| 2018 |
Patricia Westendorf |
How to update a CEP? An analysis of the regulatory activities in a middle-sized pharmaceutical company, taking account of the new Q&A of the EMA *** |
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| 2018 |
Angela Zambrano |
Global regulatory dynamics in response to the challenges of innovation in gene and cell therapy products: An overview |
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| 2017 |
Stefan Brunkhorst |
The Prescription Status and Its Implications for Pharmaceutical Companies *** |
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| 2017 |
Alice Burger |
Comparison of Pharmacovigilance in Germany and Japan *** |
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| 2017 |
Monica Cano |
History of attention deficit and hyperactivity disorder linked to Methylphenidate: A regulatory overview of the product lifecycle |
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| 2017 |
Dr. Thi Hong Nhung Do |
Options of innovative vaccine approval without human efficacy data *** |
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| 2017 |
Dr. Valeria Facchinetti |
Toward expanded patient access to gene and cell therapy products: a comparative study of the regulatory approaches in the European Union, the United States and Japan *** |
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| 2017 |
André Fischer |
The Swiss Überprüfungsverfahren – Similarities and differences to the EU Referral procedure *** |
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| 2017 |
Gabriele Gempel-Drey |
Medicinal products for geriatric patients in Germany - Current status of regulatory requirements and clinical reality *** |
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| 2017 |
Cordula Grandpierre-Verhees |
The challenge of filing a drug application for an NCE for human use for the US and EU in parallel - An overview of the potential differences between the US and EU CTD dossiers and essential pre-application activities |
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| 2017 |
Dr. Rita Grimm |
Use of Extrapolation, Modelling & Simulation Studies in Paediatric Investigation Plans – an analysis of PIP opinions from 2007 – 2016 *** |
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| 2017 |
Sylvia Haser |
The regulatory approach to obtain marketing authorisation for locally acting cutaneous used medicinal products from a generic pharmaceutical company's point of view with a focus on quality of the products *** |
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| 2017 |
Dr. Ulrich Heiser |
Evaluation of Recent Scientific and Regulatory Developments in Alzheimer's Disease and Their Impact on the Clinical Development of a Disease-Modifying Therapy *** |
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| 2017 |
Dr. Sandra Hennig |
Companion Diagnostics for Personalised Medicines – the Regulatory Framework for their (co-) Registration in the EU and the USA *** |
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| 2017 |
Dr. Gunther Kauselmann |
Precision Medicine and the N-of-1 Clinical Trial Concept *** |
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| 2017 |
Diane Kleinjohann |
Regulatory aspects concerning extracts from cannabis with low Δ9-tetrahydrocannabinol content |
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| 2017 |
Dr. Jenny Lauterbach |
Beauflagte Schulungsmaterialen als zusätzliche Risikominimierungsmaßnahme in Deutschland. Eine kritische Analyse aus Sicht der Industrie, der Ärzte und Behörden *** |
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| 2017 |
Dr. Andreas Lippert |
Quo vadis phase I trials in the EU? |
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| 2017 |
Dr. Helen Meyer-Martin |
The increasing burden of Allergic Asthma – Regulatory framework of common treatment strategies and innovative therapies |
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| 2017 |
Dr. Dimitrios Mintsioglou |
Quality Management in clinical trials: Comparison of the requirements stated in the Integrated Addendum to ICH E6(R1) Guideline for Good Clinical Practice E6(R2) for medicinal products and the ISO 14155:2011 for medical devices *** |
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