px;">On 10th-12th May 2018, EURORDIS hosted the ninth European Conference on Rare Diseases & Orphan Products (ECRD) in Vienna, welcoming almost 1000 participants from more than 50 countries. </span></p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.braincouncil.eu/activities/news/professor-marc-dooms-presents-the-golup-declaration-at-the-ecrd/" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p style="text-align: left;"><span style="font-size: 20px;"><strong>Off-label use of medicines: The need for good practice guidelines – the International Journal of Risk and Safety in Medicine</strong><strong><span style="font-size: 20px;"> </span> </strong></span></p> <p style="text-align: left;"><span style="font-size: 20px;">Article written by Dooms and Killick in which they present a set of guidelines for best practice in off-label use rooted in the need to ensure patient safety above all other concerns.</span></p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="https://www.ncbi.nlm.nih.gov/pubmed/28885218" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <p> <span style="font-size: 20px;"><strong>“EU needs guidelines on off-label us of medicines” argues MEP Piernicola Pedicini</strong></span> <span style="font-size: 20px;">Since the European Parliament requested better guidance on the widespread off-label use of medicine, very little has been done, writes Piernicola Pedicini</span> </p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://library.myebook.com/theparliament/pm-457-12-june-2017/642/#page/20" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>Response to Professor Guido Rasi: Roundtable to discuss solutions to regulate off-label use </strong></h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.braincouncil.eu/golup/wp-content/uploads/2017/06/Letter-Roundtable-to-discuss-solutions-to-regulate-off-label-use-30-May-2017.pdf" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>Working together towards clear EU Guidelines on the Off-Label Use of Medicinal Products</strong></h4> <p><span style="font-size: 20px;">Our response to the European Commission’s study on off-label use in the EU</span> </p> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.braincouncil.eu/golup/wp-content/uploads/2017/03/EBC-Co.-statement-on-EC-study-on-OLU-study.pdf" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>Promoting off-label use: where to draw the line?</strong></h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.pmlive.com/pharma_news/promoting_off-label_use_where_to_draw_the_line_1185834" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>Research study by JAMA Internal Medicine: </strong></h4> <h4 class="event-title">Association of Off-label Drug Use and Adverse Drug Events in an Adult Population</h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2467782" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4><strong>Response from EMA: Upholding the Good Off-Label Use Practice </strong></h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.braincouncil.eu/golup/?page_id=8775&preview=true" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4><strong>Call to EMA: Upholding the Good Off-Label Use Practice </strong></h4> <h4>Letter addressed to Professor Guido Rasi, Executive Director, European Medicines Agency, on behalf of the GOLUP Coalition</h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.braincouncil.eu/golup/wp-content/uploads/2016/11/Upholding-Good-Off-Label-Use-Practice-final-2.pdf" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div 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href="http://www.braincouncil.eu/activities/news/launch-of-the-golup-website/" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section></div></section><section class="blox " style=" padding-top:px; padding-bottom:px; background-size: cover; min-height:px; background-color:#f2f2f2;"><div class="max-overlay" style="background-color:#ffffff"></div><div class="wpb_row vc_row-fluid full-row"><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>European Multiple Sclerosis Platform</strong> A patient safety initiative: promoting good practice for off-label use of medicines</h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://www.emsp.org/news-messages/2894/" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-2 vc_col-has-fill"><div class="vc_column-inner vc_custom_1473934368083"><div class="wpb_wrapper"> <div class="wpb_single_image wpb_content_element vc_align_right wpb_animate_when_almost_visible wpb_top-to-bottom"> <figure class="wpb_wrapper vc_figure"> <div class="vc_single_image-wrapper vc_box_border_grey"><img width="52" height="57" src="https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/news-icon-1.jpg" class="vc_single_image-img attachment-full" alt="" decoding="async" loading="lazy" /></div> </figure> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h4 class="event-title"><strong>EFNA – European Federation of Neurological Associations</strong> Good practice for the off-label use of medicines – Save the Date</h4> </div> </div> </div></div></div><div class="wpb_column vc_column_container vc_col-sm-4"><div class="vc_column-inner "><div class="wpb_wrapper"><a href="http://efna.net/good-practice-for-the-off-label-use-of-medicines-save-the-date/" class="button green large " target="_blank"><i class="none"></i>NEWS DETAIL</a></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space1"></div></div></div></section><section class="wpb_row hide_section"><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_row wpb_row vc_inner vc_row-fluid vc_row-o-content-top vc_row-flex"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_top-to-bottom vc_custom_1468158361880 li_white"> <div class="wpb_wrapper"> <h3 style="text-align: center;"><span style="color: #ffffff;">WHAT IS GOOD PRACTICE?</span></h3> <p><span style="color: #ffffff;">The signatories of this declaration believe that off-label use of medicinal products <strong>should only occur if the following criteria are met</strong>:</span></p> <ul> <li><span style="color: #ffffff; font-size: 20px;">Presence of a severe, life-impairing or life-threatening condition;</span></li> <li><span style="color: #ffffff; font-size: 20px;">Absence of authorised treatment or repeated treatment failure;</span></li> <li><span style="color: #ffffff; font-size: 20px;">Absence of alternative treatments authorised for the condition;</span></li> <li><span style="color: #ffffff; font-size: 20px;">The off-label use is supported by strong evidence in scientific literature;</span></li> <li><span style="color: #ffffff; font-size: 20px;">The patient has been educated and has given his or her informed consent;</span></li> <li><span style="color: #ffffff; font-size: 20px;">Presence of established reporting routes for adverse events and linked to off-label use.</span></li> </ul> </div> </div> </div></div></div></div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_row wpb_row vc_inner vc_row-fluid vc_custom_1467756304496 vc_row-o-content-middle vc_row-flex"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_left-to-right"> <div class="wpb_wrapper"> <h3>These criteria, independently identified by <span style="color: #006db2;"><strong>Professor Marc Dooms</strong></span>, stem from decades of research and clinical practice and serve to provide a <span style="color: #006db2;"><strong>clear framework</strong></span> on when and how the off-label use of medicinal products could safely take place.</h3> </div> </div> <hr class="vertical-space1"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_left-to-right"> <div class="wpb_wrapper"> <h3><span style="color: #006db2;">They do not purport to limit the off-label use, but intend to provide a harmonised approach for its occurrence in order to maintain the highest levels of patient safety and minimise any adverse events.</span></h3> </div> </div> </div></div></div></div></div></div></div></section></div></section><section class="parallax-sec blox aligncenter hide_section " style=" padding-top:px; padding-bottom:px; background: url('https://www.braincouncil.eu/golup/wp-content/uploads/2015/05/background-pills.jpg') no-repeat center; min-height:300px; " data-stellar-background-ratio="0.6"><div class="max-overlay" style="background-color:"></div><div data-stellar-ratio="1" class="wpb_row vc_row-fluid "><div class="container"><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space2"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h2 style="text-align: center;"><strong>CALL TO ACTION!</strong></h2> </div> </div> <div class="vc_empty_space" style="height: 10px" ><span class="vc_empty_space_inner"></span></div> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3 style="text-align: center;">We believe health professionals should be supported by the public bodies and authorities responsible for the approval and use of medicines whose role is to protect public health. Physicians need to be given the freedom to uphold their pledge towards their patients to act ethically and put the patient’s interest first.</h3> </div> </div> <hr class="vertical-space4"></div></div></div><div class="wpb_column vc_column_container vc_col-sm-2"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></div></div></section><section class="container"><div class="row-wrapper-x"><section class="wpb_row hide_section"><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_row wpb_row vc_inner vc_row-fluid vc_row-o-content-top vc_row-flex"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"><hr class="vertical-space4"> <div class="wpb_text_column wpb_content_element "> <div class="wpb_wrapper"> <h3><strong>Who we are</strong></h3> </div> </div> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_top-to-bottom vc_custom_1468157604585"> <div class="wpb_wrapper"> <p> The Declaration on Good Off-Label Use Practices is open to any national and European organisation which supports its principles and objectives. <strong>Current signatories include: </strong> </p> </div> </div> </div></div></div></div></div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner "><div class="wpb_wrapper"><div class="vc_row wpb_row vc_inner vc_row-fluid vc_row-o-content-middle vc_row-flex"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner vc_custom_1467758047638"><div class="wpb_wrapper"> <div class="wpb_text_column wpb_content_element wpb_animate_when_almost_visible wpb_appear"> <div class="wpb_wrapper"> <h6 style="letter-spacing: 3px; margin-bottom: 16px; font-weight: 500;"> </h6> <p style="background: #F7C51E; padding: 35px; border-radius: 5px;">We thus call on the <strong>European Medicines Agency</strong> to adopt strict guidelines to support healthcare practioners to take their decision on the basis of the medical need of their patients and ensure economic benefit does not prevail over public health.</p> </div> </div> </div></div></div></div></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></section><section class="wpb_row "><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner "><div class="wpb_wrapper"></div></div></div></section> </div></section> <section id="pre-footer"> </section> <footer id="footer" > <section class="container footer-in"> <div class="row"> <div class="col-md-6"><div class="widget"><h5 class="subtitle">NAVIGATION</h5><div class="menu-footer-menu-container"><ul id="menu-footer-menu" class="menu"><li id="menu-item-8150" class="menu-item menu-item-type-custom menu-item-object-custom menu-item-has-children menu-item-8150"><a href="#">WHAT OFF-LABEL MEANS</a> <ul class="sub-menu"> <li id="menu-item-8414" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8414"><a href="https://www.braincouncil.eu/golup/for-healthcare-professionals/">For healthcare professionals</a></li> <li id="menu-item-8415" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8415"><a href="https://www.braincouncil.eu/golup/for-patients/">For Patients</a></li> <li id="menu-item-8413" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8413"><a href="https://www.braincouncil.eu/golup/for-regulatory-authorities/">For Regulatory Authorities</a></li> <li id="menu-item-8412" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8412"><a href="https://www.braincouncil.eu/golup/for-medical-research/">For Medical Research</a></li> <li id="menu-item-8422" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8422"><a href="https://www.braincouncil.eu/golup/examples-of-off-label-use/">Examples of off-label use</a></li> </ul> </li> <li id="menu-item-8453" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8453"><a href="https://www.braincouncil.eu/golup/our-proposal/">Our proposal</a></li> <li id="menu-item-8496" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8496"><a href="https://www.braincouncil.eu/golup/about-us/">About us</a></li> <li id="menu-item-8610" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8610"><a href="https://www.braincouncil.eu/golup/follow-the-campaign/">Follow the campaign</a></li> <li id="menu-item-8545" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8545"><a href="https://www.braincouncil.eu/golup/qa/">Q&A</a></li> </ul></div></div></div> <div class="col-md-6"><div class="widget"><h5 class="subtitle">CONTACT</h5> <div class="textwidget"><h6 style="color:#8a8a8a;">EUROPEAN BRAIN COUNCIL</h6> <h6>ADDRESS</h6> <p style="color:#8a8a8a;font-size:16px;">Fondation Universitaire<br> Rue d’Egmont 11<br> 1000 Bruxelles – Belgium</p> <h6>CONTACT</h6> <p style="color:#8a8a8a;font-size:16px;">info@braincouncil.eu<br> T + 32 (0)2 513 27 57 </p> </div> </div></div> </div> </section>  <section class="footbot"> <div class="container"> <div class="col-md-6"> <div class="footer-navi"> </div> </div> <div class="col-md-6"> <div class="footer-navi floatright"> © [wpsos_year] DESIGN AND DEVELOPMENT WWW.GUENOLEFRANCOIS.COM - GUENOLEFRANCOIS@GMAIL.COM </div> </div> </div> </section>  </footer>  <span id="scroll-top"><a class="scrollup"><i class="fa-chevron-up"></i></a></span></div>   <script type="text/javascript"> jQuery(document).ready(function(){ jQuery(function() { var header = jQuery("#header.horizontal-w"); 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