Context:

Many clinical trials are performed today in hospitals and require more and more involvement by hospital pharmacists. They are needed to ensure good clinical practice according to the trial protocol. For example, hospital pharmacists provide protocol-specific training and written instructions for the pharmacy staff explaining how to handle studied drugs. They are also involved in reviewing packaging and storage arrangements and advising patients on the correct use of the drug being studied along with many other items.

This seminar describes the work of hospital pharmacists in such trials based on their practical experiences in different countries and different type of studies to help participants to take part in future studies.

Teaching goals:

• To review the role of the hospital pharmacist in clinical trials (phase I clinical trials, clinical trials co-ordination, research and development, research ethics committees, clinical supply)
• To describe clinical trial EU legislation
• To provide examples of cooperation between hospital pharmacists and industrial companies.

Learning objectives:

After the seminar the delegates should be able to:

• Understand the role of the hospital pharmacist in clinical trials
• Have an overview of the EU legislation regarding clinical trials
• Support participation of the hospital pharmacist in clinical trials