| 2013 |
Ariane Wölfer |
Regulatory requirements for clinical trials in Singapore, Hong Kong, Taiwan and South Korea -hurdles and opportunities, and development strategies |
|
|
| 2013 |
Alexandra Zoller |
Implementation of a global regulatory change control process – challenge and chance for a generic pharmaceutical company "Definition of a regulatory change control process taking different regulatory requirements regarding change control of different countries (e.g. differences within EU vs. US) into account to ensure a constant supply chain" |
|
|
| 2013 |
Florentina Zymberi |
Regulatory electronic Document Management System (eDMS) in the pharmaceutical industry |
|
|
| 2012 |
Elwira Baldyga |
Biosimilars in the EU and the USA: Impact of regulations on the development, registration and marketing process and consequences from the reimbursement system in Germany |
|
|
| 2012 |
Marcus Baur |
Choice of study location for a First-in-Human study with a biological product - a critical decision for a biotech company |
|
|
| 2012 |
Dr. Holger Berk |
The legislative framework for veterinary medicinal products in Europe under revision - A review on primary objectives, key issues, policy options and their impact assessment |
|
|
| 2012 |
Prof. Dr. Dr. Thomas Bieber |
Stratified medicine: A new challenge for the academia, industry, regulators and patients |
|
|
| 2012 |
Christian Biegel |
EudraVigilance Medicinal Product Dictionary - a challenge for authorities and marketing authorisation holders |
|
|
| 2012 |
Jürgen Blömer |
User Safety Risk Assessment (USRA) - Part of the overall Risk / Benefit Assessment of veterinary medicinal products (VMP) in Europe |
|
|
| 2012 |
Nicole Dévaud |
Veterinary medicinal products authorised for rabbits in the European Union - Causes for insufficient availability and consequences on human and animal health |
|
|
| 2012 |
Dr. Axel Dienemann |
Pharmaceutical development of medicines for paediatric use - requirements, challenges and implications |
|
|
| 2012 |
Dr. Sven Enders |
Case Study: An In-Market Drug Approved for Several Indications - AMNOG and Its Impacts |
|
|
| 2012 |
Stephanie Gelsen |
Legislation around Wholesalers and Impact of new Developments of the EU GDP Guideline |
|
|
| 2012 |
Dr. Astrid Gerhardt |
Exceptional Japan filing of a biologic mature product |
|
|
| 2012 |
Christian Hanke |
Project-, Drug-, and Business Development in a Biotech SME |
|
|
| 2012 |
Ulrich Härtel |
Clinical trial standard protocols, approaches for more regulatory efficiency? |
|
|
| 2012 |
Dr. Martin M. Hartge |
HTA of orphan oncological medicinal products - A current critical assessment and discussion from authority, KOL and industry point of view |
|
|
| 2012 |
Pia Helfrich |
Investigator-Initiated Trials on Medical Devices - Legal Basis and Regulatory Aspects |
|
|
| 2012 |
Dr. Leonie Hempel |
Challenges and Chances of the Development of Biosimilar Monoclonal Antibodies in the EU |
|
|
| 2012 |
Dr. Matthias Hübner |
Worldwide Regulatory Strategy for the Development and Submission of a Recombinant Product antagonizing the Action of a Medicinal Product |
|
|
