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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.