| 2002 |
Lena M. S. Perquy |
CTD: Quality Overall Summary vs. Expert Report. Advantages and Disadvantages from the View of the Applicant and the Competent Authority |
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| 2002 |
Erika Piest |
Requirements for the presentation of data in Module 3 of the CTD for new drug products |
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| 2002 |
Dr. Frank-Torsten Raschko |
Access to unlicensed pharmaceuticals. An overview of the legal options for patients in Germany, France and the USA |
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| 2002 |
Dr. Wolf-Rüdiger Schlag |
Analytical validation of medicinal products in contract laboratories: From the task description to an SOP for the routine analysis - an overview |
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| 2002 |
Dr. Jens Schletter |
Specific regulatory requirements for stem cell-based therapies |
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| 2002 |
Beate Schmidt |
Current regulatory requirements for clincal trials in selected EU Member States and the potential impact of the Clinical Trial Directive compared to the U.S. situation |
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| 2002 |
Claudia Schmolze |
Regulatory Requirements to the Quality of Parenteral Medicinal Products according to the Common Technical Document |
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| 2002 |
Andrea Schorr |
Bracketing and Matrixing: Discussion of the regulatory requirements from a scientific point of view and drawing up of a sample testing plan for a combined bracketing/matrixing design. Where is the justifiable limit for a reduction? |
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| 2002 |
Dr. Irmela Schuller |
Key issues of drug regulatory affairs: A synopsis for medical doctors |
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| 2002 |
Dr. Diane Seimetz |
Early Market Access - Regulatory Environment in the EU and the USA and Essential Requirements within the Pharmaceutical Company |
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| 2002 |
Dr. Dorith Stauch-Steffens |
Regulatory Requirements concerning Development Pharmaceutics and Manufacturing of a Medicinal Product: A Critical Analysis from Pharmaceutical Technological View |
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| 2002 |
Sandra Strobl |
Variation applications within the European Community for a) innovative medicinal products authorised by centralised procedure, b) new medicinal products authorised by mutual recognition procedure |
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| 2002 |
Dr. Anja Tischlich |
Regulatory and economic conditions for clinical trials in children |
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| 2002 |
Ngoc Hanh Trieu |
The Swiss registration system - current development |
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| 2002 |
Dr. Daniela Völker |
Current Regulatory Issues in the Assessment of Manufacturing of Active Substances |
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| 2002 |
Dr. Christian Witt |
Influence of the EU-enlargement on the procedures for granting marketing authorisations for medicinal products in a single European market |
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| 2001 |
Claudia Lydia Abel |
Haemophilia Conventional Therapy and Gene Therapy related to EU-Guidelines |
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| 2001 |
Dr. Beate Ackermann |
The Internet presentation of national regulatory authorities in Europe and Japan |
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| 2001 |
Dr. Elke Bertram-Neis |
Orphan Drugs and rare diseases |
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| 2001 |
Dr. Michaela Bleile-Röhrlich |
Established active substances: Process of registration and regulatory strategy for submissions in the EU |
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