{"id":"https://openalex.org/W4226441979","doi":"https://doi.org/10.1002/9781119701101.ch6","title":"Views from Academia, Industry, Regulatory Agencies, and the Legal System","display_name":"Views from Academia, Industry, Regulatory Agencies, and the Legal System","publication_year":2021,"publication_date":"2021-11-15","ids":{"openalex":"https://openalex.org/W4226441979","doi":"https://doi.org/10.1002/9781119701101.ch6"},"language":"en","primary_location":{"id":"doi:10.1002/9781119701101.ch6","doi":"https://doi.org/10.1002/9781119701101.ch6","is_oa":false,"landing_page_url":"https://doi.org/10.1002/9781119701101.ch6","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Textbook of Pharmacoepidemiology","raw_type":"other"},"volume":{"id":"https://openalex.org/W1572959172","display_name":"Textbook of Pharmacoepidemiology"},"type":"other","indexed_in":["crossref"],"open_access":{"is_oa":false,"oa_status":"closed","oa_url":null,"any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5059157113","display_name":"Joshua J. Gagne","orcid":"https://orcid.org/0000-0001-5428-9733","observed_orcids":["https://orcid.org/0000-0001-5428-9733"]},"institutions":[{"id":"https://openalex.org/I1283280774","display_name":"Brigham and Women's Hospital","ror":"https://ror.org/04b6nzv94","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I121934306","https://openalex.org/I1283280774","https://openalex.org/I48633490"]},{"id":"https://openalex.org/I1330063522","display_name":"Johnson & Johnson (United States)","ror":"https://ror.org/03qd7mz70","country_code":"US","type":"company","lineage":["https://openalex.org/I1330063522"]},{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Joshua J. Gagne","raw_affiliation_strings":["Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA","Johnson and Johnson, New Brunswick, NJ, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA","institution_ids":["https://openalex.org/I1283280774","https://openalex.org/I136199984"]},{"raw_affiliation_string":"Johnson and Johnson, New Brunswick, NJ, USA","institution_ids":["https://openalex.org/I1330063522"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5036726043","display_name":"Jerry Avorn","orcid":"https://orcid.org/0000-0003-0255-2346","observed_orcids":["https://orcid.org/0000-0003-0255-2346"]},"institutions":[{"id":"https://openalex.org/I1283280774","display_name":"Brigham and Women's Hospital","ror":"https://ror.org/04b6nzv94","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I121934306","https://openalex.org/I1283280774","https://openalex.org/I48633490"]},{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jerry Avorn","raw_affiliation_strings":["Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA","institution_ids":["https://openalex.org/I1283280774","https://openalex.org/I136199984"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5035942809","display_name":"Nicolle M. Gatto","orcid":"https://orcid.org/0000-0002-9659-7811","observed_orcids":["https://orcid.org/0000-0002-9659-7811"]},"institutions":[{"id":"https://openalex.org/I4210106950","display_name":"Aetion (United States)","ror":"https://ror.org/02efksf92","country_code":"US","type":"company","lineage":["https://openalex.org/I4210106950"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Nicolle M. Gatto","raw_affiliation_strings":["Aetion Inc., New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Aetion Inc., New York, NY, USA","institution_ids":["https://openalex.org/I4210106950"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5110802306","display_name":"Jingping Mo","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I180857899","display_name":"Pfizer (United States)","ror":"https://ror.org/01xdqrp08","country_code":"US","type":"company","lineage":["https://openalex.org/I180857899"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Jingping Mo","raw_affiliation_strings":["Epidemiology, Worldwide Research & Development, Pfizer Inc., New York, NY, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Epidemiology, Worldwide Research & Development, Pfizer Inc., New York, NY, USA","institution_ids":["https://openalex.org/I180857899"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084218210","display_name":"Gerald J. Dal Pan","orcid":"https://orcid.org/0000-0003-4874-5864","observed_orcids":["https://orcid.org/0000-0003-4874-5864"]},"institutions":[{"id":"https://openalex.org/I1320320070","display_name":"United States Food and Drug Administration","ror":"https://ror.org/034xvzb47","country_code":"US","type":"government","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070"]},{"id":"https://openalex.org/I1333606569","display_name":"Center for Drug Evaluation and Research","ror":"https://ror.org/00yf3tm42","country_code":"US","type":"facility","lineage":["https://openalex.org/I1299022934","https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Gerald J. Dal Pan","raw_affiliation_strings":["Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA","institution_ids":["https://openalex.org/I1320320070","https://openalex.org/I1333606569"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5058552198","display_name":"June M. Raine","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4405282191","display_name":"Medicines and Healthcare products Regulatory Agency","ror":"https://ror.org/05fan1e59","country_code":"GB","type":"government","lineage":["https://openalex.org/I4405282191"]}],"countries":["GB"],"is_corresponding":false,"raw_author_name":"June Raine","raw_affiliation_strings":["Vigilance and Risk Management of Medicine, Medicines and Healthcare Products Regulatory Agency, London, UK"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Vigilance and Risk Management of Medicine, Medicines and Healthcare Products Regulatory Agency, London, UK","institution_ids":["https://openalex.org/I4405282191"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5042246725","display_name":"Shinobu Uzu","orcid":"https://orcid.org/0000-0003-2470-745X","observed_orcids":["https://orcid.org/0000-0003-2470-745X"]},"institutions":[{"id":"https://openalex.org/I91962293","display_name":"Pharmaceuticals and Medical Devices Agency","ror":"https://ror.org/03mpkb302","country_code":"JP","type":"government","lineage":["https://openalex.org/I91962293"]}],"countries":["JP"],"is_corresponding":false,"raw_author_name":"Shinobu Uzu","raw_affiliation_strings":["Pharmaceuticals and Medical Devices Agency, Tokyo, Japan"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Pharmaceuticals and Medical Devices Agency, Tokyo, Japan","institution_ids":["https://openalex.org/I91962293"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074257304","display_name":"Aaron Seth Kesselheim","orcid":"https://orcid.org/0000-0002-8867-2666","observed_orcids":["https://orcid.org/0000-0002-8867-2666"]},"institutions":[{"id":"https://openalex.org/I1283280774","display_name":"Brigham and Women's Hospital","ror":"https://ror.org/04b6nzv94","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I121934306","https://openalex.org/I1283280774","https://openalex.org/I48633490"]},{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]}],"countries":["US"],"is_corresponding":false,"raw_author_name":"Aaron S. Kesselheim","raw_affiliation_strings":["Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA","institution_ids":["https://openalex.org/I1283280774","https://openalex.org/I136199984"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5056969091","display_name":"Kerstin No\u00eblle Vokinger","orcid":"https://orcid.org/0000-0002-6997-7384","observed_orcids":["https://orcid.org/0000-0002-6997-7384"]},"institutions":[{"id":"https://openalex.org/I1283280774","display_name":"Brigham and Women's Hospital","ror":"https://ror.org/04b6nzv94","country_code":"US","type":"healthcare","lineage":["https://openalex.org/I121934306","https://openalex.org/I1283280774","https://openalex.org/I48633490"]},{"id":"https://openalex.org/I136199984","display_name":"Harvard University","ror":"https://ror.org/03vek6s52","country_code":"US","type":"education","lineage":["https://openalex.org/I136199984"]},{"id":"https://openalex.org/I202697423","display_name":"University of Zurich","ror":"https://ror.org/02crff812","country_code":"CH","type":"education","lineage":["https://openalex.org/I202697423"]}],"countries":["CH","US"],"is_corresponding":false,"raw_author_name":"Kerstin N. Vokinger","raw_affiliation_strings":["Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA","Institute for Law University of Zurich, Zurich, Switzerland"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Harvard Medical School and Brigham and Women's Hospital, Boston, MA, USA","institution_ids":["https://openalex.org/I1283280774","https://openalex.org/I136199984"]},{"raw_affiliation_string":"Institute for Law University of Zurich, Zurich, Switzerland","institution_ids":["https://openalex.org/I202697423"]}]}],"institutions":[],"countries_distinct_count":4,"institutions_distinct_count":10,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":null,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":null,"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":"73","last_page":"111"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.7705000042915344,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},"topics":[{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.7705000042915344,"subfield":{"id":"https://openalex.org/subfields/3005","display_name":"Toxicology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.0575999990105629,"subfield":{"id":"https://openalex.org/subfields/3004","display_name":"Pharmacology"},"field":{"id":"https://openalex.org/fields/30","display_name":"Pharmacology, Toxicology and Pharmaceutics"},"domain":{"id":"https://openalex.org/domains/1","display_name":"Life Sciences"}},{"id":"https://openalex.org/T10496","display_name":"Pharmaceutical Practices and Patient Outcomes","score":0.04969999939203262,"subfield":{"id":"https://openalex.org/subfields/2717","display_name":"Geriatrics and Gerontology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/pharmacoepidemiology","display_name":"pharmacoepidemiology","score":0.9890000224113464},{"id":"https://openalex.org/keywords/drug-related-problems","display_name":"drug-related problems","score":0.7329999804496765},{"id":"https://openalex.org/keywords/health-policy-evaluation","display_name":"health policy evaluation","score":0.7089999914169312},{"id":"https://openalex.org/keywords/academic-medical-centers","display_name":"academic medical centers","score":0.9269999861717224},{"id":"https://openalex.org/keywords/drug-safety-assessment","display_name":"drug safety assessment","score":0.7839999794960022},{"id":"https://openalex.org/keywords/biopharmaceutical-industry","display_name":"biopharmaceutical industry","score":0.9300000071525574},{"id":"https://openalex.org/keywords/regulatory-agencies","display_name":"regulatory agencies","score":0.7379999756813049},{"id":"https://openalex.org/keywords/risk-communication","display_name":"risk communication","score":0.8090000152587891},{"id":"https://openalex.org/keywords/health-services-research","display_name":"health services research","score":0.6159999966621399}],"concepts":[{"id":"https://openalex.org/C23276603","wikidata":"https://www.wikidata.org/wiki/Q158230","display_name":"Pharmacoepidemiology","level":3,"score":0.7872662544250488},{"id":"https://openalex.org/C2780712339","wikidata":"https://www.wikidata.org/wiki/Q5165204","display_name":"Contextualization","level":3,"score":0.6956536769866943},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.5090107917785645},{"id":"https://openalex.org/C9652623","wikidata":"https://www.wikidata.org/wiki/Q190109","display_name":"Field (mathematics)","level":2,"score":0.4489617943763733},{"id":"https://openalex.org/C12713177","wikidata":"https://www.wikidata.org/wiki/Q1900281","display_name":"Perspective (graphical)","level":2,"score":0.4252278208732605},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.40128588676452637},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.39113566279411316},{"id":"https://openalex.org/C55587333","wikidata":"https://www.wikidata.org/wiki/Q1133029","display_name":"Engineering ethics","level":1,"score":0.3817017674446106},{"id":"https://openalex.org/C539667460","wikidata":"https://www.wikidata.org/wiki/Q2414942","display_name":"Management science","level":1,"score":0.33870571851730347},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.33215489983558655},{"id":"https://openalex.org/C39549134","wikidata":"https://www.wikidata.org/wiki/Q133080","display_name":"Public relations","level":1,"score":0.3309520483016968},{"id":"https://openalex.org/C17744445","wikidata":"https://www.wikidata.org/wiki/Q36442","display_name":"Political science","level":0,"score":0.29457491636276245},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.2727009952068329},{"id":"https://openalex.org/C127413603","wikidata":"https://www.wikidata.org/wiki/Q11023","display_name":"Engineering","level":0,"score":0.26086559891700745},{"id":"https://openalex.org/C98274493","wikidata":"https://www.wikidata.org/wiki/Q128406","display_name":"Pharmacology","level":1,"score":0.22305575013160706},{"id":"https://openalex.org/C154945302","wikidata":"https://www.wikidata.org/wiki/Q11660","display_name":"Artificial intelligence","level":1,"score":0.0},{"id":"https://openalex.org/C199539241","wikidata":"https://www.wikidata.org/wiki/Q7748","display_name":"Law","level":1,"score":0.0},{"id":"https://openalex.org/C202444582","wikidata":"https://www.wikidata.org/wiki/Q837863","display_name":"Pure mathematics","level":1,"score":0.0},{"id":"https://openalex.org/C2426938","wikidata":"https://www.wikidata.org/wiki/Q3355478","display_name":"Medical prescription","level":2,"score":0.0},{"id":"https://openalex.org/C33923547","wikidata":"https://www.wikidata.org/wiki/Q395","display_name":"Mathematics","level":0,"score":0.0},{"id":"https://openalex.org/C199360897","wikidata":"https://www.wikidata.org/wiki/Q9143","display_name":"Programming language","level":1,"score":0.0},{"id":"https://openalex.org/C527412718","wikidata":"https://www.wikidata.org/wiki/Q855395","display_name":"Interpretation (philosophy)","level":2,"score":0.0}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.1002/9781119701101.ch6","doi":"https://doi.org/10.1002/9781119701101.ch6","is_oa":false,"landing_page_url":"https://doi.org/10.1002/9781119701101.ch6","pdf_url":null,"source":null,"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Textbook of Pharmacoepidemiology","raw_type":"other"}],"best_oa_location":null,"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":0.8048999905586243}],"study_designs":[],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":54,"referenced_works":["https://openalex.org/W655556232","https://openalex.org/W1530265405","https://openalex.org/W1586786051","https://openalex.org/W1603625064","https://openalex.org/W1608638993","https://openalex.org/W1646068190","https://openalex.org/W1965192447","https://openalex.org/W1970485089","https://openalex.org/W1981917230","https://openalex.org/W1983965561","https://openalex.org/W2004291012","https://openalex.org/W2004432841","https://openalex.org/W2009720384","https://openalex.org/W2010691204","https://openalex.org/W2013972563","https://openalex.org/W2021645358","https://openalex.org/W2022298818","https://openalex.org/W2023149067","https://openalex.org/W2024559544","https://openalex.org/W2028590696","https://openalex.org/W2029896549","https://openalex.org/W2030147903","https://openalex.org/W2058438891","https://openalex.org/W2063113490","https://openalex.org/W2067032911","https://openalex.org/W2077334871","https://openalex.org/W2093457547","https://openalex.org/W2094485767","https://openalex.org/W2101716521","https://openalex.org/W2103752418","https://openalex.org/W2105398884","https://openalex.org/W2111945961","https://openalex.org/W2122833169","https://openalex.org/W2137051263","https://openalex.org/W2138799102","https://openalex.org/W2139161626","https://openalex.org/W2158834553","https://openalex.org/W2161868218","https://openalex.org/W2168751125","https://openalex.org/W2312965018","https://openalex.org/W2319689835","https://openalex.org/W2330754885","https://openalex.org/W2337821671","https://openalex.org/W2403157053","https://openalex.org/W2474794522","https://openalex.org/W2560688864","https://openalex.org/W2607475628","https://openalex.org/W2750879457","https://openalex.org/W2754973711","https://openalex.org/W2765725161","https://openalex.org/W4233397445","https://openalex.org/W4247938048","https://openalex.org/W4252553827","https://openalex.org/W4391202874"],"related_works":["https://openalex.org/W4206571430","https://openalex.org/W4382072457","https://openalex.org/W1520666503","https://openalex.org/W4241227421","https://openalex.org/W4254103720","https://openalex.org/W4240519121","https://openalex.org/W3009332278","https://openalex.org/W1995549197","https://openalex.org/W2557029671","https://openalex.org/W3111241633"],"abstract_inverted_index":{"This":[0],"chapter":[1],"provides":[2],"an":[3,139],"overview":[4],"of":[5,29,32,39,74,85,103,119,124,130,132,135,141,144,151],"how":[6],"the":[7,27,40,59,92,106,115,133,142,149],"field":[8,93],"and":[9,22,45,70,89,117,122],"its":[10],"methods":[11],"can":[12,48,94],"contribute":[13],"to":[14],"these":[15],"larger":[16],"themes":[17],"in":[18,58,105],"medical":[19,79],"care":[20,61],"delivery":[21],"health":[23,60],"services":[24],"research,":[25],"from":[26],"perspective":[28],"academia.":[30],"Underuse":[31],"needed":[33],"drugs":[34],"by":[35,52],"patients":[36],"is":[37,109,138],"one":[38,46,90],"most":[41,100],"common":[42],"medication-related":[43],"problems,":[44],"that":[47],"be":[49],"readily":[50],"identified":[51],"pharmacoepidemiology.":[53],"Policy":[54],"changes":[55],"are":[56],"implemented":[57],"system":[62],"with":[63],"no":[64,71],"systematic":[65],"plans":[66],"for":[67,87],"their":[68,75],"evaluation,":[69,113],"follow-up":[72],"studies":[73],"impact.":[76],"The":[77,99],"academic":[78],"center":[80],"represents":[81],"a":[82],"special":[83],"case":[84],"inquiry":[86],"pharmacoepidemiology,":[88],"where":[91],"make":[95],"particularly":[96],"useful":[97],"contributions.":[98],"consistent":[101],"contribution":[102],"epidemiology":[104],"biopharmaceutical":[107],"industry":[108],"arguably":[110],"drug":[111],"safety":[112,120],"including":[114],"contextualization":[116],"refinement":[118],"signals,":[121],"examination":[123],"specific":[125],"research":[126],"hypotheses.":[127],"One":[128],"domain":[129],"assessment":[131],"impact":[134],"regulatory":[136,145],"activities":[137],"understanding":[140],"effectiveness":[143],"agencies\u2019":[146],"communications":[147],"about":[148],"risks":[150],"medicines.":[152]},"counts_by_year":[],"updated_date":"2026-10-14T16:39:01.820549","created_date":"2022-05-05T00:00:00"}