| 2013 |
Esther Cónsul Tejero |
Melde- und Bobachtungssystem für Medizinprodukte - eine statistische Auswertung anhand eines Beispiels |
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| 2013 |
Alex Dranov |
European View on Current Regulatory Legislation in the CIS Countries. Marketing Authorisation of Herbal Medicinal Products in Russia and the Ukraine *** |
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| 2013 |
Inga Kristin Drosse |
Antibiotics in veterinary medicine - A European Regulatory Perspective *** |
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| 2013 |
Berit Fasse |
Acceptability of brand names for human medicinal products. With focus on German non-generic OTC umbrella brand discussion |
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| 2013 |
Dr. Thomas Flötotto |
Classification of Antiseptics and Disinfectants for Human use. The Demarcation between Biocides, Medicinal Products, Medical Devices and Cosmetics *** |
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| 2013 |
Karsten Gavenis |
Conducting Clinical Trials in Orthopedic Indications in Germany |
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| 2013 |
Mecit Gedik |
Verbesserung der Arzneimittelsicherheit durch Aufnahme in das BtM-Gesetz am Beispiel des Tilidins *** |
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| 2013 |
Dr. Christine Gescher (ehemals Kundinger) |
Development and regulatory strategy for a generic dry powder inhaler for submission in EU
as per the in-vitro only option in section 5.2 of OIP guideline (CPMP/EWP/4151/00 REV. 1) *** |
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| 2013 |
Silvia Gonzalez |
FDASIA "breakthrough" drug therapies – a real regulatory breakthrough for innovations? *** |
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| 2013 |
Gilda Gordon |
A critical review of the current marketing authorisation transfer procedure in Europe *** |
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| 2013 |
Karin Hoffmann |
The Etiology of BSE and Variant Creutzfeldt-Jacob Disease in Context with the new European Legislation for Material of Animal Origin, Commission Regulation (EU) No. 722/2012 Regulatory and Scientific Experience after the first BSE/vCJD Outbreak *** |
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| 2013 |
Dr. Martin Hornberger |
The non-clinical and clinical Implications of Drug-induced Liver Injury – Test Systems, Clinical Research and Regulatory Aspects *** |
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| 2013 |
Schumacher Jeannette |
Regulatory Requirements on the Quality of Radiopharmaceuticals in EU, US and Canada in Clinical Trial Applications and in Marketing Authorisation Applications |
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| 2013 |
Dr. Svenja Johannsen |
The Special Role of Norway and Iceland in Regulatory Affairs as EEA but not EU Members (To be or not to be "a full member" - that is the question) *** |
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| 2013 |
Annette Kienapfel (geb. Lorenz) |
A review of the advancements in photosafety testing with regard to ICH’s new topic S10: Photosafety evaluation of pharmaceuticals *** |
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| 2013 |
Anja Köstner |
Similarity and Interchangeability of Biosimilars in Comparison to Generics |
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| 2013 |
Dr. Mathias Krech |
Tissue or Blood Product - Regulatory requirements concerning the manufacture and clinical use of human hematopoietic stem cells in Germany *** |
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| 2013 |
Stefan Kuhn |
Advantages, disadvantages and pitfalls in current registration procedures of medical devices |
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| 2013 |
Stephanie Laubner |
Two Article 30 Referrals – Comparison and experiences, with a main focus on the different implementations in cooperation with the same agency *** |
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| 2013 |
Milva Mateblowski |
Risk Based Monitoring – impact and benefits for small and medium-sized enterprises |
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