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DIA's Middle East and North Africa Conference to Address Regulatory Reliance and Innovation

Health authorities and industry leaders to meet in Cairo to explore strategies for increased collaboration and improving patient access to treatments

Found in: Pricing / Reimbursement

DIA a global non-profit organization of life sciences professionals, will unite stakeholders through discussions of regional regulatory reliance, developments, and strategy during the Middle East and North Africa Conference, to be held Nov. 26-27 in Cairo.

Many regulatory agencies throughout the Middle East and North Africa (MENA) are facing lengthy approval backlogs. Greater reliance on neighboring authorities promises to speed up regulatory decisions, especially after the Saudi Food and Drug Authority (SFDA) achieved the maturity level four (ML4) designation from the World Health Organization (WHO) last year.

Regulators, senior-level industry representatives, government officials, academics, and patient advocates from MENA and beyond will share case studies and insights from regulatory bodies, such as the European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA), that have adopted similar strategies.

"The path to faster drug approvals and better patient outcomes across the Middle East and North Africa starts with increased regulatory cooperation," said Marwan Fathallah, DIA's President and Chief Executive Officer. "DIA has been convening industry leaders to address the specific regulatory needs of this diverse region since 1996. As we look ahead, these discussions will continue driving policy innovations and shaping a more harmonized regulatory ecosystem."

In the opening session, the Middle East and North Africa Town Hall, representatives from regional health authorities will share their latest achievements and priorities, and engage in an interactive panel discussion. In addition, the Egypt Town Hall will spotlight the Egyptian Drug Authority (EDA), its recent developments, and its progress toward Egypt Vision 2030.

Sessions will cover several topics, including the continued push for digitalization and the use of electronic common technical documents (eCTDs) in marketing authorization applications; the new guidance regarding supply chain and sample testing; national plans for rare diseases and increasing access to orphan medicines; and how artificial intelligence (AI), which remains mostly unregulated in the region, can be implemented responsibly to increase efficiencies in the lifecycle of medicinal products.

Click here to register or view the program for the conference, which will be held at the Conrad Cairo Hotel. Media members can request credentials by emailing diaglobal@gregoryfca.com

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