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Bibliography 1. European Commission. The Notice to Applicants. Volume 2B. Medicinal products for human use. Presentation and format of the dossier. Common Technical Document (CTD) http://ec.europa.eu/enterprise/sectors/pharmaceuticals/files/eudralex/vol- 2/b/update_200805/ctd_05-2008_en.pdf 2. European Commission. The Notice to Applicants Volume 2A. Procedures for marketing authorization. Chapter 4: the centralized procedures. http://ec.europa.eu/enterprise/pharmaceuticals/eudralex/vol- 2/a/chap4rev200604%20.pdf 3. S. Garattini, V. Bertele', Europe's opportunity to open up drug regulation, “BMJ”, 2010, 340, pp. 842-3 4. J.T. O’Reilly, Implications of international drug approval system on confidentiality of business secrets in the U.S. pharmaceutical industry, “Intern Drug Approval Syst.”, 1998, 53, pp.123-32 5. Council of Europe. Convention on human rights and biomedicine (Oviedo Convention), 1996. Available at: http://www.iss.it/binary/coet/cont/ConvOviedo.1128329819.pdf. 151
Presidenza del Consiglio dei Ministri CRITERIA FOR ASCERTAINING DEATH 24th of June 2010 152
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PRESIDENT Prof. Francesco Paolo Cas
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Prof. Alberto Piazza Full Professor
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PRESENTATION The National Bioethics
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a _________________________ DEMONST
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confidence intervals. At times the
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functioning of ethical Committees,
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Introduction The National Bioethics
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Document 1. Interspecies living bei
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denucleated cytoplasm of animal spe
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weeks old, into sheep foetuses. A f
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transferring the nucleus, inserting
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Some NBC members 35 observe that th
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3.1 The state of the art Only one s
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I. The ethical value of the experim
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intentionally produced for experime
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Constitution that, like the German
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of identifying the biochemical dete
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) any other process that starts the
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As for the letter b), we observe th
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Other NBC members 73 instead have r
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present a differentiated panorama.
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Biomedicine, issued in Oviedo on th
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with regards to its practical appli
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PERSONAL REMARKS Supplementary pers
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Only one published scientific paper
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Why? Perhaps you have information w
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intervention on the object, but is
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INTRODUCTION The opinion analyses m
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animals used for experimental or ot
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alternative based on the 3Rs model
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appropriate application of the 3Rs
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Committees (named in a variety of w
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elaborating the data received highl
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Synthesis and recommendations In li
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Howard B., Hudson M., Preziosi R.,
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Appendix The working Group sent a q
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FACULTY CITY answer question 1 Facu
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natural sciences rarely Faculty of
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Faculty of veterinary medicine 3502
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Effectively, this document could ha
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PRESENTATION…………………
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25 th February 2010 in unanimity of
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Multiple factors contribute to sexu
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complement XY a female phenotype, w
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labia. Menarche does not occur, the
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made to subjective perception 116 .
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e re-masculinized) has highlighted
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this sense the guidelines focusing
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even if the boy or girl is at the s
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male or female, with great attentio
Page 102 and 103: necessary psychological support - t
Page 104 and 105: Introduction The Opinion tackles th
Page 106 and 107: 1. Outline of sport ethics 1.1 The
Page 108 and 109: values inherent to fair play agains
Page 110 and 111: development of sport, even when not
Page 112 and 113: Doping is refusing, or failing with
Page 114 and 115: Much more dramatic the size of the
Page 116 and 117: in which we must put the phenomenon
Page 118 and 119: started to turn to in order to achi
Page 120 and 121: would therefore be better to libera
Page 122 and 123: towards the use of doping substance
Page 124 and 125: Presidenza del Consiglio dei Minist
Page 126 and 127: Prof. Demetrio Neri, Prof. Andrea N
Page 128 and 129: lood relatives mentioned in the pre
Page 130 and 131: is not forbidden and it is not expl
Page 132 and 133: groups, recall common principles, s
Page 134 and 135: Bibliography As well as the bibliog
Page 136 and 137: PERSONAL REMARKS Personal remark si
Page 138 and 139: would not betray the principle of
Page 140 and 141: undergo a social positive verificat
Page 142 and 143: from the potential recipient, there
Page 144 and 145: The Undersecretary of State To the
Page 146 and 147: INTRODUCTION The document tackles t
Page 148 and 149: exclusively by the pharmaceutical i
Page 150 and 151: possible advantages would affect th
Page 154 and 155: INTRODUCTION The opinion Criteria f
Page 156 and 157: CRITERIA FOR ASCERTAINING DEATH 1.
Page 158 and 159: more in depth scientific and ethica
Page 160 and 161: standards”. Therefore, the Commis
Page 162 and 163: system and the gaseous exchange in
Page 164 and 165: individual’s death. The Author be
Page 166 and 167: - giving greater importance to thos
Page 168 and 169: of death, seen as life does not res
Page 170 and 171: “disintegration” of the organis
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Page 178 and 179: United Kindgom, the “non-heart-be
Page 180 and 181: cardiac arrests, due to causes that
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Page 184 and 185: = Whole brain death: state of total
Page 186 and 187: document by the NTC, signed by two
Page 188 and 189: Presidenza del Consiglio dei Minist
Page 190 and 191: Lorenzo d’Avack, Riccardo Di Segn
Page 192 and 193: treatment, even in the awareness th
Page 194 and 195: person to a simple means, ‘morti
Page 196 and 197: attention was paid to suicide, almo
Page 198 and 199: in the worst conditions in that con
Page 200 and 201: the act is presented to others, in
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the relationship between adverse fa
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security measures, with a reduction
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Lastly, useful initiatives set up i
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is recommended according to the gui
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Declaration of the National Bioethi
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INTRODUCTION The document tackles s
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PREMISE From 2007, which was declar
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y the abovementioned authors, which
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various situations we perceive or t
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appearance, the signs of aging, whi
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problems of the female population a
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free time is very low; this is due
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The increase in life expectancy has
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prevention”, as a strategic perio
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policies that are specifically aime
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1. “ensuring continuity of care t
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BIBLIOGRAPHICAL REFERENCES ACOG, Cl
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Sen A., Development as freedom,1999
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ATTACHMENT I The incidence of patho
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age, is instead a serious psychiatr
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cholesterol (the most harmful) incr
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that concerning tumours in general,
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There are many projects of a preven
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ATTACHMENT III Some statistical dat
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Table 3 - Women of 65 years and ove
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Table 5 - Recourse to healthcare se
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Table 7 - Sport practices of the po
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Table 9 - Disable people who are 65
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Table 11 - Net individual income fr
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Table 13 - Hope of life for those w
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PRESENTATION The document examines
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Bioethics and education in schools
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In particular the Universal Declara
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- social: the promotion of social d
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In December 2007, the International
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education in bioethics, the open qu
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system in a fairly structured way t
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namely, the need to find innovative
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In fact, the two theses do not excl
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the thesis developed by Hans Jonas
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The resumption of cooperation betwe
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stimulus 372 , as it shows, despite
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faculties 375 and humanities facult
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The training of teachers is a probl
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considered on a par with philosophi
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importance to the rational aspect o
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point and point of synthesis for sc
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Presidenza del Consiglio dei Minist
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DOCUMENT Placebo (from the Latin
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was not admissible when for example
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Bibliography 1. WORLD MEDICAL ASSOC
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23. COMMITTEE FOR MEDICINAL PRODUCT
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PRESENTATION The document addresses
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access to restricted areas and effi
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subject does not have to deposit th
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possibility of wrongly denied acces
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corrected. Compliance with these ru
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safeguards and control by means of
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3.2.3 Voluntary permanent changes T
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the most delicate aspects is also r
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conservation and organization of tr
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In the light of possible inappropri
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PRESENTATION The advancement of neu
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neurosurgical operations and the an
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causes, i.e. causes of various kind
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as the obvious fears of abandonment
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and the issues raised by the new de
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