Latest news with #RanaChalhoub


Mid East Info
13-05-2025
- Business
- Mid East Info
GS1 UAE hosts landmark healthcare workshop to fast-track national UDI implementation - Middle East Business News and Information
Industry leaders unite to accelerate implementation of GS1 UDI standards across UAE's healthcare ecosystem Dubai, United Arab Emirates – May, 2025 – GS1 UAE recently hosted an exclusive Healthcare User Group UDI Stream focused on accelerating the implementation of Unique Device Identification (UDI) for medical devices in the country. The event brought together leading experts, and global medical technology companies — including representatives from GS1 UAE, MECOMED, BD and Johnson & Johnson — to address critical challenges and explore new opportunities around UDI adoption in the UAE. With participation from both manufacturers and local agents, the event offered a well-rounded perspective on implementation of UDI, focusing on practical experiences, key lessons learned, and the most effective approaches to drive progress. Featuring keynotes, industry presentations, and an open forum for collaboration, the workshop marked as a decisive move to advance patient safety and streamline healthcare supply chains across the nation. 'Enhancing UDI implementation in the UAE requires more than individual effort — it demands a united front,' said Maha Unnisa, Healthcare Manager at GS1 UAE. 'When regulators, healthcare providers, and supply chain partners work together, we move faster, smarter, and with greater impact. At GS1 UAE, we're proud to lead this industry-wide collaboration to make traceability the standard, not the exception — and to build a healthcare system defined by transparency, safety, and trust.' The event featured insights from Rana Chalhoub, Regulatory Affairs Director at MECOMED, who emphasized the region's readiness for UDI standardisation: 'When implementing UDI regulation, it is paramount to consider a phased-in and risk-based approach along with proper transition timelines. Engaging the different MedTech stakeholders, aiming at a globally harmonized and automated UDI data submission process, is key.' Mirette Abskharoun, Associate Director of Regulatory Affairs at Johnson & Johnson, added: 'Adopting global UDI identification standards plays an important role in improving patient safety, streamlining supply chains, and facilitating better traceability'. The session concluded with a live Q&A, followed by the presentation of certificates of appreciation and commemorative trophies to distinguished speakers. Attendees also had the opportunity to network and explore how GS1's global standards — including the GS1 DataMatrix barcode, which is now mandated or recommended in healthcare regulations across 70+ countries — are shaping safer, smarter healthcare systems. This event underscores GS1 UAE's role in championing global standards and echoes GS1 Healthcare's mission to build a future where every medical product is uniquely identified, traceable, and safe for every patient, everywhere. Taking place alongside GS1 Healthcare's 20 th anniversary, the event reflects the global momentum behind two decades of driving patient safety and digital transformation through trusted, standardized barcoding systems. About GS1 UAE: GS1 is a neutral, not-for-profit organisation that provides global standards for efficient business communication. We are best known for the barcode, named in 2016 by the BBC as one of 'the 50 things that made the world economy.' GS1 standards improve the efficiency, safety and visibility of supply chains across physical and digital channels in 25 sectors. We enable organisations of all types and sizes to identify, capture and share information seamlessly. Our scale and reach – local Member Organisations in 116 countries, more than 2 million user companies and over 10 billion transactions every day – help ensure that GS1 standards create a common language that supports systems and processes across the globe.


Tahawul Tech
31-01-2025
- Health
- Tahawul Tech
Health Authorities gather in Dubai for 2025 MEA MedTech Regulatory Summit
Mecomed and the Regulatory Affairs Professionals Society (RAPS) hosted 2025 MEA MedTech Regulatory Summit at the voco Dubai in Dubai UAE on 30 January 2025. The event was the first ever collaboration between the two organisations and attracted 135 global regulatory professionals, industry leaders, and policymakers —across 25 countries—to address the evolving regulatory landscape for medical devices in the Middle East and Africa (MEA) region. 'The summit represents a vital step forward in harmonising regulatory approaches across the MEA region', said Rana Chalhoub, Regulatory Affairs Director, Mecomed. 'By aligning our efforts, we ensure compliance and create pathways for innovation that can transform patient care and improve healthcare outcomes on a broader scale'. This one-day, interactive summit provided an exceptional platform for dialogue and innovation with a focus on enhancing patient safety, streamlining regulatory processes, and encouraging technological advancements. Through a series of insightful panel discussions, interactive workshops, and keynote speeches, participants explored practical strategies and actionable insights to navigate the MEA region's unique healthcare challenges. The programme for this summit was carefully curated by experts across the medtech community to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. The agenda consisted of 29 expert speakers across six interactive sessions. Key highlights included in-depth discussions on regulatory updates and challenges specific to the MEA region, networking opportunities with leading MedTech professionals and regulatory authorities, and workshops designed to address practical challenges in compliance and market entry. The summit also highlighted the increasing importance of digital health solutions, with dedicated sessions on the integration of AI, telemedicine, and data-driven approaches into regulatory frameworks. Esteemed speakers included: Dr. Bassil Akra, Founder/Executive Consultant, AKRA TEAM Dr. Ruqaya Al Bastaki, Director of Drug Development, Emirates Drug Establishment, UAE Ministry of Health and Prevention Eng. Faiza Al Zadjali, Director of Medical Device Control, Oman MOH – Directorate General of Pharmaceutical Affairs and Drug Control Asmaa Awad, Head of Eastern Europe, Middle East, Africa Regulatory Policy, Roche Middle East Dario Belluomini, Director of Drug Department, Emirates Drug Authority (EDA) Peter Bischoff-Everding, Legal Officer, European Commission Dr. Miriam Boles, Head of Central Administration of Medical Devices, Egyptian Drug Authority Nataliya Deych, Vice President Regulatory Affairs EMEA, LATAM, Canada, Edwards Life Sciences Tracey Duffy, Chairs, IMDRF PMD Working Group and First Assistant Secretary, Medical Devices and Product Quality Division, Therapeutic Goods Administration (TGA) Australia Dr. Mohamed Hani, Head of Pharmaceuticals & Medical Devices Registration, Ministry of Health and Prevention – UAE Peter Schroeer, Vice President Regulatory Affairs EMEA and Canada, Johnson & Johnson Agnes Sitta Kijo, Technical Officer, WHO HQ Graeme Tunbridge, Senior Vice President Global Regulatory and Quality, Medical Devices, BSI Brian Savoie, Senior Vice President, Education & International Programs, Regulatory Affairs Professionals Society (RAPS), commented that 'by bringing together diverse perspectives and promoting collaboration, the summit has set the stage for a more coherent regulatory environment that prioritises patient safety while encouraging innovation'. To learn more about 2025 MEA MedTech Regulatory Summit, visit Image Credit: MEA MedTech Regulatory Summit


Zawya
30-01-2025
- Health
- Zawya
135 global regulators, health authorities, notified bodies and industry partners gather in Dubai
Dubai UAE — Mecomed and the Regulatory Affairs Professionals Society (RAPS) hosted 2025 MEA MedTech Regulatory Summit at the voco Dubai in Dubai UAE on 30 January 2025. The event was the first ever collaboration between the two organizations and attracted 135 global regulatory professionals, industry leaders, and policymakers —across 25 countries—to address the evolving regulatory landscape for medical devices in the Middle East and Africa (MEA) region. 'The summit represents a vital step forward in harmonizing regulatory approaches across the MEA region,' said Rana Chalhoub, Regulatory Affairs Director, Mecomed. 'By aligning our efforts, we ensure compliance and create pathways for innovation that can transform patient care and improve healthcare outcomes on a broader scale.' This one-day, interactive summit provided an exceptional platform for dialogue and innovation with a focus on enhancing patient safety, streamlining regulatory processes, and encouraging technological advancements. Through a series of insightful panel discussions, interactive workshops, and keynote speeches, participants explored practical strategies and actionable insights to navigate the MEA region's unique healthcare challenges. The programme for this summit was carefully curated by experts across the medtech community to ensure the highest quality discussions, knowledge exchange, and collaboration opportunities. The agenda consisted of 29 expert speakers across six interactive sessions. Key highlights included in-depth discussions on regulatory updates and challenges specific to the MEA region, networking opportunities with leading MedTech professionals and regulatory authorities, and workshops designed to address practical challenges in compliance and market entry. The summit also highlighted the increasing importance of digital health solutions, with dedicated sessions on the integration of AI, telemedicine, and data-driven approaches into regulatory frameworks. Esteemed speakers included: Dr. Bassil Akra, Founder/Executive Consultant, AKRA TEAM Dr. Ruqaya Al Bastaki, Director of Drug Development, Emirates Drug Establishment, UAE Ministry of Health and Prevention Eng. Faiza Al Zadjali, Director of Medical Device Control, Oman MOH - Directorate General of Pharmaceutical Affairs and Drug Control Asmaa Awad, Head of Eastern Europe, Middle East, Africa Regulatory Policy, Roche Middle East Dario Belluomini, Director of Drug Department, Emirates Drug Authority (EDA) Peter Bischoff-Everding, Legal Officer, European Commission Dr. Miriam Boles, Head of Central Administration of Medical Devices, Egyptian Drug Authority Nataliya Deych, Vice President Regulatory Affairs EMEA, LATAM, Canada, Edwards Life Sciences Tracey Duffy, Chairs, IMDRF PMD Working Group and First Assistant Secretary, Medical Devices and Product Quality Division, Therapeutic Goods Administration (TGA) Australia Dr. Mohamed Hani, Head of Pharmaceuticals & Medical Devices Registration, Ministry of Health and Prevention – UAE Peter Schroeer, Vice President Regulatory Affairs EMEA and Canada, Johnson & Johnson Agnes Sitta Kijo, Technical Officer, WHO HQ Graeme Tunbridge, Senior Vice President Global Regulatory and Quality, Medical Devices, BSI Brian Savoie, Senior Vice President, Education & International Programs, Regulatory Affairs Professionals Society (RAPS), commented that 'by bringing together diverse perspectives and promoting collaboration, the summit has set the stage for a more coherent regulatory environment that prioritizes patient safety while encouraging innovation.' To learn more about 2025 MEA MedTech Regulatory Summit, visit ABOUT MECOMED Mecomed is the medical devices, imaging and diagnostics trade association serving as the voice of international medical technology (MedTech) manufacturers and their regional partners across the Middle East & Africa. Mecomed aims to bring all healthcare stakeholders together to improve the quality of people's health through the timely introduction of MedTech innovations, which ultimately benefits the MEA region community. We foster good citizenship and promote ethical business behavior, working proactively with governments, regional bodies and healthcare professionals to deliver quality solutions for better patient outcomes. ABOUT REGULATORY AFFAIRS PROFESSIONALS SOCIETY (RAPS) The Regulatory Affairs Professionals Society (RAPS) is the largest global organization of professionals involved with regulatory and quality for healthcare products, including medical devices, pharmaceuticals and biologics, diagnostics, and digital health. Founded in 1976 as a neutral, nonprofit organization, RAPS supports and elevates the regulatory profession with education and training, professional standards, publications, research, networking, career development, and other valuable resources. RAPS is home to the Regulatory Affairs Certification (RAC), the only post-academic professional credential to recognize regulatory excellence. The society is headquartered in suburban Washington, D.C., with chapters and affiliates worldwide. Media Contacts: Gloria Nathaniel ProGlobal Media