Russia: Compliance Processes and Regulations

Why Should You Attend:

Improved alignment to global standards was an important step forward toward foreign access, because it eliminates conflicting standards that prevailed among provincial government agencies. Healthcare authorities and regulatory systems have now made their requirements and procedures more transparent to industry partners. Clinical trials can be conducted at a fraction of the expense.

Structured healthcare systems and insurance coverage is now more prevalent among emerging nations and predictions for growth of Rx and OTC products is impressive in this relatively untapped market.

This webinar will specifically focus on the overall regulatory compliance requirements and procedures for pharmaceuticals, medical devices, biologics and combination products in Russia. The course will cover topics relating to pre-clinical and clinical requirements, as well as, address the structure of regulatory agencies. The course content will also include descriptions of the methods by which regulators review filings and registrations and what is expected in the authorization and dossier maintenance of licensed products throughout their life.

Learning Objectives:

This course will provide training on:

• The nation’s regulatory structure
• Understanding the specific procedures for pharmaceuticals, medical devices, biologics and combination products
• How to begin your company’s involvement in Russia: local licenses, in-country personnel required and facilities required or contracted
• Clinical trials: When are clinical trials needed? When are they not? Healthcare authority requirements, the application process, ethics committee approval, CRO selection and start-up
• The current key regulations effecting product development and your company’s product pipeline
• Product licensing/registration; licensing differences across product types
• Pricing establishment
• Healthcare insurance systems and reimbursement
• Understanding the local concerns and specific challenges in working with each country’s regulatory authority
• Understanding the local culture: realistic expectations, timing on reviews, effective strategies for adding each market to your company’s global market presence
• Information necessary for effective dossier preparation; or how does one take an already approved dossier and turn it into an acceptable submission package
• Strategies for streamlining the registration application process for faster approval
• Maintenance on authorized products
• License renewals
• Import/export; licenses and supply chain considerations

Areas Covered in the Webinar:

Russia

• Country Profile/Healthcare System
• Key Country Information
• Strategic Considerations: Why Russia/Eastern European Structure /Hub Locations
• Governmental and Regulatory Authorities/Agencies/Structure
• Company Establishment; Licenses and Key Personnel
• Establishing In-Country Partners/Distributors
• In-Country Operational Considerations; Licenses, Personnel, Operations
• Requirements to Conduct Clinical Trials/Approvals/GCP
• Licensing Products
• Innovative Drugs
• Generics/Similars
• Orphan Drugs
• Biologics/Vaccines
• Medical Devices
• Combination Products
• Variations and Amendments to Licenses
• GMP and Inspections
• Packaging and Labeling requirements
• Price Establishment
• Insurance Reimbursement
• Import/Export/Customs Clearance
• Taxes/Duties
• Advertising and Promotion Allowances or Restrictions
• Vigilance Reporting/Post-Marketing Requirements
• Patents and Trademarks; Protecting Your Intellectual Property
• Local Customs/Cultural Issues/Building Business Relationships
• Working with Local Agencies/Authorities
• Conclusions

Who Will Benefit:

This course will be beneficial to personnel whose responsibilities require knowledge of the Russian regulatory, quality, and import/export requirements. This includes:

• Regulatory professionals
• Quality assurance personnel
• Clinical staff
• Staff engaged in the manufacturing process
• Personnel involved in supply chain management, global business development and general management
• Administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements

Robert J Russell
President, RJR Consulting, Inc.

For the past 9 years, Robert J. Russell has been the president of RJR Consulting, Inc. The company assists the pharmaceutical, medical device and biotech industries in understanding and complying with international regulations affecting compliance, new product development, manufacturing and quality assurance. RJR has offices in Columbus, OH, Washington DC, and Brussels, Belgium with exclusive affiliates across Asia and Latin America. Mr. Russell has 28 years of past industry experience as a CMC specialist, R&D director and global director of regulatory affairs for Merion Merrill Dow Pharmaceuticals and Cordis-Dow Medical Devices. He has a BS and MS degree in chemistry.

Topic Background:

More than ever, the world has become one integrated market for conducting global clinical research and for expanding the market for pharmaceuticals, biologics, medical devices and combination products. The time and expense of bringing new products to market continue to challenge budgets and existing balance sheets. While it is necessary to continue to have a robust pipeline of new patented products, global producers have been evaluating how best to begin participating in the emerging markets of Russia. Manufacturers are looking to tap into the large population areas of the world and bring innovative products to these patient populations. Taking products which already have existing country licenses and expanding these licenses into nations like Russia is proving to be an effective strategy for those who have begun.

Russia has been improving the sophistication of their regulatory agency governing the food and life science products industry in recent years. This has included amending GMP, GLP, GCP, GSP and other regulations allowing their country policies to further align more with international standards of practice. This better alignment will assist the growth in Russia for new and already licensed elsewhere products. For manufacturers and distributors of life science products in Russia, it is important to pay close attention to the pace at which their healthcare agencies implement these changes. Manufacturers and distributors must in turn add this knowledge and adjust their standard operating procedures when necessary to ensure compliance with the evolving regimes.

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