0A4F4F9BD490A749D5437F821CF06DF1
Provision 10017-E/2017 ANMAT: Promoting Cooperation Between ANMAT and Jurisdictional Health Authorities for the Evaluation and Oversight of Clinical Research Sites and Investigators
http://servicios.infoleg.gob.ar/infolegInternet/anexos/275000-279999/279820/norma.htm
http://leaux.net/URLS/ConvertAPI Text Files/6C0EC90080E25B18FFFF5D871C844C34.en.txt
Examining the file media/Synopses/6C0EC90080E25B18FFFF5D871C844C34.html:
This file was generated: 2020-07-14 10:48:30
| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Political / stateless persons
Searching for indicator nation:
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p.(None): A.N.M.A.T. No. 6677/10, will provide the following information:
p.(None): 1) In relation to the Research Ethics Committee (CEI) and the Informed Consent:
p.(None): a) Name and address of the CEI involved.
p.(None): b) CEI means of contact (email, telephone, and / or others)
p.(None): c) Version of the informed consent approved by the CEI.
p.(None): d) Detailed opinion of the result of the evaluation carried out by the acting CEI countersigned by the Ministry of Health of the jurisdiction, or the authority designated by it.
p.(None): 2) In relation to the Research Center:
p.(None): a) Name and address of the research center
p.(None): b) Means of contact of the research center (email, telephone, and / or others)
p.(None): c) Definition of the level of care complexity of the center, and its correspondence with the requirement of the proposed clinical study.
p.(None): 3) Regarding the main researcher:
p.(None): a) Last name and first name of the principal investigator.
p.(None): b) Curriculum vitae of the main researcher (detailing means of contact).
p.(None): c) Correspondence of their history and suitability with the requirement of the proposed clinical study.
p.(None): ARTICLE 3º.- The A.N.M.A.T. Federal will be in charge of managing and facilitating all the aspects inherent in specifying the signing of the agreements.
p.(None): ARTICLE 4º.- Register. Give it to the National Directorate of the Official Registry for publication. Contact the Undersecretariat for Policies, Regulation and Oversight of the
p.(None): Ministry of Health of the Nation, to all the ministries of Health of the provincial jurisdictions and of the Autonomous City of Buenos Aires (CABA), to the Industrial Chamber
p.(None): from Argentine Pharmaceutical Laboratories (CILFA), to the Argentine Chamber of Medicinal Specialties (CAEMe), to the Business Chamber of Pharmaceutical Laboratories
p.(None): (COOPERALA), to the Argentine Chamber of Clinical Research Organizations (CAOIC), to the Argentine Chamber of Producers of Generic and Use Medicines
p.(None): Hospital (CAPGEN), and the Argentine Chamber of Over-the-Counter Medicines (CAPEMVeL). Contact the National Institute of Medicines, the Directorate of
p.(None): Computing and the Planning and Institutional Relations Directorate. Fulfilled, file. - Carlos Alberto Chiale.
...
Social / philosophical differences/differences of opinion
Searching for indicator opinion:
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p.(None): intervention of its competition.
p.(None): That it acts by virtue of the powers conferred by Decree No. 1490/92 and Decree No. 101 dated December 16, 2015.
p.(None): Thus,
p.(None): THE NATIONAL ADMINISTRATOR OF THE NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY,
p.(None): HAS:
p.(None): ARTICLE 1.- The signing of cooperation agreements between this National Administration and the health authorities of each provincial jurisdiction and the City is promoted.
p.(None): Autonomous of Buenos Aires (CABA), in order that they assume the commitment to evaluate and monitor the ethical and methodological aspects of the studies of
p.(None): clinical pharmacology that are carried out in their respective jurisdictions, as well as the evaluation of the level of complexity of the research center and the
p.(None): background and suitability of the principal investigator.
p.(None): ARTICLE 2º.- The cooperation agreement will contemplate that for the clinical pharmacology studies to be initiated in each jurisdiction, the highest health authority, or whoever
p.(None): reliably designate, within the term established in article 5 of the A.N.M.A.T. No. 4008/17, which replaces point 2.2 of the Annex to the Provision
p.(None): A.N.M.A.T. No. 6677/10, will provide the following information:
p.(None): 1) In relation to the Research Ethics Committee (CEI) and the Informed Consent:
p.(None): a) Name and address of the CEI involved.
p.(None): b) CEI means of contact (email, telephone, and / or others)
p.(None): c) Version of the informed consent approved by the CEI.
p.(None): d) Detailed opinion of the result of the evaluation carried out by the acting CEI countersigned by the Ministry of Health of the jurisdiction, or the authority designated by it.
p.(None): 2) In relation to the Research Center:
p.(None): a) Name and address of the research center
p.(None): b) Means of contact of the research center (email, telephone, and / or others)
p.(None): c) Definition of the level of care complexity of the center, and its correspondence with the requirement of the proposed clinical study.
p.(None): 3) Regarding the main researcher:
p.(None): a) Last name and first name of the principal investigator.
p.(None): b) Curriculum vitae of the main researcher (detailing means of contact).
p.(None): c) Correspondence of their history and suitability with the requirement of the proposed clinical study.
p.(None): ARTICLE 3º.- The A.N.M.A.T. Federal will be in charge of managing and facilitating all the aspects inherent in specifying the signing of the agreements.
p.(None): ARTICLE 4º.- Register. Give it to the National Directorate of the Official Registry for publication. Contact the Undersecretariat for Policies, Regulation and Oversight of the
p.(None): Ministry of Health of the Nation, to all the ministries of Health of the provincial jurisdictions and of the Autonomous City of Buenos Aires (CABA), to the Industrial Chamber
p.(None): from Argentine Pharmaceutical Laboratories (CILFA), to the Argentine Chamber of Medicinal Specialties (CAEMe), to the Business Chamber of Pharmaceutical Laboratories
p.(None): (COOPERALA), to the Argentine Chamber of Clinical Research Organizations (CAOIC), to the Argentine Chamber of Producers of Generic and Use Medicines
p.(None): Hospital (CAPGEN), and the Argentine Chamber of Over-the-Counter Medicines (CAPEMVeL). Contact the National Institute of Medicines, the Directorate of
...
General/Other / Relationship to Authority
Searching for indicator authority:
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p.(None): That the active participation of all health jurisdictions in that same purpose is timely and necessary, strengthening the evaluating and auditing bodies
p.(None): local and helping to unify the prevailing criteria in the country.
p.(None): That also constitutes an additional guarantee for the subjects participating in clinical pharmacology studies than the jurisdictional authorities, through the committees
p.(None): of ethics, are involved in the evaluation and authorization process of the studies that are carried out in their respective jurisdictions.
p.(None): That the National Institute of Medicines, the Directorate for Evaluation and Registration of Medicines of INAME and the General Directorate of Legal Affairs, have taken the
p.(None): intervention of its competition.
p.(None): That it acts by virtue of the powers conferred by Decree No. 1490/92 and Decree No. 101 dated December 16, 2015.
p.(None): Thus,
p.(None): THE NATIONAL ADMINISTRATOR OF THE NATIONAL ADMINISTRATION OF MEDICINES, FOOD AND MEDICAL TECHNOLOGY,
p.(None): HAS:
p.(None): ARTICLE 1.- The signing of cooperation agreements between this National Administration and the health authorities of each provincial jurisdiction and the City is promoted.
p.(None): Autonomous of Buenos Aires (CABA), in order that they assume the commitment to evaluate and monitor the ethical and methodological aspects of the studies of
p.(None): clinical pharmacology that are carried out in their respective jurisdictions, as well as the evaluation of the level of complexity of the research center and the
p.(None): background and suitability of the principal investigator.
p.(None): ARTICLE 2º.- The cooperation agreement will contemplate that for the clinical pharmacology studies to be initiated in each jurisdiction, the highest health authority, or whoever
p.(None): reliably designate, within the term established in article 5 of the A.N.M.A.T. No. 4008/17, which replaces point 2.2 of the Annex to the Provision
p.(None): A.N.M.A.T. No. 6677/10, will provide the following information:
p.(None): 1) In relation to the Research Ethics Committee (CEI) and the Informed Consent:
p.(None): a) Name and address of the CEI involved.
p.(None): b) CEI means of contact (email, telephone, and / or others)
p.(None): c) Version of the informed consent approved by the CEI.
p.(None): d) Detailed opinion of the result of the evaluation carried out by the acting CEI countersigned by the Ministry of Health of the jurisdiction, or the authority designated by it.
p.(None): 2) In relation to the Research Center:
p.(None): a) Name and address of the research center
p.(None): b) Means of contact of the research center (email, telephone, and / or others)
p.(None): c) Definition of the level of care complexity of the center, and its correspondence with the requirement of the proposed clinical study.
p.(None): 3) Regarding the main researcher:
p.(None): a) Last name and first name of the principal investigator.
p.(None): b) Curriculum vitae of the main researcher (detailing means of contact).
p.(None): c) Correspondence of their history and suitability with the requirement of the proposed clinical study.
p.(None): ARTICLE 3º.- The A.N.M.A.T. Federal will be in charge of managing and facilitating all the aspects inherent in specifying the signing of the agreements.
p.(None): ARTICLE 4º.- Register. Give it to the National Directorate of the Official Registry for publication. Contact the Undersecretariat for Policies, Regulation and Oversight of the
p.(None): Ministry of Health of the Nation, to all the ministries of Health of the provincial jurisdictions and of the Autonomous City of Buenos Aires (CABA), to the Industrial Chamber
p.(None): from Argentine Pharmaceutical Laboratories (CILFA), to the Argentine Chamber of Medicinal Specialties (CAEMe), to the Business Chamber of Pharmaceutical Laboratories
p.(None): (COOPERALA), to the Argentine Chamber of Clinical Research Organizations (CAOIC), to the Argentine Chamber of Producers of Generic and Use Medicines
p.(None): Hospital (CAPGEN), and the Argentine Chamber of Over-the-Counter Medicines (CAPEMVeL). Contact the National Institute of Medicines, the Directorate of
p.(None): Computing and the Planning and Institutional Relations Directorate. Fulfilled, file. - Carlos Alberto Chiale.
...
Orphaned Trigger Words
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| authority | Relationship to Authority |
| nation | stateless persons |
| opinion | philosophical differences/differences of opinion |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
Applicable Type / Vulnerability / Indicator Overlay for this Input