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Presentacin EUDRACT PowerPoint PPT Presentation
Presentacin EUDRACT - INAP Jornada Participaci n Espa a e-Goverment Uni n Europea 10 de ... EUDRA = European Union Drugs Regulatory Authorities. Estrategia telem tica de la EMEA ...
INAP Jornada Participaci n Espa a e-Goverment Uni n Europea 10 de ... EUDRA = European Union Drugs Regulatory Authorities. Estrategia telem tica de la EMEA ...
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The BRIDG model: a shared domain analysis model of regulated clinical research PowerPoint PPT Presentation
The BRIDG model: a shared domain analysis model of regulated clinical research - Working with PDQ, clinicaltrials.gov and European EUDRACT ... caBIG.nci.nih.gov. https://www.BRIDGproject.org. R&D Expenditures ($B) 1986-2004 ...
Working with PDQ, clinicaltrials.gov and European EUDRACT ... caBIG.nci.nih.gov. https://www.BRIDGproject.org. R&D Expenditures ($B) 1986-2004 ...
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Ethics Committees PowerPoint PPT Presentation
Ethics Committees - insurance or indemnity to cover the liability of sponsor and investigator ... Sponsors must quote ethics reference number and also EUDRACT number ...
insurance or indemnity to cover the liability of sponsor and investigator ... Sponsors must quote ethics reference number and also EUDRACT number ...
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Clinical Trials Directive PowerPoint PPT Presentation
Clinical Trials Directive - Legal and ethical responsibility to MHRA, patient and employer. Personally and professionally liable for decisions. Assessed by inspection by MHRA ...
Legal and ethical responsibility to MHRA, patient and employer. Personally and professionally liable for decisions. Assessed by inspection by MHRA ...
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PHARMACOVIGILANCE PowerPoint PPT Presentation
PHARMACOVIGILANCE - Made statutory by the EU Clinical Trials Directive 1st May 2004 ... Concomitant Drugs and Medical History. Any other relevant information. Signed Date. Print Name ...
Made statutory by the EU Clinical Trials Directive 1st May 2004 ... Concomitant Drugs and Medical History. Any other relevant information. Signed Date. Print Name ...
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Regulatory Requirements of European Union (EU) PowerPoint PPT Presentation
Regulatory Requirements of European Union (EU) - Regulatory Requirements of European Union (EU)
Regulatory Requirements of European Union (EU)
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Textes PowerPoint PPT Presentation
Textes - Title: PowerPoint Presentation Last modified by: chassany-o Created Date: 1/1/1601 12:00:00 AM Document presentation format: Affichage l' cran
Title: PowerPoint Presentation Last modified by: chassany-o Created Date: 1/1/1601 12:00:00 AM Document presentation format: Affichage l' cran
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ICH ESSENTIAL DOCUMENTS PowerPoint PPT Presentation
ICH ESSENTIAL DOCUMENTS - 1977 Food and Drug Administration (FDA) issued proposed ... Change of posology of the IMP. Change of comparator. Statistical analysis. Substantial Amendments ...
1977 Food and Drug Administration (FDA) issued proposed ... Change of posology of the IMP. Change of comparator. Statistical analysis. Substantial Amendments ...
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Special populations What makes them so special AGAH Association for Applied Human Pharmacology Annua PowerPoint PPT Presentation
Special populations What makes them so special AGAH Association for Applied Human Pharmacology Annua - OJ L 262/22 14.10.2003. Annex 13. Manufacture of investigational medicinal products ... Detailed guidance on the collection, verification and presentation of adverse ...
OJ L 262/22 14.10.2003. Annex 13. Manufacture of investigational medicinal products ... Detailed guidance on the collection, verification and presentation of adverse ...
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Le projet de rpertoire des Essais Cliniques de mdicaments PowerPoint PPT Presentation
Le projet de rpertoire des Essais Cliniques de mdicaments - Chef du D partement de l'Evaluation des M dicaments Statut Particulier et des ... l'autorit comp tente met en place et diffuse des r pertoires de recherches ...
Chef du D partement de l'Evaluation des M dicaments Statut Particulier et des ... l'autorit comp tente met en place et diffuse des r pertoires de recherches ...
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Conducting research: How to get started, carry it out and get published PowerPoint PPT Presentation
Conducting research: How to get started, carry it out and get published - Conducting research: How to get started, carry it out and get published
Conducting research: How to get started, carry it out and get published
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La procdure dautorisation dessai clinique portant sur un mdicament Journe dinformation du 20 novembr PowerPoint PPT Presentation
La procdure dautorisation dessai clinique portant sur un mdicament Journe dinformation du 20 novembr - Journ e d'information du 20 novembre 2006 DIRC Rh ne Alpes Auvergne ... Document de r f rence pour caract re attendu/inattendu des EIG. Journ e d'information du ...
Journ e d'information du 20 novembre 2006 DIRC Rh ne Alpes Auvergne ... Document de r f rence pour caract re attendu/inattendu des EIG. Journ e d'information du ...
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The Integrated Research PowerPoint PPT Presentation
The Integrated Research - A single on-line facility with common data being entered only once and ... Underlined links (e.g. dataset, forms or question / sections) Tabs ...
A single on-line facility with common data being entered only once and ... Underlined links (e.g. dataset, forms or question / sections) Tabs ...
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Enron Update PowerPoint PPT Presentation
Enron Update - 5. Data Collected for Sponsor as patients receive treatment ... Patient Recruitment. Electronic Data Collection & Management. Outsourced Clinical Activities ...
5. Data Collected for Sponsor as patients receive treatment ... Patient Recruitment. Electronic Data Collection & Management. Outsourced Clinical Activities ...
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Data collection, storage and some ethics PowerPoint PPT Presentation
Data collection, storage and some ethics - www.ClinicalTrials.gov - reports during and after study on progression, safety, results ... FDA (www.fda.gov/oc/gcp/guidance.html) Europe (www.efpia.org/6_publ ...
www.ClinicalTrials.gov - reports during and after study on progression, safety, results ... FDA (www.fda.gov/oc/gcp/guidance.html) Europe (www.efpia.org/6_publ ...
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Applied Clinical Trials European Summit PowerPoint PPT Presentation
Applied Clinical Trials European Summit - THE CHANGING NATURE OF ETHICAL REVIEW Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph., Clinical Pharmacologist University of Groningen (NL)
THE CHANGING NATURE OF ETHICAL REVIEW Prof. JanHasker G. Jonkman, Ph.D., F.C.P., F.R.Q.A., R.Ph., Clinical Pharmacologist University of Groningen (NL)
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International%20Clinical%20Trials PowerPoint PPT Presentation
International%20Clinical%20Trials - Art 11 Exchange of information. Art 12 Suspension of the trial or infringements. Detail Guidance ! ... Recombinant DNA technology ...
Art 11 Exchange of information. Art 12 Suspension of the trial or infringements. Detail Guidance ! ... Recombinant DNA technology ...
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Intervenant : Pierre Henri Bertoye PowerPoint PPT Presentation
Intervenant : Pierre Henri Bertoye - Nouvelle version attendue. Modifications de forme surtout. Version ... Nouvelle version attendue. Versions avril 2004. Nouvelles versions attendues. 5. Directive ...
Nouvelle version attendue. Modifications de forme surtout. Version ... Nouvelle version attendue. Versions avril 2004. Nouvelles versions attendues. 5. Directive ...
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Le rpertoire des Essais Cliniques de mdicaments PowerPoint PPT Presentation
Le rpertoire des Essais Cliniques de mdicaments - Chef du D partement de l'Evaluation des M dicaments Statut Particulier et des Essais ... Donn es administratives de la recherche. Donn es descriptives de la ...
Chef du D partement de l'Evaluation des M dicaments Statut Particulier et des Essais ... Donn es administratives de la recherche. Donn es descriptives de la ...
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The PACE Trial PowerPoint PPT Presentation
The PACE Trial - ... patients with the chronic fatigue syndrome / myalgic encephalomyelitis or encephalopathy ... specialist chronic fatigue clinics. SSMC Alone. APT SSMC. CBT ...
... patients with the chronic fatigue syndrome / myalgic encephalomyelitis or encephalopathy ... specialist chronic fatigue clinics. SSMC Alone. APT SSMC. CBT ...
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Internet et Cancer PowerPoint PPT Presentation
Internet et Cancer - Outils mol culaires pour les tumeurs d'origines ind termin s ... Recherche de projets de recherche pour adresser le patient vers un centre investigateur ...
Outils mol culaires pour les tumeurs d'origines ind termin s ... Recherche de projets de recherche pour adresser le patient vers un centre investigateur ...
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Comments on IRB Modeling Reflecting on Todays Discussion Comparing IRB Models for Multisite Pediatri PowerPoint PPT Presentation
Comments on IRB Modeling Reflecting on Todays Discussion Comparing IRB Models for Multisite Pediatri - Comparing IRB Models for Multisite Pediatric Studies. National Center for ... An Appreciation of IRBs. 60 year history. the institutionalization of ethics' ...
Comparing IRB Models for Multisite Pediatric Studies. National Center for ... An Appreciation of IRBs. 60 year history. the institutionalization of ethics' ...
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VenUS III: RCT of ultrasound for venous ulcers PowerPoint PPT Presentation
VenUS III: RCT of ultrasound for venous ulcers - We are looking for 266 people with a verruca to take part in a research study. ... Jayne Robinson at the Northampton University Podiatry Clinic on 01604 627303 ...
We are looking for 266 people with a verruca to take part in a research study. ... Jayne Robinson at the Northampton University Podiatry Clinic on 01604 627303 ...
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International Clinical Trials: Current Issues in Clinical Trial Regulation and Future Reforms: EU, US, and Beyond: a European perspective PowerPoint PPT Presentation
International Clinical Trials: Current Issues in Clinical Trial Regulation and Future Reforms: EU, US, and Beyond: a European perspective - ... inspection, and must be maid available to the sponsor while ... Minors : French Law prohibits trials on minors if they refuse or withdraw their consent. ...
... inspection, and must be maid available to the sponsor while ... Minors : French Law prohibits trials on minors if they refuse or withdraw their consent. ...
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MRCDH Joint Project UK Trial Managers Network 20 May 2004 PowerPoint PPT Presentation
MRCDH Joint Project UK Trial Managers Network 20 May 2004 - WS2: Quality partnerships - Marc Taylor ( Noreen Caine) ... Lead: Noreen Caine. Management of a clinical trials portfolio. WS3: Initiation to commencement ...
WS2: Quality partnerships - Marc Taylor ( Noreen Caine) ... Lead: Noreen Caine. Management of a clinical trials portfolio. WS3: Initiation to commencement ...
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The EU Clinical Trials Directive PowerPoint PPT Presentation
The EU Clinical Trials Directive - 2001/83/EC Currently legally binding. Tissues & Cells Directive ... For incapacitated adults must have consent from: Personal legal representative or ...
2001/83/EC Currently legally binding. Tissues & Cells Directive ... For incapacitated adults must have consent from: Personal legal representative or ...
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FACULTE DE MEDECINE RENE DESCARTES M1 SANTE LOI HURIET ET DIRECTIVE EUROPEENNE SUR LES ESSAIS CLINIQUES Professeur G PowerPoint PPT Presentation
FACULTE DE MEDECINE RENE DESCARTES M1 SANTE LOI HURIET ET DIRECTIVE EUROPEENNE SUR LES ESSAIS CLINIQUES Professeur G - FACULTE DE MEDECINE RENE DESCARTES M1 SANTE LOI HURIET ET DIRECTIVE EUROPEENNE SUR LES ESSAIS CLINIQUES Professeur G rard PONS Service de Pharmacologie Clinique
FACULTE DE MEDECINE RENE DESCARTES M1 SANTE LOI HURIET ET DIRECTIVE EUROPEENNE SUR LES ESSAIS CLINIQUES Professeur G rard PONS Service de Pharmacologie Clinique
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Experience of a MHRA Inspection Aled Rees Senior Lecturer Centre for Endocrine and Diabetes Sciences PowerPoint PPT Presentation
Experience of a MHRA Inspection Aled Rees Senior Lecturer Centre for Endocrine and Diabetes Sciences - The aftermath. Attended end of inspection report on the Friday afternoon ... The aftermath. Inspection report issued to the Trust February 28th. 11 page summary! ...
The aftermath. Attended end of inspection report on the Friday afternoon ... The aftermath. Inspection report issued to the Trust February 28th. 11 page summary! ...
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Hans Stцtter MD PowerPoint PPT Presentation
Hans Stцtter MD - New regulation for paediatric medicinal products issues and opportunities-Hans St tter MD Internal Medicine + Oncology/Haematology Clinical Reviewer Division ...
New regulation for paediatric medicinal products issues and opportunities-Hans St tter MD Internal Medicine + Oncology/Haematology Clinical Reviewer Division ...
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European Commission EMEA Conference on the Operation of the Clinical Trials Directive Directive 2001 PowerPoint PPT Presentation
European Commission EMEA Conference on the Operation of the Clinical Trials Directive Directive 2001 - Expedited or periodic safety information ... Expedite all SUSARs. Expedite local SUSARs and Periodic Line Listings for foreign SUSARs ...
Expedited or periodic safety information ... Expedite all SUSARs. Expedite local SUSARs and Periodic Line Listings for foreign SUSARs ...
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NIHR CLAHRC for Northwest London PowerPoint PPT Presentation
NIHR CLAHRC for Northwest London - Knowledge management/transfer. E learning. Maximising across the CLAHRC(s) ... Shifting the Balance. Making Step Change Happen. Opportunities I ...
Knowledge management/transfer. E learning. Maximising across the CLAHRC(s) ... Shifting the Balance. Making Step Change Happen. Opportunities I ...
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Sin ttulo de diapositiva PowerPoint PPT Presentation
Sin ttulo de diapositiva - ... Sanidad bajo la supervisi n del Consejo Internacional del Sistema Nacional de Salud. ... CONSENTIMIENTO POR REPRESENTACI N: INCAPACES DE DAR CONSENTIMIENTO ...
... Sanidad bajo la supervisi n del Consejo Internacional del Sistema Nacional de Salud. ... CONSENTIMIENTO POR REPRESENTACI N: INCAPACES DE DAR CONSENTIMIENTO ...
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Clinical Trials in Finland PowerPoint PPT Presentation
Clinical Trials in Finland - Deals with ethical issues related to health care and the status and rights of ... Collects and distributes information on ethical questions evolved in health care ...
Deals with ethical issues related to health care and the status and rights of ... Collects and distributes information on ethical questions evolved in health care ...
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Les essais cliniques de phase 3 PowerPoint PPT Presentation
Les essais cliniques de phase 3 - Objectif g n ral : confirmer les propri t s th rapeutiques d'un ... Mol cules appartenant la m me classe th rapeutique. tudes de pharmacologie (bio ...
Objectif g n ral : confirmer les propri t s th rapeutiques d'un ... Mol cules appartenant la m me classe th rapeutique. tudes de pharmacologie (bio ...
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WHAT NCTU CAN DO FOR YOU PowerPoint PPT Presentation
WHAT NCTU CAN DO FOR YOU - The NCTU has been established to support the conduct of a broad spectrum of ... Our remit is the design, conduct and analysis of RCTs, and other high quality studies ...
The NCTU has been established to support the conduct of a broad spectrum of ... Our remit is the design, conduct and analysis of RCTs, and other high quality studies ...
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Presentazione di PowerPoint PowerPoint PPT Presentation
Presentazione di PowerPoint - Title: Presentazione di PowerPoint Author: Ministero della Salute Last modified by: tomino Created Date: 11/4/2004 2:24:30 PM Document presentation format
Title: Presentazione di PowerPoint Author: Ministero della Salute Last modified by: tomino Created Date: 11/4/2004 2:24:30 PM Document presentation format
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MHRA GCP Inspection 21st PowerPoint PPT Presentation
MHRA GCP Inspection 21st - CI pharmacovigilance responsibilities Timely collection of data recording and notification to sponsor Appropriate assessments undertaken data completeness ...
CI pharmacovigilance responsibilities Timely collection of data recording and notification to sponsor Appropriate assessments undertaken data completeness ...
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The Paediatric Regulation PowerPoint PPT Presentation
The Paediatric Regulation - the Paediatric Committee (PDCO) ... by Paediatric Committee in ... Obligation to submit results compliant with agreed Paediatric Investigation Plan (PIP) ...
the Paediatric Committee (PDCO) ... by Paediatric Committee in ... Obligation to submit results compliant with agreed Paediatric Investigation Plan (PIP) ...
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The Future of Clinical Trials PowerPoint PPT Presentation
The Future of Clinical Trials - 'To us, science and research constitute a front-line service, as they ... 3 Review Millenium CRFs' (- more) 4 Sort Careers. 5 & Regulation? Direction. next NRI ...
'To us, science and research constitute a front-line service, as they ... 3 Review Millenium CRFs' (- more) 4 Sort Careers. 5 & Regulation? Direction. next NRI ...
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LA PHARMACOVIGILANCE PowerPoint PPT Presentation
LA PHARMACOVIGILANCE - LA PHARMACOVIGILANCE Dr Marie-Jos phe JEAN-PASTOR Centre R gional de Pharmacovigilance H pital Salvator - Marseille 43962 - 04 91 74 75 60
LA PHARMACOVIGILANCE Dr Marie-Jos phe JEAN-PASTOR Centre R gional de Pharmacovigilance H pital Salvator - Marseille 43962 - 04 91 74 75 60
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Vigilance des essais cliniques PowerPoint PPT Presentation
Vigilance des essais cliniques - Vigilance des essais cliniques 17 novembre 2005 Dr Philippe VELLA ... EIG attendu fr quence accrue. Ev nements ind sirables graves li s aux proc dures de l'EC ...
Vigilance des essais cliniques 17 novembre 2005 Dr Philippe VELLA ... EIG attendu fr quence accrue. Ev nements ind sirables graves li s aux proc dures de l'EC ...
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Des CCPPRB aux CPP: Nouvelles missions des CPP Modalits de prsentation du dossier de demande davis a PowerPoint PPT Presentation
Des CCPPRB aux CPP: Nouvelles missions des CPP Modalits de prsentation du dossier de demande davis a - Modalit s de pr sentation du dossier de demande d'avis aux CPP ... un formulaire de demande additionnel (sp cifique aux comit s) Organisation et ...
Modalit s de pr sentation du dossier de demande d'avis aux CPP ... un formulaire de demande additionnel (sp cifique aux comit s) Organisation et ...
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Elaboraci PowerPoint PPT Presentation
Elaboraci - Title: Elaboraci n de un protocolo de ensayo cl nico en terapias avanzadas y llevarlo a buen t rmino Author: Isabel Portero S nchez Last modified by
Title: Elaboraci n de un protocolo de ensayo cl nico en terapias avanzadas y llevarlo a buen t rmino Author: Isabel Portero S nchez Last modified by
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Drug Quality and Safety: Comparison of EMEA and FDA Rules PowerPoint PPT Presentation
Drug Quality and Safety: Comparison of EMEA and FDA Rules - ... most products on the EU market were approved by Member State agencies. ... GMPs apply to Active Pharmaceutical Ingredients After Eprex and Chiron, ...
... most products on the EU market were approved by Member State agencies. ... GMPs apply to Active Pharmaceutical Ingredients After Eprex and Chiron, ...
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The EU Clinical Trial Directive Implementation : The Realistic Approach in the Netherlands PowerPoint PPT Presentation
The EU Clinical Trial Directive Implementation : The Realistic Approach in the Netherlands - Dossiers for both entities should be identical. EU Clinical Trial Directive: Implementation: ... Dossier dependent upon various factors (Type product; ...
Dossiers for both entities should be identical. EU Clinical Trial Directive: Implementation: ... Dossier dependent upon various factors (Type product; ...
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Protocol Development and Statistical Analysis Plans PowerPoint PPT Presentation
Protocol Development and Statistical Analysis Plans - Protocol Development and Statistical Analysis Plans Petra Rauchhaus TCTU Clinical Trials Statistician
Protocol Development and Statistical Analysis Plans Petra Rauchhaus TCTU Clinical Trials Statistician
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Phase pilote : Difficults Solutions envisages PowerPoint PPT Presentation
Phase pilote : Difficults Solutions envisages - Phase pilote : Difficult s solutions envisag es Dr Philippe VELLA ... BI adresser l'occasion d'une nouvelle demande d'AEC en pr cisant les modif. ...
Phase pilote : Difficult s solutions envisag es Dr Philippe VELLA ... BI adresser l'occasion d'une nouvelle demande d'AEC en pr cisant les modif. ...
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AMIA Clinical Trial Working Group 14 November 2006 PowerPoint PPT Presentation
AMIA Clinical Trial Working Group 14 November 2006 - Global, open, multidisciplinary, non-profit organization ... Established groups in Europe and Japan. ... Project Leader: Rhonda Facile (rfacile@cdisc.org) ...
Global, open, multidisciplinary, non-profit organization ... Established groups in Europe and Japan. ... Project Leader: Rhonda Facile (rfacile@cdisc.org) ...
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BRIDG: A Shared Analysis Model of the Domain of Clinical Trials Research PowerPoint PPT Presentation
BRIDG: A Shared Analysis Model of the Domain of Clinical Trials Research - BRIDG: A Shared Analysis Model of the Domain of Clinical Trials Research
BRIDG: A Shared Analysis Model of the Domain of Clinical Trials Research
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Los Informes Periodicos de Seguridad PowerPoint PPT Presentation
Los Informes Periodicos de Seguridad - Title: Presentaci n de PowerPoint Last modified by: sfernandez Created Date: 1/1/1601 12:00:00 AM Document presentation format: Presentaci n en pantalla
Title: Presentaci n de PowerPoint Last modified by: sfernandez Created Date: 1/1/1601 12:00:00 AM Document presentation format: Presentaci n en pantalla
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Sminaire IFIS novembre 2005 PowerPoint PPT Presentation
Sminaire IFIS novembre 2005 - tablissements pharmaceutiques (EP) et pharmacies usage int rieur (PUI) ... (ENTR/CT1, revision 2 October 2005 ; ENTR/CT2, April 2004) IMP Dossier ...
tablissements pharmaceutiques (EP) et pharmacies usage int rieur (PUI) ... (ENTR/CT1, revision 2 October 2005 ; ENTR/CT2, April 2004) IMP Dossier ...
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Farmacovigilancia Mundial: Una Perspectiva Actual PowerPoint PPT Presentation
Farmacovigilancia Mundial: Una Perspectiva Actual - All effective drugs are associated with some level of risk. ... to continue to access the important benefits of drugs by managing these risks ...
All effective drugs are associated with some level of risk. ... to continue to access the important benefits of drugs by managing these risks ...
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Presentaci PowerPoint PPT Presentation
Presentaci - Title: Presentaci n de PowerPoint Author: valfaro Last modified by: valfaro Created Date: 12/23/2004 6:50:26 PM Document presentation format: Presentaci n en pantalla
Title: Presentaci n de PowerPoint Author: valfaro Last modified by: valfaro Created Date: 12/23/2004 6:50:26 PM Document presentation format: Presentaci n en pantalla
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RCC%20CME%20Project%20Faculty PowerPoint PPT Presentation
RCC%20CME%20Project%20Faculty - Eric Jonasch, MD Robert J Motzer, MD David I Quinn, MBBS, PhD Brian I Rini, MD Walter Stadler, MD Nicholas J Vogelzang, MD Michael B Atkins, MD Ronald M Bukowski, MD
Eric Jonasch, MD Robert J Motzer, MD David I Quinn, MBBS, PhD Brian I Rini, MD Walter Stadler, MD Nicholas J Vogelzang, MD Michael B Atkins, MD Ronald M Bukowski, MD
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David Malka, MD, PhD Head of Gastrointestinal Tumor Group Department of Oncologic Medicine Institut Gustave Roussy Villejuif, France PowerPoint PPT Presentation
David Malka, MD, PhD Head of Gastrointestinal Tumor Group Department of Oncologic Medicine Institut Gustave Roussy Villejuif, France - Treatment of Advanced HER2-Negative Gastroesophageal Carcinomas David Malka, MD, PhD Head of Gastrointestinal Tumor Group Department of Oncologic Medicine
Treatment of Advanced HER2-Negative Gastroesophageal Carcinomas David Malka, MD, PhD Head of Gastrointestinal Tumor Group Department of Oncologic Medicine
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PhUSE Heidelberg, Germany PowerPoint PPT Presentation
PhUSE Heidelberg, Germany - ... RCRIM NIH/NCI NLM EFPIA EMEA MHLW KIKO PhRMA JPMA CDC Reference Information Model RIM LAB eCTD LOINC ISO SNOMED MedDRA ODM SDS = Organization = Dictionary, ...
... RCRIM NIH/NCI NLM EFPIA EMEA MHLW KIKO PhRMA JPMA CDC Reference Information Model RIM LAB eCTD LOINC ISO SNOMED MedDRA ODM SDS = Organization = Dictionary, ...
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