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<title>Education Archives - Drug Safety and Pharmacovigilance Course</title>
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<title>Advanced Clinical Data Science</title>
<link>https://medipharmsolutions.com/courses/advanced-clinical-data-science/</link>
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<pubDate>Mon, 11 Aug 2014 04:21:43 +0000</pubDate>
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<p>The post <a href="https://medipharmsolutions.com/courses/advanced-clinical-data-science/">Advanced Clinical Data Science</a> appeared first on <a href="https://medipharmsolutions.com">Drug Safety and Pharmacovigilance Course </a>.</p>
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<div class="vc_empty_space" style="height: 32px"><span class="vc_empty_space_inner"></span></div><h2 style="font-size: 27px;line-height: 1.3em;text-align: center" class="vc_custom_heading vc_do_custom_heading" >Learn More about Clinical Data Science, Understanding EHRs and Informatics using real world Clinical Data.</h2><div class="vc_separator wpb_content_element vc_separator_align_center vc_sep_width_10 vc_sep_border_width_4 vc_sep_pos_align_center vc_separator_no_text vc_sep_color_blue vc_custom_1686304661773 wpb_content_element vc_custom_1686304661773 wpb_content_element" ><span class="vc_sep_holder vc_sep_holder_l"><span class="vc_sep_line"></span></span><span class="vc_sep_holder vc_sep_holder_r"><span class="vc_sep_line"></span></span>
</div><div class="vc_row wpb_row vc_inner vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner"><div class="wpb_wrapper"><section class="vc_cta3-container"><div class="vc_general vc_do_cta3 vc_cta3 vc_cta3-style-classic vc_cta3-shape-rounded vc_cta3-align-left vc_cta3-color-classic vc_cta3-icons-on-border vc_cta3-icon-size-md vc_cta3-icons-left"><div class="vc_cta3-icons"><div class="vc_icon_element vc_icon_element-outer vc_do_icon vc_icon_element-align-left"><div class="vc_icon_element-inner vc_icon_element-color-blue vc_icon_element-size-md vc_icon_element-style- vc_icon_element-background-color-grey" ><span class="vc_icon_element-icon fas fa-braille" ></span></div></div></div><div class="vc_cta3_content-container"><div class="vc_cta3-content"><header class="vc_cta3-content-header"><h4 style="line-height: 1.6em;text-align: left" class="vc_custom_heading vc_do_custom_heading" >Professional Certification in Clinical Data Science</h4></header><p>Through our cutting edge rentention learning methods using LMS , we offer you the best Drug Safety training program.</p>
</div></div></div></section></div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner"><div class="wpb_wrapper"><section class="vc_cta3-container"><div class="vc_general vc_do_cta3 vc_cta3 vc_cta3-style-classic vc_cta3-shape-rounded vc_cta3-align-left vc_cta3-color-classic vc_cta3-icons-on-border vc_cta3-icon-size-md vc_cta3-icons-left"><div class="vc_cta3-icons"><div class="vc_icon_element vc_icon_element-outer vc_do_icon vc_icon_element-align-left"><div class="vc_icon_element-inner vc_icon_element-color-blue vc_icon_element-size-md vc_icon_element-style- vc_icon_element-background-color-grey" ><span class="vc_icon_element-icon fas fa-braille" ></span></div></div></div><div class="vc_cta3_content-container"><div class="vc_cta3-content"><header class="vc_cta3-content-header"><h4 style="line-height: 1.6em;text-align: left" class="vc_custom_heading vc_do_custom_heading" >Clinical Data Science Training Mentorship</h4></header><p>Most Impactful factor in your success is having subject matter experts as your career mentors. <span style="visibility: hidden;">sadsaa sfas sadas sadas sadas asdsa asf</span></p>
</div></div></div></section></div></div></div></div><div class="vc_row wpb_row vc_inner vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner"><div class="wpb_wrapper"><section class="vc_cta3-container"><div class="vc_general vc_do_cta3 vc_cta3 vc_cta3-style-classic vc_cta3-shape-rounded vc_cta3-align-left vc_cta3-color-classic vc_cta3-icons-on-border vc_cta3-icon-size-md vc_cta3-icons-left"><div class="vc_cta3-icons"><div class="vc_icon_element vc_icon_element-outer vc_do_icon vc_icon_element-align-left"><div class="vc_icon_element-inner vc_icon_element-color-blue vc_icon_element-size-md vc_icon_element-style- vc_icon_element-background-color-grey" ><span class="vc_icon_element-icon fas fa-braille" ></span></div></div></div><div class="vc_cta3_content-container"><div class="vc_cta3-content"><header class="vc_cta3-content-header"><h4 style="line-height: 1.6em;text-align: left" class="vc_custom_heading vc_do_custom_heading" >Best Online Clinical Data Science Training Modules</h4></header><p>Which are crafted for current drug safety market needs, making our training course, the most practical application of Clinical data science methods.</p>
</div></div></div></section></div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner"><div class="wpb_wrapper"><section class="vc_cta3-container"><div class="vc_general vc_do_cta3 vc_cta3 vc_cta3-style-classic vc_cta3-shape-rounded vc_cta3-align-left vc_cta3-color-classic vc_cta3-icons-on-border vc_cta3-icon-size-md vc_cta3-icons-left"><div class="vc_cta3-icons"><div class="vc_icon_element vc_icon_element-outer vc_do_icon vc_icon_element-align-left"><div class="vc_icon_element-inner vc_icon_element-color-blue vc_icon_element-size-md vc_icon_element-style- vc_icon_element-background-color-grey" ><span class="vc_icon_element-icon fas fa-braille" ></span></div></div></div><div class="vc_cta3_content-container"><div class="vc_cta3-content"><header class="vc_cta3-content-header"><h4 style="line-height: 1.6em;text-align: left" class="vc_custom_heading vc_do_custom_heading" >Comprehensive Clinical Data Science Curriculum</h4></header><p>Understand electronic health record data types and structures, , provide appropriate clinical and scientific interpretation of applied analyses.</p>
</div></div></div></section></div></div></div></div><div class="vc_row wpb_row vc_inner vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner"><div class="wpb_wrapper"><section class="vc_cta3-container"><div class="vc_general vc_do_cta3 vc_cta3 vc_cta3-style-classic vc_cta3-shape-rounded vc_cta3-align-left vc_cta3-color-classic vc_cta3-icons-on-border vc_cta3-icon-size-md vc_cta3-icons-left"><div class="vc_cta3-icons"><div class="vc_icon_element vc_icon_element-outer vc_do_icon vc_icon_element-align-left"><div class="vc_icon_element-inner vc_icon_element-color-blue vc_icon_element-size-md vc_icon_element-style- vc_icon_element-background-color-grey" ><span class="vc_icon_element-icon fas fa-braille" ></span></div></div></div><div class="vc_cta3_content-container"><div class="vc_cta3-content"><header class="vc_cta3-content-header"><h4 style="line-height: 1.6em;text-align: left" class="vc_custom_heading vc_do_custom_heading" >Hands-on Advanced Clinical Data Science</h4></header><p>Learn SQL, SAS and R programming skills with real world clinical data.</p>
</div></div></div></section></div></div></div><div class="wpb_column vc_column_container vc_col-sm-6"><div class="vc_column-inner"><div class="wpb_wrapper"><section class="vc_cta3-container"><div class="vc_general vc_do_cta3 vc_cta3 vc_cta3-style-classic vc_cta3-shape-rounded vc_cta3-align-left vc_cta3-color-classic vc_cta3-icons-on-border vc_cta3-icon-size-md vc_cta3-icons-left"><div class="vc_cta3-icons"><div class="vc_icon_element vc_icon_element-outer vc_do_icon vc_icon_element-align-left"><div class="vc_icon_element-inner vc_icon_element-color-blue vc_icon_element-size-md vc_icon_element-style- vc_icon_element-background-color-grey" ><span class="vc_icon_element-icon fas fa-braille" ></span></div></div></div><div class="vc_cta3_content-container"><div class="vc_cta3-content"><header class="vc_cta3-content-header"><h4 style="line-height: 1.6em;text-align: left" class="vc_custom_heading vc_do_custom_heading" >Collaborations</h4></header><p>Leverage our network with our 100% Job placement assistance.<span style="visibility: hidden;"> sadas sdsafsf sdfdsf sdfdsfg dfdsf dsfsd ddsf</span></p>
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<h5><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>MODULES -</strong> 25</h5>
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<h5><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>HRS OF LEARNING-</strong> 300+</h5>
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<h5><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>MONTHS -</strong> 3</h5>
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<h5><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>FAQs-</strong> 450+</h5>
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<h5><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>MOCK INTERVIEW FAQs-</strong> 150+</h5>
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</div><div class="vc_tta-container" data-vc-action="collapseAll"><div class="vc_general vc_tta vc_tta-accordion vc_tta-color-grey vc_tta-style-classic vc_tta-shape-rounded vc_tta-o-shape-group vc_tta-controls-align-default vc_tta-o-all-clickable"><div class="vc_tta-panels-container"><div class="vc_tta-panels"><div class="vc_tta-panel" id="1686311277652-d0b0b1ee-45e1" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title vc_tta-controls-icon-position-left"><a href="#1686311277652-d0b0b1ee-45e1" data-vc-accordion data-vc-container=".vc_tta-container"><i class="vc_tta-icon fas fa-book"></i><span class="vc_tta-title-text">PROGRAM OVERVIEW</span><i class="vc_tta-controls-icon vc_tta-controls-icon-plus"></i></a></h4></div><div class="vc_tta-panel-body">
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<p style="font-size: 16px;">The primary role of clinical data management is to produce and maintain high-quality data from data entry through analysis. Performed correctly, the result of clinical data management is a dataset that is accurate, secure, reliable, and ready for analysis at the end of a study.</p>
<p style="font-size: 16px;">Who this program is for: Life Science, Pharma or Medical Graduate, Clinical Research and IT Professionals</p>
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<ul>
<li>To Understand study data that is collected, organized, and saved to meet compliance requirements, such as CFR21 Part 11, good manufacturing practices (GMP), and good clinical practice (GCP).</li>
<li>Develop advanced knowledge of the roles and responsibilities of various functionaries in CDM department such as Clinical Data Manager, Data Management Assistant, Data Team Lead (DTL), Database Programmer/Designer, Medical Coder/Writer, Clinical Data Coordinator, Clinical Data Analyst, Biostatistician.</li>
<li>Practice the process of Query writing</li>
<li>Detailed training in EDC tool and medical writing</li>
<li>Thorough knowledge of Protocol Review and CRF Review</li>
<li>Competence in managing end to end process in Data Management Plan.</li>
<li>Working experience in EDC tool and edit checks writing.</li>
<li>Soft skills development for Interview success.</li>
</ul>
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</div></div></div></div></div></div><div class="vc_tta-container" data-vc-action="collapseAll"><div class="vc_general vc_tta vc_tta-accordion vc_tta-color-grey vc_tta-style-classic vc_tta-shape-rounded vc_tta-o-shape-group vc_tta-controls-align-default vc_tta-o-all-clickable"><div class="vc_tta-panels-container"><div class="vc_tta-panels"><div class="vc_tta-panel" id="1686311916153-da1863c4-3081" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title vc_tta-controls-icon-position-left"><a href="#1686311916153-da1863c4-3081" data-vc-accordion data-vc-container=".vc_tta-container"><i class="vc_tta-icon fas fa-book"></i><span class="vc_tta-title-text">CURRICULAM</span><i class="vc_tta-controls-icon vc_tta-controls-icon-plus"></i></a></h4></div><div class="vc_tta-panel-body">
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<ul>
<li>History and Why Pharmacovigilance</li>
<li>Drug Development process</li>
<li>ICH -GCP guidelines – PV perspective</li>
<li>Oracle Argus suite training</li>
<li>Adverse Drug Reactions (ADRs)</li>
<li>ICSR – Work flow states and timelines</li>
<li>Serious Adverse events (SAEs) & SUSARs</li>
<li>MedDRA</li>
<li>Drug coding</li>
<li>Labelling Assessment</li>
<li>Causality Assessment</li>
<li>Narrative writing</li>
<li>Query generation</li>
<li>Follow up assessment</li>
<li>Report generation and submission</li>
<li>AOSE – Analysis of Similar events</li>
<li>Reporting timelines</li>
<li>Regulations and regulatory Databases</li>
<li>Structure of Drug Safety department and cross functional teams.</li>
<li>SOPS and working guidance in PV</li>
<li>Medical devices</li>
<li>Target medical events</li>
<li>Vendor management</li>
<li>Audits and Inspection</li>
<li>Product quality complaints</li>
<li>FAQs – Interview process</li>
<li>Recent Updates to Drug Safety</li>
<li>Future trends in Drug Safety</li>
</ul>
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</div></div></div></div></div></div><div class="vc_tta-container" data-vc-action="collapseAll"><div class="vc_general vc_tta vc_tta-accordion vc_tta-color-grey vc_tta-style-classic vc_tta-shape-rounded vc_tta-o-shape-group vc_tta-controls-align-default vc_tta-o-all-clickable"><div class="vc_tta-panels-container"><div class="vc_tta-panels"><div class="vc_tta-panel" id="1686311977016-87349691-fdfa" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title vc_tta-controls-icon-position-left"><a href="#1686311977016-87349691-fdfa" data-vc-accordion data-vc-container=".vc_tta-container"><i class="vc_tta-icon fas fa-book"></i><span class="vc_tta-title-text">DURATION</span><i class="vc_tta-controls-icon vc_tta-controls-icon-plus"></i></a></h4></div><div class="vc_tta-panel-body">
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<ul>
<li>Duration : 12 weeks</li>
<li>Live webinars – twice weekly – 60 min each.</li>
<li>50 Self Paced online LMS Modules.</li>
<li>500 Hours of learning material – videos/ppts/assignments.</li>
<li>Updated as per ICH/FDA guidelines.</li>
<li>Recommended books provided.</li>
<li>Hands-on Argus Safety database operation.</li>
<li>Certification upon successful completion.</li>
</ul>
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<p><strong>Drug Safety Associate -</strong> MediPharm Solutions, the best Drug Safety Associate training institute in USA, offers 100% job placement assistance.</p>
<p><strong>Case Processor -</strong> This certification training for Drug safety Associate offers one on one mentoring access with the top minds with vast experience in Drug Safety.</p>
<p><strong>Drug Safety physician-</strong> Our Drug Safety Associate online courses cover all current industry standard topics, needed to make you job ready.</p>
<p><strong>Medical Director-</strong> Get a professional certification in Drug Safety Associate from us , which is prepared by the industry experts in Drug Safety and Pharmacovigilance.</p>
<p><strong>Safety specialist-</strong> If you are looking to start a Drug Safety Associate career, apply for the best Drug Safety Associate training in USA through our Advanced Drug Safety and Pharmacovigilance certificate program.</p>
<p><strong>Safety lead</strong></p>
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</div></div></div></div></div></div><div class=" ubtn-ctn-center "><button type="button" id="ubtn-4427" class="ubtn ult-adjust-bottom-margin ult-responsive ubtn-normal ubtn-no-hover-bg none ubtn-sep-icon ubtn-sep-icon-at-right ubtn-shd ubtn-center shd-bottom tooltip-67d63a280d8a6" data-hover="" data-border-color="" data-bg="#dd9933" data-hover-bg="" data-border-hover="" data-shadow-hover="0 5px ;" data-shadow-click="none" data-shadow="0 5px ;" data-shd-shadow="5" data-ultimate-target='#ubtn-4427' data-responsive-json-new='{"font-size":"","line-height":""}' style="font-weight:normal;border:none;box-shadow: 0 5px ;background: #dd9933;color: #ffffff;"><span class="ubtn-data ubtn-icon"><i class="Defaults-arrow-right" style="font-size:0px;color:;"></i></span><span class="ubtn-hover" style="background-color:"></span><span class="ubtn-data ubtn-text " >Contact Now</span></button></div></div></div></div></div><div class="vc_row wpb_row vc_row-fluid"><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></div><div class="vc_row wpb_row vc_row-fluid"><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: 2px"><span class="vc_empty_space_inner"></span></div><h2 style="text-align: center" class="vc_custom_heading vc_do_custom_heading" >CLINICAL DATA MANAGEMENT PROGRAM</h2>
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<p style="font-size: 16px; line-height: 1.9em;">Clinical Data Management (CDM) is the handling of information that results from clinical trials. All aspects of processing study information are part of clinical data management. This includes developing and maintaining software systems, databases, processes, procedures, training, and protocols to support collecting, cleaning, and managing subject or trial data.</p>
<p style="font-size: 16px; line-height: 1.9em;">Clinical Data Management is one of the most important phases in life cycle of a clinical trial of any drug or medical device before submission to the regulatory authorities for approval.</p>
<p style="font-size: 16px; line-height: 1.9em;">Mission of this program is to achieve knowledge of how to obtain trial data, which is consistent, accurate, validated and archived at the end before submission.</p>
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</div><p>The post <a href="https://medipharmsolutions.com/courses/advanced-clinical-data-science/">Advanced Clinical Data Science</a> appeared first on <a href="https://medipharmsolutions.com">Drug Safety and Pharmacovigilance Course </a>.</p>
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<title>Advanced Drug Safety and Pharmacovigilance</title>
<link>https://medipharmsolutions.com/courses/drug-safety-and-pharmacovigilance/</link>
<dc:creator><![CDATA[admin]]></dc:creator>
<pubDate>Tue, 24 Jun 2014 12:19:17 +0000</pubDate>
<guid isPermaLink="false">https://demo4.om-associates.in/?post_type=dt_courses&p=4716</guid>
<description><![CDATA[<p>.</p>
<p>The post <a href="https://medipharmsolutions.com/courses/drug-safety-and-pharmacovigilance/">Advanced Drug Safety and Pharmacovigilance</a> appeared first on <a href="https://medipharmsolutions.com">Drug Safety and Pharmacovigilance Course </a>.</p>
]]></description>
<content:encoded><![CDATA[<div class="wpb-content-wrapper"><div class="vc_row wpb_row vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-8"><div class="vc_column-inner"><div class="wpb_wrapper">
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<h4 style="font-size: 23px;line-height: 1.3em;text-align: center" class="vc_custom_heading vc_do_custom_heading" >Introduction to Drug Safety and Pharmacovigilance</h4><div class="vc_separator wpb_content_element vc_separator_align_center vc_sep_width_10 vc_sep_border_width_4 vc_sep_pos_align_center vc_separator_no_text vc_sep_color_blue vc_custom_1686721855229 wpb_content_element vc_custom_1686721855229 wpb_content_element" ><span class="vc_sep_holder vc_sep_holder_l"><span class="vc_sep_line"></span></span><span class="vc_sep_holder vc_sep_holder_r"><span class="vc_sep_line"></span></span>
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<p style="font-size: 16px; line-height: 1.9em; text-align: justify;">Pharmacovigilance, also known as drug safety, is the pharmacological science relating to the collection, detection, assessment, monitoring, and prevention of adverse effectswithpharmaceuticalproducts.</p>
<p style="font-size: 16px; line-height: 1.9em; text-align: justify;">The activity that is most commonly associated with pharmacovigilance and which consumes a significant amount of resources for regulatory authorities, is that of adverse event reporting. Adverse event (AE) reporting involves the receipt, triage, data entering, assessment, distribution, reporting (if appropriate), and archiving of AE data and documentation. The source of AE reports may include: spontaneous reports,solicited reports; reports from clinical or post-marketing studies; reports from literature sources; reports from the media and reports reported to drug regulatory authorities themselves. For pharmaceutical companies, AE reporting is a regulatory requirement in most countries. AE reporting also provides data to these companies and drug regulatory authorities that play a key role in assessing therisk-benefitprofileof agivendrug.</p>
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<h6><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>Modules - 40</strong></h6>
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<h6><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>HRS of Learning- 500+</strong></h6>
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<h6><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>Months - 3</strong></h6>
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<h6><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>FAQs- 450+</strong></h6>
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<h6><i class="fa fa-check-square-o" style="color: blue;"></i> <strong>Mock Interview FAQs- 150+</strong></h6>
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<a class="paoc-popup-click paoc-popup-cust-7516 paoc-popup-simple_link paoc-popup-link" href="javascript:void(0);">Enroll Now</a>
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<div class="vc_empty_space" style="height: 32px"><span class="vc_empty_space_inner"></span></div></div></div></div></div><div class="vc_row wpb_row vc_row-fluid"><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 class="vc_row wpb_row vc_inner vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"><h2 style="font-size: 27px;text-align: center" class="vc_custom_heading vc_do_custom_heading" >USP</h2></div></div></div></div><div class="vc_row wpb_row vc_inner vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-4 vc_col-has-fill"><div class="vc_column-inner vc_custom_1686722426373"><div class="wpb_wrapper">
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<div class="vc_single_image-wrapper vc_box_border_grey"><img decoding="async" width="103" height="104" src="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6.png" class="vc_single_image-img attachment-full" alt="" title="default-course6" srcset="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6.png 103w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6-100x100.png 100w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6-95x95.png 95w" sizes="(max-width: 103px) 100vw, 103px" /></div>
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<h4 style="color: #dd9933; text-align: center; line-height: 1.5em;"><strong>Hands-on Advanced Drug Safety Training</strong></h4>
<p style="text-align: center;">from end to end case processing with narrative writing and MedDRA coding. <span style="visibility: hidden;">bbkkfhgfhfhfhhfhfhfhfhfhbjbkjbkbkbbkbbkbjnk</span></p>
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<div class="vc_single_image-wrapper vc_box_border_grey"><img decoding="async" width="103" height="104" src="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course7.png" class="vc_single_image-img attachment-full" alt="" title="default-course7" srcset="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course7.png 103w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course7-100x100.png 100w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course7-95x95.png 95w" sizes="(max-width: 103px) 100vw, 103px" /></div>
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<h4 style="color: #dd9933; text-align: center; line-height: 1.5em;"><strong>Drug Safety Training Mentorship<span style="visibility: hidden;"> dsaasdacsdscfcdsca</span></strong></h4>
<p style="text-align: center;">Most Impactful factor in your success is having subject matter experts as your career mentors. <span style="visibility: hidden;">bbkkbjbkjbkbkbbkbbkbjnk</span></p>
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<div class="vc_single_image-wrapper vc_box_border_grey"><img loading="lazy" decoding="async" width="103" height="104" src="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course3.png" class="vc_single_image-img attachment-full" alt="" title="default-course3" srcset="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course3.png 103w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course3-100x100.png 100w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course3-95x95.png 95w" sizes="(max-width: 103px) 100vw, 103px" /></div>
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<h4 style="color: #dd9933; text-align: center; line-height: 1.5em;"><strong>Best online Drug Safety Training Modules</strong></h4>
<p style="text-align: center;">which are crafted for current drug safety market needs, making our training course, the most sought after Drug Safety certification program.</p>
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<div class="vc_single_image-wrapper vc_box_border_grey"><img decoding="async" width="103" height="104" src="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6.png" class="vc_single_image-img attachment-full" alt="" title="default-course6" srcset="https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6.png 103w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6-100x100.png 100w, https://medipharmsolutions.com/wp-content/uploads/2016/01/default-course6-95x95.png 95w" sizes="(max-width: 103px) 100vw, 103px" /></div>
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<h4 style="color: #dd9933; text-align: center; line-height: 1.5em;"><strong>Comprehensive Drug Safety Curriculum</strong></h4>
<p style="text-align: center;">For Drug Safety Associate training, with case processing, Aggregate reports such as PSUR/PBRERs, Signal detection, and Risk Management.</p>
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<h4 style="color: #dd9933; text-align: center; line-height: 1.5em;"><strong>Professional Certification in Drug Safety and Pharmacovigilance</strong></h4>
<p style="text-align: center;">Through our cutting edge rentention learning methods using LMS , we offer you the best Drug Safety training program.</p>
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<h4 style="color: #dd9933; text-align: center; line-height: 1.5em;"><strong>Drug Safety Collaborations <span style="visibility: hidden;">sakjdjkaskdkas</span></strong></h4>
<p style="text-align: center;">Leverage our network with our 100% Job placement <span style="visibility: hidden;"> sdadasfasfasda asdfsdfasfas sdfdsfsdfsd sdfsdgdsg bdgdsgds sdfgsdgsg</span></p>
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</div></div></div></div><div class="vc_empty_space" style="height: 32px"><span class="vc_empty_space_inner"></span></div><div class="vc_row wpb_row vc_inner vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"><h2 style="font-size: 27px;text-align: center" class="vc_custom_heading vc_do_custom_heading" >Overview</h2><div class="vc_empty_space" style="height: 32px"><span class="vc_empty_space_inner"></span></div></div></div></div></div></div></div></div></div><div class="vc_row wpb_row vc_row-fluid"><div class="wpb_column vc_column_container vc_col-sm-12"><div class="vc_column-inner"><div class="wpb_wrapper"><div class="vc_tta-container" data-vc-action="collapse"><div class="vc_general vc_tta vc_tta-tabs vc_tta-color-grey vc_tta-style-classic vc_tta-shape-rounded vc_tta-spacing-1 vc_tta-tabs-position-top vc_tta-controls-align-left"><div class="vc_tta-tabs-container"><ul class="vc_tta-tabs-list"><li class="vc_tta-tab vc_active" data-vc-tab><a href="#1686715535329-5fdf0a5a-6309" data-vc-tabs data-vc-container=".vc_tta"><span class="vc_tta-title-text">Program Overview</span></a></li><li class="vc_tta-tab" data-vc-tab><a href="#1686715535329-cbf52899-91cf" data-vc-tabs data-vc-container=".vc_tta"><span class="vc_tta-title-text">Objectives</span></a></li><li class="vc_tta-tab" data-vc-tab><a href="#1686715627012-fb5d841b-ec02" data-vc-tabs data-vc-container=".vc_tta"><span class="vc_tta-title-text">Curriculam</span></a></li><li class="vc_tta-tab" data-vc-tab><a href="#1686715679535-337208cf-5e8b" data-vc-tabs data-vc-container=".vc_tta"><span class="vc_tta-title-text">Duration</span></a></li><li class="vc_tta-tab" data-vc-tab><a href="#1686715731356-cf1a2141-a4a6" data-vc-tabs data-vc-container=".vc_tta"><span class="vc_tta-title-text">Career Paths</span></a></li></ul></div><div class="vc_tta-panels-container"><div class="vc_tta-panels"><div class="vc_tta-panel vc_active" id="1686715535329-5fdf0a5a-6309" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title"><a href="#1686715535329-5fdf0a5a-6309" data-vc-accordion data-vc-container=".vc_tta-container"><span class="vc_tta-title-text">Program Overview</span></a></h4></div><div class="vc_tta-panel-body">
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<p style="font-size: 16px; line-height: 1.9em; text-align: justify;">The Advanced Drug Safety and Pharmacovigilance Certificate program is a very unique training program. The program provides a thorough understanding of the basic concepts of drug safety and risk management throughout the process of drug development and its life cycle in the open market either as a patent or generic drug. This exposure prepares students to understand and appreciate the various types and grades of Adverse Events.</p>
<p style="font-size: 16px; line-height: 1.9em; text-align: justify;">Students are trained to correlate the Adverse Event with any vital and systemic abnormality resulting from this and understand the causal relation of the drug known as Adverse Drug Reaction (ADR). This further builds the analytical skills needed to differentiate between the progress of the disease and ADR as a signal. This program will focus on the regulatory issues across global governmental agencies like the FDA, EMA, ICH, and others that improve safety.</p>
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</div></div><div class="vc_tta-panel" id="1686715535329-cbf52899-91cf" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title"><a href="#1686715535329-cbf52899-91cf" data-vc-accordion data-vc-container=".vc_tta-container"><span class="vc_tta-title-text">Objectives</span></a></h4></div><div class="vc_tta-panel-body">
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<li>Understand the FDA, EU-EMA, and ICH regulations for drug safety and pharmacovigilance.</li>
<li>Develop advanced knowledge of the roles and responsibilities of various functionaries in Drug Safety departments, such as the Drug Safety Physician, Drug Safety Data Analyst, Drug Safety Associate or specialist, Drug Safety Data Entry Associate, Drug Safety Triage Officer, Drug Safety Scientist, Drug Safety Regulatory Associate, and etc.</li>
<li>Practice the processes of triage, data entry, medical review, as well as reporting through the Oracle® Argus software.</li>
<li>Detailed training in MedDRA coding and medical narrative writing for SAE reports.</li>
<li>Expertise in narrative writing for various regulatory requirements.</li>
<li>Capability for conducting end to end ICSR case management.</li>
<li>Evolve and implement problem solving practices.</li>
<li>Competency to handle pharmacovigilance audits.</li>
<li>Working experience in Oracle Argus Software.</li>
<li>Soft Skills development for interview success</li>
</ul>
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</div></div><div class="vc_tta-panel" id="1686715627012-fb5d841b-ec02" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title"><a href="#1686715627012-fb5d841b-ec02" data-vc-accordion data-vc-container=".vc_tta-container"><span class="vc_tta-title-text">Curriculam</span></a></h4></div><div class="vc_tta-panel-body">
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<li>History and Why Pharmacovigilance</li>
<li>Drug Development process</li>
<li>ICH -GCP guidelines – PV perspective</li>
<li>Oracle Argus suite training</li>
<li>Adverse Drug Reactions (ADRs)</li>
<li>ICSR – Work flow states and timelines</li>
<li>Serious Adverse events (SAEs) & SUSARs</li>
<li>MedDRA</li>
<li>Drug coding</li>
<li>Labelling Assessment</li>
<li>Causality Assessment</li>
<li>Narrative writing</li>
<li>Query generation</li>
<li>Follow up assessment</li>
<li>Report generation and submission</li>
<li>AOSE – Analysis of Similar events</li>
<li>Reporting timelines</li>
<li>Regulations and regulatory Databases</li>
<li>Structure of Drug Safety department and cross functional teams.</li>
<li>SOPS and working guidance in PV</li>
<li>Medical devices</li>
<li>Target medical events</li>
<li>Vendor management</li>
<li>Audits and Inspection</li>
<li>Product quality complaints</li>
<li>FAQs – Interview process</li>
<li>Recent Updates to Drug Safety</li>
<li>Future trends in Drug Safety</li>
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</div></div><div class="vc_tta-panel" id="1686715679535-337208cf-5e8b" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title"><a href="#1686715679535-337208cf-5e8b" data-vc-accordion data-vc-container=".vc_tta-container"><span class="vc_tta-title-text">Duration</span></a></h4></div><div class="vc_tta-panel-body">
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<li>Duration : 12 weeks</li>
<li>Live webinars – twice weekly – 60 min each.</li>
<li>50 Self Paced online LMS Modules.</li>
<li>500 Hours of learning material – videos/ppts/assignments.</li>
<li>Updated as per ICH/FDA guidelines.</li>
<li>Recommended books provided.</li>
<li>Hands-on Argus Safety database operation.</li>
<li>Certification upon successful completion.</li>
</ul>
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</div></div><div class="vc_tta-panel" id="1686715731356-cf1a2141-a4a6" data-vc-content=".vc_tta-panel-body"><div class="vc_tta-panel-heading"><h4 class="vc_tta-panel-title"><a href="#1686715731356-cf1a2141-a4a6" data-vc-accordion data-vc-container=".vc_tta-container"><span class="vc_tta-title-text">Career Paths</span></a></h4></div><div class="vc_tta-panel-body">
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<p style="font-size: 16px; line-height: 1.8em;"><strong>Drug Safety Associate -</strong> MediPharm Solutions, the best Drug Safety Associate training institute in USA, offers 100% job placement assistance.</p>
<p style="font-size: 16px; line-height: 1.8em;"><strong>Case Processor-</strong> This certification training for Drug safety Associate offers one on one mentoring access with the top minds with vast experience in Drug Safety.</p>
<p style="font-size: 16px; line-height: 1.8em;"><strong>Drug Safety physician -</strong> Our Drug Safety Associate online courses cover all current industry standard topics, needed to make you job ready.</p>
<p style="font-size: 16px; line-height: 1.8em;"><strong>Medical Director-</strong> Get a professional certification in Drug Safety Associate from us , which is prepared by the industry experts in Drug Safety and Pharmacovigilance.</p>
<p style="font-size: 16px; line-height: 1.8em;"><strong>Safety specialist -</strong> If you are looking to start a Drug Safety Associate career, apply for the best Drug Safety Associate training in USA through our Advanced Drug Safety and Pharmacovigilance certificate program.</p>
<p style="font-size: 16px; line-height: 1.8em;">Safety lead</p>
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</div><p>The post <a href="https://medipharmsolutions.com/courses/drug-safety-and-pharmacovigilance/">Advanced Drug Safety and Pharmacovigilance</a> appeared first on <a href="https://medipharmsolutions.com">Drug Safety and Pharmacovigilance Course </a>.</p>
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