| 1 |
Basics of Clinical Trials
- Definition der Klinischen Prüfung
- Phasen der Arzneimittelprüfung
- Anwendungsbeobachtungen
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| 2 |
Good Clinical Practice
- Terminology
- Essential documents
- Archiving
- Audit
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| 3 |
GCP Inspections |
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| 4 |
Ethics in Clinical Research
- Declaration of Helsinki
- Ethics approval process
- Informed consent
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| 5 |
Investigational Medicinal Products Documentation |
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| 6 |
Relevant Items in Clinical Trials |
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| 7 |
Clinical Pharmacology
- Phase I studies - background
- Pharmacokinetics, ADME,
- Bioavailability
- Populationkinetics
- Pharmacogenetics
- Pharmacodynamics
- PK/PD-Correlation
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| 8 |
Biometry in Clinical Research
- Statistische Auswertung
- Studiendesigns
- Multiples Testen
- Fallzahlbestimmung
- Datenmanagement
- Metaanalyse
- Subgruppenauswertung
- Interimsanalyse
- Epidemiologie
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| 9 |
Clinical Trial Guidelines 1
- Women
- Elderly
- Children
- Vulnerable subjects
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| 10 |
Regulatory Process in Clinical Development
- Paragraphen im AMG
- Vorlegung
- Überwachung, Audits, Inspektionen
- Europäische Besonderheiten
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| 11 |
Clinical Trial Directive 2001/20/EC
- Chiral active substances
- Fixed combination medical products
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| 12 |
Clinical Trials Guideline 2
- Vaccines
- Immunoglobulines
- Plasma-derived factors
- Recombinant factors
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| 13 |
Clinical Development of Vaccines
- Background
- European public assessment reports
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| 14 |
Clinical Development of Blood Products
- Background
- European public assessment reports
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| 15 |
Clinical Trials Guidelines 3
- Drug Interactions
- QT-Interval prolongation
- Control group
- Modified release dosage forms
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| 16 |
Safety in Clinical Trials
- Definitionen
- Causality assessment
- Anzeigepflicht, Meldungen
- Guidelines
- Stufenplan
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| 17 |
Clinical Trial Guidelines 4 |
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| 18 |
Clinical Section of Application Dossier
- Directive 75/318/EEC
- Notice to applicants
- Common technical document
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| 19 |
Clinical Trial Performance
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Dr. Ingrid Klingmann,
Wezembeek-Oppem
