Regulatory Affairs in Emerigng Markets 2014

Key Topics

• Case study: Practical advice for successful registration in Russia under the New Law on Drugs 2010
• Understanding the impact of the New Law on Drugs 2010 in Russia and further upcoming changes
• Examining the current status of the Customs Union between Russia, Kazakhstan and Belarus and impact on industry
• INTERACTIVE EXPERIENCE EXCHANGE: Sharing experiences of registration under the Russia 2010 New Drug Law
• Benefits and challenges for clinical studies in CIS countries
• Successful registration of generics products in Russia and CIS countries and practically carrying out bioequivalence (BE) studies
• Successfully managing global complex OTC submissions from the corporate perspective when Russia is in scope
• Outlining requirements and expectations for orphan drugs in Russia and the CIS region
• Complying with country-specific labelling and packaging requirements in Turkey, MENA and South Africa
• Regulatory environment and practical advice for market entry in Ukraine, Belarus, Kazakhstan, Moldova, Georgia, Armenia, Azerbaijan and more..
• Case study: Successful registration in Brazil
• Regulatory framework in North Africa and practical advice for market entry, including Algeria, Tunisia, Morocco and Libya
• Practical advice on registering a product in China
• Understanding the complex regulatory framework for registration in Mexico
• Sharing experiences of product registration in Asia-Pacific
• Reviewing the regulatory environment and practical aspects for market entry in Korea
• Success strategies for generic product registration in Asia-Pacific