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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2021 |
Alexandra Federer |
Digitalization: Challenges and opportunities for the pharmaceutical industry with regard to advertisement and trade (digital shelfs) *** |
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2021 |
Francesca Haaf |
The antiviral remdesivir - an example of expedited approval procedures in the USA within the Covid-19 pandemic *** |
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2021 |
Corinna Herkenhoff |
Rezepturarzneimittel in Deutschland: Rezeptur- und Fertigarzneimittel im Vergleich. Ist die Herstellung nach ApBetrO noch zeitgemäß? *** |
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2021 |
Kristina Hoffmann |
Electronic product information - The global status quo and possible ePI advancements in the EU |
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2021 |
Johannes Korward |
Dry Eye Disease: Regulatory Requirements Differ Around the Globe – with Implications for Product Development and Patient Access. A review of standards for new ophthalmic therapies in key pharmaceutical markets. *** |
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2021 |
Dr. Karin Kroboth |
A Comparative Analysis of Antibody Drug Conjugates in Europe and the US |
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2021 |
Julia Leuthner |
PUMA-Arzneimittel in der Nutzenbewertung nach § 35a SGB V (2014-2019) |
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2021 |
Theresa Löschmann |
The Company Core Patient Information (CCPI) - a useful tool for regulatory compliance? |
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2021 |
Katarzyna Makosch |
Worksharing procedure - what’s the point? An overview about worksharing procedure as regulatory tool |
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2021 |
Dr. Sarah Matheisl |
Quality-related Challenges of Viral Vector-based Gene Therapy *** |
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