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Purdue, Lilly Partner For Russian Pharmaceutical Training
A newly formed partnership that included participants from Eli Lilly and Co. and Purdue Research Park-based Chao Center provided training to the Russian agency Roszdravnadzor that is equivalent to the U.S. Food and Drug Administration.
Lilly, the Chao Center for Industrial Pharmacy & Contract Manufacturing and the Parenteral Drug Association (PDA) partnered with health policy-makers from Roszdravnadzor in Moscow to conduct the training. Roszdravnadzor, the surveillance and inspection agency for medicines and medical supplies within Russia's Ministry of Healthcare and Social Development, is considered the country's equivalent to the FDA.
Goals for the training included improving Roszdravnadzor's knowledge of current Good Manufacturing Practices, advancing Russian standards for manufacturing pharmaceutical technology and quality control, and achieving an ongoing international dialogue between Rozdravnadzor and other regulators on laws and regulations in pharmaceutical operations and inspections.
The ultimate beneficiaries of this partnership are the patients utilizing pharmaceuticals in Russia, according to participants.
"Common global standards in pharmaceutical manufacturing are in the best interests of public health and patient safety," said Frank Deane, Ph.D., president of manufacturing operations at Lilly. "Partnering with regulatory agencies and manufacturers is an important step toward achieving these standards."
Fionnuala Walsh, Ph.D., vice president of quality at Eli Lilly and Co., said sharing best practices with Russia and other countries not only will support meeting this challenge but also will help Lilly, the Chao Center and the PDA fine-tune their own training practices in the United States.
"One of the global challenges that pharmaceutical companies face is ensuring the quality and integrity of medicines that are manufactured and distributed in different countries," Walsh said.
The Chao Center manufactures and distributes the late-lifecycle drug Seromycin®, which is used to treat multidrug-resistant tuberculosis. The drug was developed by Lilly.
"An important mission of the Chao Center is to teach future pharmaceutical scientists and drug manufacturers the production and distribution of late-lifecycle drugs," said Joseph B. Hornett, senior vice president, treasurer and COO of the Purdue Research Foundation, which manages the Chao Center. "One of the best ways we can do this is to make sure we provide a global experience for our students and for the people working in the Chao Center. We can take what we learn from our partnership with the Russian Inspectorate and incorporate it into our own training and educational programs."
Officials from the Russian Inspectorate and Roszdravnadzor are expected to participate in hands-on training in manufacturing simulation facilities at Lilly, the Chao Center in Indiana, as well as the PDA in Bethesda, Md., in the coming months, said Hugh Sutherland, director of manufacturing and quality training and development at Lilly.