{"id":"https://openalex.org/W7204234753","doi":"https://doi.org/10.1002/bcp.70783","title":"Implementation and use of risk minimization control tools in the EU: A multistakeholder survey","display_name":"Implementation and use of risk minimization control tools in the EU: A multistakeholder survey","publication_year":2026,"publication_date":"2026-08-26","ids":{"openalex":"https://openalex.org/W7204234753","doi":"https://doi.org/10.1002/bcp.70783","pmid":"https://pubmed.ncbi.nlm.nih.gov/42648741"},"language":"en","primary_location":{"id":"doi:10.1002/bcp.70783","doi":"https://doi.org/10.1002/bcp.70783","is_oa":true,"landing_page_url":"https://doi.org/10.1002/bcp.70783","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bcp.70783","source":{"id":"https://openalex.org/S13842274","display_name":"British Journal of Clinical Pharmacology","issn_l":"0306-5251","issn":["0306-5251","1365-2125"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British Journal of Clinical Pharmacology","raw_type":"journal-article"},"volume":null,"type":"article","indexed_in":["crossref","pubmed"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bcp.70783","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5005730329","display_name":"Sharon C. M. Essink","orcid":"https://orcid.org/0000-0003-2079-4816","observed_orcids":["https://orcid.org/0000-0003-2079-4816"]},"institutions":[{"id":"https://openalex.org/I193662353","display_name":"Utrecht University","ror":"https://ror.org/04pp8hn57","country_code":"NL","type":"education","lineage":["https://openalex.org/I193662353"]},{"id":"https://openalex.org/I4210150351","display_name":"Medicines Evaluation Board","ror":"https://ror.org/05mv4rb84","country_code":"NL","type":"education","lineage":["https://openalex.org/I4210150351"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Sharon C. M. Essink","raw_affiliation_strings":["Department of Pharmacovigilance, Medicines Evaluation Board  Utrecht The Netherlands","Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"],"raw_orcid":"https://orcid.org/0000-0003-2079-4816","affiliations":[{"raw_affiliation_string":"Department of Pharmacovigilance, Medicines Evaluation Board  Utrecht The Netherlands","institution_ids":["https://openalex.org/I4210150351"]},{"raw_affiliation_string":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands","institution_ids":["https://openalex.org/I193662353"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5014825618","display_name":"Iris Rebecca Joosse","orcid":"https://orcid.org/0000-0001-7677-8589","observed_orcids":["https://orcid.org/0000-0001-7677-8589"]},"institutions":[{"id":"https://openalex.org/I193662353","display_name":"Utrecht University","ror":"https://ror.org/04pp8hn57","country_code":"NL","type":"education","lineage":["https://openalex.org/I193662353"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Iris R. Joosse","raw_affiliation_strings":["Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands","institution_ids":["https://openalex.org/I193662353"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5008135668","display_name":"Maximilian Salcher\u2010Konrad","orcid":"https://orcid.org/0000-0002-5628-5266","observed_orcids":["https://orcid.org/0000-0002-5628-5266"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Maximilian Salcher\u2010Konrad","raw_affiliation_strings":["WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute  Vienna Austria"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute  Vienna Austria","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5083348629","display_name":"Melanie Walter","orcid":"https://orcid.org/0000-0003-3241-522X","observed_orcids":["https://orcid.org/0000-0003-3241-522X","https://orcid.org/0009-0001-3010-0729"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"Melanie Walter","raw_affiliation_strings":["WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute  Vienna Austria"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"WHO Collaborating Centre for Pharmaceutical Pricing and Reimbursement Policies, Pharmacoeconomics Department Austrian National Public Health Institute  Vienna Austria","institution_ids":[]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5060570196","display_name":"Elena Deligianni","orcid":"https://orcid.org/0009-0000-5119-3306","observed_orcids":["https://orcid.org/0009-0000-5119-3306"]},"institutions":[{"id":"https://openalex.org/I147962203","display_name":"Democritus University of Thrace","ror":"https://ror.org/03bfqnx40","country_code":"GR","type":"education","lineage":["https://openalex.org/I147962203"]}],"countries":["GR"],"is_corresponding":false,"raw_author_name":"Elena Deligianni","raw_affiliation_strings":["School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece","institution_ids":["https://openalex.org/I147962203"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5119187668","display_name":"Dimitra Tsioumela","orcid":"https://orcid.org/0009-0008-7951-9089","observed_orcids":["https://orcid.org/0009-0008-7951-9089"]},"institutions":[{"id":"https://openalex.org/I147962203","display_name":"Democritus University of Thrace","ror":"https://ror.org/03bfqnx40","country_code":"GR","type":"education","lineage":["https://openalex.org/I147962203"]}],"countries":["GR"],"is_corresponding":false,"raw_author_name":"Dimitra Tsioumela","raw_affiliation_strings":["School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece","institution_ids":["https://openalex.org/I147962203"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5129712078","display_name":"Christos Kontogiorgis","orcid":"https://orcid.org/0000-0001-7835-8246","observed_orcids":["https://orcid.org/0000-0001-7835-8246"]},"institutions":[{"id":"https://openalex.org/I147962203","display_name":"Democritus University of Thrace","ror":"https://ror.org/03bfqnx40","country_code":"GR","type":"education","lineage":["https://openalex.org/I147962203"]}],"countries":["GR"],"is_corresponding":false,"raw_author_name":"Christos Kontogiorgis","raw_affiliation_strings":["School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"School of Medicine, Laboratory of Hygiene and Environmental Protection, Dragana University Campus Democritus University of Thrace  Alexandroupolis Greece","institution_ids":["https://openalex.org/I147962203"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5017538000","display_name":"Elita Poplavska","orcid":"https://orcid.org/0000-0002-9649-2120","observed_orcids":["https://orcid.org/0000-0002-9649-2120"]},"institutions":[{"id":"https://openalex.org/I4210126294","display_name":"Riga Stradi\u0146\u0161 University","ror":"https://ror.org/03nadks56","country_code":"LV","type":"education","lineage":["https://openalex.org/I4210126294"]}],"countries":["LV"],"is_corresponding":false,"raw_author_name":"Elita Poplavska","raw_affiliation_strings":["Department of Pharmacology and Pharmacotherapy, Faculty of Pharmacy and Institute of Public Health Riga Stradi\u0146\u0161 University  Riga Latvia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology and Pharmacotherapy, Faculty of Pharmacy and Institute of Public Health Riga Stradi\u0146\u0161 University  Riga Latvia","institution_ids":["https://openalex.org/I4210126294"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5148288347","display_name":"Iluta \u017d\u012bgure","orcid":null,"observed_orcids":[]},"institutions":[{"id":"https://openalex.org/I4210126294","display_name":"Riga Stradi\u0146\u0161 University","ror":"https://ror.org/03nadks56","country_code":"LV","type":"education","lineage":["https://openalex.org/I4210126294"]}],"countries":["LV"],"is_corresponding":false,"raw_author_name":"Iluta \u017d\u012bgure","raw_affiliation_strings":["Department of Pharmacology and Pharmacotherapy, Faculty of Pharmacy and Institute of Public Health Riga Stradi\u0146\u0161 University  Riga Latvia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacology and Pharmacotherapy, Faculty of Pharmacy and Institute of Public Health Riga Stradi\u0146\u0161 University  Riga Latvia","institution_ids":["https://openalex.org/I4210126294"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5061256924","display_name":"Christina E. Hoeve","orcid":"https://orcid.org/0000-0002-8432-0604","observed_orcids":["https://orcid.org/0000-0002-8432-0604"]},"institutions":[{"id":"https://openalex.org/I4210104433","display_name":"National Institute for Public Health and the Environment","ror":"https://ror.org/01cesdt21","country_code":"NL","type":"facility","lineage":["https://openalex.org/I4210104433"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Christina E. Hoeve","raw_affiliation_strings":["Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands","institution_ids":["https://openalex.org/I4210104433"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5028944613","display_name":"Teresa Leonardo Alves","orcid":"https://orcid.org/0000-0003-4967-1916","observed_orcids":["https://orcid.org/0000-0003-4967-1916"]},"institutions":[{"id":"https://openalex.org/I4210104433","display_name":"National Institute for Public Health and the Environment","ror":"https://ror.org/01cesdt21","country_code":"NL","type":"facility","lineage":["https://openalex.org/I4210104433"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Teresa Leonardo Alves","raw_affiliation_strings":["Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands","institution_ids":["https://openalex.org/I4210104433"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5089830882","display_name":"Ella D. van Vliet","orcid":"https://orcid.org/0000-0001-6226-5491","observed_orcids":["https://orcid.org/0000-0001-6226-5491"]},"institutions":[{"id":"https://openalex.org/I193662353","display_name":"Utrecht University","ror":"https://ror.org/04pp8hn57","country_code":"NL","type":"education","lineage":["https://openalex.org/I193662353"]},{"id":"https://openalex.org/I4210104433","display_name":"National Institute for Public Health and the Environment","ror":"https://ror.org/01cesdt21","country_code":"NL","type":"facility","lineage":["https://openalex.org/I4210104433"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Ella D. van Vliet","raw_affiliation_strings":["Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands","Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"],"raw_orcid":"https://orcid.org/0000-0001-6226-5491","affiliations":[{"raw_affiliation_string":"Centre for Health Protection National Institute for Public Health and the Environment (RIVM)  Bilthoven The Netherlands","institution_ids":["https://openalex.org/I4210104433"]},{"raw_affiliation_string":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands","institution_ids":["https://openalex.org/I193662353"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5032150372","display_name":"Renato Ferreira\u2010da\u2010Silva","orcid":"https://orcid.org/0000-0001-6517-6021","observed_orcids":["https://orcid.org/0000-0001-6517-6021"]},"institutions":[{"id":"https://openalex.org/I182534213","display_name":"Universidade do Porto","ror":"https://ror.org/043pwc612","country_code":"PT","type":"education","lineage":["https://openalex.org/I182534213"]}],"countries":["PT"],"is_corresponding":false,"raw_author_name":"Renato Ferreira\u2010da\u2010Silva","raw_affiliation_strings":["RISE\u2010Health, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine University of Porto  Porto Portugal"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"RISE\u2010Health, Department of Community Medicine, Information and Health Decision Sciences, Faculty of Medicine University of Porto  Porto Portugal","institution_ids":["https://openalex.org/I182534213"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5050663367","display_name":"Ana Kodri\u010d","orcid":"https://orcid.org/0000-0003-4033-3451","observed_orcids":["https://orcid.org/0000-0003-4033-3451"]},"institutions":[{"id":"https://openalex.org/I153976015","display_name":"University of Ljubljana","ror":"https://ror.org/05njb9z20","country_code":"SI","type":"education","lineage":["https://openalex.org/I153976015"]}],"countries":["SI"],"is_corresponding":false,"raw_author_name":"Ana Kodri\u010d","raw_affiliation_strings":["Faculty of Pharmacy University of Ljubljana  Ljubljana Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Pharmacy University of Ljubljana  Ljubljana Slovenia","institution_ids":["https://openalex.org/I153976015"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5052251495","display_name":"Mitja Kos","orcid":"https://orcid.org/0000-0002-6801-6450","observed_orcids":["https://orcid.org/0000-0002-6801-6450"]},"institutions":[{"id":"https://openalex.org/I153976015","display_name":"University of Ljubljana","ror":"https://ror.org/05njb9z20","country_code":"SI","type":"education","lineage":["https://openalex.org/I153976015"]}],"countries":["SI"],"is_corresponding":false,"raw_author_name":"Mitja Kos","raw_affiliation_strings":["Faculty of Pharmacy University of Ljubljana  Ljubljana Slovenia"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Faculty of Pharmacy University of Ljubljana  Ljubljana Slovenia","institution_ids":["https://openalex.org/I153976015"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5067000131","display_name":"Juan Erviti","orcid":"https://orcid.org/0000-0003-3396-2102","observed_orcids":["https://orcid.org/0000-0003-3396-2102"]},"institutions":[{"id":"https://openalex.org/I4210112085","display_name":"Navarre Institute of Health Research","ror":"https://ror.org/023d5h353","country_code":"ES","type":"education","lineage":["https://openalex.org/I4210112085"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Juan Erviti","raw_affiliation_strings":["Innovation and Organization Unit, Navarre Health Service Spain/Navarra Institute for Health Research (IdiSNA)  Pamplona Spain"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Innovation and Organization Unit, Navarre Health Service Spain/Navarra Institute for Health Research (IdiSNA)  Pamplona Spain","institution_ids":["https://openalex.org/I4210112085"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5005204150","display_name":"Marta Guti\u00e9rrez\u2010Valencia","orcid":"https://orcid.org/0000-0002-3229-6614","observed_orcids":["https://orcid.org/0000-0002-3229-6614"]},"institutions":[{"id":"https://openalex.org/I4210112085","display_name":"Navarre Institute of Health Research","ror":"https://ror.org/023d5h353","country_code":"ES","type":"education","lineage":["https://openalex.org/I4210112085"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Marta Guti\u00e9rrez\u2010Valencia","raw_affiliation_strings":["Innovation and Organization Unit, Navarre Health Service Spain/Navarra Institute for Health Research (IdiSNA)  Pamplona Spain"],"raw_orcid":"https://orcid.org/0000-0002-3229-6614","affiliations":[{"raw_affiliation_string":"Innovation and Organization Unit, Navarre Health Service Spain/Navarra Institute for Health Research (IdiSNA)  Pamplona Spain","institution_ids":["https://openalex.org/I4210112085"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5029690041","display_name":"Luis Carlos Saiz","orcid":"https://orcid.org/0000-0002-9143-5709","observed_orcids":["https://orcid.org/0000-0002-9143-5709"]},"institutions":[{"id":"https://openalex.org/I4210112085","display_name":"Navarre Institute of Health Research","ror":"https://ror.org/023d5h353","country_code":"ES","type":"education","lineage":["https://openalex.org/I4210112085"]}],"countries":["ES"],"is_corresponding":false,"raw_author_name":"Luis Carlos Saiz","raw_affiliation_strings":["Innovation and Organization Unit, Navarre Health Service Spain/Navarra Institute for Health Research (IdiSNA)  Pamplona Spain"],"raw_orcid":"https://orcid.org/0000-0002-9143-5709","affiliations":[{"raw_affiliation_string":"Innovation and Organization Unit, Navarre Health Service Spain/Navarra Institute for Health Research (IdiSNA)  Pamplona Spain","institution_ids":["https://openalex.org/I4210112085"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5138523553","display_name":"Sofia K\u00e4lvemark Sporrong","orcid":"https://orcid.org/0000-0001-5848-8625","observed_orcids":["https://orcid.org/0000-0001-5848-8625"]},"institutions":[{"id":"https://openalex.org/I123387679","display_name":"Uppsala University","ror":"https://ror.org/048a87296","country_code":"SE","type":"education","lineage":["https://openalex.org/I123387679"]}],"countries":["SE"],"is_corresponding":false,"raw_author_name":"Sofia K\u00e4lvemark Sporrong","raw_affiliation_strings":["Department of Pharmacy Uppsala University  Uppsala Sweden"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy Uppsala University  Uppsala Sweden","institution_ids":["https://openalex.org/I123387679"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5140207200","display_name":"Emelie Karlsson","orcid":"https://orcid.org/0009-0001-4229-0259","observed_orcids":["https://orcid.org/0009-0001-4229-0259"]},"institutions":[{"id":"https://openalex.org/I123387679","display_name":"Uppsala University","ror":"https://ror.org/048a87296","country_code":"SE","type":"education","lineage":["https://openalex.org/I123387679"]}],"countries":["SE"],"is_corresponding":false,"raw_author_name":"Emelie Karlsson","raw_affiliation_strings":["Department of Pharmacy Uppsala University  Uppsala Sweden"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Department of Pharmacy Uppsala University  Uppsala Sweden","institution_ids":["https://openalex.org/I123387679"]}]},{"author_position":"middle","author":{"id":"https://openalex.org/A5072642810","display_name":"Christine Leopold","orcid":"https://orcid.org/0000-0002-2046-8490","observed_orcids":["https://orcid.org/0000-0002-2046-8490"]},"institutions":[{"id":"https://openalex.org/I193662353","display_name":"Utrecht University","ror":"https://ror.org/04pp8hn57","country_code":"NL","type":"education","lineage":["https://openalex.org/I193662353"]}],"countries":["NL"],"is_corresponding":false,"raw_author_name":"Christine Leopold","raw_affiliation_strings":["Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"],"raw_orcid":null,"affiliations":[{"raw_affiliation_string":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands","institution_ids":["https://openalex.org/I193662353"]}]},{"author_position":"last","author":{"id":"https://openalex.org/A5054001832","display_name":"Marie L. De Bruin","orcid":"https://orcid.org/0000-0001-9197-7068","observed_orcids":["https://orcid.org/0000-0001-9197-7068"]},"institutions":[{"id":"https://openalex.org/I193662353","display_name":"Utrecht University","ror":"https://ror.org/04pp8hn57","country_code":"NL","type":"education","lineage":["https://openalex.org/I193662353"]}],"countries":["NL"],"is_corresponding":true,"raw_author_name":"Marie L. De Bruin","raw_affiliation_strings":["Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands"],"raw_orcid":"https://orcid.org/0000-0001-9197-7068","affiliations":[{"raw_affiliation_string":"Division of Pharmacoepidemiology and Clinical Pharmacology Utrecht Institute for Pharmaceutical Sciences, Utrecht University  Utrecht The Netherlands","institution_ids":["https://openalex.org/I193662353"]}]}],"institutions":[],"countries_distinct_count":7,"institutions_distinct_count":9,"corresponding_author_ids":["https://openalex.org/A5054001832"],"corresponding_institution_ids":["https://openalex.org/I193662353"],"apc_list":{"value":4780,"currency":"USD","value_usd":4780},"apc_paid":{"value":4780,"currency":"USD","value_usd":4780},"fwci":0.0,"has_fulltext":true,"cited_by_count":0,"citation_normalized_percentile":{"value":0.68492984,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":null,"issue":null,"first_page":null,"last_page":null},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11943","display_name":"Pharmacovigilance and Adverse Drug Reactions","score":0.39750000834465027,"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":0.39750000834465027,"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/T14396","display_name":"Healthcare Regulation","score":0.30660000443458557,"subfield":{"id":"https://openalex.org/subfields/3605","display_name":"Health Information Management"},"field":{"id":"https://openalex.org/fields/36","display_name":"Health Professions"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11649","display_name":"Pharmaceutical industry and healthcare","score":0.06790000200271606,"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"}}],"keywords":[{"id":"https://openalex.org/keywords/implementation-barriers-and-facilitators","display_name":"implementation barriers and facilitators","score":0.8519999980926514},{"id":"https://openalex.org/keywords/regulatory-implementation","display_name":"regulatory implementation","score":0.7670000195503235},{"id":"https://openalex.org/keywords/stakeholder-experiences","display_name":"stakeholder experiences","score":0.7590000033378601},{"id":"https://openalex.org/keywords/national-competent-authorities","display_name":"national competent authorities","score":0.8140000104904175},{"id":"https://openalex.org/keywords/marketing-authorization-holders","display_name":"marketing authorization holders","score":0.972000002861023},{"id":"https://openalex.org/keywords/biosimilars","display_name":"biosimilars","score":0.6859999895095825},{"id":"https://openalex.org/keywords/orphan-drugs","display_name":"orphan drugs","score":0.38199999928474426}],"concepts":[{"id":"https://openalex.org/C61521584","wikidata":"https://www.wikidata.org/wiki/Q705899","display_name":"Accreditation","level":2,"score":0.5577999949455261},{"id":"https://openalex.org/C160735492","wikidata":"https://www.wikidata.org/wiki/Q31207","display_name":"Health care","level":2,"score":0.5525000095367432},{"id":"https://openalex.org/C2775924081","wikidata":"https://www.wikidata.org/wiki/Q55608371","display_name":"Control (management)","level":2,"score":0.5321000218391418},{"id":"https://openalex.org/C201305675","wikidata":"https://www.wikidata.org/wiki/Q852998","display_name":"Stakeholder","level":2,"score":0.517799973487854},{"id":"https://openalex.org/C108759981","wikidata":"https://www.wikidata.org/wiki/Q788590","display_name":"Authorization","level":2,"score":0.5108000040054321},{"id":"https://openalex.org/C195094911","wikidata":"https://www.wikidata.org/wiki/Q14167904","display_name":"Process management","level":1,"score":0.4203000068664551},{"id":"https://openalex.org/C56739046","wikidata":"https://www.wikidata.org/wiki/Q192060","display_name":"Knowledge management","level":1,"score":0.4147000014781952},{"id":"https://openalex.org/C509550671","wikidata":"https://www.wikidata.org/wiki/Q126945","display_name":"Medical education","level":1,"score":0.40639999508857727},{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.4025000035762787},{"id":"https://openalex.org/C104863432","wikidata":"https://www.wikidata.org/wiki/Q614304","display_name":"Pharmacy","level":2,"score":0.3971000015735626},{"id":"https://openalex.org/C2910001868","wikidata":"https://www.wikidata.org/wiki/Q458","display_name":"European union","level":2,"score":0.38909998536109924},{"id":"https://openalex.org/C144133560","wikidata":"https://www.wikidata.org/wiki/Q4830453","display_name":"Business","level":0,"score":0.36480000615119934},{"id":"https://openalex.org/C2778917124","wikidata":"https://www.wikidata.org/wiki/Q7309705","display_name":"Regulatory science","level":2,"score":0.3605000078678131},{"id":"https://openalex.org/C2779328685","wikidata":"https://www.wikidata.org/wiki/Q1475557","display_name":"Patient safety","level":3,"score":0.35580000281333923},{"id":"https://openalex.org/C2780984029","wikidata":"https://www.wikidata.org/wiki/Q2930198","display_name":"Stakeholder engagement","level":2,"score":0.3546000123023987},{"id":"https://openalex.org/C2777589142","wikidata":"https://www.wikidata.org/wiki/Q6770899","display_name":"Marketing authorization","level":2,"score":0.35179999470710754},{"id":"https://openalex.org/C39896193","wikidata":"https://www.wikidata.org/wiki/Q380344","display_name":"Descriptive statistics","level":2,"score":0.3456000089645386},{"id":"https://openalex.org/C2780665704","wikidata":"https://www.wikidata.org/wiki/Q959298","display_name":"Intervention (counseling)","level":2,"score":0.3310999870300293},{"id":"https://openalex.org/C2779598192","wikidata":"https://www.wikidata.org/wiki/Q17514788","display_name":"Prior authorization","level":2,"score":0.3305000066757202},{"id":"https://openalex.org/C159110408","wikidata":"https://www.wikidata.org/wiki/Q121176","display_name":"Nursing","level":1,"score":0.31139999628067017},{"id":"https://openalex.org/C177212765","wikidata":"https://www.wikidata.org/wiki/Q627335","display_name":"Workflow","level":2,"score":0.3066999912261963},{"id":"https://openalex.org/C2779473830","wikidata":"https://www.wikidata.org/wiki/Q1540899","display_name":"MEDLINE","level":2,"score":0.29510000348091125},{"id":"https://openalex.org/C32896092","wikidata":"https://www.wikidata.org/wiki/Q189447","display_name":"Risk management","level":2,"score":0.2854999899864197},{"id":"https://openalex.org/C26517878","wikidata":"https://www.wikidata.org/wiki/Q228039","display_name":"Key (lock)","level":2,"score":0.2777999937534332},{"id":"https://openalex.org/C41008148","wikidata":"https://www.wikidata.org/wiki/Q21198","display_name":"Computer science","level":0,"score":0.2754000127315521},{"id":"https://openalex.org/C195910791","wikidata":"https://www.wikidata.org/wiki/Q1324077","display_name":"Medical record","level":2,"score":0.2728999853134155},{"id":"https://openalex.org/C29122968","wikidata":"https://www.wikidata.org/wiki/Q1414816","display_name":"Incentive","level":2,"score":0.26829999685287476},{"id":"https://openalex.org/C163355716","wikidata":"https://www.wikidata.org/wiki/Q2154783","display_name":"Risk perception","level":3,"score":0.26669999957084656},{"id":"https://openalex.org/C112930515","wikidata":"https://www.wikidata.org/wiki/Q4389547","display_name":"Risk analysis (engineering)","level":1,"score":0.26089999079704285},{"id":"https://openalex.org/C20136886","wikidata":"https://www.wikidata.org/wiki/Q749647","display_name":"Interoperability","level":2,"score":0.2574999928474426},{"id":"https://openalex.org/C39389867","wikidata":"https://www.wikidata.org/wiki/Q380767","display_name":"Corporate governance","level":2,"score":0.2556000053882599},{"id":"https://openalex.org/C170130773","wikidata":"https://www.wikidata.org/wiki/Q216378","display_name":"Usability","level":2,"score":0.25369998812675476},{"id":"https://openalex.org/C184356942","wikidata":"https://www.wikidata.org/wiki/Q830382","display_name":"Best practice","level":2,"score":0.25110000371932983}],"mesh":[],"locations_count":2,"locations":[{"id":"doi:10.1002/bcp.70783","doi":"https://doi.org/10.1002/bcp.70783","is_oa":true,"landing_page_url":"https://doi.org/10.1002/bcp.70783","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bcp.70783","source":{"id":"https://openalex.org/S13842274","display_name":"British Journal of Clinical Pharmacology","issn_l":"0306-5251","issn":["0306-5251","1365-2125"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British Journal of Clinical Pharmacology","raw_type":"journal-article"},{"id":"pmid:42648741","doi":null,"is_oa":false,"landing_page_url":"https://pubmed.ncbi.nlm.nih.gov/42648741","pdf_url":null,"source":{"id":"https://openalex.org/S4306525036","display_name":"PubMed","issn_l":null,"issn":null,"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":[],"host_organization":"https://openalex.org/I1299303238","host_organization_name":"National Institutes of Health","host_organization_lineage":["https://openalex.org/I1299303238"],"host_organization_lineage_names":[],"type":"repository"},"license":null,"license_id":null,"version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British journal of clinical pharmacology","raw_type":"Journal Article"}],"best_oa_location":{"id":"doi:10.1002/bcp.70783","doi":"https://doi.org/10.1002/bcp.70783","is_oa":true,"landing_page_url":"https://doi.org/10.1002/bcp.70783","pdf_url":"https://onlinelibrary.wiley.com/doi/pdfdirect/10.1002/bcp.70783","source":{"id":"https://openalex.org/S13842274","display_name":"British Journal of Clinical Pharmacology","issn_l":"0306-5251","issn":["0306-5251","1365-2125"],"is_oa":false,"is_in_doaj":false,"is_core":true,"listed_in":["anvur-scientific","cwts-core","dongbi-b","doyens","jufo-2","ki-jl-2","medline","norway-2","poland-100","russia-white-list-2","vabb-shw"],"host_organization":"https://openalex.org/P4310320595","host_organization_name":"Wiley","host_organization_lineage":["https://openalex.org/P4310320595"],"host_organization_lineage_names":["Wiley"],"type":"journal"},"license":"cc-by-nc","license_id":"https://openalex.org/licenses/cc-by-nc","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"British Journal of Clinical Pharmacology","raw_type":"journal-article"},"sustainable_development_goals":[{"display_name":"Good health and well-being","score":0.9537000060081482,"id":"https://metadata.un.org/sdg/3"}],"sustainable_development_goals_aurora":[{"display_name":"Partnerships for the goals","score":0.4739128351211548,"id":"https://metadata.un.org/sdg/17"}],"study_designs":[{"display_name":"Observational Study","id":"https://openalex.org/study-designs/observational-study"}],"awards":[],"funders":[{"id":"https://openalex.org/F4320321010","display_name":"Universiteit Utrecht","ror":"https://ror.org/04pp8hn57"},{"id":"https://openalex.org/F4320321644","display_name":"College ter Beoordeling van Geneesmiddelen","ror":"https://ror.org/041evnj42"},{"id":"https://openalex.org/F4320335216","display_name":"Rijksinstituut voor Volksgezondheid en Milieu","ror":"https://ror.org/01cesdt21"}],"has_content":{"grobid_xml":true,"pdf":true},"content_urls":{"pdf":"https://content.openalex.org/works/W7204234753.pdf","grobid_xml":"https://content.openalex.org/works/W7204234753.grobid-xml"},"referenced_works_count":3,"referenced_works":["https://openalex.org/W1505489204","https://openalex.org/W3152957192","https://openalex.org/W4391969002"],"related_works":[],"abstract_inverted_index":{"AIMS:":[0],"This":[1],"study":[2],"characterized":[3],"stakeholders'":[4],"experiences":[5],"with":[6,127,149,178,240],"national":[7,46],"implementation":[8,59,95,98,129,138,216,224,233],"of":[9,62,107,134,156],"risk":[10],"minimization":[11],"control":[12],"tools":[13],"(RMCTs),":[14],"such":[15],"as":[16,139,176,220],"healthcare":[17,20,172],"professional":[18],"qualification,":[19],"facility":[21],"accreditation":[22],"and":[23,54,73,88,99,110,146,165,190,209,247],"medical":[24],"intervention":[25],"prior":[26,163,210],"to":[27,192],"treatment":[28],"initiation,":[29],"for":[30,144,152,188,195],"eight":[31,35,77],"medicinal":[32],"products":[33,78],"across":[34,93],"European":[36],"Union":[37],"countries.":[38],"METHODS:":[39],"We":[40,117],"conducted":[41],"a":[42,159],"cross-sectional":[43],"survey":[44],"among":[45],"competent":[47],"authorities,":[48],"marketing":[49],"authorization":[50],"holders,":[51],"physicians,":[52],"pharmacists":[53],"other":[55],"stakeholders":[56],"involved":[57],"in":[58,64],"or":[60,141,180],"use":[61],"RMCTs":[63,157],"Austria,":[65],"Greece,":[66],"Latvia,":[67],"the":[68,200],"Netherlands,":[69],"Portugal,":[70],"Slovenia,":[71],"Spain":[72],"Sweden.":[74],"The":[75,154],"following":[76],"were":[79,91,104,114,130,168],"included:":[80],"Aspaveli\u00ae,":[81],"Fintepla\u00ae,":[82],"Revlimid\u00ae/generics,":[83],"Soliris\u00ae/biosimilars,":[84],"Spravato\u00ae,":[85,147],"Strimvelis\u00ae,":[86],"Uptravi\u00ae":[87],"Yescarta\u00ae.":[89],"Experiences":[90,126],"assessed":[92],"two":[94],"phases:":[96],"regulatory":[97,128,137,223],"integration":[100,229],"into":[101,171,230],"healthcare.":[102,231],"Outcomes":[103],"perceived":[105,175,219],"ease":[106],"implementation,":[108],"barriers":[109],"enablers.":[111,169],"Descriptive":[112],"analyses":[113],"performed.":[115],"RESULTS:":[116],"received":[118],"202":[119],"valid":[120],"entries,":[121],"representing":[122],"286":[123],"stakeholder-product":[124],"combinations.":[125],"heterogeneous.":[131],"Approximately":[132],"75%":[133,194],"respondents":[135],"rated":[136],"difficult":[140,143],"very":[142,181],"Fintepla\u00ae":[145,189],"compared":[148],"about":[150,193],"25%":[151],"Uptravi\u00ae.":[153],"complexity":[155],"was":[158,173,199,217,225],"key":[160],"barrier,":[161,202],"while":[162],"experience":[164,211],"peer":[166,207],"learning":[167,208],"Integration":[170],"predominantly":[174],"easy,":[177],"easy":[179,182],"ratings":[183],"ranging":[184],"from":[185,236],"over":[186],"90%":[187],"Spravato\u00ae":[191],"Revlimid\u00ae/generics.":[196],"Administrative":[197],"effort":[198],"main":[201],"whereas":[203],"clinical":[204],"guidelines,":[205],"training,":[206],"facilitated":[212],"integration.":[213],"CONCLUSIONS:":[214],"RMCT":[215],"generally":[218],"feasible,":[221],"although":[222],"more":[226],"challenging":[227],"than":[228],"Successful":[232],"may":[234],"benefit":[235],"flexible":[237],"design,":[238],"alignment":[239],"existing":[241],"systems,":[242],"feasibility":[243],"assessment,":[244],"stakeholder":[245],"engagement":[246],"clear":[248],"guidance.":[249]},"counts_by_year":[],"updated_date":"2026-10-13T10:08:12.033832","created_date":"2026-08-27T00:00:00"}