H.E. Dr. Fatima Al Kaabi: EDE is committed to establishing a regulatory environment that supports innovation, ensures patient safety, and enhances clinical research

UAE, Dubai: The Emirates Drug Establishment (EDE), in collaboration with the Drug Information Association (DIA), Middle East and Africa Office, organised the first Clinical Research Forum in the UAE at the American University in Dubai.

Sponsored by the pharmaceutical company Amgen, the forum brought together a distinguished group of representatives from regulatory authorities, academic institutions, international organisations, healthcare entities, and pharmaceutical and technology companies.

The event aimed to reinforce the UAE’s position as a leading regional hub for clinical research while highlighting the nation’s commitment to building a knowledge- and innovation-driven healthcare ecosystem.

A series of specialised sessions were held on the sidelines of the event, addressing regulatory aspects of clinical research, research ethics and data protection, research quality, academic–industry partnerships.

The sessions also discussed the readiness of research centres, and innovative approaches to attracting clinical studies to the UAE and the wider region, in addition to discussions on the operational preparedness of research sites.

Participating in the forum were Dr. Shaikha Al Mazrouei, Director of Reference National Laboratory, Drug Department, Emirates Drug Establishment (EDE), along with representatives from the Department of Health – Abu Dhabi, the Dubai Health Authority, the University of Sharjah, the American University in Dubai, New York University Abu Dhabi, Cleveland Clinic Abu Dhabi, AstraZeneca, Amgen, the event’s sponsor, and several other entities involved in clinical research.

EDE pivotal role

The EDE's move to organise the forum aligns with its strategy to oversee and coordinate the regulatory framework for medical products and the research associated with them through a set of key priorities.

These include developing a health sciences sector supported by advanced technologies to ensure pharmaceutical security, drive the growth of medical industries, and cultivate a research environment that accelerates access to innovative therapies while enhancing transparency and international cooperation in the pharmaceutical field.

Her Excellency Dr. Fatima Al Kaabi, Director General of the Emirates Drug Establishment, emphasised that the Establishment is committed to building a world-class regulatory environment that stimulates innovation, safeguards patient health, and helps drive meaningful progress in clinical research.

Al Kaabi noted that the EDE will spare no effort to develop flexible, transparent, and forward-looking regulatory frameworks that keep pace with global developments in medical products and clinical research.

Her Excellency added: “The Emirates Drug Establishment operates with a holistic vision to reinforce pharmaceutical security, ensure the sustainable availability of medical products at competitive prices, and promote the national pharmaceutical model to the highest international standards.”

“We are equally committed to encouraging specialised research and developmental studies within the UAE and to providing an integrated regulatory environment supported by a robust pharmacovigilance system. We will continue to enhance global partners’ confidence in the UAE market and position the country as a preferred destination for hosting advanced clinical studies and research,” Al Kaabi said.

Empowering research centers

Meanwhile, Dr. Shaikha Al Mazrouei said: “The UAE’s first Clinical Research Forum provides a practical platform to strengthen collaboration with partners from regulatory authorities, universities, hospitals, and pharmaceutical companies and explore how to advance the country’s clinical research ecosystem.”

“The Emirates Drug Establishment is keen to empower research centres by streamlining regulatory procedures, providing clear guidance and standards, and promoting a culture of quality and ethical compliance. These efforts would not only help attract more clinical studies to the UAE but also support effective partnerships with the healthcare and pharmaceutical sectors at the regional and global levels,” Al Mazrouei added.

Integrated research ecosystem

In her opening remarks, Dr. Omnia Darwish, General Manager of the Drug Information Association (DIA) for the Middle East and Africa, stressed the importance of the forum, describing it as a pivotal milestone for shaping the future of clinical research in the UAE.

She clarified that the main objective behind the event was to transition from individual initiatives to a coordinated, sustainable national research ecosystem that aligns with the highest international standards and best practices.

Darwish noted that collaboration with the Emirates Drug Establishment, regulatory authorities, universities, and healthcare institutions will enhance the region’s position among the world’s leading countries in clinical research.

She highlighted three key goals the forum seeks to achieve, including strengthening collaboration between government entities and various sectors, standardising regulatory, ethical, and operational frameworks, and building a sustainable environment that enables high-quality clinical research.

Darwish also praised the role that the World Health Organization play in supporting governance, ethical oversight, and capacity-building for clinical research across the region.

Research Partnership

Additionally, Dr. Naira Manoubi, representing Amgen, stated: “The partnership between the pharmaceutical industry, regulators, and universities is a key driver of building research capabilities and attracting global clinical trials to the UAE.”

For her part, Dr. Muriel Zaatar from the American University in Dubai added that universities “play a pivotal role in preparing research talent and supporting scientific excellence, and hosting this forum reflects our commitment to strengthening the capabilities of the next generation.”

Strengthening Governance

Dr. Arshad Altaf from the World Health Organization said: “The WHO encourages countries to strengthen governance, standardise ethical oversight, and build research capacity. What has been achieved today in the UAE is nothing short of remarkable and sets an inspiring example for the region.”

Dr. Nail Abdel Samad from Cleveland Clinic Abu Dhabi emphasised that “the UAE’s integrated research ecosystem paves the way for conducting advanced and cutting-edge clinical trials aligned with the highest international standards.”

Data Readiness

Dr. Manal Tayma from New York University Abu Dhabi noted that “national data readiness is a fundamental element for shaping the future of scientific research, and the ‘Future of UAE Health’ clinical study is a clear testament to the country’s ability to conduct large-scale, high-quality clinical research.”

Bendhia Kariappa from Pure Health added that “collaboration between the public and private sectors in the healthcare domain is the best pathway to building comprehensive research capabilities in the UAE.”

The forum concluded by reaffirming that the UAE is making a transformative leap in developing its clinical research ecosystem, driven by a clear national vision, strong regulatory leadership, and a collaborative approach that reinforces the country’s position as a global hub for clinical research. The Emirates Drug Establishment has emerged as a key partner in aligning national efforts and shaping a unified, integrated regulatory and research framework across the UAE.