| 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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| 2017 |
Dr. Tobias Morawe |
Moving into future - a pure electronic package leaflet as a chance for patients, the pharmaceutical industry and health authorities |
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| 2017 |
Dr. Barbara Oberwallner |
Implementation of authority requirements or recommendations into the package leaflet – a comparative study in three European countries *** |
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| 2017 |
Dr. Elza Okon |
Marketing authorization process and regulation of veterinary medicinal products in the CIS countries *** |
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| 2017 |
Sabine Prohl |
Background, evaluation, and impact of the new EMA-guideline: "Guideline on setting health base exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities" *** |
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| 2017 |
Anna Reifschneider |
The new U.S. FDA regulations on biocompatibility and reprocessing for medical devices *** |
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| 2017 |
Julia Richnow |
Benefit-Risk Assessment of Human Medicines - A Comparison of EMA’s and FDA’s Approach *** |
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| 2017 |
Dr. Georgeta-Irina Sava-Piroddi |
Biomarkers in oncological drug development: the potential and the challenges leading the way towards personalized medicine |
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| 2017 |
Dr. Gritt Schäfer |
Biotechnology: Regulatory Requirements On Continuous Manufacturing for (glycosylated) Monoclonal Antibodies *** |
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| 2017 |
Ute Scheibel |
Regulatory considerations in cooperation of small and medium-sized enterprises with their foreign business partners regarding marketing authorisation applications for herbal medicinal products *** |
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| 2017 |
Dominik Sebastian |
Clinical Evidence Under the New Regulation 2017/746/EU on In Vitro Diagnostic Medical Devices |
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