| 2024 |
Dr. Sabine Küppers |
Development of Tissue Engineered Products in the EU - Will the European Commission’s and EMA's Action Plan on Advanced Therapy Medicinal Products make the difference? *** |
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| 2024 |
Michael Link |
Comparative Analysis of Evaluation and Reimbursement Pathways for Digital Health Applications in Germany, France, and Belgium - Current Status and Outlook for the EU *** |
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| 2024 |
Guy Noel Mouoffo |
Enhancing Regulatory Reliance practices in international cooperation: A Focus on Information Sharing |
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| 2024 |
Dr. Gilbert Müller |
Drug Name (Un-)Likeness - Methods and Strategies to Find an Approvable Drug Name *** |
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| 2024 |
Dr. Thilo Nölke |
Veterinary Regulatory Measures to Counteract Antimicrobial Resistance in Germany and on EU-Level *** |
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| 2024 |
Dr. Mahsa Rahbari |
Benefits of Structured Content Management for Labeling Compliance in the Pharmaceutical Industry |
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| 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 |
Dr. 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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