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Introduction To Regulatory Affairs In The MENA Region

Course summary
2 days
Online courses
Professional Training

Course description

Introduction To Regulatory Affairs In The MENA Region

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 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

Suitability - Who should attend?

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

Outcome / Qualification etc.

Introduction To Regulatory Affairs In The MENA Region

Training Course Content

  • 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

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

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Average rating 5

Based on 2 reviews

Regulatory Affairs Excellence Director, Hikma Pharmaceuticals
The course was very well presented. Having a small group was hugely beneficial as it was more focused.
Junior International DRA Project Manager, Actelion Pharmaceuticals
I enjoyed the interactive elements of the course and the trainer being open to questions.
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Course rating
Based on 2 reviews
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