Module Leaders: R. Maciulaitis, Lithuania and D. Niese, Germany - under discussion In this module the early clinical development of medicines from non-clinical to phase II clinical evaluation will be reviewed. The definition and the functional significance of the Proof of Concept in medicnes development will be discussed in detail.
Early studies in patients: dose-finding / proof of concept studies and their impact on drug development plan Clinical trial design (including legal, regulatory, ethical and practical aspects): international differences Principles and application of statistics in clinical trials Procedures for clinical trial data collection (paper and electronic) and data management (including validation processes) to ensure optimal quality data Key strategic issues in the clinical trial process, in terms of legislative requirements and Good Clinical Practice (GCP) The role of the investigator drug brochure (IDB) Principles and practical relevance of ethical issues in biomedical research.8. Legal and ethical provisions for protection of clinical trial subjects
Quality - GMP, GCP, GLP