Orphan medicinal products in Europe and United States to cover needs of patients with rare diseases: an increased common effort is to be foreseen von Giannuzzi, Viviana, Conte, Rosa, Landi, Annalisa, Ottomano, Serena Antonella, Bonifazi, Donato, Baiardi, Paola, Bonifazi, Fedele, Ceci, Adriana

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The creation of an adaptable informed consent form for research purposes to overcome national and institutional bottlenecks in ethics review: experience from rare disease registrie... von Landi, Annalisa, Mimouni, Yanis, Giannuzzi, Viviana, Schaefer, Franz, Altavilla, Annagrazia, Gibson, Spencer, Julkowska, Daria

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Target therapy for high-risk neuroblastoma treatment: integration of regulatory and scientific tools is needed von Ceci, Adriana, Conte, Rosa, Didio, Antonella, Landi, Annalisa, Ruggieri, Lucia, Giannuzzi, Viviana, Bonifazi, Fedele

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Getting your DUCs in a row - standardising the representation of Digital Use Conditions von Jeanson, Francis, Gibson, Spencer J., Alper, Pinar, Bernier, Alexander, Woolley, J. Patrick, Mietchen, Daniel, Strug, Andrzej, Becker, Regina, Kamerling, Pim, Sanchez Gonzalez, Maria del Carmen, Mah, Nancy, Novakowski, Ann, Wilkinson, Mark D., Benhamed, Oussama Mohammed, Landi, Annalisa, Krog, Georg Philip, Müller, Heimo, Riaz, Umar, Veal, Colin, Holub, Petr, van Enckevort, Esther, Brookes, Anthony J.

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Mapping of Data-Sharing Repositories for Paediatric Clinical Research—A Rapid Review von Felisi, Mariagrazia, Bonifazi, Fedele, Toma, Maddalena, Pansieri, Claudia, Leary, Rebecca, Hedley, Victoria, Cornet, Ronald, Reggiardo, Giorgio, Landi, Annalisa, D’Ercole, Annunziata, Malik, Salma, Nally, Sinéad, Sen, Anando, Palmeri, Avril, Bonifazi, Donato, Ceci, Adriana

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Common conditions of use elements. Atomic concepts for consistent and effective information governance von Sanchez Gonzalez, Maria del Carmen, Kamerling, Pim, Iermito, Mariapia, Casati, Sara, Riaz, Umar, Veal, Colin D., Maini, Monika, Jeanson, Francis, Benhamed, Oussama Mohammed, van Enckevort, Esther, Landi, Annalisa, Mimouni, Yanis, Le Cornec, Clèmence, Coviello, Domenico A., Franchin, Tiziana, Fusco, Francesca, Ramírez García, Jose Antonio, van der Zanden, Loes F. M., Bernier, Alexander, Wilkinson, Mark D., Mueller, Heimo, Gibson, Spencer J., Brookes, Anthony J.

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Neuroautonomic evaluation of patients with unexplained syncope: incidence of complex neurally mediated diagnoses in the elderly von Rafanelli, Martina, Morrione, Alessandro, Landi, Annalisa, Ruffolo, Emilia, Chisciotti, Valentina M, Brunetti, Maria A, Marchionni, Niccolò, Ungar, Andrea

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Different Strategies to Execute Multi-Database Studies for Medicines Surveillance in Real-World Setting: A Reflection on the European Model von Gini, Rona, Sturkenboom, Miriam C. J., Sultana, Janet, Cave, Alison, Landi, Annalisa, Pacurariu, Alexandra, Roberto, Giuseppe, Schink, Tania, Candore, Gianmario, Slattery, Jim, Trifiro, Gianluca

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Different Strategies to Execute Multi‐Database Studies for Medicines Surveillance in Real‐World Setting: A Reflection on the European Model von Gini, Rona, Sturkenboom, Miriam C. J., Sultana, Janet, Cave, Alison, Landi, Annalisa, Pacurariu, Alexandra, Roberto, Giuseppe, Schink, Tania, Candore, Gianmario, Slattery, Jim, Trifirò, Gianluca

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Early inflammation as a footprint of increased mortality risk in infants living with HIV from three African countries von Morrocchi, Elena, Pascucci, Giuseppe R., Cotugno, Nicola, Pighi, Chiara, Dominguez-Rodriguez, Sara, Petrara, Maria Raffaella, Tagarro, Alfredo, Kuhn, Louise, Cotton, Mark F., Otwombe, Kennedy, Lain, Maria G., Vaz, Paula, Barnabas, Shaun L., Spyer, Moira J., Lopez, Elisa, Fernández-Luis, Sheila, Nhampossa, Tacilta, Maiga, Almoustapha I., Dolo, Oumar, De Rossi, Anita, Rojo, Pablo, Giaquinto, Carlo, Lichterfeld, Mathias, Violari, Avy, Smit, Theresa, Behuhuma, Osee, Klein, Nigel, De Armas, Lesley, Pahwa, Savita, Rossi, Paolo, Palma, Paolo

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Overview of the European post‐authorisation study register post‐authorization studies performed in Europe from September 2010 to December 2018 von Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier‐Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgrò, Valentina, Lalagkas, Panagiotis‐Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Roque Pereira, Leonardo, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, Trifirò, Gianluca

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Overview of the EU PAS register post-authorization studies performed in Europe from September 2010 to December 2018 von Sultana, Janet, Crisafulli, Salvatore, Almas, Mariana, Antonazzo, Ippazio Cosimo, Baan, Esme, Bartolini, Claudia, Bertuccio, Maria Paola, Bonifazi, Fedele, Capuano, Annalisa, Didio, Antonella, Ehrenstein, Vera, Felisi, Mariagrazia, Ferrajolo, Carmen, Fontana, Andrea, Francisca, Remy, Fourrier-Reglat, Annie, Fortuny, Joan, Gini, Rosa, Hyeraci, Giulia, Hoeve, Christel, Kontogiorgis, Christos, Isgro, Valentina, Lalagkas, Panagiotis-Nikolaos, L'Abbate, Luca, Layton, Deborah, Landi, Annalisa, Narduzzi, Silvia, Pereira, Leonardo Roque, Poulentzas, Georgios, Rafaniello, Concetta, Roberto, Giuseppe, Scondotto, Giulia, Sportiello, Liberata, Toma, Maddalena, Toussi, Massoud, Verhamme, Katia, Volpe, Elisabetta, Trifiro, Gianluca

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Survey by TEDDY European Network of Excellence for Paediatric Clinical Research demonstrates potential for Europe‐wide trials von Ruggieri, Lucia, Bonifazi, Donato, Landi, Annalisa, Bonifazi, Fedele, Bartoloni, Franco, Costello, Mary, Felisi, Maria Grazia, Gasthuys, Elke, Godo, Anila, Martinon Torres, Federico, Nadal, David, Nuytinck, Lieve, Rocchi, Francesca, Turner, Mark, Ceci, Adriana

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The “A” of FAIR – As Open as Possible, as Closed as Necessary von Landi, Annalisa, Thompson, Mark, Giannuzzi, Viviana, Bonifazi, Fedele, Labastida, Ignasi, da Silva Santos, Luiz Olavo Bonino, Roos, Marco

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Failures to further developing orphan medicinal products after designation granted in Europe: an analysis of marketing authorisation failures and abandoned drugs von Giannuzzi, Viviana, Landi, Annalisa, Bosone, Enrico, Giannuzzi, Floriana, Nicotri, Stefano, Torrent-Farnell, Josep, Bonifazi, Fedele, Felisi, Mariagrazia, Bonifazi, Donato, Ceci, Adriana

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Role of Early Symptoms in Assessment of Syncope in Elderly People: Results from the Italian Group for the Study of Syncope in the Elderly von Galizia, Galizia, Abete, Pasquale, Mussi, Chiara, Noro, Gabriele, Morrione, Alessandro, Langellotto, Assunta, Landi, Annalisa, Cacciatore, Francesco, Masotti, Giulio, Rengo, Franco, Marchionni, Niccolò, Ungar, Andrea

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Diagnosis and Characteristics of Syncope in Older Patients Referred to Geriatric Departments von Ungar, Andrea, Mussi, Chiara, Del Rosso, Attilio, Noro, Gabriele, Abete, Pasquale, Ghirelli, Loredana, Cellai, Tommaso, Landi, Annalisa, Salvioli, Gianfranco, Rengo, Franco, Marchionni, Niccolò, Masotti, Giulio

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The 'A' of FAIR - As Open as Possible, as Closed as Necessary von Landi, Annalisa, Thompson, Mark, Giannuzzi, Viviana, Bonifazi, Fedele, Labastida i Juan, Ignasi, 1970, Bonino da Silva Santos, Luiz Olavo, Roos, Marco

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Inquadramento della sincope "difficile": quali sono le indicazioni agli esami di secondo livello? von Andrea Ungar, Alessandro Morrione, Martina Rafanelli, Alice Maraviglia, Annalisa Landi, Francesca Caldi, Valentina Maddalena Chisciotti, Emilia Ruffolo, Niccolo' Marchionni, Attilio Del Rosso

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Evaluation of "complex syncope: what are the indications for second-level investigations? von Ungar, Andrea, Morrione, Alessandro, Rafanelli, Martina, Maraviglia, Alice, Landi, Annalisa, Caldi, Francesca, Chisciotti, Valentina Maddalena, Ruffolo, Emilia, Marchionni, Niccolò, Del Rosso, Attilio

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