{"id":21138,"date":"2019-12-10T07:22:23","date_gmt":"2019-12-10T07:22:23","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/pharmacovigilance-pharma-7th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-v\/"},"modified":"2019-12-10T07:22:23","modified_gmt":"2019-12-10T07:22:23","slug":"pharmacovigilance-pharma-7th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-v","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/pharmacovigilance-pharma-7th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-v\/","title":{"rendered":"Pharmacovigilance Pharma 7th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective V)"},"content":{"rendered":"<p>Pharmacovigilance Pharma 7th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective V) detail syllabus for Pharmacy (Pharma), 2017 regulation is collected from the <a href=\"https:\/\/www.annauniv.edu\/\" target=\"_blank\" rel=\"noopener\">Anna Univ<\/a> official website and presented for students of Anna University. The details of the course are: course code (PY8017), Category (PE), Contact Periods\/week (3), Teaching hours\/week (3), Practical Hours\/week (0). The total course credits are given in combined syllabus.<\/p>\n<p>For all other pharma 7th sem syllabus for b.tech 2017 regulation anna univ you can visit <a href=\"..\/pharma-7th-sem-syllabus-for-b-tech-2017-regulation-anna-univ\">Pharma 7th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects<\/a>. For all other Professional Elective V subjects do refer to <a href=\"..\/professional-elective-v-pharma-7th-sem-syllabus-for-b-tech-2017-regulation-anna-univ\">Professional Elective V<\/a>. The detail syllabus for pharmacovigilance is as follows.<\/p>\n<p><h4>Course Objective:<\/h4>\n<ul>\n<li>The course intends to provide knowledge about development and global scenario of pharmacovigilance and establishment of pharmacovigilance programme in an organization<\/li>\n<li>To develops the skills of classifying drugs, diseases and adverse drug reactions.<\/li>\n<\/ul>\n<p><h4>Unit I<\/h4>\n<p>For complete syllabus and results, class timetable and more pls <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a>. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.<\/p>\n<p><h4>Unit II<\/h4>\n<p><strong>Sources of Data<\/strong><br \/>\nAnatomical, therapeutic and chemical classification of drugs &#8211; International classification of diseases -Daily defined doses &#8211; International Nonproprietary Names for drugs &#8211; Drug dictionaries and coding in pharmacovigilance &#8211; WHO adverse reaction terminologies &#8211; MedDRA and StandardisedMedDRA queries &#8211; WHO drug dictionary &#8211; Eudravigilance medicinal product dictionary Information resources in pharmacovigilance &#8211; Basic drug information resources -Specialised resources for ADRs Establishing pharmacovigilance programme &#8211; Pre-clinical studies-Human volunteer studies &#8211; Clinical trials &#8211; Post-marketing surveillance &#8211; Systematic reviews and meta-analysis &#8211;\n<\/p>\n<p><h4>Unit III<\/h4>\n<p><strong>Pharmacovigilance Methods<\/strong><br \/>\nPharmacovigilance methods &#8211; Passive surveillance &#8211; Spontaneous reports and case series -Stimulated reporting &#8211; Active surveillance &#8211; Sentinel sites, drug event monitoring and registries -Comparative observational studies &#8211; Cross sectional study, case control study and cohort study -Targeted clinical investigations. Communication in pharmacovigilance &#8211; Effective communication in Pharmacovigilance -Communication in Drug Safety Crisis management &#8211; Communicating with Regulatory Agencies, Business Partners, Healthcare facilities and Media.\n<\/p>\n<p><h4>Unit IV<\/h4>\n<p>For complete syllabus and results, class timetable and more pls <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a>. Its a light weight, easy to use, no images, no pdfs platform to make students life easier.<\/p>\n<p><h4>Unit V<\/h4>\n<p><strong>Pharmacogenomics of Adverse Drug Reactions<\/strong><br \/>\nDrug safety evaluation in special population &#8211; Pediatrics &#8211; Pregnancy and lactation &#8211; Geriatrics. CIOMS &#8211; CIOMS Working Groups &#8211; CIOMS Form. CDSCO (India) and Pharmacovigilance &#8211; D&amp;C Act and Schedule Y &#8211; Differences in Indian and global pharmacovigilance requirements\n<\/p>\n<p><h4>Course Outcome:<\/h4>\n<p>At the completion of course, the student will be able<\/p>\n<ul>\n<li>To report adverse drug reaction in proper format.<\/li>\n<li>To analyze and compare the data generated during pharmacovigilance study<\/li>\n<li>To manage and adhere with regulatory requirements of different country.<\/li>\n<\/ul>\n<p><h4>Text Books:<\/h4>\n<ol>\n<li>SumitVerma, S and Gulati, Y. Fundamentals of Pharmacovigilance, Paras Medical Publishers, 2017<\/li>\n<li>Gupta, S. K. Text book of Pharmacovigilance, Jaypee Brothers Medical Publishers, 2011.<\/li>\n<li>Mohanta, G.P and Manna, P.K. A Textbook of Pharmacovigilance: Concept and Practice, PharmaMed Press, 2015.<\/li>\n<\/ol>\n<p><h4>References:<\/h4>\n<ol>\n<li>Andrews, E.B and Moore, N. Manns Pharmacovigilance, Wiley-Blackwel, 3rd Edition, 2014.<\/li>\n<li>Waller, P and Harrison iWoolrych, M. An Introduction to Pharmacovigilance, Wiley-Blackwel, 2nd Edition, 2017<\/li>\n<li>Orleans-Lindsay, J. Pharmacovigilance Medical Writing: A Good Practice Guide, Wiley-Blackwell, 2012.<\/li>\n<\/li>\n<\/ol>\n<p>For detail syllabus of all other subjects of B.Tech Pharma, 2017 regulation do visit <a href=\"..\/category\/pharma+7th-sem\">Pharma 7th Sem syllabus for 2017 Regulation<\/a>.<\/p>\n<p>Dont forget to <a href=\"https:\/\/play.google.com\/store\/apps\/details?id=ini.istudy\" target=\"_blank\" rel=\"noopener\">download iStudy<\/a> for latest syllabus and results, class timetable and more.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Pharmacovigilance Pharma 7th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective V) detail syllabus for Pharmacy (Pharma), 2017 regulation is collected from the Anna Univ official website and [&hellip;]<\/p>\n","protected":false},"author":2297,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_bbp_topic_count":0,"_bbp_reply_count":0,"_bbp_total_topic_count":0,"_bbp_total_reply_count":0,"_bbp_voice_count":0,"_bbp_anonymous_reply_count":0,"_bbp_topic_count_hidden":0,"_bbp_reply_count_hidden":0,"_bbp_forum_subforum_count":0,"footnotes":""},"categories":[50,90],"tags":[],"class_list":["post-21138","post","type-post","status-publish","format-standard","hentry","category-7th-sem","category-pharma"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/21138","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/users\/2297"}],"replies":[{"embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/comments?post=21138"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/21138\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=21138"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=21138"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=21138"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}