Association of International Pharmaceutical Manufacturers  (AIPM)

Federal Service on surveillance in healthcare and social development

US Pharmacopeia (USP)

Publishing Group “GEOTAR - Media”

Round Table

«ACTUAL requirements to the standarDization, quality control and production of drugs. Russian edition of us pharmacopeia – national formularY”

The Round Table is organized by Association of International Pharmaceutical Manufacturers (AIPM) in partnership with Federal Service on surveillance in healthcare and social development, US Pharmacopeia (USP) and Publishing Group “GEOTAR - Media”.

Wednesday, April 8, 2009

8.45 – 11:00

Marriott Grand Hotel

Moscow, Ul. Tverskaya, 26

Hall:

Arkhangelskiy + Pavlovskiy

Simultaneous interpreting will be provided

Participants

Association of International Pharmaceutical Manufacturers

Vladimir Shipkov, Executive Director

Representatives of AIPM member – companies  (General Managers, representatives of Regulatory, Medical and Quality Control departments)

USP

Roger Williams, Executive Vice President and Chief Executive Officer

Richard Wailes, Vice-President on Marketing and Sales

Kathy Flanagan, Marketing and Publications

Kirill Burimski, Program Manager

Helen Kharab, International Projects Manager

Federal Service on surveillance in healthcare and social development

Valentina Kosenko, Ph.D., Head of State control organization Department on medical products and means of rehabilitation of Federal Control Service in Health Care and Social Development.

Sergey Budanov, Directod of FGU “NCESMP”

Publishing Group Geotar - Media

Kamil Saitkoulov, General Director

Setchenov Moscow Medical Academy

Vladimir Dorofeev, Professor

Agenda

9.00 – 11.00

1. Vladimir Shipkov, Roger Williams, Introduction – 10 min.
2. Valentina Kosenko, Sergey Budanov,  Standardization of quality of drugs in Russia. Partnership in harmonization of drug quality requirements.
3. Roger Williams, Development of USP-NF standards – 20 min.
4. Rich Wales, Products of USP: publications, reference standards, others – 15 min.
5. Kamil Saitkoulov. Russian publication of USP-NF: current status and future plans – 10 min.
6. Vladimir Dorofeev, Standardization and drug quality control. Harmonization of pharmacopeial requirements – 10 min.
7. Other topics and discussion