{"id":376,"date":"2019-01-17T08:41:48","date_gmt":"2019-01-17T08:41:48","guid":{"rendered":"http:\/\/206.71.52.87\/~newwebproject\/?page_id=376"},"modified":"2019-08-09T07:09:52","modified_gmt":"2019-08-09T07:09:52","slug":"pharmacovigilance-plan","status":"publish","type":"page","link":"https:\/\/cdsatoolkit.thsti.in\/?page_id=376","title":{"rendered":"Pharmacovigilance Plan"},"content":{"rendered":"<div class=\"flex_column av_one_half  flex_column_div first  \" style='padding:0px 15px 0px 2px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr1\"><strong>Clinical Trials Toolkit &#8211; India<\/strong><\/div>\n<\/div><\/section><\/div>\n<div class=\"flex_column av_one_half  flex_column_div   \" style='padding:0px -20px 10px 0px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><div class=\"dfr\" style=\"text-align: right;\"><strong><strong>You are in: Home \/ Routemap \/ <\/strong>Pharmacovigilance Plan<\/strong><\/div>\n<\/div><\/section><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='sdew' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-376'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_one_fifth  flex_column_div first  \" style='padding:0px 0px 0px 12px ; border-radius:0px; '><div class='avia-button-wrap avia-button-left '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=374' class='avia-button   avia-icon_select-yes-left-icon avia-color-custom avia-size-small avia-position-left '  style='background-color:#1d66a3; border-color:#1d66a3; color:#ffffff; ' ><span class='avia_button_icon avia_button_icon_left ' aria-hidden='true' data-av_icon='\ue888' data-av_iconfont='entypo-fontello'><\/span><span class='avia_iconbox_title' >Previous<\/span><\/a><\/div><\/div><div class=\"flex_column av_three_fifth  flex_column_div   \" style='padding:0px 0px 0px 0px ; border-radius:0px; '><div style='padding-bottom:10px;' class='av-special-heading av-special-heading-h2  blockquote modern-quote modern-centered   '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Pharmacovigilance Plan<\/h2><div class='special-heading-border'><div class='special-heading-inner-border' ><\/div><\/div><\/div><\/div><div class=\"flex_column av_one_fifth  flex_column_div   \" style='padding:15px 0px 0px -15px ; border-radius:0px; '><div class='avia-button-wrap avia-button-right '><a href='https:\/\/cdsatoolkit.thsti.in\/?page_id=378' class='avia-button   avia-icon_select-yes-right-icon avia-color-custom avia-size-small avia-position-right '  style='background-color:#1d66a3; border-color:#1d66a3; color:#ffffff; ' ><span class='avia_iconbox_title' >Next<\/span><span class='avia_button_icon avia_button_icon_right' aria-hidden='true' data-av_icon='\ue889' data-av_iconfont='entypo-fontello'><\/span><\/a><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_1' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-376'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='lop1' class='avia-section main_color avia-section-default avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-376'><div class='entry-content-wrapper clearfix'>\n<section class=\"avia_codeblock_section  avia_code_block_0\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_codeblock '  itemprop=\"text\" > [avia_codeblock_placeholder uid=\"0\"] <\/div><\/section>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_2' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-376'><div class='entry-content-wrapper clearfix'><\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='nbvc' class='avia-section main_color avia-section-large avia-no-shadow avia-bg-style-scroll   container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-376'><div class='entry-content-wrapper clearfix'>\n<div class=\"flex_column av_two_third  flex_column_div first  \" style='padding:8px 0px 0px 14px ; border-radius:0px; '><section class=\"av_textblock_section \"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock  '   itemprop=\"text\" ><p style=\"text-align: justify;\">Pharmacovigilance (PV) is the science and activities related to the detection, assessment, understanding and prevention of adverse effects or any other drug related problem. The objective of PV is to provide reliable, balanced information for the effective assessment of the risk-benefit profile of drugs to ensure patient safety in relation to the use of drugs.<\/p>\n<p style=\"text-align: justify;\">Pharmacovigilance is an integral part of the clinical drug development process and plays a critical role in marketing approval\/authorisation of drug by the regulatory authority. The pharmacovigilance activities (in form of pharmacovigilance plan) are built into the clinical trial protocols for each phase (phase I, II &amp; III) of the trial. Subsequent to successful completion of all the clinical trial phases, the drug regulatory authority grants marketing approval \/authorisation to the drug provided the risk-benefit assessment is favourable.<\/p>\n<p style=\"text-align: justify;\">The knowledge regarding the safety profile of a product may change over time, through expanded use. Once the drug is approved for marketing, the pharmacovigilance activities continue in the post-marketing phase and until such time the drug remains available in the market. For instance, during the early post-marketing period, a larger population might use the product over a short period, resulting in new information that might impact the associated benefits and risks. Thus, pharmacovigilance is a dynamic process and requires safety information to be evaluated on a continuous basis for the assessment of the risk-benefit profile of the drug.<\/p>\n<p style=\"text-align: justify;\">In India, the Central Drugs Standard Control Organization (CDSCO) is responsible for conducting the Pharmacovigilance Programme of India.\u00a0 For this purpose, CDSCO has set up a National Coordinating Centre at Indian Pharmacopoeia Commission (<a href=\"http:\/\/www.ipc.gov.in\/\" target=\"_blank\" rel=\"noopener noreferrer\">IPC<\/a>). The IPC has published guidance documents for pharmacovigilance requirements in India.<\/p>\n<p style=\"text-align: justify;\">Marketing authorisation holders are required to set up appropriate pharmacovigilance system, to collect and assess adverse reactions and to submit Periodic Safety Update Reports (PSUR), for a period of at least four years to CDSCO. In consultation with expert committees, CDSCO may extend the duration of this data beyond 4 years. The PSUR data should be submitted to CDSCO in the prescribed format as per the Fifth Schedule (page 229) of the <a href=\"https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/NewDrugs_CTRules_2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">New Drugs and Clinical Trial Rules, 2019<\/a>.<\/p>\n<h4><strong>Resources and further reading:<\/strong><\/h4>\n<ul style=\"margin-top: 0.5em !important;\">\n<li style=\"text-align: justify;\">Pharmacovigilance guidance document for Market Authorisation Holders of Pharmaceutical Products, Indian Pharmacopoeia Commission in collaboration with Central Drugs Standard Control Organization, 2018, available <a href=\"http:\/\/ipc.gov.in\/PvPI\/pub\/Guidance%20Document%20for%20Marketing%20Authorization%20Holders.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">Guidance for Industry on Pharmacovigilance Requirements for Biological Products, Central Drugs Standard Control Organization, 2017, available <a href=\"http:\/\/www.cdsco.nic.in\/writereaddata\/pharmacovigilanceGuidance.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">The Importance of Pharmacovigilance, Safety Monitoring of Medicinal Products, World Health Organization, 2002, available <a href=\"http:\/\/apps.who.int\/medicinedocs\/pdf\/s4893e\/s4893e.pdf?ua=1\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">Amale et al., 2018, Pharmacovigilance Process in India: an overview, Journal of Pharmacovigilance, available <a href=\"https:\/\/www.omicsonline.org\/open-access\/ppharmacovigilance-process-in-india-an-overviewp-2329-6887-1000259.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 26.02.2019).<\/li>\n<li style=\"text-align: justify;\">New Drugs and Clinical Trial Rules, 2019, G.S.R. 227(E), Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, available <a href=\"https:\/\/cdsco.gov.in\/opencms\/export\/sites\/CDSCO_WEB\/Pdf-documents\/NewDrugs_CTRules_2019.pdf\" target=\"_blank\" rel=\"noopener noreferrer\">online<\/a> (last accessed on 004.2019).<\/li>\n<\/ul>\n<\/div><\/section><\/div><div class=\"flex_column av_one_third  flex_column_div   \" style='padding:2px 2px 0px 0px ; border-radius:0px; '><div class='avia-builder-widget-area clearfix '><div id=\"custom_html-3\" class=\"widget_text widget clearfix widget_custom_html\"><h3 class=\"widgettitle\">Key Components<\/h3><div class=\"textwidget custom-html-widget\"><div class=\"hjubv\">\r\n\t\r\n\r\n<ol style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=1075\" style=\"color: #000;\">Trial Planning<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=319\" style=\"color: #000;\">Trial Design<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=309\" style=\"color: red;\">Sponsorship<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=333\" style=\"color: red;\">Funding<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=339\" style=\"color: #000;\">Internationally Funded Trials<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=862\" style=\"color: #000;\">Trial Set-Up<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=343\" style=\"color: red;\">Protocol Development<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=345\" style=\"color: red;\">Essential Documents<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=873\" style=\"color: red;\">Case Record Form<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=877\" style=\"color: red;\">Informed Consent Documents<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=880\" style=\"color: red;\">Investigator\u2019s Brochure<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=885\" style=\"color: #000;\">Trial Master File<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=363\" style=\"color: #000;\">Laboratory Related Documents<\/a><\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"9\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=419\" style=\"color: #000;\">Risk Management<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=372\" style=\"color: #000;\">Quality and Process Management<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=374\" style=\"color: #000;\">Sponsor Specific Processes and Documents<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=376\" style=\"color: #000;\">Pharmacovigilance Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=378\" style=\"color: #000;\">Monitoring Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=962\" style=\"color: #000;\">Safety Management Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=384\" style=\"color: #000;\">Randomisation System Development and User Acceptance Testing<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=386\" style=\"color: #000;\">Database Design, Development and User Acceptance Testing<\/a> <\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=355\" style=\"color: #000;\">Statistical Analysis Plan<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=380\" style=\"color: #000;\">Data Management Plan<\/a> <\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"11\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=399\" style=\"color: #000;\">Site Feasibility and Selection<\/a><\/li>\r\n<\/ol>\t\r\n<p class=\"kaw\">\r\n<ul style=\"margin-top: -23px;\">\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=401\" style=\"color: #000;\">Site Identification and Evaluation<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=382\" style=\"color: #000;\">Site-specific Processes and Documents<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=906\" style=\"color: red;\">Clinical Trial Agreement and Investigator\u2019s Undertaking<\/a><\/li>\r\n\t<li style=\"color:#7a7a7a !important\"><a href=\"\/?page_id=409\" style=\"color: #000;\">Site Staff Training<\/a><\/li>\r\n<\/ul>\r\n<\/p>\r\n<ol start=\"12\" style=\"margin-left: 15px !important;\">\r\n\t<li><a href=\"\/?page_id=812\" style=\"color: #000;\">Trial Drug Supplies<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=815\" style=\"color: #000;\">Approvals and Registration<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=421\" style=\"color: red;\">Regulatory Approval<\/a><\/li>\r\n    <li style=\"color:red !important\"><a href=\"\/?page_id=425\" style=\"color: red;\">Ethics Approval<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=852\" style=\"color: red;\">Clinical Trial Registration<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=423\" style=\"color: #000;\">Other Approvals<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=433\" style=\"color: red;\">Final Protocol<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=836\" style=\"color: #000;\">Management and Oversight Groups<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=439\" style=\"color: #000;\">Trial Begins<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=453\" style=\"color: #000;\">Trial Conduct<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=498\" style=\"color: #000;\">Trial Close-Out<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=518\" style=\"color: #000;\">Statistical Analysis and Reports<\/a><\/li>\r\n\t<li><a href=\"\/?page_id=510\" style=\"color: #000;\">Communication and Dissemination of Results<\/a><\/li>\r\n\t<li style=\"color:red !important\"><a href=\"\/?page_id=522\" style=\"color: red;\">Archiving<\/a><\/li>\r\n<\/ol>\r\n\t<\/div><\/div><\/div><div id=\"search-4\" class=\"widget clearfix widget_search\"><h3 class=\"widgettitle\">Search<\/h3>\n\n<form action=\"https:\/\/cdsatoolkit.thsti.in\/\" id=\"searchform\" method=\"get\" class=\"\">\n\t<div>\n\t\t<input type=\"submit\" value=\"\ue803\" id=\"searchsubmit\" class=\"button avia-font-entypo-fontello\" \/>\n\t\t<input type=\"text\" id=\"s\" name=\"s\" value=\"\" placeholder='Search' \/>\n\t\t\t<\/div>\n<\/form><\/div><\/div><\/div>\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='after_section_3' class='main_color av_default_container_wrap container_wrap sidebar_right'   ><div class='container' ><div class='template-page content  av-content-small alpha units'><div class='post-entry post-entry-type-page post-entry-376'><div class='entry-content-wrapper 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