Dubai will host the 11th GCC Regulatory Affairs Summit from 22-26 June 2026 at the Mövenpick Grand Al Bustan. Held under the theme “Shaping the Future of Regulatory Affairs: Trust, Technology & Transformation,” the event brings together more than 650 key figures including regional regulators, regulatory affairs leaders, and industry decision-makers to address the evolving landscape of compliance and innovation.

The 2026 edition will address key priorities shaping pharmaceutical regulation across the region, including regional regulatory authority updates, ATMPs, vaccines, biologics and biosimilars, OTC standards, pharmaceutical localization, regional manufacturing, track and trace, and supply chain resilience.

The programme will also spotlight AI in regulatory oversight, digital regulatory control, pharmacovigilance innovation, patient-centric safety, inspection readiness, pharmaceutical quality oversight, and AI-driven quality systems.

The event will feature three focused conferences: the GCC Regulatory Affairs Pharma Summit on 22-23 June, the GCC Pharmacovigilance Training on 24-25 June, and the GCC Quality Conference on 26 June. The programme will also include a full day of hands-on eCTD Training on 25 June, supported by eCTD Workshop Sponsor, cormeo | Docuvera – EXTEDO – Rote Liste – medicines.ie.

“Over the past decade, the GCC Regulatory Affairs Summit has evolved in line with the region’s pharmaceutical regulatory landscape,” said Dr. Mona Al Moussli, Chairman of the GCC Regulatory Affairs Summit. “The 2026 edition reaffirms our commitment to providing a trusted platform where stakeholders from the public and private sectors can share knowledge, strengthen collaboration, and advance regulatory excellence across the GCC.”

The 2026 edition is supported by leading sponsors representing the pharmaceutical, regulatory technology, compliance and supply chain sectors including Coalition for Epidemic Preparedness and Innovations (CEPI), Haleon, Gulf Pharmaceutical Industries (Julphar), VISIOTT | TPS, Ipsen, Schlafender Hase, and EVOTEQ.

Other key sponsors include Neuraxpharm, Galderma, Biocon Limited, LSPedia, Arcera Life Sciences, Pi Pharma Intelligence, AKT Health, Veragence Pharma Consultancy, CosmoTrace and PRA Consultancy, among others. Their participation reinforces the summit’s focus on regulatory excellence across the GCC pharmaceutical sector.

“The pace of regulatory change requires professionals to move beyond awareness and focus on practical implementation,” said Dr. Najiba Al Shezawy, Co-Chairman of the GCC Regulatory Affairs Summit. “This year’s programme will support practical discussions on regulatory challenges, digital transformation, pharmacovigilance readiness, quality expectations, and the systems needed to build a more resilient pharmaceutical sector.”

Building on more than a decade of regional engagement, the summit remains a key meeting point for the pharmaceutical regulatory sector, supporting dialogue between regulators and industry through expert presentations, panel discussions, workshops, case-based learning, and networking opportunities.

To find out more about the GCC Regulatory Affairs Summit and view the latest agendas, visit: www.pramagcc.com/

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