THIS COURSE HAS BEEN POSTPONED
The course will give an overview of clinical pharmacology, define phase 1 studies and describe how they fit into the clinical development programme. Delegates will be guided through the regulatory and clinical aspects of phase 1 studies and identify the
key safety and ethical issues that need to be managed. The issues relating to design, set-up, choosing subjects and conduct of phase 1 studies will be discussed. The course will use trainer input, exercises, and delegate interaction.
• Give an overview of Clinical Pharmacology.
• Define Phase 1 studies and describe how they fit into the clinical development programme.
• The delegates will be guided through the regulatory and clinical aspects of Phase 1 studies and identify the key safety and ethical issues that need to be managed.
• The issues relating to design, set-up, choosing subjects and conduct of Phase 1 studies will be discussed.
• Clinical Pharmacology – terminology and definitions.
• Overview of Phase 1 Studies
• Patient populations.
• Phase 1 clinics.
• Ethical considerations.
• The EU Directive and legal requirements.
• Types of Phase I studies
• Considerations in Phase I study design.
• Adverse events/adverse drug reactions.
• Data collection and monitoring.