| 2013 |
Dr. Karin Schleisiek |
The new role of excipients: Developments in the framework of GMP and the impact for the pharmaceutical industry |
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| 2013 |
Simon Schmidmeier |
Two years AMNOG and early benefit assessment pursuant to § 35a SGB V - a critical review from the manufacturer´s point of view |
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| 2013 |
Marlene Schulzensohn |
How to place human medical devices on the market? An overview and critical examination of the regulatory requirements in Germany versus those in the United States *** |
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| 2013 |
Dr. Verena Schummer |
Developments in anticancer immunotherapies for use in combination *** |
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| 2013 |
Svenja Seyler-Junker |
Evaluation of design and layout of folding boxes of centrally approved medicinal products using a decision matrix developed from legal requirements and available guidance documents *** |
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| 2013 |
Beate Stadler |
Pharmacovigilance Referrals - Changes in line with the new Pharmacovigilance Legislation 2010 / 2012 *** |
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| 2013 |
Dr. Silke Stender |
Regulatory requirements for products used for In-vitro Fertilisation (IVF) and Assisted Reproduction Technologies (ART) according to MEDDEV 2.2/4 *** |
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| 2013 |
Dr. Marion Tegeler |
Regulatory Requirements & Cultural Challenges for Registration of Generic, Human, Oral Medicinal Products in Southeast-Asia: A Comparison of Regulatory Efforts Exerting to the Registration Process in Malaysia, Thailand and Vietnam *** |
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| 2013 |
Andreas Vogt |
The planned transformation of Directive 98/79/EC on in vitro diagnostic medical devices into a Regulation. Possible regulatory consequences for the development and release of in vitro diagnostics *** |
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| 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" *** |
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| 2013 |
Florentina Zymberi |
Regulatory electronic Document Management System (eDMS) in the pharmaceutical industry |
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| 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 |
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| 2012 |
Marcus Baur |
Choice of study location for a First-in-Human study with a biological product - a critical decision for a biotech company |
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| 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 |
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| 2012 |
Jürgen Blömer |
User Safety Risk Assessment (USRA) - Part of the overall Risk / Benefit Assessment of veterinary medicinal products (VMP) in Europe |
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| 2012 |
Nicole Dévaud |
Veterinary medicinal products authorised for rabbits in the European Union - Causes for insufficient availability and consequences on human and animal health *** |
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| 2012 |
Dr. Axel Dienemann |
Pharmaceutical development of medicines for paediatric use - requirements, challenges and implications |
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| 2012 |
Dr. Sven Enders |
Case Study: An In-Market Drug Approved for Several Indications - AMNOG and Its Impacts |
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| 2012 |
Stephanie Gelsen |
Legislation around Wholesalers and Impact of new Developments of the EU GDP Guideline |
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| 2012 |
Dr. Astrid Gerhardt |
Exceptional Japan filing of a biologic mature product |
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