| 2002 |
Miriam Hoffmann |
Advantages and disadvantages of the changes intended in the "Review 2001" with regard to Renewals of Marketing Authorisations and the impact on post-marketing surveillance *** |
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| 2002 |
Wolfram D. Hummel |
Quality Management Systems (QMS) in the Context of Planning for and Controlling the Quality of Drugs |
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| 2002 |
Uta Kästner |
Arzneimittelsicherheit Aut-idem eine Gratwanderung zwischen therapeutischem Anspruch und finanziellen Zwängen *** |
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| 2002 |
Dr. Christian Krezdorn |
Project Report on: Theory and Reality of Multiple Applications in National Procedure, MRP and CP Demonstrated by Practical Case Reports |
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| 2002 |
Dr. Angelika Leinweber |
Regulatory Requirements concerning Process Validation: Differentiation of the Requirements for Registration Purpose in Comparison with the Requirements according to GMP *** |
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| 2002 |
Patricia Lüer |
Alternative methods for animal testing in the drug regulatory environment |
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| 2002 |
Dr. Hans-Jürgen Mika |
GMP Relating to Medicinal Products - Quality Instrument or Regulatory Burden *** |
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| 2002 |
Dr. Daniela Monella |
Current Regulatory issues in the assessment of the manufacturing of active pharmaceutical ingredients |
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| 2002 |
Uta Müller |
Elektronische Einreichung von Zulassungsunterlagen - Stand und Möglichkeiten für die Zukunft |
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| 2002 |
Kris Pelzer |
Chemical-Pharmaceutical Documentation for Pressurised Metered Dose Inhalers *** |
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| 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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