{"id":53401,"date":"2023-01-30T13:02:10","date_gmt":"2023-01-30T12:02:10","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/pharmacovigilance-for-drug-safety-regulatory-affairs-and-pv-auditors-broadening-your-knowledge-training-course-february-22-24-2023-researchandmarkets-com\/"},"modified":"2023-01-30T13:02:10","modified_gmt":"2023-01-30T12:02:10","slug":"pharmacovigilance-for-drug-safety-regulatory-affairs-and-pv-auditors-broadening-your-knowledge-training-course-february-22-24-2023-researchandmarkets-com","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/pharmacovigilance-for-drug-safety-regulatory-affairs-and-pv-auditors-broadening-your-knowledge-training-course-february-22-24-2023-researchandmarkets-com\/","title":{"rendered":"Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors &#8211; Broadening your Knowledge Training Course (February 22-24, 2023) &#8211; ResearchAndMarkets.com"},"content":{"rendered":"<div>\n<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5725563\/pharmacovigilance-drug-safety-regulatory-affairs?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nwzpjl&amp;utm_campaign=1814538+-+Pharmacovigilance+for+Drug+Safety%2C+Regulatory+Affairs+and+PV+Auditors+-+Broadening+your+Knowledge+Training+Course+(February+22-24%2C+2023)&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">&#8220;Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors &#8211; Broadening your Knowledge Training Course&#8221;<\/a> conference has been added to <strong>ResearchAndMarkets.com&#8217;s<\/strong> offering.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20230130005341\/en\/1699215\/4\/logo.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20230130005341\/en\/1699215\/21\/logo.jpg\"><\/a><\/p>\n<p>\nThe importance of drug and medical device safety is paramount and the regulations and requirements applicable to the discipline of pharmacovigilance are extensive and complex.\n<\/p>\n<p>\nThis course has been designed for those wishing to learn more than the basics of Pharmacovigilance, who want to expand their knowledge and explore what they would like to learn next in this complex area.\n<\/p>\n<p>\nIt will give a comprehensive overview of all aspects of PV from global pharmacovigilance and safety standards to where drug safety fits within the company. Safety reporting, adverse reactions vs adverse events, and clinical drug safety will be addressed. It will introduce Medical Device reporting and look at both EU and FDA regulations. Pre-clinical animal and in-vitro studies will also be covered as will post-marketing drug safety. How to collect quality data and specific clinical areas such as Pregnancy and At Risk Groups will be discussed.\n<\/p>\n<p>\nOverall this course will provide a thorough and extensive overview of pharmacovigilance and will equip delegates with the ability to apply the knowledge gained to enhance their role within the company.\n<\/p>\n<p>\n<strong>Key Topics Covered:<\/strong>\n<\/p>\n<p>\n<strong>Background and Introduction to Pharmacovigilance<\/strong>\n<\/p>\n<ul>\n<li>\nThe WHO and Safety Reporting\n<\/li>\n<li>\nCIOMS &#8211; Function and Purpose\n<\/li>\n<li>\nICH &#8211; Composition and Guidelines\n<\/li>\n<\/ul>\n<p>\n<strong>Global Pharmacovigilance and Safety Standards<\/strong>\n<\/p>\n<ul>\n<li>\nDefinitions of Terms (ICH) used in Pharmacovigilance\n<\/li>\n<li>\nAdverse reactions versus Adverse events\n<\/li>\n<li>\nSerious and Non-serious &#8211; definitions\n<\/li>\n<li>\nExpected or unexpected reactions or events\n<\/li>\n<li>\nExpedited reporting\n<\/li>\n<\/ul>\n<p>\n<strong>Global Pharmacovigilance and Safety Standards (continued)<\/strong>\n<\/p>\n<p>\n<strong>Pharmacovigilance and its Role in Other Departments<\/strong>\n<\/p>\n<ul>\n<li>\nPharmacovigilance &#8211; where does it fit in the Company?\n<\/li>\n<li>\nMedical Information and Drug Safety\n<\/li>\n<li>\nRegulatory Dept. and Drug Safety\n<\/li>\n<li>\nClinical and Drug Safety\n<\/li>\n<li>\nCommercial, Marketing and Drug Safety\n<\/li>\n<\/ul>\n<p>\n<strong>Clinical Drug Safety<\/strong>\n<\/p>\n<ul>\n<li>\nBasic principles &#8211; key features for capturing Drug Safety data\n<\/li>\n<li>\nCase Record Form Design and Data Capture\n<\/li>\n<li>\nData Management and Drug Safety &#8211; Clinical versus Safety Databases\n<\/li>\n<li>\nAssessment of Individual Serious Adverse Event Reports\n<\/li>\n<\/ul>\n<p>\n<strong>Post Marketing Drug Safety<\/strong>\n<\/p>\n<ul>\n<li>\nDifferences in Clinical and Post Marketing Drug Safety\n<\/li>\n<li>\nEuropean Marketing Safety and Causality\n<\/li>\n<li>\nPost Marketing Safety in the USA\n<\/li>\n<li>\nPost Marketing Safety in Japan\n<\/li>\n<\/ul>\n<p>\n<strong>Causality Assessments in Pharmacovigilance<\/strong>\n<\/p>\n<ul>\n<li>\nAssessments for Clinical Safety and Causality\n<\/li>\n<li>\nPost Marketing Safety and Causality\n<\/li>\n<li>\nCausality Definitions\n<\/li>\n<li>\nCompany versus Reporter Causality\n<\/li>\n<li>\nPros and Cons of Causality Definitions\n<\/li>\n<\/ul>\n<p>\n<strong>Pre-Clinical Animal and In vitro Studies<\/strong>\n<\/p>\n<ul>\n<li>\nICH Guidelines and Animal and In vitro Studies\n<\/li>\n<li>\nEU and FDA regulations and Animal Studies\n<\/li>\n<li>\nToxicity Studies\n<\/li>\n<li>\nGenotoxicity, mutagenicity and Carcinogenicity Studies\n<\/li>\n<\/ul>\n<p>\n<strong>MedDRA &#8211; Introductory<\/strong>\n<\/p>\n<ul>\n<li>\nBackground Information concerning the Introduction of MedDRA\n<\/li>\n<li>\nThe MSSO and MedDRA\n<\/li>\n<li>\nMedDRA Coding capabilities and approaches\n<\/li>\n<li>\nMedDRA Versions and Development of the Dictionary\n<\/li>\n<li>\nOld Dictionaries and Data Conversion\n<\/li>\n<\/ul>\n<p>\n<strong>Collecting Good Quality Safety Information<\/strong>\n<\/p>\n<ul>\n<li>\nWhy the need for good Quality Safety Information?\n<\/li>\n<li>\nWhat constitutes good safety information?\n<\/li>\n<li>\nDiffering regulations concerning safety data collection requirements\n<\/li>\n<li>\nDesigning a system to collect good-quality information\n<\/li>\n<\/ul>\n<p>\n<strong>The Blinded Study and Safety Reporting<\/strong>\n<\/p>\n<ul>\n<li>\nDefinition of a Blinded Study\n<\/li>\n<li>\nBlinded Studies involving Company Products, Comparator Products and Placebo\n<\/li>\n<li>\nRegulations and Guidelines for Blinded Study Safety Reporting\n<\/li>\n<li>\nUnblinding and Emergency Unblinding\n<\/li>\n<li>\nBlinding and Biometrics\n<\/li>\n<\/ul>\n<p>\n<strong>An Introduction to Medical Device Reporting<\/strong>\n<\/p>\n<ul>\n<li>\nDefinition of a Medical Device\n<\/li>\n<li>\nSafety Reporting of Medical Devices\n<\/li>\n<li>\nFDA Regulations concerning Medical Devices and Safety\n<\/li>\n<li>\nEU Regulations concerning Medical Devices and Safety\n<\/li>\n<\/ul>\n<p>\n<strong>The Need for Capturing Pregnancy Data<\/strong>\n<\/p>\n<ul>\n<li>\nPregnancy Information Sources\n<\/li>\n<li>\nPregnancy Data Forms, data capture and appearance in Safety Reviews\n<\/li>\n<li>\nRegulations concerning pregnancy data capture\n<\/li>\n<\/ul>\n<p>\n<strong>Drug Safety and At Risk Groups<\/strong>\n<\/p>\n<ul>\n<li>\nRegulations and Guidelines in connection with At Risk Groups\n<\/li>\n<li>\nAnalysis of Data from at risk Groups\n<\/li>\n<li>\nIdentification of at Risk Groups\n<\/li>\n<li>\nReporting new findings concerning at risk groups\n<\/li>\n<\/ul>\n<p>\n<strong>Medical Aspects of Liver Disease and Hepatic Adverse Drug Reactions<\/strong>\n<\/p>\n<ul>\n<li>\nBasic Physiology and Definitions\n<\/li>\n<li>\nCommon Liver Conditions\n<\/li>\n<li>\nDrug effects on the Liver\n<\/li>\n<li>\nPharmacovigilance evaluations with Hepatic ADRs\n<\/li>\n<\/ul>\n<p>\n<strong>Medical Aspects of Renal Adverse Drug Reactions<\/strong>\n<\/p>\n<ul>\n<li>\nBasic Renal Physiology\n<\/li>\n<li>\nDrug Induced Renal Disease\n<\/li>\n<li>\nRenal Disease and ADRs\n<\/li>\n<li>\nRenal Function and Dosing in relation to ADRs\n<\/li>\n<\/ul>\n<p>\n<strong>Medical Aspects of Haematological and Immunological Adverse Drug Reactions<\/strong>\n<\/p>\n<ul>\n<li>\nBlood Composition and Normal values\n<\/li>\n<li>\nMechanism of action of Drugs on Blood Parameters\n<\/li>\n<li>\nType A and B reactions\n<\/li>\n<\/ul>\n<p>\n<strong>Medical Aspects of Cardiovascular Disease and Adverse Drug Reactions<\/strong>\n<\/p>\n<ul>\n<li>\nBasic Physiology and Heart Rhythm\n<\/li>\n<li>\nQT Interval Prolongation and Drugs\n<\/li>\n<li>\nCardiovascular Disease and Drugs &#8211; contraindications\n<\/li>\n<li>\nDrug Induced Cardiac ADRs\n<\/li>\n<\/ul>\n<p>\n<strong>Speakers:<\/strong>\n<\/p>\n<p>\nGraeme Ladds\n<\/p>\n<p>\nDirector\n<\/p>\n<p>\nPharSafer Associates Ltd.\n<\/p>\n<p>\nGraeme Ladds, Director of PharSafer, has over 22 years&#8217; experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety &amp; Medical Information, Graeme went on to become Head of Global Pharmacovigilance at Shire Pharmaceuticals.\n<\/p>\n<p>\nThe last 11 years have been spent in his consultancy company, PharSafer Associates Ltd. During this time, Graeme has been involved in establishing pharmacovigilance in companies, performing audits across Europe and the USA, SOP writing, acting as QP for companies, and helping with regulatory inspections.\n<\/p>\n<p>\nFor more information about this conference visit <a target=\"_blank\" href=\"https:\/\/www.researchandmarkets.com\/reports\/5725563\/pharmacovigilance-drug-safety-regulatory-affairs?utm_source=BW&amp;utm_medium=PressRelease&amp;utm_code=nwzpjl&amp;utm_campaign=1814538+-+Pharmacovigilance+for+Drug+Safety%2C+Regulatory+Affairs+and+PV+Auditors+-+Broadening+your+Knowledge+Training+Course+(February+22-24%2C+2023)&amp;utm_exec=como322prd\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.researchandmarkets.com\/r\/rl4smy<\/a>\n<\/p>\n<p>\n<strong>About ResearchAndMarkets.com<\/strong>\n<\/p>\n<p>\nResearchAndMarkets.com is the world&#8217;s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nResearchAndMarkets.com<br \/>\n<br \/>Laura Wood, Senior Press Manager<br \/>\n<br \/><a target=\"_blank\" href=\"&#x6d;&#97;i&#x6c;&#116;o&#x3a;&#112;r&#x65;&#x73;&#115;&#x40;&#x72;&#101;s&#x65;&#97;r&#x63;&#104;a&#x6e;&#x64;&#109;&#x61;&#x72;&#107;e&#x74;&#115;&#46;&#x63;&#111;m\" rel=\"nofollow noopener\" shape=\"rect\">pr&#101;&#115;&#115;&#x40;&#x72;&#x65;&#x73;ea&#114;&#99;&#104;&#x61;&#x6e;&#x64;&#x6d;ar&#107;&#101;&#116;&#x73;&#x2e;&#x63;&#x6f;m<\/a><br \/>For E.S.T Office Hours Call 1-917-300-0470<br \/>\n<br \/>For U.S.\/ CAN Toll Free Call 1-800-526-8630<br \/>\n<br \/>For GMT Office Hours Call +353-1-416-8900\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors &#8211; Broadening your Knowledge Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. The importance of drug and medical device safety is paramount and the regulations and requirements applicable to the discipline of pharmacovigilance are extensive and complex. This course has been designed for &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/pharmacovigilance-for-drug-safety-regulatory-affairs-and-pv-auditors-broadening-your-knowledge-training-course-february-22-24-2023-researchandmarkets-com\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-53401","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge Training Course (February 22-24, 2023) - ResearchAndMarkets.com - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/pharmacovigilance-for-drug-safety-regulatory-affairs-and-pv-auditors-broadening-your-knowledge-training-course-february-22-24-2023-researchandmarkets-com\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors - Broadening your Knowledge Training Course (February 22-24, 2023) - ResearchAndMarkets.com - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"DUBLIN&#8211;(BUSINESS WIRE)&#8211;The &#8220;Pharmacovigilance for Drug Safety, Regulatory Affairs and PV Auditors &#8211; Broadening your Knowledge Training Course&#8221; conference has been added to ResearchAndMarkets.com&#8217;s offering. 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The importance of drug and medical device safety is paramount and the regulations and requirements applicable to the discipline of pharmacovigilance are extensive and complex. This course has been designed for ... 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