| 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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| 2022 |
Dr. Nico Steiert |
Entwicklung von "skinny labelling": eine Betrachtung aus der regulatorischen und Patentperspektive *** |
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| 2022 |
Dr. Sabrina Stöhr |
State-of-the-Art Reporting of Clinical Trial Results - Suitability of ICH E3 in a Changing Regulatory Landscape *** |
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| 2022 |
Dr. Birthe Inken Sumpf |
Verordnung (EU) 2019/6 für Tierarzneimittel - Allgemeine Zielsetzung der Verordnung mit Fokus auf die Antibiotikaresistenzproblematik und die Verschreibungskaskade *** |
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| 2022 |
Dr. Carina Tirler |
A review of regulatory drivers and anticipated changes to be adopted by 2025 |
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| 2022 |
Isabel Valentin Verdeguer |
Rare diseases and market access to orphan drugs - analysis of the related legislation in the region of LATAM from a comparative perspective with Europe and USA |
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| 2022 |
Dr. Marian Wiegand |
Regulatory-conform development of mucosal vaccines with a focus on quality, nonclinical and clinical aspects |
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