{"id":36,"date":"2017-06-13T10:59:16","date_gmt":"2017-06-13T14:59:16","guid":{"rendered":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/?page_id=36"},"modified":"2017-07-24T14:36:22","modified_gmt":"2017-07-24T18:36:22","slug":"course-materials","status":"publish","type":"page","link":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/course-schedule\/course-materials\/","title":{"rendered":"Course Materials"},"content":{"rendered":"<p>Materials for each session are listed below\u00a0in chronological order\u00a0and can be previewed and downloaded in advance of the meeting date and time.<\/p>\n<h3>Monday July 10<\/h3>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Newton-MQPH-Boston-Talk-One-Two-10-July-2017.pptx\">Medicine Quality-Definitions and Public Health Impact Parts I and II<\/a> \u00a0&#8211; P. Newton<\/p>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/1.-Ravinetto-Supply-chains-10.07.17-Final-Draft.pdf\">Pharmaceutical Supply Chains in Low and Middle-Income Countries <\/a>&#8211; R. Ravinetto<\/p>\n<p><em>Readings:<\/em><\/p>\n<ul>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2008-TMIH-MSF-substandards-Final.pdf\">Substandard medicines in resource-poor settings: a problem that can no longer be ignored<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2017BMJGH-Changes-to-supply-chains-LMICs.pdf\">Do changes to supply chains and procurement processes yield cost savings and improve availability of pharmaceuticals, vaccines or health products? A Systematic Review <\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2.-Ravinetto-GMP-PQ-MQAS-10.07.17-Final-Draft.pdf\">GMP, MQAS for Procurement Agencies and Prequalification <\/a>&#8211; R. Ravinetto<\/p>\n<p><em>Readings:<\/em><\/p>\n<ul>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2010-Newton-Impact-of-poor-quality-med-in-DCs.pdf\">Impact of poor-quality medicines in the &#8216;developing&#8217; world <\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2016-JPPP-Poor-quality-Advocacy-Pedagogy.pdf\">Fighting poor-quality medicines in LMICs: the importance of advocacy and pedagogy <\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2017-WHO_DI-70-years-standards.pdf\">Norms and Standards: 70 years of WHO standards on medicines quality <\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/170614-Quamed-Factsheet-on-quality.pdf\">Access to Quality Medicines in Developing Countries: A Selection of Literature <\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/CCailletVF2.pdf\">Epidemiology and Sampling with Group Exercise <\/a>&#8211; C. Caillet<\/p>\n<h3>Tuesday July 11<\/h3>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/Phanouvong-S-Med-Regulation-at-Shortcourse-medquality-and-public-health-BU-Jul-10-14-2017.pdf\">Medicine Regulations in LMICs: Parts I and II <\/a>&#8211; S. Phanouyoung<\/p>\n<p><em>Useful Links:<\/em><\/p>\n<ul>\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=Y0jzs6rb1o8&amp;feature=youtu.be\">Pharamacide: Mekong documentary film (full)<\/a><\/li>\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=2h96W3w03RY&amp;feature=youtu.be\">Pharmacide: Mekong documentary film (1\/3)<\/a><\/li>\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=H4IovKaOCZI&amp;feature=youtu.be\">Pharmacide: Mekong documentary film (2\/3)<\/a><\/li>\n<li><a href=\"https:\/\/www.youtube.com\/watch?v=F15n098pf8A&amp;feature=youtu.be\">Pharmacide: Mekong documentary film (3\/3)<\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/ChatterjeeS-Boston-Univerity-Course-Slides-July-11-2017-Final-.pptx\">Protecting the U.S. Drug Supply Chain<\/a> &#8211; S. Vaswani Chatterjee<\/p>\n<p><em>Useful Links:<\/em><\/p>\n<ul>\n<li><a href=\"https:\/\/www.fda.gov\/safety\/recalls\/\">Recalls, Withdrawals, Safety Alerts<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/safety\/medwatch\/\">Medwatch<\/a><\/li>\n<li><a href=\"https:\/\/www.accessdata.fda.gov\/scripts\/drugshortages\/default.cfm\">Drug Shortages<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/Drugs\/GuidanceComplianceRegulatoryInformation\/EnforcementActivitiesbyFDA\/WarningLettersandNoticeofViolationLetterstoPharmaceuticalCompanies\/ucm482462.htm#ODSIR\">Office of Drug Security, Integrity, and Response Warning Letters<\/a><\/li>\n<li><a href=\"https:\/\/www.fda.gov\/Drugs\/DrugSafety\/DrugIntegrityandSupplyChainSecurity\/ucm439169.htm\">FDA Letters to Doctors Who May Have Purchased Counterfeit or Unapproved Prescription Drugs<\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/3.-Ravinetto-Ethics-11.7.16-Final-Draft.pdf\">Quality of Medicines: An Ethical Issue?<\/a> &#8211;\u00a0R. Ravinetto<\/p>\n<p><em>Readings:<\/em><\/p>\n<ul>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2015-IJME-Quality-medicines-Ethical-issue.pdf\">The quality of medicines: an ethical issue?<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2016-TMIH-Ethical-challenges-quality-surveys.pdf\">Ethical challenges in designing and conducting medicine quality surveys<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2017-CIOMS-EthicalGuidelines.pdf\">International Ethical Guidelines for Health-related Research Involving Humans<\/a><\/li>\n<\/ul>\n<p>Group Exercise &#8211; R. Ravinetto<\/p>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/VFWHO-Boston-Short-Course-Delegates.pdf\">Substandard and Falsified Medical Products<\/a>&#8211; M. Deats<\/p>\n<h3>Wednesday July 12<\/h3>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/4.-Ravinetto-MQAS-Exercise-12.7.17.pdf\">Group Exercise (MQAS)<\/a> led by R. Ravinetto<\/p>\n<p><em>Readings<\/em>:<\/p>\n<ul>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2014-WHO-MQAS-TRS986-annex3.pdf\">Model quality assurance system for procurement agencies<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2017-BMJGH-Poor-products-Shiny-boxes.pdf\">Quality assurance of medicines supplied to LMICs: poor products in shiny boxes?<\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/PQM-Intro-slides_Jude-Nwokike-1.pptx\">Promoting the Quality of Medicines <\/a>&#8211; J. Nwokike<\/p>\n<p><em>Readings:<\/em><\/p>\n<ul>\n<li><a href=\"http:\/\/apps.who.int\/medicinedocs\/en\/d\/Js21304en\/\">Medicines Quality Database:\u00a0A Free Public Resource <\/a><\/li>\n<li><a href=\"https:\/\/extranet.who.int\/prequal\/sites\/default\/files\/documents\/UNCoLSC_2015.pdf\">Survey of the Quality of Medicines Identified by the United Nations Commission on Life Saving Commodities for Women and Children <\/a><\/li>\n<li>Johnston and David Holt Article: <a href=\"https:\/\/www.ncbi.nlm.nih.gov\/pmc\/articles\/PMC4137817\/\">Substandard drugs:\u00a0a potential crisis for public health <\/a><\/li>\n<li><a href=\"http:\/\/apps.who.int\/medicinedocs\/en\/d\/Js21335en\/\">Comparative Analysis of Pharmacovigilance Systems in Five Asian Countries\u00a0<\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/5.-Ravinetto-Jacobs-MDs-IVDs-12.7.17-Final-Draft.pdf\">Medical Devices<\/a> and <a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/6.-Ravinetto-Vaccines-12.7.17-Final-Draft.pdf\">Vaccines<\/a> &#8211; R. Ravinetto<\/p>\n<p><em>Readings<\/em>:<\/p>\n<ul>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2016-PlosNTD-RDT-for-NTDs-A-case-study.pdf\">Rapid Diagnostic Tests for Neglected Infectious Diseases: A Case Study<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2017-WHO-Model-Reg-Framework-MDs-IVDs.pdf\">WHO Global Model for Regulatory Framework MDs IVDs<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/2017-WHO-PREQUALIFICATION-OF-IVDs.pdf\">WHO Global Model for Regulatory Framework for Medical Devices <\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/Lieberman-Handouts-1-of-2.pdf.docx\">Field Screening of Medicines <\/a>&#8211; M. Lieberman<\/p>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/06\/Lieberman-Handouts-2-of-2.docx\">High Performance Liquid Chromatography (HPLC)<\/a> &#8211; M. Lieberman<\/p>\n<h3>Thursday July 13<\/h3>\n<p>Group Exercise: Epidemiology and Sampling &#8211; C. Caillet<\/p>\n<p><em>Readings:<\/em><\/p>\n<ul>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Newton-Fake-Artesunate-Lancet-2001.pdf\">Fake artesunate in southeast Asia<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Tabernero-FE-Laos-AJTMH-2015.pdf\">The Global Pandemic of Falsified Medicines: Laboratory and Field Innovations and Policy Perspectives<\/a><\/li>\n<li><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Khojah-LQAS-Pharm-\u00e3nd-Pharm-2013.pdf\">The Quality of Medicines in Community Pharmacies in Riyadh, Saudi Arabia: A Lot Quality Assurance Sampling (LQAS)-Based Survey<\/a><\/li>\n<\/ul>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Review-of-Different-Technologies-and-Devices-2.pptx\">Review of the Different Technologies and Devices<\/a> &#8211; S. Zambrzycki\u00a0and C. Caillet<\/p>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Mass-Spectrometry-Poor-Quality-Medicines_Gaul_Draft2.pptx\">Chemical Analysis: Mass Spectrometry and Forensic Techniques <\/a>&#8211; D. Gaul<\/p>\n<p>Internet Pharmacies &amp; Medicine Quality- T. Muntinga<\/p>\n<h3>Friday July 14<\/h3>\n<p>Robust Technology Development for Drug Quality Testing: Lessons from\u00a0the\u00a0lab, boardrooms and field\u00a0&#8211; M. Zaman and D. Desai<\/p>\n<p>Counterfeit Medicines: A North American Perspective &#8211; B. Donnelly<\/p>\n<p><a href=\"\/qualityofmedicalproducts\/files\/2017\/07\/Session-Medicines-for-NCD-Friday-July-14_v3.pdf\">Medicines for NCDs <\/a>&#8211; R. Laing and V. Wirtz<\/p>\n<p>&nbsp;<\/p>\n<h3>Continued Reading<\/h3>\n<p>Bostonia recently published an <a href=\"http:\/\/www.bu.edu\/bostonia\/summer17\/bad-medicine\/\">article<\/a> on the topic of substandard drugs and describes work that Muhammad Zaman, Veronika Wirtz and Paul Newton have done exploring and addressing this topic.<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Materials for each session are listed below\u00a0in chronological order\u00a0and can be previewed and downloaded in advance of the meeting date and time. Monday July 10 Medicine Quality-Definitions and Public Health Impact Parts I and II \u00a0&#8211; P. Newton Pharmaceutical Supply Chains in Low and Middle-Income Countries &#8211; R. Ravinetto Readings: Substandard medicines in resource-poor settings: [&hellip;]<\/p>\n","protected":false},"author":13114,"featured_media":0,"parent":16,"menu_order":1,"comment_status":"closed","ping_status":"closed","template":"","meta":[],"_links":{"self":[{"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/pages\/36"}],"collection":[{"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/users\/13114"}],"replies":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/comments?post=36"}],"version-history":[{"count":44,"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/pages\/36\/revisions"}],"predecessor-version":[{"id":385,"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/pages\/36\/revisions\/385"}],"up":[{"embeddable":true,"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/pages\/16"}],"wp:attachment":[{"href":"https:\/\/sites.bu.edu\/qualityofmedicalproducts\/wp-json\/wp\/v2\/media?parent=36"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}