| 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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| 2015 |
Stephan Hurtmanns |
European Union Article 31 referral procedures: a case study on the example of GVK Biosciences |
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| 2015 |
Katharina Illgen |
Non-human primates in research and safety testing |
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| 2015 |
Muhammad Zahid Iqbal |
The application of the quality by design approach for the analytical method development in the pharmaceutical industry |
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| 2015 |
Dr. Helene Kern |
How to develop a fictitious combined ATMP regarding non-clinical and early clinical phase: A possible SME Scenario *** |
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| 2015 |
Dr. Iris Krugmann |
The Role of Alcohol in Pharmaceutical Products *** |
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| 2015 |
Lucille Küng |
Phytopharmaceuticals: Analysis of the authorised landscape in the EU and resulting submission
opportunities and challenges from the view of a SME *** |
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| 2015 |
Lisa Kunzmann |
Interactions between Regulatory Affairs and Pharmacovigilance |
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| 2015 |
Dr. Christa Lamping |
The Applicability of Scientific Guidelines to Allergens of Biological and Biotechnological Origin - A User Manual *** |
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| 2015 |
Celine Lentrodt |
The new European Pharmacovigilance Legislation and its impact on the Generics Industry |
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| 2015 |
Dr. Elke Maneke |
Article 45 EU Worksharing Procedure conducted according to Paediatric Regulation (EC) 1901/2006: What has been accomplished for paediatric use? – A Retrospective Analysis *** |
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