Introduction to Regulatory Affiars in the MENA Region 2014

Topics

• Critical overview of regulatory requirements for gaining pharmaceutical marketing authorization in key MENA markets
• Organisation and structure of key national regulatory authorities and working groups
• Specific requirements to support drug submissions in this region
• What the authorities expect to ensure first-time approval of your application to avoid costly delays
• Realistic submission timelines based on real examples

Who should Attend

Consultants, Managers, Project Officers and Project Leaders involved in:

• Regulatory Operations
• Regulatory Affairs
• Emerging Markets
• International Regulatory Affairs
• Dossier Management
• Global Regulatory Operations
• Information Management