Randomized Controlled Trials Versus Real World Evidence: Neither Magic Nor Myth
Eichler, Hans‐Georg, Pignatti, Francesco, Schwarzer‐Daum, Brigitte, Hidalgo‐Simon, Ana, Eichler, Irmgard, Arlett, Peter, Humphreys, Anthony, Vamvakas, Spiros, Brun, Nikolai, Rasi, Guido
Published in Clinical pharmacology and therapeutics (01.05.2021)
Published in Clinical pharmacology and therapeutics (01.05.2021)
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Journal Article
Towards a better use of scientific advice for developers of advanced therapies
Tavridou, Anna, Rogers, Dolca, Bonelli, Milton, Schiel, Anja, Hidalgo‐Simon, Ana
Published in British journal of clinical pharmacology (01.06.2021)
Published in British journal of clinical pharmacology (01.06.2021)
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Journal Article
EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells
Celis, Patrick, Farinelli, Giada, Hidalgo‐Simon, Ana, Meij, Pauline, Tihaya, Mara, Schüssler‐Lenz, Martina, Timón, Marcos
Published in British journal of clinical pharmacology (01.05.2024)
Published in British journal of clinical pharmacology (01.05.2024)
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Journal Article
Identifiability of Biologicals: An Analysis Using EudraVigilance, the European Union's Database of Reports of Suspected Adverse Drug Reactions
Correia Pinheiro, Luis, Giezen, Thijs J., Wolff‐Holz, Elena, Weise, Martina, Laslop, Andrea, Hidalgo‐Simon, Ana
Published in Clinical pharmacology and therapeutics (01.11.2021)
Published in Clinical pharmacology and therapeutics (01.11.2021)
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Journal Article
Evaluation of the effectiveness of risk minimization measures
Prieto, Luis, Spooner, Almath, Hidalgo-Simon, Ana, Rubino, Annalisa, Kurz, Xavier, Arlett, Peter
Published in Pharmacoepidemiology and drug safety (01.08.2012)
Published in Pharmacoepidemiology and drug safety (01.08.2012)
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Journal Article
Authorization of Vaccines in the European Union
Hidalgo-Simon, Ana, Botgros, Radu, Cochino, Emil
Published in Molecular Frontiers journal (01.06.2021)
Published in Molecular Frontiers journal (01.06.2021)
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Journal Article
Safety monitoring of Influenza A/H1N1 pandemic vaccines in EudraVigilance
Kurz, Xavier, Domergue, François, Slattery, Jim, Segec, Andrej, Szmigiel, Agnieszka, Hidalgo-Simon, Ana
Published in Vaccine (10.06.2011)
Published in Vaccine (10.06.2011)
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Journal Article
Regulatory approaches to stimulate innovative renal replacement therapies
Wieringa, Fokko P, Sheldon, Murray I, Hidalgo-Simon, Ana
Published in Nature reviews. Nephrology (01.10.2020)
Published in Nature reviews. Nephrology (01.10.2020)
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Journal Article
Comparison Between Paediatric and Adult Suspected Adverse Drug Reactions Reported to the European Medicines Agency: Implications for Pharmacovigilance
Blake, Kevin V., Zaccaria, Cosimo, Domergue, Francois, La Mache, Edith, Saint-Raymond, Agnes, Hidalgo-Simon, Ana
Published in Paediatric drugs (01.08.2014)
Published in Paediatric drugs (01.08.2014)
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