| 2023 |
Dr. Mirjam Schröder |
Extension of PSUSA outcomes to other active substances or respective mono / fixed-dose combination product(s) *** |
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| 2023 |
Melike Uzun |
Current Quality Requirements for mRNA-based Drug Substances |
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| 2022 |
Dr. Verena Becker |
Kinderarzneimittel in der frühen Nutzenbewertung: Eine Übersicht mit Fokus auf den Evidenztransfer zur Bewertung des Zusatznutzens *** |
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| 2022 |
Ariane Bruche |
Optimization of post-trial patient treatment - A challenge of highest regulatory need *** |
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| 2022 |
Dr. Peter Buschmann |
Monographs of the European Pharmacopoeia on medicinal products containing chemically defined active substances, Implications on marketing authorisation application, surveillance, and authorisations in the European Union |
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| 2022 |
Dr. Sibylle Eisbach |
Towards the unmet medical need of children – Reflection on future changes of the EU paediatric legislation *** |
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| 2022 |
Dr. Berit Grützke |
Klinische Prüfungen mit Medizinprodukten unter Verordnung (EU) 2017/745 aus der praktischen Perspektive *** |
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| 2022 |
Carolin Himpel |
Medicines for vulnerable populations - current regulatory status *** |
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| 2022 |
Larissa Hoffmann |
Regulatory Strategy Considerations to Support the Development of a New Estriol Releasing Vaginal Ring Product *** |
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| 2022 |
Dr. Maria Huthmacher (geb. Schacker) |
Comparison of the EU and US paediatric legislations and critical analysis of the expected impact of the FDA’s "RACE for Children Act" on the development of paediatric cancer medicines *** |
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| 2022 |
Anne Jeschke |
Opportunities and challenges of reformulation using levothyroxine as an example |
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| 2022 |
Jelena Katic |
Effectiveness of Risk Minimisation Measures in the EU - Evaluation Strategies and Impact on Regulatory Decisions *** |
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| 2022 |
Linda Krempl |
Between recognition, reliance, and lead. Will new Facilitated Regulatory Pathways (FRPs) have the potential to promote Swissmedic to a first wave agency? *** |
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| 2022 |
Dr. Birgül Kurt |
Verbot von Titandioxid in der Lebensmittelbranche und regulatorische Auswirkungen auf die Arzneimittelindustrie *** |
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| 2022 |
Kerstin Leuschke |
Marketing authorisations (MAs) of medicines for human use approved via centralised procedure compared to MAs approved via decentralized, mutual recognition procedure and/or purely national procedures in the EU/EEA - Consideration of the significant influence on maintenance activities/workload and on costs (fees) (examples und survey) *** |
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| 2022 |
Elisabeth Lieschke |
Valsartan Case and its Consequences for Regulatory Affairs Activities of Marketing Authorization Holders |
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| 2022 |
Mona Linser |
Medicinal products for minors - Different regulatory approaches and conduction of clinical trials on the example of antidiabetics *** |
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| 2022 |
Dr. Tanja Marzluf |
Implementation of the EU Regulation on health technology assessment (HTA) - Chances and challenges - *** |
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| 2022 |
Volker Mauel |
Ansätze zur Verbesserung der Überwachung der Arzneimittelversorgungssicherheit durch Nutzung und Auswertung regulatorischer Daten *** |
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| 2022 |
Nikoleta Papavramidou |
Heutige Hürden für den fairen Zugang zu innovativen Behandlungen für Patienten mit seltenen Erkrankungen in Europa |
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