| 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) *** |
|
|
| 2013 |
Silvia Gonzalez |
FDASIA "breakthrough" drug therapies – a real regulatory breakthrough for innovations? *** |
|
|
| 2013 |
Gilda Gordon |
A critical review of the current marketing authorisation transfer procedure in Europe *** |
|
|
| 2013 |
Dr. Martin Hornberger |
The non-clinical and clinical Implications of Drug-induced Liver Injury – Test Systems, Clinical Research and Regulatory Aspects *** |
|
|
| 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) *** |
|
|
| 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 *** |
|
|
| 2013 |
Anja Köstner |
Similarity and Interchangeability of Biosimilars in Comparison to Generics |
|
|
| 2013 |
Dr. Mathias Krech |
Tissue or Blood Product - Regulatory requirements concerning the manufacture and clinical use of human hematopoietic stem cells in Germany *** |
|
|
| 2013 |
Stefan Kuhn |
Advantages, disadvantages and pitfalls in current registration procedures of medical devices |
|
|
| 2013 |
Stephanie Laubner |
Two Article 30 Referrals – Comparison and experiences, with a main focus on the different implementations in cooperation with the same agency *** |
|
|
| 2013 |
Milva Mateblowski |
Risk Based Monitoring – impact and benefits for small and medium-sized enterprises |
|
|
| 2013 |
Dr. Sonja Obermann |
Off-Label Use of Medicines – General Aspects, Challenges and Strategies *** |
|
|
| 2013 |
Dr. Astrid Oelmann |
Definition and Establishment of the Regulatory Starting Material in the Synthesis of Chemical Pharmaceutical Drug Substances in Europe |
|
|
| 2013 |
Dr. Claudia Osterhage |
Quality of APIs and Starting Materials used for the Manufacture of Medicinal Products in the EU Including Risks for Genotoxic Impurities |
|
|
| 2013 |
Claudia Pönisch |
Medication errors and the European Pharmacovigilance legislation - specific focus on Biomedicines |
|
|
| 2013 |
Verena Prusinovsky |
Medicinal Products for Nebulisation in Europe: Requirements, Challenges and Options *** |
|
|
| 2013 |
Anna Sahl |
Relevance of a Certificate of Pharmaceutical Product for registration and Life Cycle Management of imported Drugs. How is the WHO Certification Scheme implemented by National Health Authorities outside of the ICH? *** |
|
|
| 2013 |
Marcus Schade |
Conduct of Clinical Trials in Latin American Countries: Background, Regulatory Framework and Implementation of relevant EU Requirements *** |
|
|
| 2013 |
Alexandra Scheibe geb. Kürzel |
Impact of the Implementation of Directive 2004/24/EC: Development of Marketing Authorisations for Herbal Medicinal Products and Registrations for Traditional Herbal Medicinal Products in Germany in the European Regulatory Environment *** |
|
|
| 2013 |
Dr. Christiane Scherer |
How to define the acceptable evaluation threshold (AET) for large volume parenterals (LVPS): European regulatory requirements and their practical implementation outweighing patients` needs versus safety *** |
|
|
