Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth von Eichler, Hans‐Georg, Pignatti, Francesco, Schwarzer‐Daum, Brigitte, Hidalgo‐Simon, Ana, Eichler, Irmgard, Arlett, Peter, Humphreys, Anthony, Vamvakas, Spiros, Brun, Nikolai, Rasi, Guido

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Environmental risk assessment of advanced therapies containing genetically modified organisms in the EU von Whomsley, Rhys, Palmi Reig, Victoria, Hidalgo‐Simon, Ana

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Towards a better use of scientific advice for developers of advanced therapies von Tavridou, Anna, Rogers, Dolca, Bonelli, Milton, Schiel, Anja, Hidalgo‐Simon, Ana

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Advanced therapies are ready to take centre stage: Academia's involvement with regulation needs to raise its game von Hidalgo‐Simon, Ana, Fibbe, Willem E.

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EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells von Celis, Patrick, Farinelli, Giada, Hidalgo‐Simon, Ana, Meij, Pauline, Tihaya, Mara, Schüssler‐Lenz, Martina, Timón, Marcos

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Identifiability of Biologicals in Adverse Drug Reaction Reports Received From European Clinical Practice von Vermeer, Niels S., Giezen, Thijs J., Zastavnik, Sofia, Wolff‐Holz, Elena, Hidalgo‐Simon, Ana

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Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions von Correia Pinheiro, Luis, Giezen, Thijs J., Wolff‐Holz, Elena, Weise, Martina, Laslop, Andrea, Hidalgo‐Simon, Ana

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From Laboratory to Patient: The Evolving Path to Become a Medicine von Hidalgo-Simon, Ana

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Evaluation of the effectiveness of risk minimization measures von Prieto, Luis, Spooner, Almath, Hidalgo-Simon, Ana, Rubino, Annalisa, Kurz, Xavier, Arlett, Peter

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Authorization of Vaccines in the European Union von Hidalgo-Simon, Ana, Botgros, Radu, Cochino, Emil

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Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance von Kurz, Xavier, Domergue, François, Slattery, Jim, Segec, Andrej, Szmigiel, Agnieszka, Hidalgo-Simon, Ana

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Regulatory approaches to stimulate innovative renal replacement therapies von Wieringa, Fokko P., Sheldon, Murray I., Hidalgo-Simon, Ana

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Autoimmune disorders after immunisation with Influenza A/H1N1 vaccines with and without adjuvant: EudraVigilance data and literature review von Isai, Alina, Durand, Julie, Le Meur, Steven, Hidalgo-Simon, Ana, Kurz, Xavier

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Comparison Between Paediatric and Adult Suspected Adverse Drug Reactions Reported to the European Medicines Agency: Implications for Pharmacovigilance von Blake, Kevin V., Zaccaria, Cosimo, Domergue, Francois, La Mache, Edith, Saint-Raymond, Agnes, Hidalgo-Simon, Ana

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Endothelial integrity as a major factor in cold preservation of lung for transplatation von Hidalgo-Simon, Maria Ana

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