arete-zoe, llc study guide...course organization . the course consists of video lectures and...
TRANSCRIPT
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STUDY
GUIDE
PHARMACEUTICAL SUPPLY CHAIN
INTEGRITY AND SECURITY
PART II
CHAPTER: GLOBALIZATION
8/9/2016
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http://coursebuilder.vmedu.com/Courses/Index?courseId=2482http://coursebuilder.vmedu.com/Courses/Index?courseId=2482http://coursebuilder.vmedu.com/Courses/Index?courseId=2482
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COURSE
ORGANIZATION
The course consists of video lectures and assigned reading.
Final evaluation contains quiz with questions from the
included materials and tests understanding of the topic.
Assigned reading
Understanding of these materials is essential for successful
completion of the course evaluation.
Suggested reading
These materials are included to add context and depth for
students who are interested to learn more details.
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GLOBALIZATION
Shipping routes
Good manufacturing practices
Geography: Manufacturing
FDA: GDUFA & FDA offices abroad
U.S. Drug Master Files
EU Registered manufacturing sites
Global markets
Geography: Markets
Trends: Consolidation
Trends: Outsourcing
Supply disruptions: Drug shortages - USA
Supply disruptions: Drug shortages - Europe
High-impact accidents
Piracy in the high seas
Global maritime risk
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SHIPPING ROUTES
World Shipping Council: Trade routes
http://www.worldshipping.org/about-the-
industry/global-trade/trade-routes
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Fastcodesign: World’s shipping routes
http://www.fastcodesign.com/3059346/infographic-of-the-day/mapping-the-stunning-complexity-of-the-worlds-shipping-routes
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http://www.worldshipping.org/about-the-industry/global-trade/trade-routeshttp://www.fastcodesign.com/3059346/infographic-of-the-day/mapping-the-stunning-complexity-of-the-worlds-shipping-routes
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SHIPPING ROUTES
8/9/2016
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SeaRates
https://www.searates.com/reference/portdist
ance/
Cargo ship journeys (trip duration)
http://www.freighterexpeditions.com.au/all-
cargo-ship-routes
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https://www.searates.com/reference/portdistance/https://www.searates.com/reference/portdistance/https://www.searates.com/reference/portdistance/https://www.searates.com/reference/portdistance/http://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routeshttp://www.freighterexpeditions.com.au/all-cargo-ship-routes
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SHIPPING ROUTES
World’s ships real time
http://www.dailymail.co.uk/sciencetech/article-2636152/Watch-worlds-ships-sail-planets-oceans-REAL-TIME-Interactive-map-reveals-crowded-routes-taken-worlds-vessels.html
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Routes vulnerable to piracy
http://www.marineinsight.com/marine-
piracy-marine/7-important-shipping-routes-
vulnerable-to-maritime-piracy/
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http://www.dailymail.co.uk/sciencetech/article-2636152/Watch-worlds-ships-sail-planets-oceans-REAL-TIME-Interactive-map-reveals-crowded-routes-taken-worlds-vessels.htmlhttp://www.dailymail.co.uk/sciencetech/article-2636152/Watch-worlds-ships-sail-planets-oceans-REAL-TIME-Interactive-map-reveals-crowded-routes-taken-worlds-vessels.htmlhttp://www.marineinsight.com/marine-piracy-marine/7-important-shipping-routes-vulnerable-to-maritime-piracy/
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SHIPPING ROUTES
Conflict over Gibraltar: Who has
control?
https://www.geolounge.com/conflict-
gibraltar-control/
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Vice News: Spain-UK Dispute Over
Gibraltar Flares Up After Warning
Shots Incident With US Nuclear Sub
https://news.vice.com/article/british-ship-fires-
warning-shots-at-spanish-ships-trying-to-block-
us-submarine-near-gibraltar
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https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://www.geolounge.com/conflict-gibraltar-control/https://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltarhttps://news.vice.com/article/british-ship-fires-warning-shots-at-spanish-ships-trying-to-block-us-submarine-near-gibraltar
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SHIPPING ROUTES
18 maps that explain maritime
security in Asia
https://amti.csis.org/atlas/
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China’s maritime chokepoints
https://geopoliticalfutures.com/chinas-
maritime-choke-points/
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https://amti.csis.org/atlas/https://amti.csis.org/atlas/https://geopoliticalfutures.com/chinas-maritime-choke-points/
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SHIPPING ROUTES
Why is the South China Sea
contentious?
http://www.bbc.com/news/world-asia-pacific-
13748349
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Showdown in the South China Sea:
How did we get here?
http://www.cnn.com/2015/10/28/asia/china-
south-china-sea-disputes-explainer/
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http://www.bbc.com/news/world-asia-pacific-13748349http://www.bbc.com/news/world-asia-pacific-13748349http://www.cnn.com/2015/10/28/asia/china-south-china-sea-disputes-explainer/http://www.cnn.com/2015/10/28/asia/china-south-china-sea-disputes-explainer/
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SHIPPING ROUTES
War College: Will there be war in the
South China Sea?
https://soundcloud.com/war_college/will-
there-be-war-in-the-south
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Arete-Zoe, LLC
Peele, RB: The importance of maritime
chokepoints
http://strategicstudiesinstitute.army.mil/pubs/
parameters/Articles/97summer/peele.htm
If you’re looking for a place on the globe
likely to spark a world war, you could do
worse than the South China Sea. The
United States, China, Vietnam, Taiwan, the
Philippines and Japan all have claims there.
China is building artificial islands and the
U.S. Navy is patrolling close by. There have
been confrontations at sea and in the air.
This week on War College, we’re looking at
this global sore spot and asking just how
heated is the situation likely to get.
"Man's natural habitat is land, and land dominates
his conscious endeavor--social, economic,
political, and military. Yet, almost three quarters of
his world is ocean. It is the original source of life
for all earth's species; it is the essential means of
global transport for man's produce, commerce,
and military strength. While the world ocean is
beyond sight of much of mankind, its influence is
ubiquitous.“
James E. Toth, "Military Strategy Note: Strategic
Geography," Washington: Industrial College of the Armed
Forces, 1995, p. 1.
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https://soundcloud.com/war_college/will-there-be-war-in-the-southhttps://soundcloud.com/war_college/will-there-be-war-in-the-southhttp://strategicstudiesinstitute.army.mil/pubs/parameters/Articles/97summer/peele.htmhttp://strategicstudiesinstitute.army.mil/pubs/parameters/Articles/97summer/peele.htm
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GOOD MANUFACTURING
PRACTICES
FDA: Drug Applications and Current Good Manufacturing Practice (CGMP) Regulations http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htm
21 CFR part 210 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210
21 CFR part 211 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211
ISPE. “Good Manufacturing Practice (GMP).” ISPE. http://www.ispe.org/gmp-resources
FDA: OPS Process Analytical Technology - (PAT) Initiative http://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdf http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm088828.htm
ICH. “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients.” ICH. Accessed December 14, 2015. http://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.html
Commission Directive 2003/94/EC, of 8 October 2003, Laying down the Principles and Guidelines of Good Manufacturing Practice in Respect of Medicinal Products for Human Use and Investigational Medicinal Products for Human Use. http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm
UK GMP and GDP https://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice
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http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm090016.htmhttp://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211http://www.ispe.org/gmp-resourceshttp://www.ispe.org/gmp-resourceshttp://www.ispe.org/gmp-resourceshttp://www.ispe.org/gmp-resourceshttp://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdfhttp://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdfhttp://www.fda.gov/downloads/Drugs/.../Guidances/ucm070305.pdfhttp://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm088828.htmhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://www.ich.org/products/guidelines/quality/quality-single/article/good-manufacturing-practice-guide-for-active-pharmaceutical-ingredients.htmlhttp://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htmhttp://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htmhttp://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htmhttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practicehttps://www.gov.uk/guidance/good-manufacturing-practice-and-good-distribution-practice
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GEOGRAPHY:
MANUFACTURING
Lindman, Johan, Jonas Timsjö, and Nancy Özbek. “Looking over the Shoulders of Giants:
A Study of the Geography of Big Pharma R&D and Manufacturing Operations,”
November 2008. http://www.vinnova.se/upload/epistorepdf/va-08-13.pdf
EvaluatePharma. “World Preview 2014, Outlook to 2020.” EvaluatePharma, 2014.
http://info.evaluategroup.com/rs/evaluatepharmaltd/images/EP240614.pdf
Government of India “Annual Report 2014-15.” Government of India. “Annual Report 2014-
2015.” Government of India Ministry of Chemicals & Fertilizers Department of
Pharmaceuticals, 2015.
http://www.pharmaceuticals.gov.in/sites/default/files/AnnualReport201415.pdf
EFPIA. “The Pharmaceutical Industry in Figures,” 2015.
http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015
IDMA. “Pharmaceuticals for Patient Benefit. Annual Report 2014-15.” IDMA, 2015.
http://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdf
UNCTAD Secretariat. “Local Production of Pharmaceuticals and Related Technology
Transfer in Developing Countries.” United Nations, Geneva, 2011.
http://apps.who.int/medicinedocs/documents/s19062en/s19062en.pdf.
8/9/2016
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http://www.vinnova.se/upload/epistorepdf/va-08-13.pdfhttp://www.vinnova.se/upload/epistorepdf/va-08-13.pdfhttp://www.vinnova.se/upload/epistorepdf/va-08-13.pdfhttp://www.vinnova.se/upload/epistorepdf/va-08-13.pdfhttp://www.vinnova.se/upload/epistorepdf/va-08-13.pdfhttp://www.vinnova.se/upload/epistorepdf/va-08-13.pdfhttp://info.evaluategroup.com/rs/evaluatepharmaltd/images/EP240614.pdfhttp://info.evaluategroup.com/rs/evaluatepharmaltd/images/EP240614.pdfhttp://www.pharmaceuticals.gov.in/sites/default/files/AnnualReport201415.pdfhttp://www.pharmaceuticals.gov.in/sites/default/files/AnnualReport201415.pdfhttp://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.efpia.eu/mediaroom/271/21/The-Pharmaceutical-Industry-in-figures-Edition-2015http://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://www.idma-assn.org/pdf/54-agm-annual-report-2014-15.pdfhttp://apps.who.int/medicinedocs/documents/s19062en/s19062en.pdf
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FDA: GDUFA &
OFFICES ABROAD
FDA: Generic Drug User Fee Amendments of 2012 http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htm
GDUFA performance reports: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceR
eports/ucm384247.htm
FDA Global offices
http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/d
efault.htm
8/9/2016
Arete-Zoe, LLC
ARETE-ZOE, LLC
https://www.aretezoe.com/ 13 of 24
http://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htmhttp://www.fda.gov/ForIndustry/UserFees/GenericDrugUserFees/default.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm384247.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm384247.htmhttp://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/ucm384247.htmhttp://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/default.htmhttp://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/default.htmhttp://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/default.htm
-
U.S. DRUG MASTER
FILES
8/9/2016
Arete-Zoe, LLC
http://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htm
ARETE-ZOE, LLC
https://www.aretezoe.com/ 14 of 24
http://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htmhttp://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htm
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EU REGISTERED
SITES
8/9/2016
Arete-Zoe, LLC
http://eudragmdp.ema.europa.eu/inspections/displayHome.do
ARETE-ZOE, LLC
https://www.aretezoe.com/ 15 of 24
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EU: PARALLEL TRADE
8/9/2016
Arete-Zoe, LLC
Parallel trade: Which factors determine the flow of goods in Europe?
https://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdf
EMA: Parallel registry http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002370.jsp&mid=WC0b01ac058004d5c1
ARETE-ZOE, LLC
https://www.aretezoe.com/ 16 of 24
https://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttps://www.imshealth.com/files/web/Germany/Publikationen/ReportsWhitepapers/Parallel-trade-with-drugs-Whitepaper-IMSHealth-042015.pdfhttp://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002370.jsp&mid=WC0b01ac058004d5c1http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002370.jsp&mid=WC0b01ac058004d5c1http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002370.jsp&mid=WC0b01ac058004d5c1http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002370.jsp&mid=WC0b01ac058004d5c1http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/07/news_detail_002370.jsp&mid=WC0b01ac058004d5c1
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GLOBAL MARKETS
8/9/2016
Arete-Zoe, LLC
Beijing Review. China Pledges to Speed Entry of U.S. Pharmaceuticals, 2014. https://www.youtube.com/watch?v=8ik3ka86zxw
Directorate for financial and enterprise affairs competition committee.
“Competition Issues in the Distribution of Pharmaceuticals,” Vol. 2014, 2014. http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=DAF/COMP/GF(2014)6&docLangua
ge=En
ARETE-ZOE, LLC
https://www.aretezoe.com/ 17 of 24
https://www.ice.gov/doclib/news/library/speeches/140227kubiak.pdfhttps://www.ice.gov/doclib/news/library/speeches/140227kubiak.pdfhttps://www.youtube.com/watch?v=8ik3ka86zxwhttps://www.youtube.com/watch?v=8ik3ka86zxwhttp://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=DAF/COMP/GF(2014)6&docLanguage=Enhttp://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=DAF/COMP/GF(2014)6&docLanguage=Enhttp://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=DAF/COMP/GF(2014)6&docLanguage=En
-
TRENDS:
CONSOLIDATION
Grabowski, Henry G, and Margaret Kyle. “Mergers and Alliances in Pharmaceuticals: Effects on Innovation and R&D Productivity.” In The Economics of Corporate Governance and Mergers, Vol. 2008. Edward Elgar Publishing Limited, 2008. http://margaretkyle.net/G-K%20Merger%20chapter.pdf
Davidovic, David. “The History of Bio-Pharma Industry M&As, Lessons Learned and Trends to Watch.” PM 360 Online, May 23, 2014. https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/
“Market Challenges, Patients and Activists, and Industry Consolidation: 1980 - Present.” Chemical and Engineering News, 2005 https://pubs.acs.org/cen/coverstory/83/8325/8325market.html
Fisher, Nicole, and Scott Liebman. “Are M&A Replacing R&D In Pharma?” Forbes, April 22, 2015. http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57
WMN. “Container Shipping: Consolidate or Die?” World Maritime News, 2016 http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/
8/9/2016
Arete-Zoe, LLC
ARETE-ZOE, LLC
https://www.aretezoe.com/ 18 of 24
http://margaretkyle.net/G-K Merger chapter.pdfhttp://margaretkyle.net/G-K Merger chapter.pdfhttp://margaretkyle.net/G-K Merger chapter.pdfhttp://margaretkyle.net/G-K Merger chapter.pdfhttps://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://www.pm360online.com/the-history-of-bio-pharma-industry-mas-lessons-learned-and-trends-to-watch/https://pubs.acs.org/cen/coverstory/83/8325/8325market.htmlhttps://pubs.acs.org/cen/coverstory/83/8325/8325market.htmlhttps://pubs.acs.org/cen/coverstory/83/8325/8325market.htmlhttp://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://www.forbes.com/sites/nicolefisher/2015/04/22/are-ma-replacing-rd-in-pharma/#11aa6cd1cb57http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/http://worldmaritimenews.com/archives/184348/container-shipping-consolidate-or-die/
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TRENDS:
OUTSOURCING
Carroll, John. “Big Pharma Is Using Its Venture Cash to Outsource Early R&D
to Biotech.” FiercePharma, January 31, 2014. http://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotech
Getz, Ken. “Outsourcing Relationships and Their Evolving Impact on Clinical
Trial Performance.” 2014. https://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdf
Langer, Eric S. “Pharmaceutical Outsourcing Trends: The Next Decade.”
BioPharm International, no. Outsourcing Special Issue (March 2012). http://bioplanassociates.com/publications/articles/2012/BioPharmIntl_PharmaOutsourcingTren
ds_Mar2012.pdf
Ponemon Institute. “Securing Outsourced Consumer Data.” Ponemon Institute,
March 11, 2013. http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d95
9a23-e745-4783-ab13-7901307630f1
8/9/2016
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ARETE-ZOE, LLC
https://www.aretezoe.com/ 19 of 24
http://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttp://www.fiercebiotech.com/venture-capital/big-pharma-using-its-venture-cash-to-outsource-early-r-d-to-biotechhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttps://www.veeva.com/cn/wp-content/uploads/2014/03/Getz-Veeva-Presentation-2014-1.pdfhttp://bioplanassociates.com/publications/articles/2012/BioPharmIntl_PharmaOutsourcingTrends_Mar2012.pdfhttp://bioplanassociates.com/publications/articles/2012/BioPharmIntl_PharmaOutsourcingTrends_Mar2012.pdfhttp://bioplanassociates.com/publications/articles/2012/BioPharmIntl_PharmaOutsourcingTrends_Mar2012.pdfhttp://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1http://www.nymity.com/Free_Privacy_Resources/Previews/ReferencePreview.aspx?guid=5d959a23-e745-4783-ab13-7901307630f1
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SUPPLY DISRUPTIONS:
DRUG SHORTAGES - USA
U.S. Congress. An Act To Amend the Federal Food, Drug, and Cosmetic Act
to Revise and Extend the User-Fee Programs for Prescription Drugs and
Medical Devices, to Establish Userfee Programs for Generic Drugs and
Biosimilars, and for Other Purposes. (FDASIA), 2012. http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM373078.pdf
FDA Drug shortages: http://www.fda.gov/Drugs/DrugSafety/DrugShortages/
FDA Drug shortages database: http://www.accessdata.fda.gov/scripts/drugshortages/default.cfm
FDA Report to Congress 2015: http://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM488353.pdf
8/9/2016
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https://www.aretezoe.com/ 20 of 24
http://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM373078.pdfhttp://www.fda.gov/downloads/NewsEvents/Newsroom/FactSheets/UCM373078.pdfhttp://www.fda.gov/Drugs/DrugSafety/DrugShortages/http://www.fda.gov/Drugs/DrugSafety/DrugShortages/http://www.accessdata.fda.gov/scripts/drugshortages/default.cfmhttp://www.accessdata.fda.gov/scripts/drugshortages/default.cfmhttp://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM488353.pdfhttp://www.fda.gov/downloads/Drugs/DrugSafety/DrugShortages/UCM488353.pdf
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SUPPLY DISRUPTIONS:
DRUG SHORTAGES - EUROPE
EFPIA. “Policy Proposals to Minimise Medicine Supply Shortages in
Europe,” February 28, 2014. http://www.efpia.eu/uploads/Modules/Documents/pac-280214-ai6-a2-shortages-position-paper-final.pdf
“Medicines Shortages in European Hospitals: Results of the Largest Pan-
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HIGH-IMPACT
ACCIDENTS
Phillips, Tom, and Ryan Fergus. “Tianjin Blasts: China Orders Nationwide
Checks on Dangerous Chemicals.” The Guardian, August 14, 2014. https://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-
chemicals
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https://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttps://www.theguardian.com/world/2015/aug/14/tianjin-explosions-china-orders-checks-chemicalshttp://www.thelancet.com/journals/lancet/article/PIIS0140-6736(15)00394-3/fulltext
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PIRACY ON THE HIGH SEAS
8/9/2016
Arete-Zoe, LLC
https://www.icc-ccs.org/piracy-reporting-centre/live-piracy-map
ARETE-ZOE, LLC
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GLOBAL MARITIME RISK
8/9/2016
Arete-Zoe, LLC
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http://www.shipping.nato.int/GMR/Pages/default.aspxhttp://www.shipping.nato.int/GMR/Pages/default.aspx