The Impact of COVID‐19 on the Initiation of Clinical Trials in Europe and the United States by Lasch, Florian, Psarelli, Eftychia‐Eirini, Herold, Ralf, Mattsson, Andrea, Guizzaro, Lorenzo, Pétavy, Frank, Schiel, Anja

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Health horizons: Future trends and technologies from the European Medicines Agency's horizon scanning collaborations by Vignali, Valentina, Hines, Philip A, Cruz, Ana Glória, Ziętek, Barbara, Herold, Ralf

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Involvement of the European Medicines Agency in multi-stakeholder regulatory science research projects: experiences of staff members and project coordinators by Saesen, Robbe, Machado, Matilde, Crifo, Bianca, Liu, Lifang, de Vries, Corinne, Herold, Ralf, Llinares Garcia, Jordi, Huys, Isabelle

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The European Medicines Agency: An Overview of Its Mission, Responsibilities, and Recent Initiatives in Cancer Drug Regulation by PIGNATTI, Francesco, GRAVANIS, Lordanis, HEROLD, Ralf, VAMVAKAS, Spiros, JONSSON, Bertil, MARTY, Michel

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How to develop new systemic treatments in ultra-rare cancers with high unmet needs? The case of alveolar soft-part sarcoma by Stacchiotti, Silvia, Bouche, Gauthier, Herold, Ralf, Pantziarka, Pan, Schuster, Kathrin, Wilson, Roger, Pignatti, Francesco, Kasper, Bernd

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Pharmacometrics for Regulatory Decision Making: Status and Perspective by Manolis, Efthymios, Herold, Ralf

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Revocation of the conditional marketing authorisation of a cancer medicine: The olaratumab experience by Herold, Ralf, Camarero, Jorge, Melchiorri, Daniela, Sebris, Zigmars, Enzmann, Harald, Pignatti, Francesco

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Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group by Piccinin, Claire, Basch, Ethan, Bhatnagar, Vishal, Calvert, Melanie, Campbell, Alicyn, Cella, David, Cleeland, Charles S, Coens, Corneel, Darlington, Anne-Sophie, Dueck, Amylou C, Groenvold, Mogens, Herold, Ralf, King-Kallimanis, Bellinda L, Kluetz, Paul G, Kuliś, Dagmara, O'Connor, Daniel, Oliver, Kathy, Pe, Madeline, Reeve, Bryce B, Reijneveld, Jaap C, Wang, Xin Shelley, Bottomley, Andrew

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EMA Recommendation for the Pediatric Indications of Plerixafor (Mozobil) to Enhance Mobilization of Hematopoietic Stem Cells for Collection and Subsequent Autologous Transplantatio... by Karres, Dominik, Ali, Sahra, Hennik, Paula B., Straus, Sabine, Josephson, Filip, Thole, Geanne, Glerum, Pieter J., Herberts, Carla, Babae, Negar, Herold, Ralf, Papadouli, Irene, Pignatti, Francesco

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Pharmacometrics for Regulatory Decision Making by Manolis, Efthymios, Herold, Ralf

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Can a Multistakeholder Prioritization Structure Support Regulatory Decision Making? A Review of Pediatric Oncology Strategy Forums Reflecting on Challenges and Opportunities of thi... by Karres, Dominik, Lesa, Giovanni, Ligas, Franca, Annunen, Pia, Dartel, Maaike, Demolis, Pierre, Galluzzo, Sara, Herold, Ralf, Criekingen, Olga Kholmanskikh, Stoyanova‐Beninska, Violeta, Norga, Koen

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Setting International Standards in Analyzing Patient-Reported Outcomes and Quality of Life Endpoints in Cancer Clinical Trials-Innovative Medicines Initiative (SISAQOL-IMI): stakeh... by Alanya, Ahu, Falk, Ragnhild Sorum, Bjordal, Kristin, Chang, Jane, Cislo, Paul, Coens, Corneel, Dirven, Linda, Speck, Rebecca M, Fitzgerald, Kristina, Galinsky, Jayne, Giesinger, Johannes M, Holzner, Bernhard, Le Cessie, Saskia, O'Connor, Daniel, Oliver, Kathy, Quinten, Chantal, Schlichting, Michael, Ren, Jinma, Roychoudhury, Satrajit, Taphoorn, Martin J B, Velikova, Galina, Wintner, Lisa M, Bottomley, Andrew, Bui, Cat, Kamalakar, Rajesh, Sail, Kavita, Sen, Rohini, Turner, Sean C, Cocks, Kim, Su, Yun, Peil, Barbara, Voorhaar, Maarten, Wong, Brendon, Dekanic Arbanas, Gracia, Kuljanic, Karin, Rede, Ivana, Arraras, Juan, Coons, Stephen Joel, Murray, Lindsey, Pignatti, Francesco, Martinelli, Francesca, Musoro, Jammbe, Dafni, Ourania, De Vries, Elisabeth, Gyawali, Bishal, Kiesewetter, Barbara, Roitberg, Felipe, Schoepf, Felix, Tschuggnall, Michael, Sasseville, Maxime, Soltys, Katherine, Ferrer, Montserrat, Garin, Olatz, Vilagut, Gemma, Schürmann, Christoph, Wieseler, Beate, Snyder, Claire, Alonso Abad, Ariel, Bogaerts, Kris, Brackx, Febe, Molenberghs, Geert, Verbeke, Geert, Choi, Jan, Thomassen, Doranne, Geissler, Jan, Sauerbrei, Willi, Pilz, Micha Johannes, Campbell, Lisa, Rantell, Khadija, Desplanques, Gregoire, Regnault, Antoine, Morgan, Kate, Plate, Ananda, ten Seldam, Silene, Terada, Mitsumi, Mizusawa, Junki, Wilder Smith, Ashley, Reksten, Tove Ragna, Cappelleri, Joseph, de Besi, Patrizia, Russell-Smith, Alexander, Sandin, Rickard, Mamolo, Carla, Tu, Dongsheng, Petersen, Morten, Cleeland, Charlie, Williams, Lori, Calvert, Melanie, Cruz Rivera, Samantha, Aiyegbusi, Olalekan Lee, Goetghebeur, Els, Van Lancker, Kelly, Boele, Florien, Gilbert, Alexandra, Peacock, Rosemary, King, Madeleine, Bhatnagar, Vishal, Fiero, Mallorie, Johnson, Laura Lee, Rodriguez, Lisa

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Development of a neonatal adverse event severity scale through a Delphi consensus approach by Salaets, Thomas, Turner, Mark A, Short, Mary, Ward, Robert M, Ariagno, Ronald L, Wade, Kelly, Thomson, Merran, Roberts, Eve, Harrison, Judy, Baer, Gerri, Allegaert, Karel, Allen, Marilee, Allen, Albert, Freimane, Dina Apele, Aschner, Judy, Ballard, Roberta, Belew, Yodit, Bellflower, Bobby, Bhatt-Mehta, Varsha, Blum, Mike, Bonardi, Chiara, Bondurant, Patti, Boylan, Geraldine, Buracchio, Teresa, Burnett, Amber, Burnham, Janelle, Chen, Alice, Clay, Bob, Connolly, Eamonn, Darsey, Edress, Lisa, Roberto De, Degl, Jennifer, Dempsey, Eugene, Diacovo, Tom, Dionne, Janis, Duchon, Jennifer, Eklund, Wakako, Fabbri, Laura, Fielder, Alistair, Freilich, Emily, Fürst-Recktenwald, Sabine, Graham, Tamorah, Green, Dionna, Grogan, Cristal, Heiselman, Darell, Hellström, Ann, Herold, Ralf, Hibbs, Anna Maria, Hirschfeld, Steven, Brown, Mary Hise, Holberton, Jim, Iveli, Pablo, Jobe, Alan, Kayton, Allyson, Kenner, Carole, Kraft, Walter, Kusuda, Satoshi, Lewis, Tamorah, Lui, Kei, Lutsar, Irja, Mangili, Alexandra, McCune, Susan, McDonald, Karen, McPherson, Christopher, Miller, Washington UniversityThomas, Ming, Jeffrey, Modi, Neena, Morrison, Maya, Mulugeta, Lily, Nakamura, Hide, Noel, Gary, Olshansky, Miki, Oschman, Alex, Padula, Mike, Peiris, Vasum, Koplowitz, Luana Pesco, Pham, Josh, Pilon, Aprile, Portman, Ron, Pressler, Ronit, Rabe, Heike, Raju, Tonse, Savani, Rashmin, Segal, Robert, Senterre, Thibault, Shah, Prakesh, Sheridan, Philip, Sherwin, Catherine, Singh, Rajendra, Soul, Janet, Spence, Kaye, Storari, Linda, Taminiau, Jan, Anker, John Van Den, Venkataraman, Preeti, Walker, Karen, Wilson, Janice, Zajicek, Anne, Zaloga, Gary, Zeldis, Stav

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Implementation of mechanism of action biology-driven early drug development for children with cancer by Pearson, Andrew D.J, Herold, Ralf, Rousseau, Raphaël, Copland, Chris, Bradley-Garelik, Brigid, Binner, Debbie, Capdeville, Renaud, Caron, Hubert, Carleer, Jacqueline, Chesler, Louis, Geoerger, Birgit, Kearns, Pamela, Marshall, Lynley V, Pfister, Stefan M, Schleiermacher, Gudrun, Skolnik, Jeffrey, Spadoni, Cesare, Sterba, Jaroslav, van den Berg, Hendrick, Uttenreuther-Fischer, Martina, Witt, Olaf, Norga, Koen, Vassal, Gilles

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Pharmacokinetic and pharmacodynamic study of doxorubicin in children with cancer: results of a “European Pediatric Oncology Off-patents Medicines Consortium” trial by Krischke, Miriam, Hempel, Georg, Völler, Swantje, André, Nicolas, D’Incalci, Maurizio, Bisogno, Gianni, Köpcke, Wolfgang, Borowski, Matthias, Herold, Ralf, Boddy, Alan V., Boos, Joachim

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Role of modeling and simulation in pediatric investigation plans by Manolis, Efthymios, Osman, Tariq Eldirdiry, Herold, Ralf, Koenig, Franz, Tomasi, Paolo, Vamvakas, Spiros, Raymond, Agnes Saint

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Bridging the gap: a review of dose investigations in paediatric investigation plans by Hampson, Lisa V., Herold, Ralf, Posch, Martin, Saperia, Julia, Whitehead, Anne

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Secondary malignant neoplasms after intensive treatment of relapsed acute lymphoblastic leukaemia in childhood by Borgmann, Anja, Zinn, Christina, Hartmann, Reinhard, Herold, Ralf, Kaatsch, Peter, Escherich, Gabriele, Möricke, Anja, Henze, Günter, von Stackelberg, Arend

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13C-urea breath test threshold calculation and evaluation for the detection of Helicobacter pylori infection in children by Herold, Ralf, Becker, Michael

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A European Network of Paediatric Research at the European Medicines Agency (Enpr-EMA) by Ruperto, Nicolino, Eichler, Irmgard, Herold, Ralf, Vassal, Gilles, Giaquinto, Carlo, Hjorth, Lars, Valls-i-Soler, Adolf, Peters, Christina, Helms, Peter J, Raymond, Agnès Saint

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