| 2023 |
Kay Pötzsch |
"The Fair Minimum": Wie deutsche Arzneimittelproduktinformation geschlechtsneutral werden kann *** |
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| 2023 |
Ketki Revashankar Purohit |
A retrospective landscape assessment of the use of real-world data in the FDAs recent (Jan 2019-Jun 2022) regulatory decision making for the pharmaceutical products *** |
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| 2023 |
Dr. Bernhard Richard |
Assuring data integrity for CMC regulatory submissions using custom digital tools *** |
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| 2023 |
Annette Rogge-Toehgiono |
Use of digital technologies in healthcare: approvals in the borderline area between medical device and medical aid – investigation and evaluation of regulatory chances and challenges - medical software applications *** |
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| 2023 |
Dr. Verena Schipper |
Real-world evidence in the German HTA process – acceptance by G-BA in the European regulatory and HTA context *** |
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| 2023 |
Norbert Schmid-Eickhoff |
Compassionate Use in Deutschland - eine Übersicht der regulatorischen Rahmenbedingungen und Analyse der durchgeführten Verfahren seit Inkrafttreten der Verordnung über das Inverkehrbringen von Arzneimitteln ohne Genehmigung oder ohne Zulassung in Härtefällen (AMHV), 2010 *** |
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| 2023 |
Dr. Martina Schmidt-Lonhart |
Betäubungsmittel in der Palliativmedizin *** |
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| 2023 |
Dr. Olga Schneider |
Mechanism of action-based approach for the evaluation of the paediatric strategy of CAR-T cell therapies and monoclonal antibodies authorised in the EU for the treatment of tumors of haematopoietic and lymphoid tissue *** |
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| 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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