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Conférences

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Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Post approval and registry studies (Ileana PIÑA)

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.➢ Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology ...
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Conférences

le (33m43s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 1 : Comparative effectiveness studies (Rita REDBERG)

MODIGLIANI Lunch Debate Session 1 - Friday November 30, 2012THE DEVICE THERAPY TRIALISTS WORKSHOPChairpersons: Gaetano DE FERRARI, Pavia, ITA - Ileana PIÑA, New York, USAWebcast: Tariq AHMAD, Durham, USADevice trial methodology, regulatory and implementation issuesAdvances in interventional medical devices are increasingly affecting cardiovascular therapy, just as pharmacological innovation did the generation before. Yet, designing and conducting a device trial is challenging and drug trial designs may not necessarily be applied fully to device trials.➢ Although there is increasing recognition that this development process substantially differs from that for drugs, how much device trial methodology may deviate from drug trial methodology ...
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Conférences

le (36m30s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 :Regulatory viewpoint (Pieter DE GRAEF)

MODIGLIANI Workshop 1 - Friday November 30, 2012 :THE THROMBOSIS TRIALISTS WORKSHOPDOSE AND TARGET PATIENT POPULATIONS ISSUESChairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROMWebcast: Johanne SILVAIN, Paris, FRAThe development of new antithrombotic agents is a challenging area of cardiovascular medicine.These agents generally have a narrow therapeutic margin, and it is often difficult to find the optimal balance between efficacy (reduction of ischemic events) and safety (no excess of bleeding events).➢ Phase II trials are designed to generate signals of safety and efficacy and to select the dose or doses for phase III pivotal trials. However, phase II data ...
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Conférences

le (27m43s)

Commencements de l’écriture et impacts civilisationnels - Chapitre 1

Commencements de l’écriture et impacts civilisationnels constitue le premier chapitre de la Grande Leçon Jack Goody et l’empire de la littératie.Lorsque le Professeur Jack Goody évoque les modes de communication différenciés que sont pour l’anthropologue l’oralité et l’écriture, il entend, sans accréditer l‘idée d’un « Grand partage » oral/écrit, mettre en évidence une propriété majeure de l’écriture (son pouvoir cumulatif), là où les productions de la parole se distinguent par leur mouvance.Cette ressource est accessible pour les personnes atteintes de handicaps visuels et auditifs.
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Conférences

le (34m35s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Lunch Session 3 : The value of repeat events in post discharge hospitalized HF trials (Stuart POCOCK)

MODIGLIANI Lunch Debate Session 3 - Saturday December 1st, 2012:HEART FAILURE TRIALISTS WORKSHOPLEARNING FROM RECENT TRIALS AND SHAPING THE FUTURE OF HEART FAILURE TRIALSChairpersons: Alexandre MEBAZAA, Paris, FRA - Christopher O’CONNOR, Durham, USAWebcast: Daniela DOBRE, Nancy, FRADecreasing the very high mortality and rate of re-hospitalization associated with acute worsening HF is one of the most important unmet needs in cardiovascular medicine. Despite positive signals in Phase II studies, no drug has proven to reduce the appallingly high mortality or readmission rates. The reasons for these ‘failed’ trials are multiple, including the adequacy of candidate drugs, dosing, patient selection and disease ...
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Conférences

le (16m50s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 5 : Identifying new targets: Monoclonal Antibody Inhibitor of PCSK9 (Wolfgang KOENIG)

MODIGLIANI Workshop 5 - Saturday December 1st, 2012THE ATHEROSCLEROSIS TRIALISTS FORUMChairpersons: Wolfgang KOENIG, Ulm, GER - Anthony WIERZBICKI, London, GBRWebcast: Tabassome SIMON, Paris, FRAWill new compounds be able to reduce the residual risk in high risk patients when treatment targets based on new ESC guidelines have been achieved (e.g. LDL-C < 70mg/dl)?Despite widespread early intervention in acute coronary syndromes and complete revascularization of stenotic lesions complemented by aggressive polypharmacotherapy, still a high percentage of patients develop a secondary event.This has been shown in various registries and recent data from the GRACE registry have suggested that we grossly underestimate long-term risk ...
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Conférences

le (22m57s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Debate Session 4 : What endpoint for securing approval and reimbursement (Andrew FARB - Ileana PIÑA)

MODIGLIANI Debate Session 4 - Saturday December 1st, 2012:HEART FAILURE REMOTE MONITORING TRIALSChairpersons: Stefan ANKER, Berlin, GER - Ileana PIÑA, New York, USAWebcast: Daniela DOBRE, Nancy, FRACase studies and ultimate methodology for future trialsRemote monitoring remains an appealing option for following patients after a heart-failure hospitalization. Trials employing common strategies (simple phone calls with a nurse and Telemonitoring of vital signs) have in general not demonstrated improvement in survival and or reduction in risk of readmission; meta-analysis of telemonitoring trials using these common strategies, however, have shown improvements in survival and hospitalization rates. Recently, trials of more complex implanted remote ...
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Conférences

le (12m26s)

Cardiovascular Clinical Trialists (CVCT) Forum – Paris 2012 - Workshop 1 : How to secure the optimal dose(s) for phase III? (Nancy GELLER)

MODIGLIANI Workshop 1 - Friday November 30, 2012 :THE THROMBOSIS TRIALISTS WORKSHOPDOSE AND TARGET PATIENT POPULATIONS ISSUESChairpersons: Peter CLEMMENSEN, Copenhagen, DEN - George-Andrei DAN, Bucharest, ROMWebcast: Johanne SILVAIN, Paris, FRAThe development of new antithrombotic agents is a challenging area of cardiovascular medicine.These agents generally have a narrow therapeutic margin, and it is often difficult to find the optimal balance between efficacy (reduction of ischemic events) and safety (no excess of bleeding events).➢ Phase II trials are designed to generate signals of safety and efficacy and to select the dose or doses for phase III pivotal trials. However, phase II data ...
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Conférences

le (1h32m25s)

L’innovation pédagogique dans le contexte de l’enseignement supérieur

Après avoir introduit la notion d’innovation dans le contexte de l’enseignement supérieur, la conférence épinglera trois grandes tendances innovantes actuelles (le pilotage par l’étudiant de sa propre formation, les approches « programme » et leurs conséquences, et enfin l’arrivée des « Massive Open Online Courses ») avant de proposer quelques réflexions conclusives.
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Entretiens

le (21m40s)

Semiotics of the media

Guido IPSEN is working as a Professor for Scientific Communication and Media Semiotics at the University of Dortmund, Germany. He hosts the faculty’s Forum for Cultural Studies, works as an advisor for scientific journals, and coordinates various projects on an international scale. He focuses on lecturing transdisciplinary subjects with semiotic and historical background. He also wrote an online introduction to linguistics and several papers and articles on semiotic and linguistic issues. After a thesis on the semiotics of hybrid structures in hypertext networks in 2001, he is now working on a second book. The project is a Historical Semiotics of ...
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