| 2023 |
Deanna Yuching Balakhonova |
An Overview of Current Regulatory Environment Regarding Artificial Intelligent (AI)-Based Medical Device Software (MDSW) in EU |
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| 2023 |
Justin-Christopher Bell |
Regulatory Informatics and Labelling Management Systems - Recent Developments and Description of a State-of-the-Art Labelling Management Software in the Pharmaceutical Industry *** |
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| 2023 |
Katharina Böhm |
Clinical Trials Regulations (CTR) – An analysis of the first clinical trial applications in the public portal of the Clinical Trials Information System (CTIS) *** |
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| 2023 |
Marianna Costa |
The regulatory challenge of determining acceptable intakes for nitrosamine drug substance-related impurities while ensuring medicinal product supply *** |
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| 2023 |
Dr. Harald G. Engemann |
A comparison of the regulatory requirements for the conduct of clinical trials respectively performance studies for medicinal products, medical devices and in-vitro diagnostic medical devices according to the European regulations (EU) 536/2014, (EU) 2017/745 and (EU) 2017/746 |
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| 2023 |
Dr. Denise Nadine Fabian |
Labeling of Drug-Device Combination (DDC) Products in Europe under the new Medical Device Regulation (EU) 2017/745 *** |
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| 2023 |
Dr. Naséra Hammouti |
Worldwide Good Distribution Practice (GDP) guideline: a regulatory need and challenge |
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| 2023 |
Yvonne Hinterstocker |
Comparison of the regulatory requirements for the proof of comparability of generic locally applied locally acting products with their originator product in the EU and USA - an overview on the current status and the latest trends |
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| 2023 |
Nicola Leven |
Preparation of a specification and description of the process validation on the manufacturing process of biological active substance streptokinase as part of the drug master file for the EU *** |
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| 2023 |
Daniela Maier |
Sind die neuen regulatorischen Bedingungen für minimalinterventionelle klinische Prüfungen praxisrelevant für klinische Prüfungen nach der Marktzulassung? |
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| 2023 |
Syed Saadi Manzoor |
The placing on the market of in vitro diagnostic medical devices under the old and new legal situation with special consideration of the possibility of a special authorization - Legal basis and Regulatory Aspects - |
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| 2023 |
Dr. Olga Petina |
Comparative analysis of the EU regulatory requirements for essential oils as ingredients for the pharmaceutical, cosmetic products and feed additives *** |
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| 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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