| 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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| 2021 |
Dr. Ilona Ahonen |
Sex hormones and their antagonists: unmet medical needs in rare and paediatric diseases |
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| 2021 |
Bilal Alyousef |
Regulatory Affairs in the Gulf Cooperation Council Region |
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| 2021 |
Rumyana Atanasova |
CMDh-Project for Harmonisation of RMPs (HaRP): Aims and results - Survey analysis of the project for risk management plan (HaRP) harmonization |
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| 2021 |
Dr. Katrin Bäsell |
Coronavirus Pandemic (COVID -19) - Influence on Pharma Industry and Competent Regulatory Authorities and corresponding strategies/actions to deal with the situation |
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| 2021 |
Dr. Claudia Benz |
Implementation and Maintenance of additional Risk Minimisation Measures (aRMM) and their interdisciplinary challenges on a local level in a global company |
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| 2021 |
André Bick |
Gesetzgebung und Maßnahmen zum Fälschungsschutz bei Arzneimitteln in der Europäischen Union, den USA und Brasilien - ein Vergleich aus behördlicher Sicht unter besonderer Berücksichtigung der Serialisierungsvorhaben |
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| 2021 |
Dr. Maria Cristina Bolanos Vasquez |
Exceptional regulatory provisions governing vaccine development and approval in a pandemic situation - a model for the regulatory future |
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| 2021 |
Dr. Kim Burgard |
Sufficient clinical evidence under MDR for legacy devices and new products. Requirements and challenges before and after CE marking. |
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| 2021 |
Dr. Manja Burggraf |
"Lessons learned" for Regulatory and Scientific Advice of Vaccines and Biologicals in Times of COVID-19 |
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| 2021 |
Dr. Xia Dong |
Regulatory Framework and Key Steps of Medical Device Registration in China under Current and Revised Regulations on Supervision and Management of Medical Devices |
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