PDA Continues In-Depth Training Series for Kazakhstan's Pharmaceutical Regulators; Drug Development Key to Country's Emergence as Modern Nation

The Parenteral Drug Association (PDA) (http://www.pda.org) last week completed the second phase of GMP training for representatives from the Republic of Kazakhstan's Ministry of Health to develop a stronger, more informed pharmaceutical regulatory agency.

PDA will train more than 100 delegates from Kazakhstan over the next three years, exposing medical and health care professionals to a broad range of manufacturing technologies and U.S. and European regulatory functions.

Kazakhstan's cultural independence is embodied in The Ministry of Health's dedication to a self-sufficient drug development and delivery industry, supported financially entirely by domestic rather than international support. The Kazakhs also have very specific technical and regulatory training requests tailored to their national needs. They intend to select the best aspects from the world's major health organizations to develop their own modern system by 2008 as part of the initiative to completely modernize the country by 2030.

"Many countries evolving into modern nations expect foreign aid to be the foundation of their emergence," said Gail Sherman, Vice President of Education and Director of PDA's Training and Research Institute. "But Kazakhstan is different; completely independent for 10 years, the country is committed to paying for the expertise and infrastructure to develop its own pharmaceutical and medical device industries. At present the United States is the largest foreign investor and more than 300 companies with U.S. participation are already established in the country," she added.

"The Association is well-positioned to offer comprehensive and practical GMP training to members of the Kazakhstan Ministry of Health and National Center for Assessment of Drugs, Items for Medical Purposes and Medical Equipment," said Robert Myers, PDA President. "This is the largest single training project PDA has undertaken to date, and is financed directly by the Republic of Kazakhstan."

The program began October 31, 2005 with a two-week training of 44 delegates at PDA's Training and Research Institute at the University of Maryland Technology Center in Baltimore, Maryland. The current class was comprised of 18 delegates.

As a nonprofit scientific organization, PDA has brought together a unique panel of volunteer experts from the Association's membership, academia, U.S. FDA, U.S. Pharmacopeia and in-house senior leadership.

The training includes sessions examining the regulatory systems and requirements necessary for the review and approval of drugs and biologic products, with an emphasis on U.S. and European regulations. Sessions also cover the science and technologies of the pharmaceutical practice, clinical trials, manufacturing issues, labeling and advertising as well as hands-on laboratory experiences relevant to pharmaceutical practices in the industry.

About PDA

The Parenteral Drug Association (PDA), Connecting People, Science and Regulation(SM), is the leading global provider of science, technology, and regulatory information and education for the pharmaceutical and biopharmaceutical community. As a nonprofit organization, PDA is committed to developing scientifically sound, practical technical information and resources to advance science and regulation through the expertise of its more than 10,000 members worldwide. More information about PDA is available at www.pda.org.

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