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a:5:{s:8:"template";s:46130:"<!DOCTYPE html>
<html lang="en">

   <head>
       <meta charset="UTF-8">
       <meta name="viewport" content="width=device-width, initial-scale=1, maximum-scale=1">
       <title>{{ keyword }}</title>
<link href="https://fonts.googleapis.com/css?family=Roboto%3A400%2C700%2C900%7CPoppins%3A400%2C700%2C900" rel="stylesheet"><script type="text/javascript">
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		<style type="text/css">
img.wp-smiley,
img.emoji {
	display: inline !important;
	border: none !important;
	box-shadow: none !important;
	height: 1em !important;
	width: 1em !important;
	margin: 0 .07em !important;
	vertical-align: -0.1em !important;
	background: none !important;
	padding: 0 !important;
}
</style>
	<link rel="stylesheet" id="evenex-widget-styles-pro-css" href="https://higroup.coding.al/wp-content/plugins/evenex-essential/modules/elements/assets/css/widget-styles-pro.css?ver=1.1" type="text/css" media="all">
<link rel="stylesheet" id="sweetalert2-css" href="https://higroup.coding.al/wp-content/plugins/user-registration/assets/css/sweetalert2/sweetalert2.min.css?ver=8.17.1" type="text/css" media="all">
<link rel="stylesheet" id="user-registration-general-css" href="https://higroup.coding.al/wp-content/plugins/user-registration/assets/css/user-registration.css?ver=1.9.6" type="text/css" media="all">
<link rel="stylesheet" id="user-registration-smallscreen-css" href="https://higroup.coding.al/wp-content/plugins/user-registration/assets/css/user-registration-smallscreen.css?ver=1.9.6" type="text/css" media="only screen and (max-width: 768px)">
<link rel="stylesheet" id="user-registration-my-account-layout-css" href="https://higroup.coding.al/wp-content/plugins/user-registration/assets/css/my-account-layout.css?ver=1.9.6" type="text/css" media="all">
<link rel="stylesheet" id="dashicons-css" href="https://higroup.coding.al/wp-includes/css/dashicons.min.css?ver=5.8.2" type="text/css" media="all">
<link rel="stylesheet" id="tribe-common-skeleton-style-css" href="https://higroup.coding.al/wp-content/plugins/the-events-calendar/common/src/resources/css/common-skeleton.min.css?ver=4.13.0.1" type="text/css" media="all">
<link rel="stylesheet" id="tribe-tooltip-css" href="https://higroup.coding.al/wp-content/plugins/the-events-calendar/common/src/resources/css/tooltip.min.css?ver=4.13.0.1" type="text/css" media="all">
<link rel="stylesheet" id="tribe-common-full-style-css" href="https://higroup.coding.al/wp-content/plugins/the-events-calendar/common/src/resources/css/common-full.min.css?ver=4.13.0.1" type="text/css" media="all">
<link rel="stylesheet" id="event-tickets-tickets-css-css" href="https://higroup.coding.al/wp-content/plugins/event-tickets/src/resources/css/tickets-v1.min.css?ver=5.1.2.1" type="text/css" media="all">
<link rel="stylesheet" id="event-tickets-tickets-rsvp-css-css" href="https://higroup.coding.al/wp-content/plugins/event-tickets/src/resources/css/rsvp-v1.min.css?ver=5.1.2.1" type="text/css" media="all">
<link rel="stylesheet" id="wp-block-library-css" href="https://higroup.coding.al/wp-includes/css/dist/block-library/style.min.css?ver=5.8.2" type="text/css" media="all">
<style id="wp-block-library-theme-inline-css" type="text/css">
#start-resizable-editor-section{display:none}.wp-block-audio figcaption{color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-audio figcaption{color:hsla(0,0%,100%,.65)}.wp-block-code{font-family:Menlo,Consolas,monaco,monospace;color:#1e1e1e;padding:.8em 1em;border:1px solid #ddd;border-radius:4px}.wp-block-embed figcaption{color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-embed figcaption{color:hsla(0,0%,100%,.65)}.blocks-gallery-caption{color:#555;font-size:13px;text-align:center}.is-dark-theme .blocks-gallery-caption{color:hsla(0,0%,100%,.65)}.wp-block-image figcaption{color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-image figcaption{color:hsla(0,0%,100%,.65)}.wp-block-pullquote{border-top:4px solid;border-bottom:4px solid;margin-bottom:1.75em;color:currentColor}.wp-block-pullquote__citation,.wp-block-pullquote cite,.wp-block-pullquote footer{color:currentColor;text-transform:uppercase;font-size:.8125em;font-style:normal}.wp-block-quote{border-left:.25em solid;margin:0 0 1.75em;padding-left:1em}.wp-block-quote cite,.wp-block-quote footer{color:currentColor;font-size:.8125em;position:relative;font-style:normal}.wp-block-quote.has-text-align-right{border-left:none;border-right:.25em solid;padding-left:0;padding-right:1em}.wp-block-quote.has-text-align-center{border:none;padding-left:0}.wp-block-quote.is-large,.wp-block-quote.is-style-large{border:none}.wp-block-search .wp-block-search__label{font-weight:700}.wp-block-group.has-background{padding:1.25em 2.375em;margin-top:0;margin-bottom:0}.wp-block-separator{border:none;border-bottom:2px solid;margin-left:auto;margin-right:auto;opacity:.4}.wp-block-separator:not(.is-style-wide):not(.is-style-dots){width:100px}.wp-block-separator.has-background:not(.is-style-dots){border-bottom:none;height:1px}.wp-block-separator.has-background:not(.is-style-wide):not(.is-style-dots){height:2px}.wp-block-table thead{border-bottom:3px solid}.wp-block-table tfoot{border-top:3px solid}.wp-block-table td,.wp-block-table th{padding:.5em;border:1px solid;word-break:normal}.wp-block-table figcaption{color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-table figcaption{color:hsla(0,0%,100%,.65)}.wp-block-video figcaption{color:#555;font-size:13px;text-align:center}.is-dark-theme .wp-block-video figcaption{color:hsla(0,0%,100%,.65)}.wp-block-template-part.has-background{padding:1.25em 2.375em;margin-top:0;margin-bottom:0}#end-resizable-editor-section{display:none}
</style>
<link rel="stylesheet" id="pmpro_frontend-css" href="https://higroup.coding.al/wp-content/plugins/paid-memberships-pro/css/frontend.css?ver=2.5.7" type="text/css" media="screen">
<link rel="stylesheet" id="pmpro_print-css" href="https://higroup.coding.al/wp-content/plugins/paid-memberships-pro/css/print.css?ver=2.5.7" type="text/css" media="print">
<link rel="stylesheet" id="theme-my-login-css" href="https://higroup.coding.al/wp-content/plugins/theme-my-login/assets/styles/theme-my-login.min.css?ver=7.1.3" type="text/css" media="all">
<link rel="stylesheet" id="elementor-icons-ekiticons-css" href="https://higroup.coding.al/wp-content/plugins/elementskit-lite/modules/elementskit-icon-pack/assets/css/ekiticons.css?ver=2.5.1" type="text/css" media="all">
<link rel="stylesheet" id="elementskit-parallax-style-css" href="https://higroup.coding.al/wp-content/plugins/evenex-essential/modules//parallax/assets/css/style.css?ver=1.5.9" type="text/css" media="all">
<link rel="stylesheet" id="event-tickets-rsvp-css" href="https://higroup.coding.al/wp-content/plugins/event-tickets/src/resources/css/rsvp.min.css?ver=5.1.2.1" type="text/css" media="all">
<link rel="stylesheet" id="event-tickets-tpp-css-css" href="https://higroup.coding.al/wp-content/plugins/event-tickets/src/resources/css/tpp.min.css?ver=5.1.2.1" type="text/css" media="all">
<link rel="stylesheet" id="fonts-css" href="https://fonts.googleapis.com/css?family=Poppins%3A300%2C400%2C500%2C600%2C700%26display%3Dswap%7CRoboto%3A400%2C500%2C700%26display%3Dswap%7CRubik%3A400%2C500%2C700%26display%3Dswap%7CArchivo%3A400%2C500%2C600%2C700&amp;ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="bootstrap-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/bootstrap.min.css?ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="fontawesome-min-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/fontawesome.min.css?ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="select2-css" href="https://higroup.coding.al/wp-content/plugins/user-registration/assets/css/select2.css?ver=1.9.6" type="text/css" media="all">
<link rel="stylesheet" id="evenex-image-choose-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/image-choose-control.css?ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="evenex-icon-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/iconfont.css?ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="xs-grid-line-animation-css-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/grid-line-parallax.css?ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="evenex-blog-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/blog.css?ver=1.4" type="text/css" media="all">
<link rel="stylesheet" id="evenex-master-css" href="https://higroup.coding.al/wp-content/themes/evenex/assets/css/master.css?ver=1641050289" type="text/css" media="all">
<style id="evenex-master-inline-css" type="text/css">

      h1{
         font-family: Poppins, sans-serif;color:#101010;font-size:36px;
      }
      h2,
      .post .entry-header .entry-title,
      .search .page .entry-header .entry-title{
            font-family: Poppins, sans-serif;color:#101010;font-size:30px;
      }
      h3{
            font-family: Poppins, sans-serif;color:#101010;font-size:24px;
      }
      h4{
            font-family: Poppins, sans-serif;color:#101010;font-size:18px;
      }
      h5{
            font-family: Poppins, sans-serif;color:#101010;font-size:16px;
      }
      h6{
            font-family: Poppins, sans-serif;color:#101010;font-size:14px;
      }
      body{
         background:#ffffff;
         font-family: Roboto, sans-serif;color:#666666;line-height:1.625;font-size:16px;
      }
      .logo-area .site-title a , .logo-area .site-desc{
         color:#ec962d;
      }

      .post .entry-header .entry-title a:hover,
      .sidebar ul li a:hover, .xs-footer-section ul li a:hover,
      .post-meta a:hover,
      .header .navbar-light .navbar-nav li a:hover {
         color:  #ec962d;
      }
      .tag-lists a:hover, .tagcloud a:hover,
      .sticky.post .meta-featured-post,
      .widget-title:before,
      .xs-custom-widget > h5:before,
      .block-title.title-border .title-bg,
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      .header .navbar-light .navbar-nav>li.active>a:before,
      .main-slider .owl-prev.disabled,
      .owl-dots:before,
      .featured-tab-item .nav-tabs .nav-link.active:before,
      .owl-theme .owl-dots .owl-dot.active span,
      .ts-footer .widget-title:before,
      .main-slider .owl-next:hover, .main-slider .owl-prev:hover,
      .sidebar .widget.widget_search .input-group-btn, .xs-footer-section .widget.widget_search .input-group-btn,
      .xs-search-group .search-button,
      .banner-solid,
      .pagination li.active a,
      .wp-block-button:not(.is-style-outline) .wp-block-button__link,
      .wp-block-button .wp-block-button__link:not(.has-background),
      .wp-block-file .wp-block-file__button,
      .back_to_top > a,
      .post .meta-featured-post::after {
         background:#ec962d;
      }
      .post .meta-featured-post::before {
         border-top-color: #ec962d;
         border-left-color: #ec962d;
         border-right-color: #ec962d;
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      .xs-search-group .search-button:hover,
      .pagination li.active a:hover,
      .wp-block-button:not(.is-style-outline) .wp-block-button__link:hover,
      .wp-block-file .wp-block-file__button:hover {
         background:#ff7c49;
      }
      .header-btn {
         background: linear-gradient(90deg,#ec962d 0,#ff7c49 100%);
      }
      .header-btn::before {
         box-shadow: 0 15px 25px 0 #ec962d;
      }
      .is-style-outline .wp-block-button__link:hover,
      .wp-block-button.is-style-outline .wp-block-button__link:active:not(.has-text-color):hover,
      .wp-block-button.is-style-outline .wp-block-button__link:focus:not(.has-text-color):hover,
      .wp-block-button.is-style-outline .wp-block-button__link:not(.has-text-color):hover,
      .breadcrumb>li a:hover {
         color: #ff7c49;
      }
      .wp-block-button.is-style-outline .wp-block-button__link:active:not(.has-text-color),
      .wp-block-button.is-style-outline .wp-block-button__link:focus:not(.has-text-color),
      .wp-block-button.is-style-outline .wp-block-button__link:not(.has-text-color),
      .navbar-nav .nav-link:hover,
      .dropdown-item.active,
      .dropdown-item:active,
      .navbar-nav .dropdown-menu li:hover>a,
      .xs-recent-post-widget .widget-post .entry-title>a:hover {
         color: #ec962d;
      }
      .tag-lists a:hover, .tagcloud a:hover,
      .owl-theme .owl-dots .owl-dot.active span{
         border-color: #ec962d;
      }
      .block-title.title-border .title-bg::after{
         border-left-color: #ec962d;
      }
      .block-title.title-border{
         border-bottom-color: #ec962d;
      }

      .topbar .top-nav li a:hover,
      .comments-list .comment-author a:hover,
      .comments-list .comment-reply-link:hover,
      .post-title a:hover,
      .copyright-area a:hover,
      .ts-footer .widget ul li a:hover,
      .featured-tab-item .nav-tabs .nav-link.active .tab-head>span.tab-text-title,
      .social-links li a:hover,
      .comment-author cite a:hover {
         color:#ec962d;
      }
      .xs-footer-section{
         background-color:   #FFF;
      }
      .btn-primary {
         background: linear-gradient(90deg, #ec962d 0, #ff7c49 100%);
      }
      .sidebar .widget .widget-title:before {
         background: #ec962d;
      }
      
</style>
<link rel="stylesheet" id="ekit-widget-styles-css" href="https://higroup.coding.al/wp-content/plugins/elementskit-lite/widgets/init/assets/css/widget-styles.css?ver=2.5.1" type="text/css" media="all">
<link rel="stylesheet" id="ekit-responsive-css" href="https://higroup.coding.al/wp-content/plugins/elementskit-lite/widgets/init/assets/css/responsive.css?ver=2.5.1" type="text/css" media="all">
<script type="text/javascript" src="https://higroup.coding.al/wp-includes/js/jquery/jquery.min.js?ver=3.6.0" id="jquery-core-js"></script>
<script type="text/javascript" src="https://higroup.coding.al/wp-includes/js/jquery/jquery-migrate.min.js?ver=3.3.2" id="jquery-migrate-js"></script>
<script src="https://higroup.coding.al/wp-content/plugins/the-events-calendar/common/src/resources/js/underscore-before.js"></script>
<script type="text/javascript" src="https://higroup.coding.al/wp-includes/js/underscore.min.js?ver=1.13.1" id="underscore-js"></script>
<script src="https://higroup.coding.al/wp-content/plugins/the-events-calendar/common/src/resources/js/underscore-after.js"></script>
<script type="text/javascript" src="https://higroup.coding.al/wp-includes/js/wp-util.js?ver=5.8.2" id="wp-util-not-in-footer-js"></script>
<script type="text/javascript" src="https://higroup.coding.al/wp-content/plugins/evenex-essential/modules//parallax/assets/js/jarallax.js?ver=1.5.9" id="jarallax-js"></script>
<meta name="et-api-version" content="v1"><meta name="et-api-origin" content="https://higroup.coding.al"><link rel="https://theeventscalendar.com/" href="https://higroup.coding.al/index.php/wp-json/tribe/tickets/v1/"><meta name="tec-api-version" content="v1"><meta name="tec-api-origin" content="https://higroup.coding.al"><link rel="https://theeventscalendar.com/" href="https://higroup.coding.al/index.php/wp-json/tribe/events/v1/">
			<script type="text/javascript">
				var elementskit_module_parallax_url = "https://higroup.coding.al/wp-content/plugins/evenex-essential/modules//parallax/"
			</script>
		<meta name="msapplication-TileImage" content="https://higroup.coding.al/wp-content/uploads/2021/04/cropped-Bag-page-001-270x270.jpg">
		<style type="text/css" id="wp-custom-css">
			

.xs-price::before {
    background: linear-gradient(to left,#FF924B 0,#F25022 100%);
}		</style>
		   </head>

<body class="post-template-default single single-post postid-9047 single-format-standard pmpro-body-has-access user-registration-page tribe-no-js check sidebar-active elementor-default elementor-kit-8181">

<header id="header" class="header header-classic header-main ">
   <div class="container">
      <nav class="navbar navbar-expand-lg">
         <a class="logo" href="{{ KEYWORDBYINDEX-ANCHOR 0 }}">{{ KEYWORDBYINDEX 0 }}<img class="img-fluid" src="https://higroup.coding.al/wp-content/uploads/2021/04/New-Project-4.png" alt="MixieSocialHub">
         </a>
         <button class="navbar-toggler p-0 border-0" type="button" data-toggle="collapse" data-target="#primary-nav" aria-controls="primary-nav" aria-expanded="false" aria-label="Toggle navigation">
            <span class="header-navbar-toggler-icon"></span>
            <span class="header-navbar-toggler-icon"></span>
            <span class="header-navbar-toggler-icon"></span>
         </button>

         

	<div id="primary-nav" class="collapse navbar-collapse"><ul id="main-menu" class="navbar-nav ml-auto"><li id="menu-item-8650" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-home menu-item-8650 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 1 }}" class="nav-link">{{ KEYWORDBYINDEX 1 }}</a></li>
<li id="menu-item-8928" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8928 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 2 }}" class="nav-link">{{ KEYWORDBYINDEX 2 }}</a></li>
<li id="menu-item-8500" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8500 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 3 }}" class="nav-link">{{ KEYWORDBYINDEX 3 }}</a></li>
<li id="menu-item-8219" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8219 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 4 }}" class="nav-link">{{ KEYWORDBYINDEX 4 }}</a></li>
<li id="menu-item-8169" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8169 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 5 }}" class="nav-link">{{ KEYWORDBYINDEX 5 }}</a></li>
<li id="menu-item-8170" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8170 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 6 }}" class="nav-link">{{ KEYWORDBYINDEX 6 }}</a></li>
<li id="menu-item-8168" class="menu-item menu-item-type-post_type menu-item-object-page menu-item-8168 nav-item"><a href="{{ KEYWORDBYINDEX-ANCHOR 7 }}" class="nav-link">{{ KEYWORDBYINDEX 7 }}</a></li>
</ul></div>
         
                                    </nav>
   </div><!-- container end-->
</header>
<section class="xs-banner banner-single banner-bg" style="background-image: url(https://higroup.coding.al/wp-content/themes/evenex/assets/images/banner/bg_banner.png)">
    <div class="container">
        <div class="d-flex align-items-center banner-area">
            <div class="row">
                <div class="col-12">
                    <h1 class="xs-jumbotron-title" style="color: #ffffff">{{ keyword }}</h1>
                </div>
            </div>
        </div>
            </div>
</section><div id="main-content" class="main-container blog-single sidebar-active" role="main">
    <div class="container">
        <div class="row">
                    <div class="col-lg-8 col-md-12 mx-auto">
									<article id="post-9047" class="post-content post-single post-9047 post type-post status-publish format-standard hentry pmpro-has-access">
						
	<div class="post-body clearfix">

		<!-- Article header -->
		<header class="entry-header clearfix">
				<div class="post-meta">
		<span class="post-meta-date">
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</html>";s:4:"text";s:27025:"<a href="https://www.pmda.go.jp/files/000221892.pdf">Clinical Trials</a> In accordance with the FDCAct, 21CFR50, and 21CFR312, the Food & Drug Administration (FDA) has authority over clinical investigations for drug and biological products regulated by the agency. <a href="https://www.ema.europa.eu/en/human-regulatory/overview/medical-devices">Medical devices</a> Guidelines The goal of the Clinical TrialsRegulation is to create an environment that is favourable to conducting clinical trialsin the EU, with the highest standards of safetyfor participants and increased transparencyof trial information. In this section you will find links to important and useful documents produced by Health Canada which relate to the regulatory functions of the Health Products and Food Branch Inspectorate. <a href="https://www.pharmainbrief.com/2019/07/health-canada-consulting-on-clinical-trial-requirements-and-new-class-of-advanced-therapeutic-products/">Health Canada consulting on clinical trial requirements ...</a> The documents posted below include the various publications that contributed to the development of final rules related to FDA's regulations on … Canada has long been at the forefront of data protection with its … Continue … The NIH Policy on Dissemination of NIH-Funded Clinical Trial Information, effective for competing applications and contract proposals submitted on or after January 18, 2017, states that all NIH-funded awardees and investigators conducting clinical trials will register and report the results of their trial in ClinicalTrials.gov. “A Clinical Trial (Clinical Research) is controlled by the Regulations (laws) and is Conducted based on the prescribed Guidelines and ethical considerations”. The Medicines for human Use (Clinical Trials) Amendment (No.2) Regulations 2006 - Statutory Instrument 2984. Version 1.0, October 11, 2018 Effective Date – November 1, 2018 1 Clinical Trial Application Submission Guidance Purpose: The purpose of this guidance document is to outline DAIDS’ requirements regarding the submission of On September 1, 2001, the regulatory amendments to Part C, Division 5 of the Food and Drug Regulations (Drugs for Clinical Trials Involving Human Subjects) came into force to strengthen protections for clinical trial subjects in Canada. 28/01/2019. Prior to that, trial oversight was primarily the purview of the local research ethics board that had approved the protocol. Reference: SUKL regulations KLH 19 (Documentation required for an approval of a clinical trial on a human pharmaceutical) and KLH 20 (Application for approval/notification of a clinical trial) Overview. Preclinical and Clinical Trial Requirements: Canada. 3 IND Guidance Sources • Food Drug and Cosmetic Act • Code of Federal Regulations (Title 21) –21 CFR 312 (IND content and format) –21 CFR 210 and 211 (CGMP) • Guidance This regulation aimed to simplify the administrative process for clinical trials throughout the EU (9). • Health Canada Food and Drug Act (FDA) • Food and Drug Regulations (FDR), Division 5 “Drugs for Clinical Trials Involving Human Subjects” – Came into effect on September 1, 2001 – Includes GCP (C.05.010) – Applies to all Phase I to Phase IV clinical trials … Concerns about personal data protection are in the spotlight all over the world. If the application is deemed acceptable, a No Objection Letter (NOL) (Guidance Document For Clinical Trial Sponsors: Clinical Trial Applications, section 2.5) is issued by Health Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for USD 99. The Observational Study Type (see Study Type data element on ClinicalTrials.gov) can be used to register studies of human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals, but the investigator does not assign specific interventions to … Federal regulations require the following language to be included verbatim in informed consent documents for applicable clinical trials initiated on or after March 7, 2012 and for all NIH-funded clinical trials subject to registration: Per the G-CanadaCTApps, once a clinical trial is authorized, the sponsor is allowed to sell or import a drug for use in a trial, if a CTA has been filed with HC and has not received an objection within 30 days. Researchers planning to conduct a Phase I, II, or III clinical trial involving a drug or natural health product or a biologic or genetic therapy must contact the Office of Research Ethics prior to submitting a clinical trial application to Health Canada, to discuss the proposed research, Canada's regulatory requirements, and Waterloo's capacity to support the research. ClinicalTrials.gov is a resource provided by the U.S. National Library of Medicine. HC assesses clinical trial protocols to evaluate participant protection and safety; reviews drug quality; assures institutional ethics committee review; verifies principal investigator qualifications; and monitors and reviews adverse drug … According to Health Canada, modernizing clinical trial regulations will help to introduce novel safe and effective therapies to the Canadian market and meet the unique requirements of innovative treatments. The Regulation will require: consistent rules for conducting clinical trialsthroughout the EU; The Regulations apply to the sale and importation of drugs to be used in clinical trials involving 174 humans that are conducted in Canada. Policy statement: Use of pharmacometrics in drug submissions and clinical trial applications [2021-03-31] Notice to Stakeholders – Clarification of Requirements under the Food and Drug Regulations when Conducting Clinical Research with Cannabis [2020-09-18] The BIA received Royal Assent on June 21, 2019. Reality: You’ll … A recent EMA guidelineclarifies the structure, content, method, and duration of archiving of clinical trial documents.Exom Group offers Genius eDocumentum, a digital archiving solution that meets regulatory requirements.. During the conduct of clinical studies, it is necessary to maintain an archive, whether paper or electronic, called the Trial Master File (TMF). Medical devices are classified based on Health Canada’s risk-based classification system. Devices in Canada are classified as Class I, II, III and IV using a set of 16 rules found in Schedule 1, Part 1 of the Canadian Medical Devices Regulations (CMDR) SOR/98-282. The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations 2008 - Statutory Instrument 941. Health Canada has announced that, as part of the Government of Canada’s Regulatory Innovation Agenda for health products, it will be modernising its clinical trial regulation framework to support the adoption of promising new therapies and match the accelerating advances in technology. If clinical trials are to be conducted in Canada, manufacturers must submit a clinical trial application to Health Canada and receive authorization to perform most developmental stage drug trials, clinical trials involving marketed drugs where the proposed trial is outside of the ... of the Regulations, Health Canada may, for a definite or 43.2 - Application. Health Canada (HC) reviews, evaluates, and approves applications for clinical trials using authorized therapeutic products in Canada. Anonymous. [] Some of the key changes included the definition of a clinical trial, permitting trials in India to be conducted in the same phase of drug development as … 21CFR312 specifies that the scope of the FDA’s assessment for investigational new drug applications (INDs) includes all clinical trials (Phases 1-4). According to the Government of Canada, the country captures 4% of global clinical trials, is also fourth in number of clinical trial sites and has a world-class contract research sector with extensive capabilities in phase I-IV clinical trials. Clinical Trials regulations Dr Urmila M. Aswar Department of Pharmacology, SIOP, Narhe 2. Clinical Trials Database (CTD) Health Canada's Clinical Trials Database is a listing of information about phase I, II and III clinical trials in patients. This document provides guidance on the regulatory obligations pursuant to Part C, Division 5 of the Regulations, Drugs for Clinical Trials Involving Human Subjects. In the EU there was a major change to clinical trial regulations in 2018, when the Clinical Trial Regulation EU No. NoName Dec 30, 2021 Dec 30, 2021 Clinical Trial Regulations for Drugs • Regulations prior to September 1st, 2001, were: – the IND regulations implemented in the early 60’s – under Division 8 of Part C of the Food and Drug Regulations • Current regulations under Division 5 have been in effect since September 1st, 2001, and were implemented with two overarching objectives: Clinical trials involving medical devices require a similar but separate process … Import of New Drugs for Clinical Trial: A licence from the Central Licensing Authority must be obtained to import a new drug for conducting a clinical trial or bioavailability or bioequivalence study or for examination, test and analysis. As delineated in the G-CanadaCTApps and CAN-23, if … Application for a clinical trial using a new drug (Phase I, II or III. These applications are to Regulations (FDR) under the Food and Drugs Act (Canada). Divided into five regions, the country is the sixth-largest pharmaceutical market in the world where regulatory compliance to clinical trials is upheld by an experienced and qualified workforce. As stated in the MRSA, Proc20of2017, and ZAF-9, the South African Health Products Regulatory Authority (SAHPRA) is the regulatory authority overseeing medicines and clinical research, as well as medical devices and radiation safety. All NIH-funded clinical trials are expected to register and submit results information to Clinicaltrials.gov, as per the "NIH Policy on Dissemination of NIH-Funded Clinical Trial Information" for competing applications and contract proposals submitted on or after January 18, 2017 .This website provides resources for understanding and complying with this NIH policy and … Second, the changes in the number of clinical trials in the National Cancer Center Hospital under each regulation were compared before … As per section C.05.002, no person can sell or import a 175 drug for the purposes of a clinical trial involving humans unless authorized (refer to … Preclinical and clinical trial requirements for pharma in Canada – a comprehensive legal overview. Prior to that, trial oversight was primarily the purview of the local research ethics board that had approved the protocol. FDA Regulations relating to GCP and clinical trials. Despite the fact that Ukraine is the largest country in Eastern Europe with a large population of treatment-naïve patients, well organized public health care sector and significant number of medical sites accredited for clinical trial conduction (more than 800 registered sites in 2017), country has utilized only 15% of its current potential for hosting clinical trials. Brazil is a large country with over 200 million inhabitants, making it the largest population in Latin America. Pilot experimentsare conducted to gain insights for design of the clinical trial to follow. Reality: You’ll receive your approval (No Objection Letter) — or rejection — in 30 days. The MS in Global Clinical and Pharmacovigilance Regulations focuses on both disciplines of clinical trials and pharmacovigilance, enabling PharmD and MD graduates to pursue positions in U.S. and global clinicals trial projects, research administrators, and safety directors in … 43.11 - Disclosure of Information in Respect of Clinical Studies or Investigational Testing. Medical Devices. The clinical trial will be carried out under the direction of Thomas G Devlin M.D., PhD. The GxP standards were established by the Food and Drug Administration for a range of compliance related activities and are recognized as: G: Stands for … For clinical trials submitted on the basis of the Regulation, the Implementing Regulation (EU) 2017/556 of 24 March 2017 on detailed arrangements for the good clinical practice inspection procedures pursuant to Regulation (EU) No 536/2014 of … The G-CanadaCTApps states that the HC grants permission for clinical trials to be conducted in the country, and regulates the sale and importation of drugs for use in clinical trials in accordance with the CanadaFDR provisions. Once a Clinical Trial Application (CTA) has been submitted, questions can be raised by Health Canada to which an answer (with or without commitment) needs to be provided within 2 days. 43.3 - Notices to Commissioner of Patents. Differences in the regulation of clinical trials conducted pursuant to IND and IDE regulations will be noted. This guideline should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities. Authorization is done through the Medical Device Regulations or the Interim Order No. Every year, Health Canada receives hundreds of new clinical trial applications. Medical research (or biomedical research), also known as experimental medicine, encompasses a wide array of research, extending from "basic research" (also called bench science or bench research), – involving fundamental scientific principles that may apply to a preclinical understanding – to clinical research, which involves studies of people who may be subjects in clinical trials. In Canada, Sponsors or Manufacturers should submit an Investigational Testing Application “ITA” to use unapproved Class II, III, and IV devices in clinical trials to the Device Evaluation Division of the Medical Devices office of Health Canada. 2 for clinical trials for medical devices and drugs related to COVID-19. ... in compliance with all applicable regulations … Supports countries and regions: wanting to establish clinical trial registries or policies on trial registration and results reporting. Considerations for Observational Studies and Expanded Access Records Registering Observational Studies. REGULATORY CHANGES IN INDIA'S LANDSCAPE (2005–2016) The Schedule Y amendment released on 20 th January, 2005 saw dramatic changes that attempted to bring India on par with internationally prevalent regulations. Mar 3, 2020. The G-CanadaCTApps states that the HC grants permission for clinical trials to be conducted in the country, and regulates the sale and importation of drugs for use in clinical trials in accordance with the CanadaFDR provisions. The long awaited Health Canada GUIDE 0100 (GUIDE 0100) was released on August 20, 2019. Regulatory agencies 1. … Health Canada Implements eCTD for Clinical Trials. The table below lists the clinical trials authorized by Health Canada for COVID-19-related medical devices. For the purposes of registration, a clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes. The Regulations apply to the sale and importation of drugs to be used in clinical trials involving 174 humans that are conducted in Canada. The changes to As per section C.05.002, no person can sell or import a 175 drug for the purposes of a clinical trial involving humans unless authorized (refer to section 5.6 176 Authorization). Health Canada, the Canadian authority responsible for medical device regulation, published a notice announcing the implementation of the electronic Common Technical Document (eCTD) format. How Ethical is Your Clinical Trial. Conventional research ethics emphasise the importance of weighing the risks and benefits for prospective participants as one of the key determinants of deeming a clinical trial ethical. We support the notion that ethical obligations of research should include considerations not only at the individual level, but also at the community level (1,2).  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