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收藏Regulatory Interactions and Learnings-RADIAL the Trials@Home Proof-of-Concept Trial on Decentralization监管互动与学习—RADIAL: Trials@Home去中心化概念验证试验
Gardarsdottir, Helga; Traore, Hamidou; Huntley, Kate; Mistry, Dinesh; de Jong, Amos J.; Legathe, Agnes; de Smedt, Tim; Askin, Scott; Heath, Megan; Corriol-Rohou, Solange; Lagerwaard, Bart; Zuidgeest, Mira G. P.; IMI Trials Home Consortium
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收藏The Rare Disease Moonshot: Paradigms Shift, Translational Medicine, and Regulatory Science for the World's Rarest Conditions
Ollivier, Cecile; Corriol-Rohou, Solange; del Alamo, Marta; Favresse, Roseline; Kostenzer, Johanna; Boudes, Mathieu; Ussi, Anton E.; Viel, Klaus; Linden, R. Michael; Chlebus, Magda
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收藏Mobilizing Patient and Public Involvement in the Development of Real-World Digital Technology Solutions: Tutorial
Keogh, Alison; Mc Ardle, Riona; Diaconu, Mara Gabriela; Ammour, Nadir; Arnera, Valdo; Balzani, Federica; Brittain, Gavin; Buckley, Ellen; Buttery, Sara; Cantu, Alma; Corriol-Rohou, Solange; Delgado-Ortiz, Laura; Duysens, Jacques; Forman-Hardy, Tom; Gur-Arieh, Tova; Hamerlijnck, Dominique; Linnell, John; Leocani, Letizia; McQuillan, Tom; Neatrour, Isabel; Polhemus, Ashley; Remmele, Werner; Saraiva, Isabel; Scott, Kirsty; Sutton, Norman; van den Brande, Koen; Vereijken, Beatrix; Wohlrab, Martin; Rochester, Lynn
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收藏On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective
Viceconti, Marco; Tome, Maria; Dartee, Wilhelmus; Knezevic, Igor; Penna, Sabina Hernandez; Mazza, Claudia; Caulfield, Brian; Garcia-Aymerich, Judith; Becker, Clemens; Maetzler, Walter; Troosters, Thierry; Sharrack, Basil; Davico, Giorgio; Corriol-Rohou, Solange; Rochester, Lynn
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收藏Science-Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels
Bowman, Christopher J.; Becourt-Lhote, Nathalie; Boulifard, Virginie; Cordts, Rudiger; Corriol-Rohou, Solange; Enright, Brian; Erkman, Linda; Harris, Jayne; Hartmann, Andreas; Hilpert, Jan; Kervyn, Sophie; Mattson, Britta; Morford, LaRonda; Muller, Mireille; Powell, Marcy; Sobol, Zhanna; Srinivasan, Rajamuthu; Stark, Claudia; Thompson, Kary E.; Turner, Katie J.; Barrow, Paul
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收藏Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?
Jaeger, Simon U.; Wohlrab, Martin; Schoene, Daniel; Tremmel, Roman; Chambers, Michael; Leocani, Letizia; Corriol-Rohou, Solange; Klenk, Jochen; Sharrack, Basil; Garcia-Aymerich, Judith; Rochester, Lynn; Maetzler, Walter; Puhan, Milo; Schwab, Matthias; Becker, Clemens
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收藏Objectively Measured Physical Activity as a COPD Clinical Trial Outcome
Burtin, Chris; Mohan, Divya; Troosters, Thierry; Watz, Henrik; Hopkinson, Nicholas S.; Garcia-Aymerich, Judith; Moy, Marilyn L.; Vogiatzis, Ioannis; Rossiter, Harry B.; Singh, Sally; Merrill, Debora D.; Hamilton, Alan; Rennard, Stephen, I; Fageras, Malin; Petruzzelli, Stefano; Tal-Singer, Ruth; Tomaszewski, Erin; Corriol-Rohou, Solange; Rochester, Carolyn L.; Sciurba, Frank C.; Casaburi, Richard; Man, William D-C; Van Lummel, Rob C.; Cooper, Christopher B.; Demeyer, Heleen; Spruit, Martijn A.; Vaes, Anouk
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收藏Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches
Bolislis, Winona Rei; Bejeuhr, Gesine; Benzaghou, Fawzi; Corriol-Rohou, Solange; Herrero-Martinez, Esteban; Hildebrand, Heidrun; Hill-Venning, Claire; Hoogland, Hans; Johnson, Craig; Joos, Angelika; Vart, Richard; Le Visage, Genevieve; Kuhler, Thomas C.
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收藏Validity and responsiveness of the Daily- and Clinical visit-PROactive Physical Activity in COPD (D-PPAC and C-PPAC) instruments
Garcia-Aymerich, Judith; Puhan, Milo A.; Corriol-Rohou, Solange; de Jong, Corina; Demeyer, Heleen; Dobbels, Fabienne; Erzen, Damijan; Frei, Anja; Gimeno-Santos, Elena; Hopkinson, Nicholas S.; Ivanoff, Nathalie; Karlsson, Niklas; Louvaris, Zafeiris; Polkey, Michael, I; Rabinovich, Roberto A.; Scuri, Mario; Tabberer, Maggie; Vogiatzis, Ioannis; Troosters, Thierry
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收藏Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines
Moseley, Jane; Vamvakas, Spiros; Berntgen, Michael; Cave, Alison; Kurz, Xavier; Arlett, Peter; Acha, Virginia; Bennett, Simon; Cohet, Catherine; Corriol-Rohou, Solange; Du Four, Emma; Lamoril, Christelle; Langeneckert, Anja; Koban, Maren; Paste, Muriel; Sandler, Susan; Van Baelen, Karin; Cangini, Agnese; Garcia, Sonia; Obach, Merce; Gimenez Garcia, Emmanuel; Varela Lema, Leonor; Jauhonen, Hanna-Mari; Rannanheimo, Piia; Morrison, Deborah; Van De Casteele, Marc; Stromgren, Anna; Viberg, Anders; Makady, Amr; Guilhaume, Chantal
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收藏Recognizing that Evidence is Made, not Born
Lim, Robyn; Lee, David K.; Sabourin, Pierre; Ferguson, John; Metcalf, Marilyn; Smith, Meredith; Corriol-Rohou, Solange; Eichler, Hans-Georg; Lumpkin, Murray; Hirsch, Gigi; Chen, Inhua Muijrers; O'Rourke, Brian; Schiel, Anja; Crabb, Nick; Aronson, Naomi; Pezalla, Edmund; Boutin, Marc; Binder, Louise; Wilhelm, Linda
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收藏Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?
Eichler, Hans-Georg; Bedlington, Nicola; Boudes, Mathieu; Bouvy, Jacoline C.; Broekmans, Andre W.; Cerreta, Francesca; Faulkner, Stuart D.; Forda, Susan R.; Joos, Angclika; Cam, Yann Le; Maycr, Mark H.; Pirard, Vinciane; Corriol-Rohou, Solange
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收藏The evolution of adaptiveness: balancing speed and evidence
Eichler, Hans-Georg; Barker, Richard; Bedlington, Nicola; Bouvy, Jacoline C.; Broekmans, Andre W.; Bucsics, Anna; Cerreta, Francesca; Corriol-Rohou, Solange; Granados, Alicia; Le Cam, Yann; Schuurman, Ad
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收藏Challenges and Opportunities in the Development of Medical Therapies for Pediatric Populations and the Role of Extrapolation
Barrett, Jeffrey S.; Bishai, Raafat; Bucci-Rechtweg, Christina; Cheung, Amy; Corriol-Rohou, Solange; Haertter, Sebastian; James, Angela; Kovacs, Steven J.; Liu, Jing; Potempa, Dennis; Strougo, Ashley; Vanevski, Konstantina
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