Use of Real-world Data for New Drug Applications and Line Extensions von Bolislis, Winona R., Fay, Myriam, Kühler, Thomas C.

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Real-World Data in the Postapproval Setting as Applied by the EMA and the US FDA von Mofid, Sarah, Bolislis, Winona Rei, Kühler, Thomas C.

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Rolling Reviews During COVID-19: The European Union Experience in a Global Context von Marinus, Roelie, Mofid, Sarah, Mpandzou, Marya, Kühler, Thomas C.

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Real-world Data and Evidence to support a switch in status from Prescription drug to Over the Counter drug as applied by the EMA, the US FDA, the MHRA, and the BfArM von Kühler, Thomas C., Ateka, Aritz, Lassoued, Zeineb, Routhier, François-Xavier, Mékary-Sawaya, Souha

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Regulatory Agilities in the Time of COVID-19: Overview, Trends, and Opportunities von Bolislis, Winona Rei, de Lucia, Maria Lucia, Dolz, Felipe, Mo, Runyi, Nagaoka, Makoto, Rodriguez, Heraclio, Woon, May Li, Yu, Wei, Kühler, Thomas C.

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Foreword Special Section on "Evolving Trends in Electrical Modeling, Validation, and Signal and Power Integrity Analysis in Electronic Packaging and Systems" von Kuhler, Thomas, Peng, Zhen

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Transparency in European Medicines Agency and US Food and Drug Administration Decision Making: Is It Possible to Identify the Rationale for Divergences in Approved Indication From... von Bujar, Magda, Ferragu, Sara, McAuslane, Neil, Liberti, Lawrence, Kühler, Thomas C.

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The Utility of Remote Inspections During the COVID-19 Health Emergency and in the Postpandemic Setting von Mofid, Sarah, Bolislis, Winona Rei, Brading, Clive, Hamilton, Nigel, Hardit, Cyril, Nagaoka, Makoto, Parain, Julien, Zanta, Maria, Kühler, Thomas C.

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Are pharmaceuticals potent environmental pollutants? part I: Environmental risk assessments of selected active pharmaceutical ingredients von CARLSSON, Carina, JOHANSSON, Anna-Karin, ALVAN, Gunnar, BERGMAN, Kerstin, KÜHLER, Thomas

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Optimizing Pediatric Medicine Developments in the European Union Through Pragmatic Approaches von 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.

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Development and Regulation of Connected Combined Products: Reflections From the Medtech & Pharma Platform Association von Kühler, Thomas C., Schoenmakers, Marc, Shergold, Oliver, Affolter, Stephan, Bolislis, Winona Rei, Foster, Ruth, Gardner, Paul, Hruschka, Svenja, Jomini, Thierry, Kaveripakam, Sathish, Mayerhofer, Karl, Scherini, Tomaso, Swierczynska, Marta, Vandal, Gretchen, Fürst-Ladani, Shayesteh

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Orphan Medicines for Pediatric Use: A Focus on the European Union von Bolislis, Winona Rei, Corriol-Rohou, Solange, Hill-Venning, Claire, Hoogland, Hans, Joos, Angelika, King, David, Kitcatt, Victoria, Le Visage, Genevieve, Kühler, Thomas C.

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From Print to Screen: Regulatory Considerations to Adopting Innovative Approaches for Patient Information and Safety von Bolislis, Winona Rei R., Mortazavi, Charlie, Riccioni, Rossana, Schaeffer, Paul-Etienne, Kühler, Thomas C.

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Are pharmaceuticals potent environmental pollutants? part II: Environmental risk assessments of selected pharmaceutical excipients von CARLSSON, Carina, JOHANSSON, Anna-Karin, ALVAN, Gunnar, BERGMAN, Kerstin, KÜHLER, Thomas

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Do Biological Medicinal Products Pose a Risk to the Environment?: A Current View on Ecopharmacovigilance von Kühler, Thomas C., Andersson, Mikael, Carlin, Gunnar, Johnsson, Ann, Åkerblom, Lennart

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SPI 2022 Held in Siegen, Germany von Griese, Elmar, Kuhler, Thomas

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Dynamic Regulatory Assessment: evolving the European Regulatory Framework for the Benefit of Patients and Public Health—an EFPIA View von Herrero-Martinez, Esteban, Hussain, Nasir, Roux, Nadege Le, MacDonald, Judith, Mayer, Mark, Palacios, Rodrigo, Kühler, Thomas C.

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To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on pub... von Kühler, Thomas Christian, Bujar, Magda, McAuslane, Neil, Liberti, Lawrence

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The impact of posttraumatic stress disorder on dysfunctional implicit and explicit emotions among women with borderline personality disorder von RÜSCH, Nicolas, CORRIGAN, Patrick W, BOHUS, Martin, KÜHLER, Thomas, JACOB, Gitta A, LIEB, Klaus

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Novel Structures Derived from 2-[[(2-Pyridyl)methyl]thio]-1H-benzimidazole as Anti-Helicobacter pylori Agents, Part 2 von CARCANAGUE, Daniel, SHUE, Youe-Kong, WUONOLA, Mark A., URIA-NICKELSEN, Maria, JOUBRAN, Camil, ABEDI, Joseph K., JONES, Jeanette, KüHLER, Thomas C.

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