Regular scheduled GMP courses “Audit of drugs, biopreparations and biopharmaceuticals manufacturing” were opened on 28 May 2007 in Moscow. The experts from TEMPO and I.M. Sechenov Moscow Medical Academy elaborated the courses curriculum. The improvement of the program and compatibility in accordance with the international educational standards in regulatory affair area were carried out in close collaboration with the experts from RAPS – Regulatory Affair Professionals Society. Among the trainers were the specialists from TEMPO member institutes, who involved in drug manufacturing and were trained before on basic GMP course “Organization of manufacturing and drug quality control in accordance with cGMP”. The current training is performed in the frame of the agreement between TEMPO and CRDF under the support provided by BioIndustry Initiative Program of the U.S. Department of States.
The roundtable “Organization of RAPS-EURASIA Branch” was carried out during the training, as well as the meeting of the Working Group. The Working Group includes Dr. Tatyana A. Guskova, Corresponding Member of the Russian Academy of Medical Sciences, Dr. Yuri Remnev, TEMPO Deputy Executive Director, Dr. Zoryana Grishina, TEMPO Educational Programs Coordinator. The Working Group was headed by Dr. Viktor A. Dmitriev, the chairman of CIS-Intergovernmental Commission on drug standartization, registration and quality control, medical products and devices. The experts from RAPS and leading U.S. biopharma took an active part in the roundtable. Mr. John P. McKenzie, Senior Program Manager, Education RAPS, informed the participants of the rountable on RAPS activities and programs. The participants supported TEMPO initiative on organization of RAPS-EURASIA Branch. The Activity Plan of the Working Group was outlined.