Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey

Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Reques...
Ausführliche Beschreibung

Gespeichert in:

Autor*in:	Chen, Lisa [verfasserIn] Scheld, Harry

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2014

Schlagwörter:	medical information drug information medical affairs compliance industry

Anmerkung:	© Drug Information Association, Inc 2014

Übergeordnetes Werk:	Enthalten in: Therapeutic innovation & regulatory science - [New York] : Springer Nature, 2013, 48(2014), 4 vom: Juli, Seite 494-497
Übergeordnetes Werk:	volume:48 ; year:2014 ; number:4 ; month:07 ; pages:494-497

Links:	Volltext

DOI / URN:	10.1177/2168479014529570

Katalog-ID:	SPR038924064

Internformat


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520			\|a Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers.
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publishDate	2014
allfields	10.1177/2168479014529570 doi (DE-627)SPR038924064 (SPR)2168479014529570-e DE-627 ger DE-627 rakwb eng Chen, Lisa verfasserin aut Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2014 Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. medical information (dpeaa)DE-He213 drug information (dpeaa)DE-He213 medical affairs (dpeaa)DE-He213 compliance (dpeaa)DE-He213 industry (dpeaa)DE-He213 Scheld, Harry aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 48(2014), 4 vom: Juli, Seite 494-497 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:48 year:2014 number:4 month:07 pages:494-497 https://dx.doi.org/10.1177/2168479014529570 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4277 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 48 2014 4 07 494-497
spelling	10.1177/2168479014529570 doi (DE-627)SPR038924064 (SPR)2168479014529570-e DE-627 ger DE-627 rakwb eng Chen, Lisa verfasserin aut Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2014 Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. medical information (dpeaa)DE-He213 drug information (dpeaa)DE-He213 medical affairs (dpeaa)DE-He213 compliance (dpeaa)DE-He213 industry (dpeaa)DE-He213 Scheld, Harry aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 48(2014), 4 vom: Juli, Seite 494-497 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:48 year:2014 number:4 month:07 pages:494-497 https://dx.doi.org/10.1177/2168479014529570 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4277 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 48 2014 4 07 494-497
allfields_unstemmed	10.1177/2168479014529570 doi (DE-627)SPR038924064 (SPR)2168479014529570-e DE-627 ger DE-627 rakwb eng Chen, Lisa verfasserin aut Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2014 Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. medical information (dpeaa)DE-He213 drug information (dpeaa)DE-He213 medical affairs (dpeaa)DE-He213 compliance (dpeaa)DE-He213 industry (dpeaa)DE-He213 Scheld, Harry aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 48(2014), 4 vom: Juli, Seite 494-497 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:48 year:2014 number:4 month:07 pages:494-497 https://dx.doi.org/10.1177/2168479014529570 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4277 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 48 2014 4 07 494-497
allfieldsGer	10.1177/2168479014529570 doi (DE-627)SPR038924064 (SPR)2168479014529570-e DE-627 ger DE-627 rakwb eng Chen, Lisa verfasserin aut Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2014 Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. medical information (dpeaa)DE-He213 drug information (dpeaa)DE-He213 medical affairs (dpeaa)DE-He213 compliance (dpeaa)DE-He213 industry (dpeaa)DE-He213 Scheld, Harry aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 48(2014), 4 vom: Juli, Seite 494-497 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:48 year:2014 number:4 month:07 pages:494-497 https://dx.doi.org/10.1177/2168479014529570 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4277 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 48 2014 4 07 494-497
allfieldsSound	10.1177/2168479014529570 doi (DE-627)SPR038924064 (SPR)2168479014529570-e DE-627 ger DE-627 rakwb eng Chen, Lisa verfasserin aut Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Drug Information Association, Inc 2014 Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. medical information (dpeaa)DE-He213 drug information (dpeaa)DE-He213 medical affairs (dpeaa)DE-He213 compliance (dpeaa)DE-He213 industry (dpeaa)DE-He213 Scheld, Harry aut Enthalten in Therapeutic innovation & regulatory science [New York] : Springer Nature, 2013 48(2014), 4 vom: Juli, Seite 494-497 (DE-627)739896415 (DE-600)2708397-4 2168-4804 nnns volume:48 year:2014 number:4 month:07 pages:494-497 https://dx.doi.org/10.1177/2168479014529570 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_121 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_152 GBV_ILN_161 GBV_ILN_165 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_206 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_374 GBV_ILN_602 GBV_ILN_636 GBV_ILN_647 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2018 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2036 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2043 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2056 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2070 GBV_ILN_2086 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2098 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2116 GBV_ILN_2118 GBV_ILN_2119 GBV_ILN_2122 GBV_ILN_2125 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2145 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2158 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2193 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_2704 GBV_ILN_2707 GBV_ILN_2889 GBV_ILN_2890 GBV_ILN_4012 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4126 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4277 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4328 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4346 GBV_ILN_4367 GBV_ILN_4393 GBV_ILN_4700 GBV_ILN_4753 AR 48 2014 4 07 494-497
language	English
source	Enthalten in Therapeutic innovation & regulatory science 48(2014), 4 vom: Juli, Seite 494-497 volume:48 year:2014 number:4 month:07 pages:494-497
sourceStr	Enthalten in Therapeutic innovation & regulatory science 48(2014), 4 vom: Juli, Seite 494-497 volume:48 year:2014 number:4 month:07 pages:494-497
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	medical information drug information medical affairs compliance industry
isfreeaccess_bool	false
container_title	Therapeutic innovation & regulatory science
authorswithroles_txt_mv	Chen, Lisa @@aut@@ Scheld, Harry @@aut@@
publishDateDaySort_date	2014-07-01T00:00:00Z
hierarchy_top_id	739896415
id	SPR038924064
language_de	englisch
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author	Chen, Lisa
spellingShingle	Chen, Lisa misc medical information misc drug information misc medical affairs misc compliance misc industry Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey
authorStr	Chen, Lisa
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issn	2168-4804
topic_title	Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey medical information (dpeaa)DE-He213 drug information (dpeaa)DE-He213 medical affairs (dpeaa)DE-He213 compliance (dpeaa)DE-He213 industry (dpeaa)DE-He213
topic	misc medical information misc drug information misc medical affairs misc compliance misc industry
topic_unstemmed	misc medical information misc drug information misc medical affairs misc compliance misc industry
topic_browse	misc medical information misc drug information misc medical affairs misc compliance misc industry
format_facet	Elektronische Aufsätze Aufsätze Elektronische Ressource
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title	Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey
ctrlnum	(DE-627)SPR038924064 (SPR)2168479014529570-e
title_full	Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey
author_sort	Chen, Lisa
journal	Therapeutic innovation & regulatory science
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container_start_page	494
author_browse	Chen, Lisa Scheld, Harry
container_volume	48
format_se	Elektronische Aufsätze
author-letter	Chen, Lisa
doi_str_mv	10.1177/2168479014529570
title_sort	compliance within medical information and the emergence of a medical information–dedicated compliance person: a benchmarking survey
title_auth	Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey
abstract	Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. © Drug Information Association, Inc 2014
abstractGer	Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. © Drug Information Association, Inc 2014
abstract_unstemmed	Abstract In light of the increasing scrutiny by governing authorities, compliance requirements for medical information (MI) departments have increased over the past few years. In response to the Food and Drug Administration (FDA) draft guidance for industry, entitled Responding to Unsolicited Requests for Off-label Information About Prescription Drugs and Medical Devices, MI groups may be changing their policies and procedures to further ensure compliance. The primary objective of this study was to benchmark industry-specific practices related to maintaining compliance in MI, particularly whether there is an emergence of a dedicated compliance person working within the MI department, whom we refer to as the MI-dedicated compliance person hereafter. A secondary objective was to identify changes to MI interactions with internal and external stakeholders that occurred in the last 2 years in response to an evolving regulatory climate. A web-based survey was disseminated to MI professionals from 49 companies between December 2012 and February 2013. Practices that were assessed include MI team training, monitoring, audits, and creation of letter responses. The results may be useful for MI groups interested in changing or comparing their compliance practices to those currently utilized by their peers. © Drug Information Association, Inc 2014
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container_issue	4
title_short	Compliance Within Medical Information and the Emergence of a Medical Information–Dedicated Compliance Person: A Benchmarking Survey
url	https://dx.doi.org/10.1177/2168479014529570
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author2	Scheld, Harry
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doi_str	10.1177/2168479014529570
up_date	2024-07-03T20:45:13.137Z
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