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The development of a new medicine is complex because it requires many different skills. Everyone involved must be aware of the main stages and be able to relate his or her responsibilities to the professional knowledge and needs of other scientists and clinicians. this course has been designed to show how toxicology,clinical investigations and regulatory practices are joined into a continuous process. It will commence with a general introduction to the process of drug development and continue with lectures on the following aspects: Toxicological requirements, Pharmaceutical and Analytical development, Marketing and Business Development, Pharmacokinetic and Metabolic studies, Phase I and healthy volunteer work: Phase II/III - trial design and protocols, and clinical project management; Handling Safety Data in development; ending on the final day with regulatory matters including marketing applications and post-marketing activities.