| 2022 |
Dr. Nico Steiert |
Entwicklung von "skinny labelling": eine Betrachtung aus der regulatorischen und Patentperspektive *** |
|
|
| 2022 |
Dr. Sabrina Stöhr |
State-of-the-Art Reporting of Clinical Trial Results - Suitability of ICH E3 in a Changing Regulatory Landscape *** |
|
|
| 2022 |
Dr. Birthe Inken Sumpf |
Verordnung (EU) 2019/6 für Tierarzneimittel - Allgemeine Zielsetzung der Verordnung mit Fokus auf die Antibiotikaresistenzproblematik und die Verschreibungskaskade *** |
|
|
| 2022 |
Dr. Carina Tirler |
A review of regulatory drivers and anticipated changes to be adopted by 2025 |
|
|
| 2022 |
Isabel Valentin Verdeguer |
Rare diseases and market access to orphan drugs - analysis of the related legislation in the region of LATAM from a comparative perspective with Europe and USA |
|
|
| 2022 |
Dr. Marian Wiegand |
Regulatory-conform development of mucosal vaccines with a focus on quality, nonclinical and clinical aspects |
|
|
| 2021 |
Dr. Ilona Ahonen |
Sex hormones and their antagonists: unmet medical needs in rare and paediatric diseases |
|
|
| 2021 |
Bilal Alyousef |
Regulatory Affairs in the Gulf Cooperation Council Region |
|
|
| 2021 |
Rumyana Atanasova |
CMDh-Project for Harmonisation of RMPs (HaRP): Aims and results - Survey analysis of the project for risk management plan (HaRP) harmonization *** |
|
|
| 2021 |
Dr. Katrin Bäsell |
Coronavirus Pandemic (COVID -19) - Influence on Pharma Industry and Competent Regulatory Authorities and corresponding strategies/actions to deal with the situation |
|
|
| 2021 |
Dr. Claudia Benz |
Implementation and Maintenance of additional Risk Minimisation Measures (aRMM) and their interdisciplinary challenges on a local level in a global company *** |
|
|
| 2021 |
André Bick |
Gesetzgebung und Maßnahmen zum Fälschungsschutz bei Arzneimitteln in der Europäischen Union, den USA und Brasilien - ein Vergleich aus behördlicher Sicht unter besonderer Berücksichtigung der Serialisierungsvorhaben *** |
|
|
| 2021 |
Dr. Maria Cristina Bolanos Vasquez |
Exceptional regulatory provisions governing vaccine development and approval in a pandemic situation - a model for the regulatory future |
|
|
| 2021 |
Dr. Kim Burgard |
Sufficient clinical evidence under MDR for legacy devices and new products. Requirements and challenges before and after CE marking. |
|
|
| 2021 |
Dr. Manja Burggraf |
"Lessons learned" for Regulatory and Scientific Advice of Vaccines and Biologicals in Times of COVID-19 |
|
|
| 2021 |
Dr. Xia Dong |
Regulatory Framework and Key Steps of Medical Device Registration in China under Current and Revised Regulations on Supervision and Management of Medical Devices *** |
|
|
| 2021 |
Alexandra Federer |
Digitalization: Challenges and opportunities for the pharmaceutical industry with regard to advertisement and trade (digital shelfs) *** |
|
|
| 2021 |
Francesca Haaf |
The antiviral remdesivir - an example of expedited approval procedures in the USA within the Covid-19 pandemic *** |
|
|
| 2021 |
Corinna Herkenhoff |
Rezepturarzneimittel in Deutschland: Rezeptur- und Fertigarzneimittel im Vergleich. Ist die Herstellung nach ApBetrO noch zeitgemäß? *** |
|
|
| 2021 |
Kristina Hoffmann |
Electronic product information - The global status quo and possible ePI advancements in the EU |
|
|
