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Introduction to Regulatory Affairs in the MENA Region

2020 Dates TBC

Radisson Blu Edwardian Grafton, London

As healthcare spending continues to rise in the Middle East and North Africa (MENA), the region has become a key growth target for pharmaceutical and biopharmaceutical companies. One challenge faced by companies is overcoming the non-harmonised regulatory landscape which contains different systems, requirements and procedures. Having a solid regulatory strategy in the region will require an in depth knowledge of the regulations and can open up a growing market.  

Using a combination of theory and practical case studies, this course will allow delegates to develop the knowledge needed to successfully navigate the pharmaceutical market in MENA. Over the two days you will cover specific regulatory requirements, new developments or particular questions of interest within the region to provide you with the confidence and competence to gain approval and manage products in these markets. Key countries discussed in the course 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 

  • 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

"I received a good overview of the requirements and process in the region. I also gained useful tips in how to navigate the region too." Global Regulatory Affairs Submission Manager, LEO Pharma

"The interaction with other delegates and the knowledgeable trainer made the course very worthwhile." Associate Director, RA lead CEE/MENA, Alexion Pharmaceuticals

I enjoyed the interactive elements of the course and the trainer being open to questions.

Junior International DRA Project Manager, Actelion Pharmaceuticals

The course was very well presented. Having a small group was hugely beneficial as it was more focused.

Regulatory Affairs Excellence Director, Hikma Pharmaceuticals

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