Introduction to Regulatory Affairs in the MENA Region 2014

The Economist Intelligence Unit (EIU) forecasts that the five MENA markets covered in this collection will represent a combined GDP of US$ 2.5 trillion in 2016, led by Turkey and Saudi Arabia. Economic development is changing the epidemiological health profile in the region, with the increasing prevalence of communicable diseases.

Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to successfully navigate the pharmaceutical market in MENA. The course leader will cover specific regulatory requirements, new developments or particular questions of interest within the region and countries to be discussed will include:

- North Africa - Morocco, Tunisia, Algeria, Libya and Egypt
- Middle East - Kingdom of Saudi Arabia, Kuwait, Bahrain, Qatar, United Arab Emirates, Oman and Yemen
- Near East - Jordan, Lebanon and Iraq
- Eurasia - Turkey

Performance and Knowledge Objectives

- Gain a critical overview of regulatory requirements for gaining marketing authorisation in key MENA markets
- Explore the organisation and structure of key national regulatory authorities and working groups
- Hear exactly what the authorities expect to ensure first-time approval of your application to avoid costly delays
- Gain a comprehensive understanding of specific requirements to support drug submissions in this region
- Establish realistic submission timelines based on real examples