Marketing Authorisation and Market Access in the Middle East: GCC and National Markets

• Pharmaceutical marketing authorisation and market access in the GCC and key national markets
• Intellectual property: Patents, data protection and regulatory considerations
• Fast-track pathways, distribution strategies and legal frameworks
• Dossier assessment, submission processes and compliance essentials
• Key quality and production requirements for market entry
• Import regulations, pharmacovigilance obligations and post-approval maintenance

Who should attend

• Regulatory affairs professionals in the pharmaceutical and healthcare industries
• Market access and business development managers focusing on the Middle East region
• Quality assurance and production specialists involved in regulatory compliance
• Legal and intellectual property experts in the pharmaceutical sector

This in-person event provides you with a comprehensive understanding of marketing authorisation and market access in the Middle East, focusing on both GCC-wide and national regulatory frameworks. Through expert-led presentations and interactive discussions, you will gain in-depth knowledge of key topics such as market entry strategies, intellectual property, product classification, pricing regulations and distribution models. The event also covers legal frameworks and lifecycle management, including dossier assessments, eCTD submissions and import regulations. Additionally, it explores pharmacovigilance requirements, post-approval maintenance and quality considerations, with a particular focus on Saudi Arabia, the UAE, Jordan, and Syria.

There will be ample opportunity for individual questions, with experts on hand to provide tailored insights and guidance.

• Gain a clear overview of marketing authorisation pathways across the Middle East.
• Develop a targeted authorisation strategy by assessing regulatory requirements and market conditions.
• Deepen your understanding of quality, production, import regulations and eCTD dossier submissions.