| 2024 |
Maria Berlenbach |
How Good Manufacturing Practice (GMP) auditing impacts the quality part of the registration dossier for Active Pharmaceutical Ingredients *** |
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| 2024 |
Katharina Dupont |
Risk minimisation measures in the pharmaceutical industry – a review of the handling of Direct Healthcare Professional Communication (DHPC) and Educational Material (EM) in Germany, Austria and Switzerland *** |
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| 2024 |
Berit Frei |
A review of the regulatory framework for Drug-Device Combination Products in Europe and the implications of the Medical Device Regulation (EU) 2017/745 implementation *** |
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| 2024 |
Dr. Jana Heidemann |
Pharmaceutical regulatory landscape in the United Kingdom after the Brexit and current regulatory changes, with focus on the Windsor Framework and the International Recognition Procedure *** |
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| 2024 |
Kevin Hohl |
Nitrosamine Risk Management for Medicinal Products: WHO's Role and a Case Study of Camzyos® *** |
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| 2024 |
Dr. Tobias Jaud |
The maze of extractables and leachables - Regulatory risk assessment of β-Glucans *** |
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| 2024 |
Jessica Jeschke |
Regulatory and Scientific Strategies to Combat Antimicrobial Resistance in the EU *** |
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| 2024 |
Eva Kreßner |
Finding a balance between the need for comprehensive transparency in clinical trials and the protection of commercially confidential information in today’s regulatory environment |
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| 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. 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. Anna Seydel |
Comparison of veterinary pharmacovigilance in the European Union under Directive 2001/82/EC versus under Regulation (EU) 2019/6 with a focus on the administrative burden for MAHs before, during, and after implementation of Regulation (EU) 2019/6 *** |
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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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