3-Hour Virtual Training: Russia Regulatory Compliance Requirements for Life Science Products

Event Information
Product Format
Prerecorded Event
180 minutes
Product Description

Understand Regulatory Compliance to Leverage the Emerging Russian Market for Life Science Products!

As the world becomes integrated, Global Clinical Research has expanded and the market for pharmaceuticals, biologics, medical devices and combination products has grown. The time and expense of bringing new products to market continue to challenge company budgets and balance sheets and 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 emerging markets. One such attractive market is Russia. Manufacturers are finding it an effective strategy to bring innovative products to these larger patient population areas, especially with products with existing country licenses and expanding these licenses into nations like Russia.

Global standards have aligned and have eliminated prevalent conflicting standards among provincial government agencies, leading to better foreign access. Healthcare Authorities and regulatory systems requirements and procedures are more transparent for industry partners and clinical trials can be conducted at a fraction of the expense.

Emerging markets have more structured healthcare systems and insurance coverage and Rx and OTC pharmaceutical products and Medical Devices products are expected to grow in relatively untapped markets such as Russia.

Russia has been improving their regulatory regime governing the food and Life Science products industry in recent years, although challenges remain. Their policies are better aligned with international standards of practice, thanks to amended GMP, GLP, GCP, GSP and other regulations, which is assisting the growth Russia for new and already licensed products. Life Science Products manufacturers and distributors in Russia, need to pay close attention to the pace at which the Healthcare Agency implements change, and they must use this knowledge to adjust their standard operating procedures, to ensure compliance with the evolving regimes.

This session with expert speaker Robert Russell specifically focuses on the overall regulatory compliance requirements and procedures for Medical Devices, Pharmaceuticals, Biologics and Combination Products in Russia. Robert will cover pre-clinical and clinical requirements, and the structure of the regulatory agencies. He will also discuss how regulators review filings and registrations and authorization and dossier maintenance requirements of licensed products throughout their lifecycle.

This session will provide a detailed overview of the regulatory requirements, local challenges and important cultural aspects of working with the lifecycle of Life Science Products (pharmaceuticals, medical devices, biologics and combination products) as an importer or producer in Russia. Understanding cultural norms, establishing relationships and protecting your intellectual property will also be discussed and will need to be integrated into your company training and corporate business strategies.

Learning Objectives

  • Russia’s Regulatory Structure / Agency Overview and How Best to Work with them for Successful Outcomes
  • Specific procedures that apply to Pharmaceuticals, Medical Devices, Biologics and Combination Products
  • Requirements for beginning in Russia: local licenses, in-country personnel required and facilities required or contracted
  • Understand when Clinical Trials are needed and what the Healthcare Authority requirements are regarding the Application Process, approval from the Ethics Committee, CRO Selection and Start-up
  • How product development and your company’s product pipeline is affected by the current key regulations
  • Product Licensing / or Registration; Licensing differences across Product Types
  • Pricing establishment
  • Healthcare Insurance systems and reimbursement
  • Understanding the local concerns and specific challenges in working with the local 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 for Russian submission
  • Strategies for streamlining the registration application process for faster approval
  • Maintenance on Authorized Products
  • License Renewals
  • Import / export; Licenses and Supply Chain considerations

Session Agenda

RUSSIA Regulatory Compliance for Life Science Products

  • Country Profile / Healthcare Systems
  • Key Country Information
  • Strategic Considerations: Why Russia? / Eastern European Structure / Hub Locations
  • Governmental & Regulatory Authorities / Agencies / Structure
  • Company Establishment; Licenses & 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 & Promotion Allowances or Restrictions
  • Vigilance Reporting / Post-Marketing Requirements
  • Patents & Trademarks; Protecting Your Intellectual Property
  • Local Customs / Cultural Issues / Building Business Relationships
  • Working with Local Agencies / Authorities
  • Conclusions & Strategy for Moving Forward

Who should attend?

This course will be beneficial to Regulatory, Quality, Clinical, Manufacturing, Supply Chain, Global Business Development and General Management personnel whose responsibilities require knowledge of Russia’s regulatory, quality and import / export requirements. Additionally, administrative staff responsible for ensuring compliance with regulatory filings and overall GCP, GMP and GLP compliance requirements will also find this training highly relevant. Global business development and general management requiring an understanding of how regulations and compliance issues must be followed in finding a local distributor / partner, setting up a company office or establishing local or contract manufacturing facility will profit from attending.


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About Our Speaker

Robert J. Russell

Robert Russell, holds a B.S. and M.S.in Chemistry. Prior to founding RJR Consulting, Inc., a Global Regulatory Consulting firm in 2001, Mr. Russell spent 28 years in the Pharmaceutical and Medical Device Industry with two Fortune 150 firms working in CMC, Global Business Development and Regulatory Affairs.

Today, Robert assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations...   More Info
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