Introduction to Regulatory Affairs in the MENA Region

• 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

Heba Hashem has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo University), RAC certified in addition to an MBA at Maastricht School of Business. For the past 20 years Heba held the position of Middle East & Africa Regulatory and Quality Head at different Pharmaceutical and Medical Device companies; Gambro, Bayer and Novo Nordisk. Heba now works for PPD as an Associate Director, Regulatory Affairs - Middle East and Africa, where she provides regulatory consulting services and training to HealthCare companies.

This course is suitable for professionals who are working in/working with affi liate offices in or are thinking of expanding into the MENA region.
In particular, the course will benefit Managers, Consultants, Project Leaders and Project Officers working in the areas of:

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