Pharmaceutical Regulations in the Russian Federation: Navigating One of the World's Hottest and Most Difficult Markets

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The rapid growth of the Russian pharmaceutical market — which is expected to increase by 20 percent in 2008 to $17 billion and by another 13 percent in 2009 to $19.2 billion — makes the U.S. and Europe seem sluggish in comparison.

Pharmaceutical companies don’t want to be left behind and miss out on the opportunity to maximize their sales potential in this ballooning market. But doing business in Russia can be very risky.

Not only is Russia’s regulatory policy on drugs excessive, it’s also arbitrarily implemented with little regard to international regulations.

Imagine trying to keep up with:

  • Random fees and unnecessary requirements to reregister products every five years
  • Demands for redundant clinical testing
  • Little government enforcement for counterfeit drugs
  • A lack of intellectual property rights enforcement, data and trademark protection

Now you can get insider information on how to overcome these hurdles and get a handle on the regulatory environment in Russia. In this 90-minute Encore presentation experts Svetlana Rudevich and Julianna Tabastajewa share their real-world experiences so you can get your drugs through the Russian regulatory maze and onto the market.

Sign up your entire team to listen in and discover:

  • The split authority and legal competence of the national government and its subjects
  • A thorough analysis of Federal Law on Pharmaceuticals No. 86-FZ and its recent amendments
  • 10 restrictions you’ll want to be aware of when advertising pharmaceuticals
  • Best practices for product registration with Russia’s Federal Health Service
  • The Federal Health Service’s requirements for preclinical and clinical trials — including informed consent protections and prohibitions of direct payments to researchers
  • Restrictions on the importation of pharmaceuticals into Russia
  • How to obtain certification of compliance with state quality standards
  • The Russian Federation’s Ministry of Health licensing procedures for the manufacture of pharmaceuticals within the country
  • Pitfalls to avoid during an inspection or audit
  • How to navigate the state regulations regarding pharmaceutical pricing
  • What liabilities you face if your products cause injury — manufacturers must compensate injured parties
  • How to protect your intellectual property under Part 4 of the Russian Civil Code

ou won’t want to miss out on this great opportunity to get your drugs into the hottest market in the world — register now! You’ll get a chance to ask your toughest questions during the Q&A session.

This presentation is a must for positions in drug and biotech companies, including:

  • Compliance officers
  • Consultants and service providers
  • Executive management
  • General and corporate counsel
  • Personnel new to the industry
  • Regulatory and legislative affairs professionals
  • Risk management specialists
  • Sales and marketing personnel
  • Training personnel

Svetlana Rudevich of Hogan and Hartson, LLP, has extensive experience in various Russian corporate transactions, including cross-border mergers and acquisitions; setting up equity and debt financing; restructuring and liquidation of business operations; regulatory issues, including antitrust, currency control, customs, consumer protection and products compliance legislation; and a wide variety of labor law issues. Svetlana advises pharmaceutical companies on various legal and commercial issues related to the access of consumer goods and pharmaceuticals to the Russian market, including product compliance, certification and customs clearance.

Julianna Tabastajewa of Hogan and Hartson, LLP, focuses her practice on intellectual property protection and litigation, pharmaceutical law, competition law, media law and franchising. Julianna advises pharmaceutical and medical device companies on issues such as performing clinical trials and importing and distributing pharmaceutical products in Russia. She also has extensive experience in domestic litigations and arbitration in Russia. Julianna has contributed significantly to new domain regulations in the Russian Federation and has written extensively on the subject.

Register now!

Date: July 28 – Aug. 15, 2008
Location: Your office or conference room (no need to travel!)
Time: Anytime

Gather your team for maximum benefit! Your investment is for one dial-in.

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