| 2015 |
Dr. Barbara Siebertz |
Patient Registries as Specific Obligations for Marketing Approvals of Orphan Drugs in the European Community *** |
|
|
| 2015 |
Simona Stratil |
Herbal Medicinal Products for Paediatric Population: Analysis of the Status quo in the European Union with Focus on Germany and Approaches to Improve the Situation *** |
|
|
| 2015 |
Dr. Birgit Thome-Kromer |
Consequences of the switch of the intended use of medical devices from human to veterinary use in Germany/Europe *** |
|
|
| 2015 |
Dr. Katharina Veltmann |
Applications for Marketing Authorization and for Registration of Herbal Medicinal Products in the Community - Different Views despite of European Harmonization *** |
|
|
| 2015 |
Dr. Mareille Warnken-Uhlich |
Assessment of Multinational Clinical Trial Aplication within the European Union: Experience and Expectation of the Voluntary Harmonization Procedure *** |
|
|
| 2015 |
Manon Waßmund |
New Conditions in the Pharmaceutical Regulation for Croatia with Accession to the European Union - Preparation, Implementation, Execution *** |
|
|
| 2015 |
Nathalie Welter |
An insight into the post-approval safety surveillance of medicinal products in the three ICH regions (EU, Japan and USA) - with particular focus on the management of safety signals *** |
|
|
| 2015 |
Anja-Simone Wiedemann |
The Impact of Measures Taken by the Federal Institute for Drugs and Medical Devices (BfArM) Regarding the Naming of Medicinal Products from 2010 to 2013 *** |
|
|
| 2015 |
Ute Worringen |
The Humanitarian Device Exemption of the United States as a Pioneering Concept in Orphan Device Regulation and its Implications for the Policy of the Regulation of Medical Devices for Small Populations in the European Union *** |
|
|
| 2014 |
Noel Bettinville |
Current CMC Variation Regulation, change-control, and compliance - outline of a proposed CMC change implementation risk assessment & planning concept that embraces regulatory premises, supply chain forecasting, and quality systems |
|
|
| 2014 |
Christian Döring |
Regulatory burden, adequate to Allergen Specific Immunotherapy? *** |
|
|
| 2014 |
Dr. Alexandra Eckhoff |
Pharmacogenomic data in the product information of medicinal products *** |
|
|
| 2014 |
Claudia Engeler-Plischka |
Sunscreen products - drug or cosmetics? A Comparison of the legal requirements for sunscreen products in Europe, Australia and United States *** |
|
|
| 2014 |
Heike Fell |
Adaptive Design Clinical Trials *** |
|
|
| 2014 |
Dr. Monika Fürlinger |
A risk benefit analysis of Biosimilars |
|
|
| 2014 |
Julia Gröger |
Comparison of the Pediatric Drug Legislation between US and EU Food and Drug Administration Safety and Innovation Act (Title V) versus EU Paediatric Regulation (EC) No 1901/2006 *** |
|
|
| 2014 |
Katja Heiss |
EMA versus US-FDA regulatory requirements regarding bioequivalence of orally administered generics *** |
|
|
| 2014 |
Dr. Florian Herb |
Impact of polymorphism of active pharmaceutical ingredients on the development of generic medicinal products *** |
|
|
| 2014 |
Dr. Maria Iwe |
Commission Proposal for a Clinical Trials Regulation: implications for ethics committees |
|
|
| 2014 |
Dr. Katja Jennißen |
Adaptive Licensing – A new approach in medicinal product authorisation *** |
|
|
