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Google Keyword Rankings for : italy drug approval process
1
https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-italy/
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https://pharmaboardroom.com/legal-articles/regulatory-pricing-and-reimbursement-overview-italy/
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2
https://www.freyrsolutions.com/pharma-regulatory-services-in-italy
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https://www.freyrsolutions.com/pharma-regulatory-services-in-italy
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3
https://uk.practicallaw.thomsonreuters.com/2-618-5124?transitionType=Default&contextData=(sc.Default)
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https://uk.practicallaw.thomsonreuters.com/2-618-5124?transitionType=Default&contextData=(sc.Default)
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4
https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step
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https://www.ema.europa.eu/en/human-regulatory/marketing-authorisation/evaluation-medicines-step-step
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5
https://www.valueinhealthjournal.com/article/S1098-3015(16)31953-2/fulltext
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https://www.valueinhealthjournal.com/article/S1098-3015(16)31953-2/fulltext
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6
https://www.lexology.com/library/detail.aspx?g=05259711-d87d-44dd-9e57-4e1d5e5b50c6
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https://www.lexology.com/library/detail.aspx?g=05259711-d87d-44dd-9e57-4e1d5e5b50c6
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7
https://www.tandfonline.com/doi/pdf/10.1179/2047480614Z.000000000205
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https://www.tandfonline.com/doi/pdf/10.1179/2047480614Z.000000000205
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8
https://journals.sagepub.com/doi/full/10.5301/maapoc.0000007
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https://journals.sagepub.com/doi/full/10.5301/maapoc.0000007
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9
https://scrip.pharmaintelligence.informa.com/PS114268/Regulation-of-Pharmaceuticals-Briefing---Italy
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https://scrip.pharmaintelligence.informa.com/PS114268/Regulation-of-Pharmaceuticals-Briefing---Italy
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10
https://journals.indexcopernicus.com/api/file/viewByFileId/693331.pdf
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https://journals.indexcopernicus.com/api/file/viewByFileId/693331.pdf
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11
https://journals.aboutscience.eu/index.php/aboutopen/article/view/2184
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https://journals.aboutscience.eu/index.php/aboutopen/article/view/2184
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12
https://www.frontiersin.org/articles/10.3389/fphar.2021.699466/full
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https://www.frontiersin.org/articles/10.3389/fphar.2021.699466/full
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13
https://pharmexcil.com/uploads/countryreports/Italy_Market_Regulatory_report2020.pdf
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https://pharmexcil.com/uploads/countryreports/Italy_Market_Regulatory_report2020.pdf
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14
https://www.maprovider.com/images/pubblicazioni/Ispor%20Annual%20European%20Congress_PHP49.pdf
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https://www.maprovider.com/images/pubblicazioni/Ispor%20Annual%20European%20Congress_PHP49.pdf
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15
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853663/
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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3853663/
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16
https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra
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https://www.fda.gov/international-programs/international-arrangements/mutual-recognition-agreement-mra
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17
https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.14138
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https://bpspubs.onlinelibrary.wiley.com/doi/full/10.1111/bcp.14138
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18
https://www.researchgate.net/publication/347646303_Time_to_reimbursement_and_negotiation_condition_in_Italy_for_drugs_approved_by_the_European_Medicines_Agency_during_the_period_2014-2019
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https://www.researchgate.net/publication/347646303_Time_to_reimbursement_and_negotiation_condition_in_Italy_for_drugs_approved_by_the_European_Medicines_Agency_during_the_period_2014-2019
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19
https://www.ashclinicalnews.org/features/geography-drug-approvals
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https://www.ashclinicalnews.org/features/geography-drug-approvals
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20
https://www.jstor.org/stable/40283728
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https://www.jstor.org/stable/40283728
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21
https://www.euro.who.int/__data/assets/pdf_file/0011/376625/pharmaceutical-reimbursement-eng.pdf
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https://www.euro.who.int/__data/assets/pdf_file/0011/376625/pharmaceutical-reimbursement-eng.pdf
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22
https://www.bmj.com/content/371/bmj.m3434
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https://www.bmj.com/content/371/bmj.m3434
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23
https://www.efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
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https://www.efpia.eu/media/554527/root-causes-unvailability-delay-cra-final-300620.pdf
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24
https://www.reuters.com/article/us-molmed-cancer-drug/italys-molmed-close-to-announcing-cancer-drug-results-idUKBREA2P23L20140326
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https://www.reuters.com/article/us-molmed-cancer-drug/italys-molmed-close-to-announcing-cancer-drug-results-idUKBREA2P23L20140326
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25
https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003726
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https://journals.plos.org/plosmedicine/article?id=10.1371/journal.pmed.1003726
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26
https://support.google.com/adspolicy/answer/176031?hl=en
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https://support.google.com/adspolicy/answer/176031?hl=en
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27
https://www.ice.it/en/invest/jaguar-health-pounces-european-market-investment-milan
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https://www.ice.it/en/invest/jaguar-health-pounces-european-market-investment-milan
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28
https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu
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https://www.raps.org/news-and-articles/news-articles/2020/1/the-essential-list-of-regulatory-authorities-in-eu
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29
https://www.sciencedirect.com/science/article/pii/S0168851021000750
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https://www.sciencedirect.com/science/article/pii/S0168851021000750
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30
https://www.garanteprivacy.it/home/docweb/-/docweb-display/docweb/1671330
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https://www.garanteprivacy.it/home/docweb/-/docweb-display/docweb/1671330
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31
https://www.bms.com/
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https://www.bms.com/
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32
https://www.abbvie.com/
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https://www.abbvie.com/
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33
https://www.commonwealthfund.org/international-health-policy-center/countries/italy
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https://www.commonwealthfund.org/international-health-policy-center/countries/italy
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34
https://www.pharmaworldmagazine.com/health-inspections-and-controls-on-medicines/
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https://www.pharmaworldmagazine.com/health-inspections-and-controls-on-medicines/
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35
https://en.wikipedia.org/wiki/European_Medicines_Agency
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https://en.wikipedia.org/wiki/European_Medicines_Agency
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36
https://www.hma.eu/
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https://www.hma.eu/
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37
https://www.jmcp.org/doi/pdf/10.18553/jmcp.1997.3.4.459
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https://www.jmcp.org/doi/pdf/10.18553/jmcp.1997.3.4.459
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38
https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-96-71/pdf/GAOREPORTS-HEHS-96-71.pdf
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https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-96-71/pdf/GAOREPORTS-HEHS-96-71.pdf
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39
https://www.iqwig.de/en/presse/in-the-focus/new-drugs-approval-benefit-assessment-coverage/2-drug-approval-and-benefit-assessment-in-other-countries/
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https://www.iqwig.de/en/presse/in-the-focus/new-drugs-approval-benefit-assessment-coverage/2-drug-approval-and-benefit-assessment-in-other-countries/
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40
https://err.ersjournals.com/content/25/141/223
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https://err.ersjournals.com/content/25/141/223
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41
https://www.dompe.com/en/media/press-releases/exscalate4cov-italian-medicines-agency-aifa-authorizes-raloxifene-clinical-trial-for-paucisymptomatic-covid-19-patients-treated-at-home-and-in-medical-facilities
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https://www.dompe.com/en/media/press-releases/exscalate4cov-italian-medicines-agency-aifa-authorizes-raloxifene-clinical-trial-for-paucisymptomatic-covid-19-patients-treated-at-home-and-in-medical-facilities
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42
https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776016
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https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2776016
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43
https://www.government.nl/topics/medicines/question-and-answer/can-i-take-my-medication-abroad
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https://www.government.nl/topics/medicines/question-and-answer/can-i-take-my-medication-abroad
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44
https://www.jazzpharma.com/
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https://www.jazzpharma.com/
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45
https://www.iconplc.com/
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https://www.iconplc.com/
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46
https://link.springer.com/article/10.1007/s10198-016-0863-5
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https://link.springer.com/article/10.1007/s10198-016-0863-5
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47
https://go.drugbank.com/
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https://go.drugbank.com/
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48
https://www.globalcompliancenews.com/2021/02/08/italy-the-aifas-clarifications-on-the-procedure-for-submitting-marketing-applications-for-covid-19-vaccines-25012021/
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https://www.globalcompliancenews.com/2021/02/08/italy-the-aifas-clarifications-on-the-procedure-for-submitting-marketing-applications-for-covid-19-vaccines-25012021/
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49
https://www.pharmaceutical-technology.com/news/italy-osteoporosis-drug-covid/
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https://www.pharmaceutical-technology.com/news/italy-osteoporosis-drug-covid/
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50
https://www.cytivalifesciences.com/en/us/solutions/emerging-biotech/knowledge-center/regulatory-review-of-new-drugs
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https://www.cytivalifesciences.com/en/us/solutions/emerging-biotech/knowledge-center/regulatory-review-of-new-drugs
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51
https://www.milbank.org/wp-content/uploads/2018/01/WOUTERS_et_al-2017-The_Milbank_Quarterly.pdf
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https://www.milbank.org/wp-content/uploads/2018/01/WOUTERS_et_al-2017-The_Milbank_Quarterly.pdf
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52
https://www.gao.gov/assets/hehs-96-71.pdf
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https://www.gao.gov/assets/hehs-96-71.pdf
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53
https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features
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https://www.gov.uk/guidance/implementing-the-falsified-medicines-directive-safety-features
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54
https://www.jpsr.pharmainfo.in/Documents/Volumes/vol11issue07/jpsr11071940.pdf
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https://www.jpsr.pharmainfo.in/Documents/Volumes/vol11issue07/jpsr11071940.pdf
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55
https://www.cambrex.com/quality-regulatory/
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https://www.cambrex.com/quality-regulatory/
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56
https://www.jacc.org/doi/10.1016/j.jacbts.2016.06.003
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https://www.jacc.org/doi/10.1016/j.jacbts.2016.06.003
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57
https://travel.state.gov/content/travel/en/international-travel/International-Travel-Country-Information-Pages/Italy.html
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https://travel.state.gov/content/travel/en/international-travel/International-Travel-Country-Information-Pages/Italy.html
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58
https://www.intexo.it/wp-content/uploads/2016/07/2015-ISPOR-Fondo-AIFA-5.pdf
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https://www.intexo.it/wp-content/uploads/2016/07/2015-ISPOR-Fondo-AIFA-5.pdf
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59
https://www.vrtx.com/
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https://www.vrtx.com/
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60
https://help.cbp.gov/s/article/Article-777?language=en_US
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https://help.cbp.gov/s/article/Article-777?language=en_US
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61
https://www.ey.com/en_gl/life-sciences/how-to-navigate-eu-regulations-for-drug-device-combination-products
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https://www.ey.com/en_gl/life-sciences/how-to-navigate-eu-regulations-for-drug-device-combination-products
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62
https://www.sanofi.com/en/
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https://www.sanofi.com/en/
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63
https://dailyreporter.esmo.org/esmo-sarcoma-gist-virtual-symposium-2022/highlighted/what-level-of-evidence-do-we-need-for-drug-approval-in-rare-cancers
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https://dailyreporter.esmo.org/esmo-sarcoma-gist-virtual-symposium-2022/highlighted/what-level-of-evidence-do-we-need-for-drug-approval-in-rare-cancers
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64
https://www.regdesk.co/italy-reg/
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https://www.regdesk.co/italy-reg/
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65
https://www.uria.com/documentos/colaboraciones/574/documento/Portugal%20_pharma_07.pdf?id=1932_en
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https://www.uria.com/documentos/colaboraciones/574/documento/Portugal%20_pharma_07.pdf?id=1932_en
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66
https://www.clinicaltrials.gov/ct2/show/NCT04317092
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https://www.clinicaltrials.gov/ct2/show/NCT04317092
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67
https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html
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https://www.nytimes.com/interactive/2020/science/coronavirus-drugs-treatments.html
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68
https://www.pda.org/pda-letter-portal/home/full-article/gmp-oversight-of-medicines-manufacturers-in-the-european-union
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https://www.pda.org/pda-letter-portal/home/full-article/gmp-oversight-of-medicines-manufacturers-in-the-european-union
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69
https://www.mckinsey.com/industries/life-sciences/our-insights/integrated-evidence-generation-a-paradigm-shift-in-biopharma
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https://www.mckinsey.com/industries/life-sciences/our-insights/integrated-evidence-generation-a-paradigm-shift-in-biopharma
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70
https://www.insideeulifesciences.com/category/food-drug-regulatory/
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https://www.insideeulifesciences.com/category/food-drug-regulatory/
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71
https://www.sofpromed.com/post-approval-studies-pas-with-drugs-in-europe-frequently-asked-questions
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https://www.sofpromed.com/post-approval-studies-pas-with-drugs-in-europe-frequently-asked-questions
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72
https://www.nature.com/articles/d41586-022-01507-3
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https://www.nature.com/articles/d41586-022-01507-3
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73
https://investors.alnylam.com/press-release?id=26776
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https://investors.alnylam.com/press-release?id=26776
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74
https://www.medicinesforeurope.com/wp-content/uploads/2022/06/New-pricing-models-for-generic-medicines.pdf
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https://www.medicinesforeurope.com/wp-content/uploads/2022/06/New-pricing-models-for-generic-medicines.pdf
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75
https://star.worldbank.org/sites/star/files/Italy-Asset-Recovery-tools-and-procedures.pdf
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https://star.worldbank.org/sites/star/files/Italy-Asset-Recovery-tools-and-procedures.pdf
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76
https://www.oecd.org/health/health-systems/Addressing-Challenges-in-Access-to-Oncology-Medicines-Analytical-Report.pdf
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https://www.oecd.org/health/health-systems/Addressing-Challenges-in-Access-to-Oncology-Medicines-Analytical-Report.pdf
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77
https://repository.upenn.edu/cgi/viewcontent.cgi?article=1037&context=ace
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https://repository.upenn.edu/cgi/viewcontent.cgi?article=1037&context=ace
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78
https://www.cancer.gov/news-events/cancer-currents-blog/2021/hairy-cell-leukemia-vemurafenib-rituximab
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https://www.cancer.gov/news-events/cancer-currents-blog/2021/hairy-cell-leukemia-vemurafenib-rituximab
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79
https://www.rand.org/content/dam/rand/pubs/research_reports/RR2900/RR2956/RAND_RR2956.pdf
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https://www.rand.org/content/dam/rand/pubs/research_reports/RR2900/RR2956/RAND_RR2956.pdf
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80
https://www.dfhcc.harvard.edu/research/clinical-research-support/document-library/
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https://www.dfhcc.harvard.edu/research/clinical-research-support/document-library/
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81
https://www.gabionline.net/layout/set/print/country-focus/italy/Licensing-Guidelines-and-Regulations
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https://www.gabionline.net/layout/set/print/country-focus/italy/Licensing-Guidelines-and-Regulations
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82
https://www.iqvia.com/
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https://www.iqvia.com/
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83
https://www3.weforum.org/docs/WEF_PHSSR_Italy_Report.pdf
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https://www3.weforum.org/docs/WEF_PHSSR_Italy_Report.pdf
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84
https://www.columbus.gov/uploadedFiles/Columbus/Departments/Development/Planning_Division/Historic_Preservation_Program/ITALIAN%20VILLAGE%20COMMISSION%20BYLAWS.pdf
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https://www.columbus.gov/uploadedFiles/Columbus/Departments/Development/Planning_Division/Historic_Preservation_Program/ITALIAN%20VILLAGE%20COMMISSION%20BYLAWS.pdf
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85
https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00027-2/fulltext
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https://www.thelancet.com/journals/lanepe/article/PIIS2666-7762(21)00027-2/fulltext
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86
https://www.mef.gov.it/en/focus/documents/PNRR-NEXT-GENERATION-ITALIA_ENG_09022021.pdf
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https://www.mef.gov.it/en/focus/documents/PNRR-NEXT-GENERATION-ITALIA_ENG_09022021.pdf
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87
https://www.epicentro.iss.it/en/voluntary-termination-pregnancy/epidemiology
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https://www.epicentro.iss.it/en/voluntary-termination-pregnancy/epidemiology
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88
https://www.federalregister.gov/documents/2005/11/23/05-23120/investigational-new-drugs-export-requirements-for-unapproved-new-drug-products
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https://www.federalregister.gov/documents/2005/11/23/05-23120/investigational-new-drugs-export-requirements-for-unapproved-new-drug-products
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89
https://oig.justice.gov/reports/DEA/a0719/final.pdf
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https://oig.justice.gov/reports/DEA/a0719/final.pdf
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90
https://www.lonza.com/about-us/our-locations
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https://www.lonza.com/about-us/our-locations
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91
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