Training Manual . — Voronezh: Publishing and Printing Center of Voronezh State University, 2010. 198 s. — ISBN 978-5-9273-1725-7 . The textbook contains organizational, regulatory, methodological and scientific and technical foundations of quality assurance, certification, state registration, quality control, efficacy and safety of medicines .. Issues of the control and resolution system functioning and quality problems at the stages of the life cycle of drugs are considered. The historical aspects of state regulation and control of the processes of creation and circulation of medicines, development of the regulatory framework in this field of activity are reflected. The publication is intended for interns and trainees of advanced training courses in the specialty "Pharmacy" .