{"id":21720,"date":"2019-12-10T07:46:01","date_gmt":"2019-12-10T07:46:01","guid":{"rendered":"https:\/\/www.inspirenignite.com\/anna-university\/bioethics-biotech-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-iv\/"},"modified":"2019-12-10T07:46:01","modified_gmt":"2019-12-10T07:46:01","slug":"bioethics-biotech-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-iv","status":"publish","type":"post","link":"https:\/\/www.inspirenignite.com\/anna-university\/bioethics-biotech-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ-professional-elective-iv\/","title":{"rendered":"Bioethics Biotech 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective IV)"},"content":{"rendered":"<p>Bioethics Biotech 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective IV) detail syllabus for Biotechnology (Biotech), 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 (BT8012), 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 biotech 6th sem syllabus for b.tech 2017 regulation anna univ you can visit <a href=\"..\/biotech-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ\">Biotech 6th Sem syllabus for B.Tech 2017 regulation Anna Univ Subjects<\/a>. For all other Professional Elective IV subjects do refer to <a href=\"..\/professional-elective-iv-biotech-6th-sem-syllabus-for-b-tech-2017-regulation-anna-univ\">Professional Elective IV<\/a>. The detail syllabus for bioethics is as follows.<\/p>\n<p><h4>Course Objective:<\/h4>\n<ul>\n<li>The course will provide Fundamental ethical to Advanced clinical trial management including drug development and trial planning; Project management in clinical trials; Consent and data protection; Quality assurance and governance.<\/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>Regulations of Clinical Trials<\/strong><br \/>\nDrug development and trial planning &#8211; pre-study requirements for clinical trials; Regulatory approvals for clinical trials; Consort statement; Trial responsibilities and protocols &#8211; roles and responsibilities of investigators, sponsors and others; Requirements of clinical trials protocols; Legislative requirements for investigational medicinal products.\n<\/p>\n<p><h4>Unit III<\/h4>\n<p><strong>Management and Ethics of Clinical Trials<\/strong><br \/>\nProject management in clinical trials &#8211; principles of project management; Application in clinical trial management; Risk assessment; Research ethics and Bioethics &#8211; Principles of research ethics; Ethicalissues in clinical trials; Use of humans in Scientific Experiments; Ethical committee system including ahistorical overview; the informed consent; Introduction to ethical codes and conduct; Introduction to animal ethics; Animal rights and use of animals in the advancement of medical technology; Introduction to laws and regulation regarding useof animals in research.\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>Quality Control and Guidelines<\/strong><br \/>\nQuality assurance and governance &#8211; quality control in clinical trials; Monitoring and audit; Inspections; Pharmacovigilance; Research governance; Trial closure and pitfalls-trial closure; Reporting and legal requirements; Common pitfalls in clinical trial management.\n<\/p>\n<p><h4>Course Outcome:<\/h4>\n<ul>\n<li>The students will acquire knowledge in all aspect of clinical trials, management and ethical standards required to conduct clinical trials.<\/li>\n<\/ul>\n<p><h4>References:<\/h4>\n<ol>\n<li>Lee, Chi-Jen; etal., Clinical Trials or Drugs and Biopharmaceuticals. CRC \/ Taylor &amp;Francis,2011.<\/li>\n<li>Matoren, Gary M. The Clinical Research Process in the Pharmaceutical Industry.Marcel Dekker,1984.<\/li>\n<\/li>\n<\/ol>\n<p>For detail syllabus of all other subjects of B.Tech Biotech, 2017 regulation do visit <a href=\"..\/category\/biotech+6th-sem\">Biotech 6th 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>Bioethics Biotech 6th Sem Syllabus for B.Tech 2017 Regulation Anna Univ (Professional Elective IV) detail syllabus for Biotechnology (Biotech), 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":[49,81],"tags":[],"class_list":["post-21720","post","type-post","status-publish","format-standard","hentry","category-6th-sem","category-biotech"],"_links":{"self":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/21720","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=21720"}],"version-history":[{"count":0,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/posts\/21720\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/media?parent=21720"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/categories?post=21720"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.inspirenignite.com\/anna-university\/wp-json\/wp\/v2\/tags?post=21720"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}