September 23^th,
2009

An Ordinary General Meeting of the Association of Clinical Trials Organizations was held.

The following issues were discussed at the meeting:

1. On the current status of the Draft Federal Law “On Circulation of Medicinal Products”. A presentation on preparation to adoption of the Draft Federal Law “On Circulation of Medicinal Products” developed by the Ministry of Public Health and Social Development of the Russian Federation was made to the participants of the meeting. Further actions of the Association in respect to bringing to interested parties’ notice of remarks and concerns of the industry in relation to possible consequences of adoption of the Draft Law in the proposed version were discussed.

3. On the procedure of clinical trials arrangement in I. M. Sechenov Moscow Medical Academy. A meeting was held with Elena Alexeevna Vol’skaya, the Head of Organizational and Methodical Department of I. M. Sechenov Moscow Medical Academy, and Irina Viacheslavovna Rogova, the Head of the Pre-Clinical and Clinical Trials Documentation Expertise Management Group of I. M. Sechenov Moscow Medical Academy. I. V. Rogova made a presentation concerning procedure of clinical trials arrangement in I. M. Sechenov Moscow Medical Academy. The participants discussed opportunities of conducting trials in clinical bases of I. M. Sechenov Moscow Medical Academy, as well as plans and prospects of the Academy for further development of this line of business. Exchange of opinions took place.