| 2022 |
Linda Krempl |
Between recognition, reliance, and lead. Will new Facilitated Regulatory Pathways (FRPs) have the potential to promote Swissmedic to a first wave agency? *** |
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| 2022 |
Dr. Birgül Kurt |
Verbot von Titandioxid in der Lebensmittelbranche und regulatorische Auswirkungen auf die Arzneimittelindustrie *** |
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| 2022 |
Kerstin Leuschke |
Marketing authorisations (MAs) of medicines for human use approved via centralised procedure compared to MAs approved via decentralized, mutual recognition procedure and/or purely national procedures in the EU/EEA - Consideration of the significant influence on maintenance activities/workload and on costs (fees) (examples und survey) *** |
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| 2022 |
Elisabeth Lieschke |
Valsartan Case and its Consequences for Regulatory Affairs Activities of Marketing Authorization Holders |
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| 2022 |
Mona Linser |
Medicinal products for minors - Different regulatory approaches and conduction of clinical trials on the example of antidiabetics *** |
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| 2022 |
Dr. Tanja Marzluf |
Implementation of the EU Regulation on health technology assessment (HTA) - Chances and challenges - *** |
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| 2022 |
Volker Mauel |
Ansätze zur Verbesserung der Überwachung der Arzneimittelversorgungssicherheit durch Nutzung und Auswertung regulatorischer Daten *** |
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| 2022 |
Nikoleta Papavramidou |
Heutige Hürden für den fairen Zugang zu innovativen Behandlungen für Patienten mit seltenen Erkrankungen in Europa |
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| 2022 |
Dr. Cecilia-Carmen Patrascan |
Medical tourism: regulatory toxicological aspects of organ donation and transplantation |
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| 2022 |
Dr. Stefanie Pektor |
Implementation rates of PROs/PROMs into European SmPCs of oncologic medicinal products *** |
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| 2022 |
Karla Peters |
A Comparative Overview of the Regulatory Landscapes Around Real-World Data/Real-World Evidence in the USA and the EU, and the Wider Perspective *** |
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| 2022 |
Magali Quetin |
The pharmacovigilance of veterinary medicinal products under Regulation (EU) 2019/6: introduction of the Pharmacovigilance System Master File *** |
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| 2022 |
Dr. Esrin Rasmussen |
New Regulation of Medical Devices in Switzerland |
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| 2022 |
Olga Rassokhina |
Artificial intelligence and Big Data in Pharmacovigilance. Current development, problems and perspectives. Regulatory aspects. |
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| 2022 |
Spyros-Dimitrios Roussos |
The Marketing Authorization transfer in the LATAM countries - Brazil, Mexico, Argentina, Colombia, Chile, Peru (major LATAM economies) and Panama, Guatemala, Costa Rica (SICA countries) & Venezuela |
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| 2022 |
Dr. Niklas Schaumann |
Supporting IDMP implementation through AI-based data extraction - An explorative approach *** |
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| 2022 |
Dr. Vivian Scheuplein |
Nonclinic for TCR-transgenic T cells for adoptive T cell therapy of cancer - current requirements for applicants to EMA and FDA |
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| 2022 |
Yuan Shi |
"State-of-the-art" in new EU medical device regulations: a review of its development in medical device law, the interpretations from stakeholders, impacts, and possible solutions for implementation *** |
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| 2022 |
Anna Sobek |
Safety Labelling Implementation - a Challenge for Marketing Authorisation Holders and an Opportunity through ePI to increase Patient Safety *** |
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| 2022 |
Dr. Daniel Sohmen |
Approval options of therapeutics for treatment of the Coronavirus disease 2019 and their current regulatory environment *** |
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