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Medical Bioethics in EU Legislation

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. Medical Bioethics in EU Legislation. March 9, 2014. Declaratia de la Helsinki iunie 1964 cu toate amendamentele inclusiv cel din octombrie 2013. Regulamentul nr. 536/2014. Directiva Comisiei Europene a Studiilor Clinice (2005/28/EC). Good Clinical Practice Protocol. Legislation - Medical Devices. Decision no. 798 of 03/07/2003. Decision no. 54 din 29/01/2009. Full list of EU useful links.

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The Objectives of the National Committee of the Medicines and Medical Devices (CNBMD)

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. The Objectives of the National Committee of the Medicines and Medical Devices (CNBMD). February 23, 2014. CNMDM in the research process:. A) Before beginning research. Ethical evaluation of research proposal;. B) After the investigation began:. Pursuing research project under ethical aspects;. Possible revaluation in the leading research phase;. Assessments made by CNMDM are made in acc...

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What is Bioethics?

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. March 9, 2014. Bioethics has become a discipline of applied ethics since the ’70s, when medical practices began to be interested in a moral approach to specific problems from the medical domain. Thus it became imperative the requirement to have a method to find solutions to moral problems, or ways to be able to assess the moral choices of the medical staff. This decision procedure becam...

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Legislation on Medical Devices in Romania

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. Legislation on Medical Devices in Romania. March 9, 2014. Hotararea guvernului nr. 798/2003 privind stabilirea condiţiilor de introducere pe piaţă şi de utilizare a dispozitivelor medicale pentru diagnostic in vitro. Hotararea guvernului nr. 54/2009 privind condiţiile introducerii pe piaţă a dispozitivelor medicale. Numar de catalog 1412. Legislation - Medical Devices.

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Act of Incorporation

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. February 23, 2014. Bioethics Committee of Medicines and Medical Devices. Order no. 34 of 09.01.2014. Enhanced Version on: 01/21/2014. Order no. 34/2014 for the amendment of Order of the Interim Minister of Health no. 1.446/2009 regarding the establishment of the National Commission of Ethics and approval of its structure. 1 Title Order is amended to read as follows:. 8220;Art . 1 &#...

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Legislation of Medical Bioethics In Romania

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. Legislation of Medical Bioethics In Romania. March 9, 2014. OMS 891/2006 – modelului Fişei pentru raportarea spontană a reacţiilor adverse la medicamente. OMS 903/2006 Principiile şi ghidurile detaliate privind buna practică în studiul clinic pentru medicamente de uz uman pentru investigaţie clinică, precum şi cerinţele pentru fabricaţia şi importul acestor medicamente. Anexa 1 la HCS 39.

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CNBMDM Communications

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National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. Completion of Communication dated 01Sep2014. Release 01.09.2014. Release 10.07.2017. Release 19.05.2014. Release 08.05.2014. Operating Regulations of the CNBMDM in its relations with companies organizing clinical studies. Release 01.03.2014. Release 20.03.2014. Release 06.03.2014. Legislation - Medical Devices. Decision no. 798 of 03/07/2003. Decision no. 54 din 29/01/2009.

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Useful Documents

http://en.bioetica-medicala.ro/documente-utile

National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. March 9, 2014. Regulations of the Comission. Legislation - Medical Devices. Decision no. 798 of 03/07/2003. Decision no. 54 din 29/01/2009. Decision no. 55 din 29/01/2009. Order no. 792 din 29/06/2006. Full list of EU useful links.

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EU Legislation on Medical Devices

http://en.bioetica-medicala.ro/legislatia-dispozitivelor-medicale-in-ue

National Committee of the Medicines and Medical Devices. Academy of Medical Sciences. Submitted and approved documents. EU Legislation on Medical Devices. March 9, 2014. Pentru mai multe informatii aceste documente se pot vizualiza de la adresa Comisiei europene :. Http:/ ec.europa.eu/consumers/sectors/medical-devices/documents/index en.htm. Legislation - Medical Devices. Decision no. 798 of 03/07/2003. Decision no. 54 din 29/01/2009. Decision no. 55 din 29/01/2009. Order no. 792 din 29/06/2006.