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. 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.
Order now 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
You won’t want to miss out on this great opportunity to get your drugs into the hottest market in the world!