{"id":110,"date":"2024-12-12T09:02:27","date_gmt":"2024-12-12T09:02:27","guid":{"rendered":"http:\/\/localhost\/acedhars\/?page_id=110"},"modified":"2025-04-02T09:49:22","modified_gmt":"2025-04-02T09:49:22","slug":"m-sc-in-pharmacovigilance","status":"publish","type":"page","link":"https:\/\/acedhars.unilag.edu.ng\/?page_id=110","title":{"rendered":"M.SC IN PHARMACOVIGILANCE"},"content":{"rendered":"\t\t<div data-elementor-type=\"wp-page\" data-elementor-id=\"110\" class=\"elementor elementor-110\" data-elementor-post-type=\"page\">\n\t\t\t\t<div class=\"elementor-element elementor-element-8a5f030 e-con-full e-flex e-con e-parent\" data-id=\"8a5f030\" data-element_type=\"container\" data-settings=\"{&quot;background_background&quot;:&quot;classic&quot;}\">\n\t\t<div class=\"elementor-element elementor-element-da939cf e-con-full e-flex e-con e-child\" data-id=\"da939cf\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-cd15bd3 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data-element_type=\"container\">\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-c91aedb e-con-full e-flex e-con e-child\" data-id=\"c91aedb\" data-element_type=\"container\">\n\t\t\t\t<div class=\"elementor-element elementor-element-5fd075d elementor-widget elementor-widget-text-editor\" data-id=\"5fd075d\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<h5>M.Sc. in Pharmacovigilance<\/h5><table border=\"1\" width=\"50%\" align=\"center\"><tbody><tr><td><h2>FOR<\/h2>Admission Requirements<br \/>Graduation Requirements<br \/>List of Courses and No. of Units by Levels in tabular form<br \/>Summary of number of units compulsory and elective coursesl<br \/>Course Contents\/Description<br \/><h4>DOWNLAOD THE DOCUMENT BELOW<\/h4><\/td><\/tr><\/tbody><\/table><h5><br \/><br \/><\/h5>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-853a893 e-con-full e-flex e-con e-child\" data-id=\"853a893\" data-element_type=\"container\">\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t<div class=\"elementor-element elementor-element-0e04dff e-flex e-con-boxed e-con e-parent\" data-id=\"0e04dff\" data-element_type=\"container\">\n\t\t\t\t\t<div class=\"e-con-inner\">\n\t\t\t\t<div class=\"elementor-element elementor-element-ac195f6 elementor-widget elementor-widget-text-editor\" data-id=\"ac195f6\" data-element_type=\"widget\" data-widget_type=\"text-editor.default\">\n\t\t\t\t<div class=\"elementor-widget-container\">\n\t\t\t\t\t\t\t\t\t<p><em>About<\/em><em>\u00a0<\/em><em>the<\/em><em>\u00a0<\/em><em>Programme<\/em><\/p><p>Pharmacovigilance is an emerging area of medical sciences with focus on assessing adverse drug reactions and improving drug therapy. This pharmacovigilance programme is designed to give students theoretical and practical knowledge in the field of pharmacovigilance. To train individuals that will be relevant to the pharmaceutical industry and health sector in the areas of improving drug and\u00a0herbal\u00a0therapy\u00a0and\u00a0minimizing\u00a0adverse\u00a0drug\u00a0reactions.\u00a0We\u00a0intend\u00a0to\u00a0collaborate\u00a0with\u00a0experts\u00a0from the industries to drive this program.<\/p><p>The aim is to train and produce world class professionals, equipped with requisite measures of knowledge and skills in pharmacovigilance that can solve adverse drug reactions related problems. The programme will<\/p><ul><li>produce skilled and competent Pharmacovigilance professionals who can work effectively at different levels in Pharmacovigilance departments of Pharmaceutical manufacturing and marketing companies, Drug Regulatory Agencies and Health facilities.<\/li><li>provide training opportunities, and conducting state-of-the-art pharmacovigilance research in orderto\u00a0prepare\u00a0the\u00a0students\u00a0for\u00a0careers\u00a0in\u00a0independent\u00a0research\u00a0or\u00a0related\u00a0careers\u00a0in\u00a0academia, industry or government<\/li><li>optimisethe science of pharmacovigilance\u00a0through collaboration with drug regulatory agency and health sectors.<\/li><\/ul><p>The\u00a0graduates\u00a0of\u00a0this\u00a0programme\u00a0will<\/p><ul><li>Have ability to undertake pharmacovigilance related research<\/li><li>Able to collaborate with relevant agencies to promote pharmacovigilance<\/li><li>Havecompetence\u00a0in\u00a0optimizing\u00a0pharmacovigilance\u00a0activities<\/li><li>Searchcompile,\u00a0analyze\u00a0and\u00a0evaluate\u00a0reports\u00a0about\u00a0adverse\u00a0drug\u00a0reactions\u00a0in\u00a0scientific literature and databases.<\/li><li>Understandvarious methods\u00a0utilized\u00a0in\u00a0<\/li><li>Assess and analyze warnings, risk management and risk communication about adverse drug<\/li><li>Assessand\u00a0analyze\u00a0the\u00a0effects\u00a0and\u00a0safety\u00a0of\u00a0<\/li><li>Tounderstand\u00a0pharmacovigilance\u00a0from\u00a0a regulatory\u00a0<\/li><li>Explainthe\u00a0importance\u00a0of\u00a0pharmacogenomics for\u00a0individual\u00a0variation in\u00a0adverse\u00a0drug\u00a0<\/li><\/ul><h4><strong><em><b><i>Admission<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>Requirements<\/i><\/b><\/em><\/strong><\/h4><p><strong><em>\u00a0<\/em><\/strong>A candidate for the M.Sc. Pharmacovigilance programme must possess credit passes in English, Mathematics,\u00a0Physics,\u00a0Chemistry\u00a0and\u00a0Biology\u00a0in\u00a0\u2018O\u2019\u00a0level\u00a0or\u00a0its\u00a0equivalent\u00a0at\u00a0one\u00a0sitting\u00a0and\u00a0a\u00a0minimum of second-class lower bachelor degree or its equivalent in Pharmacy, Medicine, Dentistry, Nursing or Pharmacology from any approved University.<\/p><p><strong><em><b><i>Graduation<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>Requirements<\/i><\/b><\/em><\/strong><\/p><p>To obtain an M.Sc. in Pharmacovigilance, a candidate must satisfy a minimum of <strong>24 units <\/strong>of courses in\u00a0minimum\u00a0of\u00a0two\u00a0(2)\u00a0semesters\u00a0and\u00a0with\u00a0cumulative\u00a0grade\u00a0point\u00a0average\u00a0(CGPA)\u00a0of\u00a02.40\u00a0at\u00a0800\u00a0level made up as follows:<\/p><ol><li>14units\u00a0of\u00a0compulsory\u00a0theory\u00a0courses<\/li><li>2units\u00a0of\u00a0Research\u00a0seminar<\/li><\/ol><ul><li>4units\u00a0of\u00a0Research\u00a0project<\/li><\/ul><ol><li>4units\u00a0of\u00a0elective\u00a0theory\u00a0courses<\/li><\/ol><p>The duration of the programme shall be minimum of two (2) semesters and maximum of four (4) semesters.<\/p><p><strong><em><b><i>List of<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>Courses<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>and<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>No<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>of<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>Units<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>by<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>Levels<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>in<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>tabular<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0form<\/i><\/b><\/em><\/strong><\/p><p><strong><em>\u00a0<\/em><\/strong><strong>800<\/strong><strong>\u00a0LEVEL<\/strong> <strong>FIRST<\/strong><strong>\u00a0<\/strong><strong>SEMESTER<\/strong><\/p><table><tbody><tr><td width=\"75\"><p><strong>COURSE <\/strong><strong>CODE<\/strong><\/p><\/td><td width=\"202\"><p><strong>COURSE<\/strong><strong>\u00a0<\/strong><strong>TITLE<\/strong><\/p><\/td><td width=\"84\"><p><strong>STATUS<\/strong><\/p><\/td><td width=\"50\"><p><strong>UNIT <\/strong><strong>S<\/strong><\/p><\/td><\/tr><tr><td width=\"75\"><p>PVG\u00a0811<\/p><\/td><td width=\"202\"><p>Overview\u00a0of\u00a0Pharmacovigilance<\/p><\/td><td width=\"84\"><p>Compulsory<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PVG\u00a0812<\/p><\/td><td width=\"202\"><p>Spontaneous\u00a0Reporting\u00a0Systems<\/p><p>(SRS)\u00a0and\u00a0Case\u00a0assessments<\/p><\/td><td width=\"84\"><p>Compulsory<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PUH\u00a0801<\/p><\/td><td width=\"202\"><p>Medical\u00a0Statistics<\/p><\/td><td width=\"84\"><p>Compulsory<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PCH\u00a0801<\/p><\/td><td width=\"202\"><p>Drug\u00a0Quality\u00a0Assurance\u00a0and<\/p><p>Total\u00a0Quality\u00a0Management<\/p><\/td><td width=\"84\"><p>Compulsory<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PCL\u00a0807<\/p><\/td><td width=\"202\"><p>Advanced Pharmacy Practice, Research Methodology &amp;<\/p><p>Medicine\u00a0Regulations<\/p><\/td><td width=\"84\"><p>Compulsory<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PCL\u00a0811<\/p><\/td><td width=\"202\"><p>Adverse Drug Reactions &amp;<\/p><p>Pharmacovigilance<\/p><\/td><td width=\"84\"><p>Compulsory<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PVG\u00a0813<\/p><\/td><td width=\"202\"><p>Pharmacovigilance<\/p><p>communication<\/p><\/td><td width=\"84\"><p>Elective<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\"><p>PCH\u00a0808<\/p><\/td><td width=\"202\"><p>Biotransformation reactions, Pharmacogenomic\/Pharmacogen<\/p><p>etics\u00a0&amp;\u00a0Personalized\u00a0medicines<\/p><\/td><td width=\"84\"><p>Elective<\/p><\/td><td width=\"50\"><p>2<\/p><\/td><\/tr><tr><td width=\"75\">\u00a0<\/td><td width=\"202\"><p><strong>Total<\/strong><strong>\u00a0Units<\/strong><\/p><\/td><td width=\"84\"><p><strong>Compulsor <\/strong><strong>y<\/strong><\/p><p><strong>Elective<\/strong><\/p><\/td><td width=\"50\"><p><strong>12<\/strong><\/p><p><strong>4<\/strong><\/p><\/td><\/tr><\/tbody><\/table><p><strong>\u00a0<\/strong><strong><b>800 <\/b><\/strong><strong><b>LEVEL<\/b><\/strong> <strong><b>SECOND<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>SEMESTER<\/b><\/strong><\/p><table><tbody><tr><td width=\"81\"><p><strong>COURSE<\/strong><\/p><p><strong>CODE<\/strong><\/p><\/td><td width=\"324\"><p><strong>COURSE<\/strong><strong>\u00a0<\/strong><strong>TITLE<\/strong><\/p><\/td><td width=\"98\"><p><strong>STATUS<\/strong><\/p><\/td><td width=\"70\"><p><strong>UNITS<\/strong><\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0821<\/p><\/td><td width=\"324\"><p>Pharmacovigilance\u00a0regulations<\/p><\/td><td width=\"98\"><p>Compulsory<\/p><\/td><td width=\"70\"><p>2<\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0828<\/p><\/td><td width=\"324\"><p>Research Seminar on Recent Advances in<\/p><p>Pharmacovigilance\u00a0and\u00a0Pharmacoepidemiology<\/p><\/td><td width=\"98\"><p>Compulsory<\/p><\/td><td width=\"70\"><p>2<\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0829<\/p><\/td><td width=\"324\"><p>Research\u00a0Project<\/p><\/td><td width=\"98\"><p>Compulsory<\/p><\/td><td width=\"70\"><p>4<\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0822<\/p><\/td><td width=\"324\"><p>Pharmacovigilance\u00a0and\u00a0Risk\u00a0Management\u00a0Systems<\/p><\/td><td width=\"98\"><p>Elective<\/p><\/td><td width=\"70\"><p>1<\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0823<\/p><\/td><td width=\"324\"><p>Signal\u00a0Detection\u00a0and\u00a0Management<\/p><\/td><td width=\"98\"><p>Elective<\/p><\/td><td width=\"70\"><p>2<\/p><\/td><\/tr><\/tbody><\/table><table><tbody><tr><td width=\"81\"><p>PVG\u00a0824<\/p><\/td><td width=\"324\"><p>Medication\u00a0error\u00a0(ME):\u00a0definition,\u00a0impact,\u00a0detection<\/p><\/td><td width=\"98\"><p>Elective<\/p><\/td><td width=\"70\"><p>1<\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0825<\/p><\/td><td width=\"324\"><p>Post-Authorization Observational Studies and Clinical Trials in PV<\/p><\/td><td width=\"98\"><p>Elective<\/p><\/td><td width=\"70\"><p>2<\/p><\/td><\/tr><tr><td width=\"81\"><p>PVG\u00a0826<\/p><\/td><td width=\"324\"><p>Pharmacovigilance\u00a0of\u00a0Herbal\u00a0Medicines<\/p><\/td><td width=\"98\"><p>Elective<\/p><\/td><td width=\"70\"><p>2<\/p><\/td><\/tr><tr><td width=\"81\"><p>RSC\u00a0821<\/p><\/td><td width=\"324\"><p>Regulation\u00a0of\u00a0Pharmaceutical,\u00a0Biologic\u00a0Products\u00a0and Medical devices<\/p><\/td><td width=\"98\"><p>Elective<\/p><\/td><td width=\"70\"><p>2<\/p><\/td><\/tr><tr><td width=\"81\">\u00a0<\/td><td width=\"324\"><p><strong>Total<\/strong><strong>\u00a0<\/strong><strong>Units<\/strong><\/p><\/td><td width=\"98\"><p><strong>Compulsory Elective<\/strong><\/p><\/td><td width=\"70\"><p><strong>8<\/strong><\/p><p><strong>10<\/strong><\/p><\/td><\/tr><\/tbody><\/table><p><strong>\u00a0<\/strong><em>Summary<\/em><em>\u00a0<\/em><em>of<\/em><em>\u00a0<\/em><em>number<\/em><em>\u00a0<\/em><em>of<\/em><em>\u00a0<\/em><em>units<\/em><em>\u00a0<\/em><em>compulsory<\/em><em>\u00a0<\/em><em>and<\/em><em>\u00a0<\/em><em>elective<\/em><em>\u00a0<\/em><em>courses<\/em><em>\u00a0<\/em><em>to<\/em><em>\u00a0<\/em><em>be<\/em><em>\u00a0<\/em><em>taken\/available<\/em><em>\u00a0<\/em><em>at<\/em><em>\u00a0<\/em><em>each<\/em><em>\u00a0<\/em><em>Level<\/em><\/p><p><em>\u00a0<\/em><\/p><table><tbody><tr><td width=\"48\">\u00a0<\/td><td colspan=\"2\" width=\"150\"><p><strong>First<\/strong><strong>\u00a0<\/strong><strong>semester<\/strong><\/p><\/td><td colspan=\"2\" width=\"150\"><p><strong>Second<\/strong><strong>\u00a0<\/strong><strong>semester<\/strong><\/p><\/td><td colspan=\"2\" width=\"146\"><p><strong>Total<\/strong><\/p><\/td><\/tr><tr><td width=\"48\"><p><strong>Level<\/strong><\/p><\/td><td width=\"82\"><p>Units of\u00a0Compulsory Courses<\/p><\/td><td width=\"68\"><p>Units of\u00a0Elective<\/p><p>Courses Available<\/p><\/td><td width=\"82\"><p>Units of\u00a0Compulsory Courses<\/p><\/td><td width=\"68\"><p>Units of\u00a0Elective<\/p><p>Courses Available<\/p><\/td><td width=\"80\"><p>Total of\u00a0Compulsory Courses<\/p><\/td><td width=\"66\"><p>Total of\u00a0Elective<\/p><p>Courses Available<\/p><\/td><\/tr><tr><td width=\"48\"><p><strong>800<\/strong><\/p><\/td><td width=\"82\"><p><strong>12<\/strong><\/p><\/td><td width=\"68\"><p><strong>4<\/strong><\/p><\/td><td width=\"82\"><p><strong>8<\/strong><\/p><\/td><td width=\"68\"><p><strong>10<\/strong><\/p><\/td><td width=\"80\"><p><strong>20<\/strong><\/p><\/td><td width=\"66\"><p><strong>14<\/strong><\/p><\/td><\/tr><\/tbody><\/table><p><em>\u00a0<\/em><\/p><p><strong><em><b><i>Course<\/i><\/b><\/em><\/strong><strong><em><b><i>\u00a0<\/i><\/b><\/em><\/strong><strong><em><b><i>Contents\/Description<\/i><\/b><\/em><\/strong><\/p><p><strong><em>\u00a0<\/em><\/strong><strong>PVG<\/strong><strong>\u00a0<\/strong><strong>811:<\/strong><strong>\u00a0<\/strong><strong>Overview<\/strong><strong>\u00a0<\/strong><strong>of<\/strong><strong>\u00a0<\/strong><strong>Pharmacovigilance<\/strong><strong>\u00a0(PV)<\/strong><\/p><p>Definitions\u00a0of adverse\u00a0event\u00a0(AE)\u00a0and\u00a0adverse\u00a0drug\u00a0reaction\u00a0(ADR).\u00a0The\u00a0scope\u00a0of\u00a0PV.\u00a0Persons\u00a0and\u00a0parties\u00a0involved\u00a0in\u00a0PV:\u00a0their concerns,\u00a0competences\u00a0and\u00a0interactions.\u00a0The\u00a0increasing complexity and\u00a0challenges\u00a0of\u00a0PV History\u00a0of\u00a0PV.\u00a0Important\u00a0ADRs\u00a0and methodological and organisational developments. The origin of modern PV: thalidomide and the emergence of ADR reporting and drug legislation. Major disasters and their impact on PV: OCs\u2013VTE, HRT\u2013breast cancer, Cerivastatin\u2013 rhabdomyolysis, Coxibs\u2013cardiovascular death, etc. The shaping of institutions, international cooperation and information exchange.\u00a0Focus\u00a0on\u00a0methods:\u00a0spontaneous\u00a0reporting.\u00a0Pharmacoepidemiology.\u00a0Data\u00a0bases\u00a0and\u00a0linkage.\u00a0Data\u00a0mining.\u00a0Genetic testing.<\/p><p><strong>PVG<\/strong><strong>\u00a0<\/strong><strong>812<\/strong>: <strong>Spontaneous<\/strong><strong>\u00a0<\/strong><strong>Reporting<\/strong><strong>\u00a0<\/strong><strong>Systems<\/strong><strong>\u00a0<\/strong><strong>(SRS)<\/strong><strong>\u00a0<\/strong><strong>and<\/strong><strong>\u00a0<\/strong><strong>Case<\/strong><strong>\u00a0<\/strong><strong>Assessment<\/strong><\/p><p>Definition, settings. Potential and limitations of SRS Definition. Potential and achievements of SRs. SRS settings and resources. Sources of spontaneous reports (SRs): Healthcare professionals (HCPs). Patients. Companies. Media. Detecting, documenting\u00a0and\u00a0reporting\u00a0of\u00a0AEs\/ADRs: Methods. Forms.\u00a0Routes.\u00a0Software.\u00a0Places\u00a0and\u00a0institutions\u00a0collecting\u00a0spontaneous reports. Informational limitations of SRs: Incomplete. No denominator. Biases. Proposed caveats. Stimulated, mandatory, solicited and targeted reporting. Computerised ICSR databases: Requirements and structure. Administration<\/p><p>Completeness. Accuracy and precision of the report. Certainty of the diagnosis. Seriousness and severity of the AE\/ADR. Causality of the AE: Purpose. Criteria and problems of the assessment. Causality of the AE: Common general and specific assessment methods. Outcome ratings, shortcomings. Reports related to vaccines. Herbals and specific situations. Reports about adverse events following immunisation (AEFI): Specific features. Causality assessment with AEFI. Reports about AEs\/ADRs with herbal medicines. Reports about AEs\/ADRs related to pregnancy and lactation.\u00a0Reports about drug-drug interactions, drug abuse and poisoning.<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>813<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacovigilance<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Communication<\/b><\/strong><\/p><p>Context and guidance.\u00a0Public health goals. Scene and climate.\u00a0Theories and guidance. Legal framework.\u00a0Experience on communication effectiveness. Crisis management, Communication with patients and healthcare professionals. Tools, channels and processes. Individual communication. Mass communication.\u00a0Involvement of the public.\u00a0Tools and channels Impact.\u00a0Feedback\u00a0and\u00a0evaluation.\u00a0\u00a0Communication\u00a0\u00a0with\u00a0patients\u00a0and\u00a0healthcare\u00a0professionals:\u00a0Contents\u00a0and presentation. Specific\u00a0medications\u00a0and\u00a0hazards.\u00a0Interaction\u00a0among\u00a0stakeholders.\u00a0Media Communication\u00a0for involvement of the public in PV processes. Interactions between stakeholders throughout the communication process. Interaction between stakeholders in relation to risk\u00a0management plans. Specifics for interaction with scientific and general media.<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>821:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacovigilance<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Regulations<\/b><\/strong><\/p><p>Facilities\u00a0at\u00a0pharmaceutical\u00a0companies.\u00a0Marketing\u00a0authorisation\u00a0holders.\u00a0Wholesalers\u00a0and\u00a0distributors.\u00a0Good\u00a0PV\u00a0Regulations. Pharmacovigilance\u00a0system\u00a0and\u00a0SOPs.\u00a0Crisis\u00a0management\u00a0plan;\u00a0QPPV.\u00a0Staff\u00a0resources\u00a0(scientific\u00a0and\u00a0administrative).\u00a0Financial resources. Technical equipment Databases (ADR reports). Performance tools. Statistical tools and methods for analyses. Product-related archives. Correspondence archives. Library and access to electronic literature databases. Study reports. Periodic Safety Update Reports (PSURs). Periodic Benefit Risk Evaluation Reports (PBRERs). Other documents: DSUR; RMP, REMS; Renewal dossiers; Reports on request.<\/p><p><strong>PVG<\/strong><strong>\u00a0<\/strong><strong>822:<\/strong><strong>\u00a0<\/strong><strong>Pharmacovigilance<\/strong><strong>\u00a0<\/strong><strong>and<\/strong><strong>\u00a0<\/strong><strong>Risk<\/strong><strong>\u00a0<\/strong><strong>Management<\/strong><strong>\u00a0<\/strong><strong>Systems<\/strong><\/p><p>Risk\u00a0Management\u00a0Plans\u00a0(RMPs).\u00a0Inspections.\u00a0Pharmacovigilance\u00a0systems:\u00a0Definition.\u00a0Stakeholders.\u00a0Operation.\u00a0Definition\u00a0and elements Contents of the \u2018Pharmacovigilance System\u2019 document. Master\u00a0file concept Pharmacovigilance systems of pharmaceutical companies. Marketing authorisation holders (MAHs) and distributors. Pharmacovigilance systems of regulatory\u00a0authorities<\/p><p>Standard operating procedures (SOPs). Maintenance of the pharmacovigilance systems. Product-related risk management systems. Rationale for establishing risk management systems and objectives.\u00a0Establishing a risk management system: Starting point and responsibilities.<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>823:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Signal<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Detection<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>and<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Management<\/b><\/strong><\/p><p>Definition\u00a0of\u00a0a\u00a0signal;\u00a0Sources.\u00a0Potentials.\u00a0Detection\u00a0by\u00a0non-statistical\u00a0medical\u00a0means.\u00a0What\u00a0is a \u2018signal\u2019?\u2013definitions by WHO, CIOMS, others. What a signal may indicate: New ADR. Higher severity or frequency. Risk factors. Wrong medication. Product faults. Sources of information which may\u00a0constitute\u00a0a signal:\u00a0ADR databases. Case-control\u00a0surveillance. Other sources. Basic requirements for signal detection and management. Stakeholders in the signal detection and management process. Detection\u00a0of\u00a0signals\u00a0for\u00a0new\u00a0ADRs\u00a0from\u00a0ADR\u00a0case-series\u00a0by\u00a0non-statistical\u00a0medical means:\u00a0Disproportionality statistics for signal detection in spontaneous ISCR databases. Principles of statistical data mining in ICSR databases. Calculating proportional reporting ratios (PRRs) and reporting odds ratios (RORs).<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>824<\/b><\/strong>:\u00a0<strong><b>Medication<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Error<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>(ME):<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Definition,<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Impact,<\/b><\/strong><strong><b>\u00a0Detection<\/b><\/strong><\/p><p>Definition and typology of MEs. Demarcation from off-label use. ME statistics and impact on public health Victims. Medical situations and medications typical for MEs. Detection of MEs: National spontaneous reporting schemes for professionals. Detection of MEs: Methods in specific healthcare settings for professionals. Detection of MEs: Patient reporting. ME reports: Description and assessment.\u00a0Description of clinical patient aspects. Description of procedural and patient adherence aspects.\u00a0Assessment of the proximal\/immediate cause. Contributing system factors. Root cause analysis (RCA). Assessment of avoidability\/preventability.<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>825:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Post-authorisation<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Observational<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Studies<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>and<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Clinical<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Trials<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>in<\/b><\/strong><strong><b>\u00a0PV<\/b><\/strong><\/p><p>Definition and objectives of post-authorisation studies. General requirements. Specific studies. Non- interventional\u00a0studies.\u00a0Pharmacoepidemiology.\u00a0Post-authorisation\u00a0studies\u00a0for confirmation\u00a0of\u00a0signals and providing data on ADR frequency and causality.\u00a0Observational studies: General formal and scientific requirements. Opportunities. Limitations. Population-oriented post-authorisation studies: Disease\u00a0studies.\u00a0Drug\u00a0utilisation\u00a0studies.\u00a0Post-authorisation\u00a0randomised\u00a0clinical\u00a0trials\u00a0in particular\u00a0\u2018large simple trials\u2019\u00a0(LSTs).\u00a0Important observational studies and their strengths and weaknesses.\u00a0Cohort\u00a0studies\u00a0in\u00a0general:\u00a0Design,\u00a0conduct,\u00a0statistical\u00a0analysis\u00a0and\u00a0presentation\u00a0of\u00a0results. Cohort-event\u00a0monitoring\u00a0(CEM)\u00a0including\u00a0PEM\u00a0as\u00a0specific\u00a0applications.\u00a0Case-control\u00a0studies. Definition of bias and confounding and principles of dealing with them.<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>826:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacovigilance<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>of<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Herbal<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Medicines<\/b><\/strong><\/p><p>Prevalence and types of herbal medicines use, Integration of herbal medicines into national health care scheme,\u00a0adverse reactions and herbal medicine toxicities,\u00a0interactions of herbal medicines with orthodox medicines, disposition of herbal medicines practitioners to reporting adverse reactions to herbal medicines.<\/p><p><strong>PVG<\/strong><strong>\u00a0<\/strong><strong>828:<\/strong><strong>\u00a0<\/strong><strong>Research<\/strong><strong>\u00a0<\/strong><strong>Seminar<\/strong><strong>\u00a0<\/strong><strong>on<\/strong><strong>\u00a0<\/strong><strong>Recent<\/strong><strong>\u00a0<\/strong><strong>Advances<\/strong><strong>\u00a0<\/strong><strong>in<\/strong><strong>\u00a0<\/strong><strong>Pharmacovigilance<\/strong><strong>\u00a0<\/strong><strong>and<\/strong><strong>\u00a0<\/strong><strong>Pharmaco-epidemiology <\/strong>Students will be required to\u00a0make seminar presentation on Pharmaco-epidemiology. The objective\u00a0is to train graduate students how to search for write up and totally present scientific information.<\/p><p><strong><b>PVG<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>829:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Research<\/b><\/strong><\/p><p>Application of Research Techniques and Development\u00a0of Research Methodologies to solve problems in any aspect of Pharmacovigilance.<\/p><p><strong><b>PUH<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>801:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Medical<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Statistics<\/b><\/strong><\/p><p>This\u00a0course\u00a0is\u00a0to equip\u00a0students\u00a0with\u00a0statistical\u00a0analysis\u00a0of\u00a0experimental\u00a0data.\u00a0Design,\u00a0conduct\u00a0and interpretation of clinical and epidemiological studies. Standard statistical concepts of data description. Hypothesis testing including test statistics, correlation, p-values, significance levels, confidence levels and linear regression.<\/p><p><strong><b>PCH<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>801:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Drug<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Quality<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Assurance<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>&amp;<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Total<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Quality<\/b><\/strong><strong><b>\u00a0Management<\/b><\/strong><\/p><p>The importance of Quality Control of Pharmaceuticals, Veterinary medicines and Agrochemicals. Personnel. Facilities and Documentation. Standard Operating Procedures (SOPs). Pharmacopoeia Monographs (USP, BP, BPC, EuP etc.). Relevant equipment and manuals needed to establish a standard\u00a0Drug\u00a0Quality\u00a0Control\u00a0Laboratory.\u00a0Regulatory\u00a0Aspects\u00a0of\u00a0Drug\u00a0and\u00a0Chemicals:\u00a0Quality\u00a0Control. Functions of Regulatory bodies such as WHO, NAFDAC PCN, PGMAN, FMOH, IPAN etc. Total Quality Management (TQM). Quantitative Aspects of Pharmaceutical Analysis: Acid- Base titrimetry. Redox titrimetry. Gravimetry. Separation Techniques: Extraction Methods and Chromatography (TLC, CC, HPLC, GC, GC\/MS, Super Critical Fluid Chromatograph). Electrochemistry Capillary Electrophoresis. UV\/Visible Spectroscopy. Fluorescence\/Phosphorescence. Atomic Absorption Spectroscopy (AAS), Validation of Analytical procedures.<\/p><p><strong><b>PCL<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>807:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Advanced<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacy<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Practice<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Research<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Methods<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>&amp;<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Medicine<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Regulation<\/b><\/strong><\/p><p>Research\u00a0Design:\u00a0Preliminary\u00a0considerations.\u00a0Selection\u00a0of\u00a0a\u00a0design.\u00a0Review\u00a0of\u00a0literature.\u00a0Use\u00a0of\u00a0theory and writing strategies. Ethical considerations. Designing Research. Introduction and purpose statement. Research questions and hypothesis. Quantitative and Qualitative Methods. Sampling Methods and Types of Sampling. Statistical evaluation: Parametric and non-parametric. Correlation. Regression. Null Hypothesis. Research methods. Protocols and procedures. Clinica1 Trials. Bioavailability and Pharmacokinetic Studies. Quality Evaluation. Regulatory bodies and the requirements. Product registration and licensing.<\/p><p><strong><b>PCL<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>811:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Adverse<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Drug<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Reactions<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>&amp;<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacovigilance<\/b><\/strong><\/p><p>Adverse Drug Reactions (ADRs) and Adverse drug events (ADEs): Occurrence and recognition in the Community. Role of prescriber. The pharmacist and patient in recognizing and documenting ADRs.<\/p><p>Pharmacovigilance. Risk Management Plan. Regulatory authorities and the Pharmaceutical Industry. Health care performed. Design of ADR and Pharmacovigilance cards\/funds for use in hospital. Community\u00a0Pharmacy\u00a0and\u00a0by the\u00a0Community\u00a0or the\u00a0populace. Their\u00a0roles\u00a0and\u00a0responsibilities\u00a0in\u00a0ADR reporting and pharmacovigilance clients.<\/p><p><strong><b>PCH<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>808:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Biotransformation<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Reactions,<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacogenomic<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>\/<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmacogenetics<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>&amp;<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Personalized <\/b><\/strong><strong><b>Medicines<\/b><\/strong><\/p><p>Drug metabolism studies: Hepatic microsomal biotransformation. Enzyme systems and metabolic pathways\u00a0involving\u00a0reactions\u00a0such\u00a0as\u00a0oxidation,\u00a0reduction,\u00a0hydrolysis\u00a0and\u00a0conjugation\u00a0reaction\u00a0(Phase 1, Phase 2 and Phase 3 bioreactions). Non-microsomal metabolic transformations involving some of the above-mentioned phases. Mechanism of biotransformation of specific groups in drugs and biological effects of\u00a0such\u00a0drugs. Literature review and current concepts\u00a0in Drug Biotransformation.<\/p><p>Methods in metabolic studies: In vitro and in vivo studies- Preparation of tissue homogenates. Preparation and purification of pure enzymes, such as the \u201cOxidases\u201d (e.g. oxidise). Methods in isolation,\u00a0identification,\u00a0and\u00a0Characterization\u00a0and\u00a0metabolites.\u00a0Biochemical\u00a0methods\u00a0of\u00a0identifying\u00a0the enzyme systems catalyzing biotransformation reactions. The use of specific\u00a0inhibitors and indicators. Principles\u00a0of\u00a0Pharmacogenomics\u00a0and\u00a0personalized\u00a0medicines\u00a0(Drug\u00a0Development\u00a0e.g.\u00a0Vaccines\u00a0against HIV and Malaria).<\/p><p><strong><b>RSC<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>821:<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Regulation<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>of<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Pharmaceutical,<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Biologic<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Products<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>and<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>Medical<\/b><\/strong><strong><b>\u00a0<\/b><\/strong><strong><b>devices<\/b><\/strong><\/p><p>The course will explore the relationships between scientific discovery, testing and regulatory oversight. It will look at the rules governing prescription and over-the-counter drugs, and look at the changes that are introduced by the burgeoning influence of genetic engineering and biological product development. It will consider the practical issues facing regulatory specialists as they work with the NAFDAC and other international regulatory bodies to secure and keep product approval. Legal framework for drug regulation ethical issues in drug\/biologic\/device development and drug\/biologic\/device use; global regulatory guidance approaches; types of communications with NAFDAC, including Investigational New Drug (IND) application, New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) requirements, and clearance and Premarket Approvals \/ Biologics Licensing Applications (PMA\/BLA) approval requirements; chemistry, manufacturing, and control (CMC) issues; and post-marketing topics..<\/p>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t","protected":false},"excerpt":{"rendered":"<p>HOME APPLY NOW M.Sc. in Pharmacovigilance FOR Admission RequirementsGraduation RequirementsList of Courses and No. of Units by Levels in tabular formSummary of number of units compulsory and elective courseslCourse Contents\/Description DOWNLAOD THE DOCUMENT BELOW About\u00a0the\u00a0Programme Pharmacovigilance is an emerging area of medical sciences with focus on assessing adverse drug reactions and improving drug therapy. This [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"elementor_header_footer","meta":{"footnotes":""},"class_list":["post-110","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=\/wp\/v2\/pages\/110","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=110"}],"version-history":[{"count":16,"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=\/wp\/v2\/pages\/110\/revisions"}],"predecessor-version":[{"id":1639,"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=\/wp\/v2\/pages\/110\/revisions\/1639"}],"wp:attachment":[{"href":"https:\/\/acedhars.unilag.edu.ng\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=110"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}