| 2015 |
Dr. Jennifer Anthöfer |
Drug Development and Critical Analysis of the Reliability of Preclinical Studies *** |
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| 2015 |
Dr. Kerstin Bade |
The revision of European Directives on medical devices 90/385/EWG (AIMDD) and 93/42/EWG (MDD): Present requirements concerning clinical investigation and clinical evaluation in comparison to Commission`s proposal for a new Regulation on medical devices and those discussed by the EU Parliament and the Council in the course of the legislation procedure |
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| 2015 |
Cora Bergmann |
Sunset Clause in Germany – Provisions for nationally authorised human medicinal products under the responsibility of the Federal Institut for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) |
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| 2015 |
Bettina Bickel |
Heparin - Changes in regulatory requirements and consequences thereof *** |
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| 2015 |
Olga Borsuk |
The repurposing of already marketing drugs to be used in the field of rare diseases: challenges, advantages and regulatory strategy in the European Union |
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| 2015 |
Yuan Chen |
Article 58 Applications - Best Access to Drugs in Developing Countries? *** |
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| 2015 |
Simone Dietz |
Implementation of GDP (2013/C 343/01) - from a logistic supplier's point of view *** |
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| 2015 |
Dr. Florian Diwischek |
Regulatory Approval options in emergency situations - a comparison between EU and US on the example of the Ebola virus *** |
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| 2015 |
Dr. Alina Frantescu |
National dossier requirements in the European countries – Last step in obtaining the marketing authorisation or rather a burden for the applicant? *** |
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| 2015 |
Sabine Günther-Commerscheidt |
Status quo 2015 - Post-Authorisation Pharmacovigilance for Human and Veterinary Medicinal Products in Germany and Europe |
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| 2015 |
Dr. Stefanie Haas |
The WHO Collaborative Registration Procedure for Medicines in Developing Countries *** |
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| 2015 |
Johanna Hanrieder |
Regulatory aspects contributing to insufficient access to high-quality essential medicines in developing countries and proposals for regulatory improvements *** |
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| 2015 |
Birgit Harrer |
Comparison of combined and related sets of medical devices with medicinal products, considering also the coming regulation for medical devices |
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| 2015 |
Dr. Mirko Hechenberger |
Q3D step 4: background, impact and consequences of an ICH guideline upon elemental impurities in drug products *** |
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| 2015 |
Erika Henkel |
Electronic submission of information on medicinal products authorized in the European Economic Area according to Article 57(2) of the Regulation (EC) No 726/2004 and the challenges of the XEVMPD *** |
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| 2015 |
Valeska Hiller |
Launch of a generic medicinal product on the European market. Development of a project management strategy taking into consideration various regulatory and legal requirements, summarized in a manual |
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| 2015 |
Dr. Urs Dominik Hobom |
Comparison of Biosimilar Registrations for the Swiss and the German Market or What CMC Can Tell Us |
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| 2015 |
Dr. Axel Hoffmann |
Transition from the Extended Eudravigilance Medicinal Product Dictionary to the ISO standards for Identification of Medicinal Products – implications, challenges, and opportunities for pharmaceutical companies |
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| 2015 |
Jan Horn |
"Earlier access to medicines" EAMS in the UK: A comprehensive overview and comparison to existing accelerated licensing procedures in the EU and Germany *** |
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| 2015 |
Rita Huber |
The new Clinical Trial Regulation and corresponding new EU portal and database: an opportunity to enhance standardisation and interoperability in regulatory systems *** |
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