How is the Pharmaceutical Industry Structured to Optimize Pediatric Drug Development? Existing Pediatric Structure Models and Proposed Recommendations for Structural Enhancement

por Severin, Thomas, Corriol-Rohou, Solange, Bucci-Rechtweg, Christina, an Haack, Kristina, Fuerst-Recktenwald, Sabine, Lepola, Pirkko, Norjavaara, Ensio, Dehlinger-Kremer, Martine, Haertter, Sebastian, Cheung, S. Y. Amy
Publicado 2020

Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches

por Rei Bolislis, Winona, 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, Geneviève, Kühler, Thomas C.
Publicado 2021

Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?

por 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
Publicado 2022

On the use of wearable sensors as mobility biomarkers in the marketing authorization of new drugs: A regulatory perspective

por Viceconti, Marco, Tome, Maria, Dartee, Wilhelmus, Knezevic, Igor, Hernandez Penna, Sabina, Mazzà, Claudia, Caulfield, Brian, Garcia-Aymerich, Judith, Becker, Clemens, Maetzler, Walter, Troosters, Thierry, Sharrack, Basil, Davico, Giorgio, Corriol-Rohou, Solange, Rochester, Lynn
Publicado 2022

Medicines Adaptive Pathways to Patients: Why, When, and How to Engage?

por Eichler, Hans‐Georg, Bedlington, Nicola, Boudes, Mathieu, Bouvy, Jacoline C., Broekmans, André W., Cerreta, Francesca, Faulkner, Stuart D., Forda, Susan R., Joos, Angelika, Le Cam, Yann, Mayer, Mark H., Pirard, Vinciane, Corriol‐Rohou, Solange
Publicado 2018

Innovations in Pediatric Therapeutics Development: Principles for the Use of Bridging Biomarkers in Pediatric Extrapolation

por Fleming, Thomas R., Garnett, Christine E., Conklin, Laurie S., Corriol-Rohou, Solange, Hariharan, Sudharshan, Hsu, Daphne, Mueller-Velten, Guenther, Mulugeta, Yeruk, Portman, Ronald, Rothmann, Mark D., Stockbridge, Norman L., Wandel, Simon, Zhang, Jialu, Yao, Lynne
Publicado 2022

Recognizing that Evidence is Made, not Born

por 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
Publicado 2019

Validity and responsiveness of the Daily- and Clinical visit-PROactive Physical Activity in COPD (D-PPAC and C-PPAC) instruments

por 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
Publicado 2021

Science‐Based Approach to Harmonize Contraception Recommendations in Clinical Trials and Pharmaceutical Labels

por Bowman, Christopher J., Becourt‐Lhote, Nathalie, Boulifard, Virginie, Cordts, Rüdiger, 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
Publicado 2022

Advanced Methods for Dose and Regimen Finding During Drug Development: Summary of the EMA/EFPIA Workshop on Dose Finding (London 4–5 December 2014)

por Musuamba, FT, Manolis, E, Holford, N, Cheung, SYA, Friberg, LE, Ogungbenro, K, Posch, M, Yates, JWT, Berry, S, Thomas, N, Corriol‐Rohou, S, Bornkamp, B, Bretz, F, Hooker, AC, Van der Graaf, PH, Standing, JF, Hay, J, Cole, S, Gigante, V, Karlsson, K, Dumortier, T, Benda, N, Serone, F, Das, S, Brochot, A, Ehmann, F, Hemmings, R, Rusten, I Skottheim
Publicado 2017

Mobilizing Patient and Public Involvement in the Development of Real-World Digital Technology Solutions: Tutorial

por Keogh, Alison, Mc Ardle, Ríona, 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
Publicado 2023

Regulatory and health technology assessment advice on postlicensing and postlaunch evidence generation is a foundation for lifecycle data collection for medicines

por 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, Pasté, Muriel, Sandler, Susan, Van Baelen, Karin, Cangini, Agnese, García, Sonia, Obach, Mercè, Gimenez Garcia, Emmanuel, Varela Lema, Leonor, Jauhonen, Hanna‐Mari, Rannanheimo, Piia, Morrison, Deborah, Van De Casteele, Marc, Strömgren, Anna, Viberg, Anders, Makady, Amr, Guilhaume, Chantal
Publicado 2020

The PROactive innovative conceptual framework on physical activity

por Dobbels, Fabienne, de Jong, Corina, Drost, Ellen, Elberse, Janneke, Feridou, Chryssoula, Jacobs, Laura, Rabinovich, Roberto, Frei, Anja, Puhan, Milo A., de Boer, Willem I., van der Molen, Thys, Williams, Kate, Pinnock, Hillary, Troosters, Thierry, Karlsson, Niklas, Kulich, Karoly, Rüdell, Katja, Brindicci, Caterina, Higenbottam, Tim, Troosters, Thierry, Dobbels, Fabienne, Decramer, Marc, Tabberer, Margaret, Rabinovich, Roberto A, MacNee, William, Vogiatzis, Ioannis, Polkey, Michael, Hopkinson, Nick, Garcia-Aymerich, Judith, Puhan, Milo, Frei, Anja, van der Molen, Thys, de Jong, Corina, de Boer, Pim, Jarrod, Ian, McBride, Paul, Kamel, Nadia, Rudell, Katja, Wilson, Frederick J., Ivanoff, Nathalie, Kulich, Karoly, Glendenning, Alistair, Karlsson, Niklas X., Corriol-Rohou, Solange, Nikai, Enkeleida, Erzen, Damijan
Publicado 2014