In February 2004, RAPS began work on the US State Department’s BioIndustry Initiative (BII), which aims to counter the threat of bioterrorism by transforming former Soviet biological weapons research and production capacities. RAPS’ role in the project is to facilitate creation of a regulatory framework and guidelines for Russian research on pharmaceuticals, vaccines and other health products. By working closely with Russian scientific, medical and regulatory policy bodies, RAPS helps establish standards and practices to align and harmonize Russian health product research and development with those of the international scientific community. These measures will help ensure the viability of Russian research within the global marketplace.
RAPS serves as an educational resource to the Russian scientific and clinical community, building competency in regulatory compliance, including Good Laboratory Practices (GLPs), Good Manufacturing Practices (GMPs) and related areas. RAPS initially trained 40 senior Russian professionals and laboratory heads in GLPs in accordance with international standards. As a result of that February 2005 program, more than 400 Russian scientists were trained by their colleagues in less than one year, and the material is now a standard part of the curriculum in medical schools, pharmacy programs and veterinary medicine throughout the country. The program was so successful that additional GLP and GMP training programs were scheduled for 2006 and 2007 in Moscow and Novosibirsk, and similar training programs are being considered for Kazakhstan and the Ukraine and possibly other CIS nations.
The GLP and GMP projects are developed in partnership with the Center of Modern Medical Technology (TEMPO), a consortium of Russian scientific and government organizations. To support these efforts, RAPS assembled an Advisory Committee of senior professionals with expertise in scientific research, health product development, health policy and regulatory compliance. The project as a whole is funded by the US State Department and is affiliated with various international and Russian agencies and organizations. In addition, RAPS works with the Research Center of Toxicology & Hygienic Regulation of Biopreparations (RCT&HRB) in Serpukhov, Russia, to develop and finalize its project work plan for “Harmonization of the Conditions to Perform Preclinical Trials According to Russian and US Standards.” The RAPS Advisory Committee conducts technical reviews of RCT&HRB’s quarterly project reports and provides written feedback. A face-to-face status review meeting in Russia was conducted in 2004, and Committee suggestions have been implemented during the course of the project. The project has been placed on hold until renovations are sufficient to warrant a future site visit.
RAPS also has worked with the Federal State Research Institution “State Research Center of Virology and Biotechnology ‘Vector,’ the Federal Service for Surveillance in Consumer Rights Protection and Human Wellbeing” (FSRI SRC VB “Vector,” Rospotrebnadzor), which is located in the Novosibirsk region of Siberia. This project involved technical reviews of quarterly reports on GMP, GLP and ISO compliance. The Russian project leader visited the RAPS office in January 2007 to discuss the project as well as the development of a training center in the Novosibirsk region of Russia.
RAPS’ Russian BioIndustry Initiative Timeline
12 February 2004— Initial subcontract signed with US Civilian Research and Development Foundation (CRDF). RAPS Russian Project Advisory Committee is organized.
27 March–2 April 2004— Familiarization visit to high-priority Russian institutes to develop recommendations for next steps.
6–9 June 2004— RAPS participates in BIO2004 conference in San Francisco, focusing on GLP training program development to provide recommendations to Russian delegation.
11 October 2004— Non-Commercial Partnership “Center of Modern Medical Technology” (TEMPO) Reception at RAPS Annual Conference.
13 October 2004—GLP Training Preparatory Meeting.
25–27 October 2004— Taraseevich Working Group Meeting for the Development of Normative Documentation for the Manufacture of Recombinant Immunobiological Products Harmonized with International Requirements.
7–17 February 2005
TEMPO/GLP Training Program—Pushchino, Russia
RAPS helps develop the curriculum and final examination for a GLP training program in February 2005 in Pushchino, Russia. Tracey Zoetis and Linda Temple, RAC, co-present lectures with Russian counterparts and provide detailed feedback after the first course concludes. The GLP training program eventually trains 80–100 Russian study directors.
September 2004–October 2007 (on hold)
Harmonization Project “2825”
RAPS works with the Research Center of Toxicology & Hygienic Regulation of Biopreparations (RCT&HRB) in Serpukhov, Russia, to develop and finalize their project work plan for the “Harmonization of the Conditions to Perform Preclinical Trials According to Russian and US Standards.” The overall goal of this project is for RCT&HRB to perform preclinical tests on a known substance (L-asparginase) in accordance with US GLPs. RAPS Advisory Committee members conduct technical reviews of RCT&HRB’s quarterly and annual reports on the project and provides written feedback. The project has been suspended until the completion of the vivarium renovations in 2008, at which time a facility audit may be scheduled.
June 2006–May 2007
Compliance Project “3282”
RAPS works with the Federal State Research Institution “State Research Center of Virology and Biotechnology ‘Vector,’ the Federal Service for Surveillance in Consumer Rights Protection and Human Wellbeing” (FSRI SRC VB “Vector,” Rospotrebnadzor) in Koltsovo, Novosibirsk Region on a GLP, GMP and ISO compliance project. RAPS Advisory Committee members conduct technical reviews of quarterly reports through March 2007. The Russian project leader visited the RAPS office in January 2007 to discuss this project’s progress. The project summary is complete but ongoing collaboration with Vector is being considered for 2008.
14 July 2006
CRDF/GLP Roundtable Conference—Astana, Kazakhstan
Co-sponsored by the Kazakhstan Ministry of Education and Science and Kazakhstan National Biotechnology Center, the “Important Issues of Implementation of International Standards of Scientific Research in the Republic of Kazakhstan” seminar features Amy Wright, PhD, RAC, of CIBA Vision presenting an overview of GLP principles and attending a roundtable discussion on the implementation of international standards and the transition of scientific laboratories to GLP compliance. Dr. Wright provides introductory articles on GLPs to the Kazakh delegation after the conference.
4-12 December 2006
TEMPO/GMP Training Program—Moscow, Russia
The GMP project mirrors the 2004/2005 GLP project, with this project focusing on the development, review and evaluation of a curriculum for a GMP training program. This intensive program covers such topics as drug manufacturing, water requirements, documentation, validation, quality assurance, inspections and audits, biologics/vaccine production and quality control as they relate to GMPs. Presenters include Marty Richard and representatives from TEMPO and the Moscow Medical Academy. Prior to the conclusion of the program, speakers participate in a roundtable exchange to discuss the application of GMP standards in Russia. On the eighth and last day of the program, trainees undergo individual final examinations.
28 May-2 June 2007
TEMPO/GMP Auditors’ Training Course— Moscow, Russia
In collaboration with the GMP Training Program in December 2006, this course trains individuals from across Russia to prepare for audit implementation, individual system audits and completing the audit. A diverse faculty consists of speakers from Moscow Medical Academy, SKIF and TEMPO as well as Marty Richard and Diane Bloomer.
Developed in 2007
TEMPO/GMP Distance Education Training Course
An additional installment of the GMP training series, the distance course was developed in collaboration with Nina Petrushova for those who were unable to attend the live training courses as well as for future training purposes across the Russian Federation. This course was designed for continuous training opportunities and officially launched in October 2007.