Russian Scientists Leverage Regulatory Know-How to Court International Healthcare Markets

Helping to build a bridge between Russian medical science and the global community, the US government has sought the expertise of the Regulatory Affairs Professionals Society (RAPS) in establishing standards and guidelines for Russian research facilities and scientific organizations. Working in collaboration with Russian authorities, RAPS is helping the countrys leading scientists harmonize their regulatory processes with those of the international community, opening a multi-million dollar market potential and the possibility of undiscovered therapeutics.

Rockville, MD (PRWEB) October 18, 2004 -- Russias unique regulations on health product development has cost the nation millions of dollars. Since the demise of the Soviet Union, the worlds 7th most populated nation has remained isolated from marketing its pharmaceutical and medical device discoveries outside of its own borders. To its fiscal detriment, Russias existing regulations are not compatible with the requirements of most countries. But through the recent efforts of the BioIndustry Initiative (BII), the Regulatory Affairs Professionals Society (RAPS), in conjunction with the US State Department, is helping Russia become a known healthcare research entity.

In order to build a bridge between Russian medical science and the global community, the US government has sought the expertise of RAPS in establishing standards and guidelines for Russian research facilities and scientific organizations. Working in close collaboration with Russian authorities, RAPS is helping the countrys leading scientists harmonize their regulatory processes with those of the international community-opening a multi-million dollar market potential and the possibility of undiscovered" therapeutics.

Zorina Pitkin, PhD, RAC, a native of Russia and a member of RAPS advisory committee for the project, likens the problem of regulatory incompatibility to differences in electrical voltages across international borders. If youre from the US and you bring a laptop computer to Europe, the voltage difference will render your laptop useless. But if you have an adaptor, you can make it work."

Similarly, if a healthcare company follows a set of regulations that satisfies the requirements of multiple countries, they can leverage their research or products for the benefit of many.

RAPS mission to help establish harmonized regulations in Russia is a component of the State Departments BII-an effort that aims to reduce terrorists access to biological weapons, facilities and expertise, and joins Russia in combating terrorism. To achieve these goals, the State Department is helping to transform former Soviet biological production facilities into channels for sustainable, commercial and peaceful applications, and is partnering with Russian scientists to develop drug and vaccine production for highly infectious diseases that affect both the former Soviet Union and the world.

RAPS brings a critical level of expertise and global scope to the BioIndustry Initiative and our efforts to provide the Russian scientific community with international reach in marketing its discoveries," said Dr. Jason Rao, Director of the BioIndustry Initiative.

To this end, four members of RAPS advisory committee recently made a trip to Moscow to evaluate Russias current regulatory environment. Using that newly acquired knowledge, the committee is now working with members of the Russian scientific community to examine ways to enhance the compatibility of Russian regulations and thus the marketability of Russian health products.

Central to RAPS efforts is the building of the regulatory affairs profession and the advancement of good laboratory practice (GLP) compliance in Russia. GLP is the systematic model through which laboratory testing is carried out in a controlled, precise manner. GLP is a critical element of international health product regulation. Without adhering to it, a companys drugs and medical devices will not pass the scrutiny of international governments.

There is a sincere willingness from the Russian scientists to learn good laboratory practice," explained Pitkin. There is also a strong demand from the Russian government to implement it. There is work to do, but the willingness is there."

According to RAPS Executive Director Sherry Keramidas, PhD, CAE, This program demonstrates the great import of regulatory compliance in every setting, every nation. It is our goal to provide the knowledge and tools to reach these goals...to enable Russia to compete on an equal playing field with scientists around the globe."

About RAPS®
RAPS is the foremost worldwide member organization creating and upholding standards of ethics, credentialing and education for the Regulatory Affairs (RA) profession within the health product sector. Founded in 1976, RAPS represents nearly 10,000 individuals worldwide, working in government, corporations, academia, research and nonprofit organizations.

As the global source for Regulatory Affairs Certification (RAC), the RA Code of Ethics, proprietary research and educational products, international conferences and the leading professional magazine, Regulatory Affairs Focus, RAPS establishes industry standards for professionalism, knowledge and achievement. Through expert education and resources, RAPS provides regulatory affairs professionals with the tools necessary to create strategic value for their organizations. The RA profession is vital to the development, approval and provision of health products, including pharmaceuticals, biologics and biotechnology, medical devices, cosmetics, veterinary products and nutritional supplements.

RAPS is a nonprofit educational/scientific organization with headquarters in Rockville, MD, and members in 45 countries in Asia, Europe, Latin America, the Middle East, North America and the Pacific Rim. RAPS is located at 11300 Rockville Pike, Suite 1000, Rockville, MD 20852; Phone: 301.770.2920; Web: www.raps.org

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