| 2018 |
Christoph Hoerth |
Change of a starting material supplier Comparison of the global post authorization change requirements with focus on the API class of synthetic peptides |
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| 2018 |
Dr. Jutta Keil |
The representation of transdermal systems in the leading pharmacopoeias within the ICH-area and the elaboration of transdermal finished product Monographs *** |
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| 2018 |
Maria Keyser |
Avoiding of falsified medicines: An overview of the legal situation and the impact on the pharmaceutical industry - with a focus on regulatory implementation |
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| 2018 |
Rosanne Kirchberg |
Cannabis in Switzerland: Considering Historic, Legal and Regulatory Aspects With Focus on Medicinal Use |
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| 2018 |
Elizabeth Klemm |
Clinical trials in Central America: an analysis of the low MRCT allocation to this region by comparing the regulatory requirements in Cuba, Dominican Republic and Puerto Rico with EU standards |
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| 2018 |
Ralf Klünder |
Besonderheiten der Arzneimittelzulassung in der Katastrophenpharmazie unter Mitbetrachtung des Geschäftsbereichs BMVg - eine Einschätzung |
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| 2018 |
Michael Kravzow |
Regulatory considerations, opportunities and challenges for pharmaceutical companies in developing a multi-vitamin/mineral product *** |
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| 2018 |
Sarah Kruck |
EU Herbal Monographs - chances and limitations in Regulatory Affairs |
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| 2018 |
Elena Lang |
Eurasian medical device regulatory system - a new challenge or a new opportunity for European medical device manufacturers? *** |
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| 2018 |
Silvia Londero |
Brief analysis of the 'Guideline of manufacture of the finished dosage form' and its impact on the industry *** |
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| 2018 |
Dr. Sandra Mahr |
Replace, Reduce, Refine - Recent Developments in Alternative Testing Methods in Pharmaceutical Toxicology and their Regulatory Acceptability in the EU *** |
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| 2018 |
Dr. Larissa Maier |
International Regulatory Lifecycle Management of Gadolinum-based Contrast Agents *** |
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| 2018 |
Iulia Menzel |
Die Rechtsstellung des Informationsbeauftragten nach § 74a AMG *** |
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| 2018 |
Dr. Carola Michielse |
Guidelines and regulations on excipients in medicinal products: an overview of developments, implications and challenges for the future *** |
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| 2018 |
Dr. Markus Molitor |
The Relevance of the Label in the Context of the Early Benefit Assessment (EBA) of Medicinal Products: a Systematic Quantification of the Deviations of Marketing Authorization Labels Compared to the Underlying Pivotal Studies and the Consequences for the Extent of Added Benefit |
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| 2018 |
Aksana Müller |
Bioequivalence requirements in the Eurasian Economic Union, the European Union, the United States of America and the People’s Republic of China |
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| 2018 |
Dr. Natalia Osmanova |
Comparison of the regulation for Good Pharmacovigilance Practice in the European Union and in the Eurasian Economic Union *** |
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| 2018 |
Rosi Puniyani |
Introduction of the ICH Q12 (Draft) Guideline: An approach to a proactive evolution of a product- Chances, risks and practicability *** |
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| 2018 |
Dr. Lasse Reefschläger |
Analysis of the EMA relocation decision - regulatory reasoning and impact on regulatory functionality of the EMA |
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| 2018 |
Dr. Sam Ringle |
Regulatory Implications Using API Cocrystals for Generic Medicinal Products within the EU and US *** |
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