arete-zoe, llc study guide...course organization . the course consists of video lectures and...

STUDY

GUIDE

PHARMACEUTICAL SUPPLY CHAIN

INTEGRITY AND SECURITY

PART II

CHAPTER: GLOBALIZATION

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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

SHIPPING ROUTES

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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

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/

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

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/

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/

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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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

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

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.

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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

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

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ARETE-ZOE, LLC


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


http://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htmhttp://www.fda.gov/drugs/developmentapprovalprocess/formssubmissionrequirements/drugmasterfilesdmfs/default.htm

EU REGISTERED

SITES

8/9/2016

Arete-Zoe, LLC

http://eudragmdp.ema.europa.eu/inspections/displayHome.do

ARETE-ZOE, LLC


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.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

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.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


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/

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

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ARETE-ZOE, LLC


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

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

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ARETE-ZOE, LLC


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

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-

European Survey on Medicines Supply Shortages in the Hospital Sector, Its

Prevalence, Nature and Impacts for Patient Care. The Evidence and Case for

Action.” European Journal of Hospital Pharmacy, October 2014. http://www.eahp.eu/practice-and-policy/medicines-shortages

Torjesen, Ingrid. “Drug Shortages: It’s Time for Europe to Act,” January 29,

2015. http://www.pharmaceutical-journal.com/news-and-analysis/features/drug-shortages-its-time-for-europe-to-act/20067701.article.

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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

PIRACY ON THE HIGH SEAS

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GLOBAL MARITIME RISK

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