| 2024 |
Dr. Isabel Ramtohul |
Impact assessment of the proposed Pharma Legislation of the European Union on a pharmaceutical industry portfolio with focus on Regulatory Data Protection and Orphan Market Exclusivity and associated conditions *** |
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| 2024 |
Alexander Reichenbach |
Regulatory considerations for CMC development of platform based mRNA vaccines *** |
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| 2024 |
Julia Schlischewski |
Medizinisches Cannabis in Deutschland seit 2017 – Eine kritische Analyse der bisherigen Entwicklung im Vergleich mit der Regulierung in Kanada |
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| 2024 |
Bich Nguyet Seipel |
The Future of Plasma-Derived Medicinal Products in the European Union under the European Commission’s Proposed Regulation on Substances of Human Origin: An Analysis of the Amendments and Their Impact *** |
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| 2024 |
Marina Semakov |
Artificial Intelligence in Regulatory Affairs CMC - Chances and Challenges *** |
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| 2024 |
Dr. Gianna Thomsen |
Development of a regulatory toolbox for the approval procedure for medicinal products for human use *** |
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| 2024 |
Felix Wolf |
Environmental challenges for medicinal products arising from the proposed pharma legislation of the European Union and consequential implications for different EU stakeholders |
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| 2023 |
Dr. Irina Anusca |
Clinical Evaluation of light-cure resin modified Dental Composite according to MDR 745/2017 |
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| 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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