


eCTD Training
Event Highlights 2026
ABOUT GCC REGULATORY AFFAIRS PHARMA SUMMIT
The GCC Regulatory Affairs Pharma Summit is the region’s premier annual event dedicated exclusively to pharmaceutical regulatory affairs in the Gulf. The summit brings together regulatory authorities, registration experts, and pharmaceutical industry leaders to discuss the latest developments in drug registration, marketing authorization, regulatory updates, and compliance frameworks across the GCC.
Recognized as one of the most influential platforms for regulatory affairs professionals, the summit supports companies operating in the GCC pharmaceutical market by offering clarity, guidance, and expert insights into evolving regulatory requirements.
Post-Event Reports
Where
Mövenpick Grand Al Bustan – Dubai, UAE
When
22-23 june 2026
SPEAKERS
50+ Expert Speakers
SEATS
400+ Delegates
Benefits of Attending
Connect with GCC Regulatory Decision-Makers
Meet 350+ professionals specializing in regulatory affairs, drug registration, dossier submissions, and pharma compliance across the GCC. Network with regulators, industry leaders, and RA specialists shaping the region’s pharmaceutical regulatory landscape.
Stay Updated on GCC Pharma Regulations
A two-day, content-rich summit featuring new guidelines, updates to marketing authorization processes, country-specific requirements, registration pathways, and harmonization efforts across GCC member states.
The Region’s Leading Regulatory Affairs Platform
Learn through dynamic sessions including expert panels, regulatory insights, case discussions, interviews, Q&A sessions, and collaborative debates focused solely on pharmaceutical regulatory affairs.
Speakers 2026
The GCC Regulatory Affairs Pharma Summit brings together leading regulatory authorities and experts to discuss drug registration updates, regulatory modernization, and best practices for navigating the GCC pharma market.
H.E. Dr. Ahmed Mohamed Al Ansari
H.E. Dr. Ahmed Mohamed Al Ansari is a highly accomplished Bahraini healthcare executive, medical educator, and strategist. He currently serves as the Chief Executive Officer of the National Health Regulatory Authority (NHRA) in the Kingdom of Bahrain, a role he has held since November 2023. With a distinguished career spanning more than two decades, he has held pivotal leadership roles across Bahrain and the Gulf region, shaping healthcare policy, advancing clinical excellence, and driving medical education reform.
Prior to his current position, Dr. Al Ansari served as the CEO of Government Hospitals in Bahrain (2020–2023), where he led the country’s largest hospital network and played a key role in preparing public hospitals for the implementation of the national health insurance system.
His earlier roles include:
- Director of Training and Planning, Supreme Council of Health (2019–2020)
- Acting Director of Training, Ministry of Health (2019–2020)
- Director of Training & Development and Head of Research, Bahrain Defence Force Hospital (2013–2019)
- Medical Education Consultant, King Fahad Medical City, Saudi Arabia (2014–2016)
- Medical Education Consultant, Prince Sattam Bin Abdulaziz University, Saudi Arabia (2014–2018), where he successfully led the transformation of a traditional six-year medical curriculum into a five-year hybrid program incorporating problem-based and case-based learning.
Dr. Al Ansari holds two PhDs – one in Medical Education (2013) and another in Leadership and Change in the Healthcare Sector (2021). He also earned a master’s in health Professions Education from Maastricht University and a Master’s in Leadership and Change from Antioch University. His clinical credentials include a fellowship in Cardiothoracic Surgery and membership in the Royal College of Surgeons in Ireland (MRCSI).
A strong advocate for evidence-based leadership and academic excellence, Dr. Al Ansari has authored more than 80 peer-reviewed publications in areas such as healthcare policy, education, psychometrics, leadership, and clinical innovation. He is also an Adjunct Professor at the Royal College of Surgeons in Ireland (2025–2028) and serves on several advisory boards, including the Bahrain Council for Health Professions Studies and the Supreme Committee for Sports Medicine.
He is widely recognized for his leadership in:
- Health system transformation and regulatory excellence
- Medical education innovation, including the development of simulation centers and hybrid curricula
- Healthcare quality and patient safety, with accomplishments such as achieving Australian accreditation for Salmaniya Medical Complex (SMC), ISO 15189 accreditation for pathology laboratories, and eliminating infection rates in surgical and neonatal units
Dr. Al Ansari’s leadership was especially impactful during the COVID-19 pandemic, during which he oversaw the management of eight treatment facilities, covering over 2,000 hospital beds and more than 6,500 employees, ensuring efficient resource allocation and uninterrupted critical care services.
In recognition of his outstanding national service and contributions to the healthcare sector, he has been honored with several prestigious awards:
- Prince Salman Bin Hamad Al Khalifa Medal for Medical Merit
- Medal of Strength
- Medal of Gallantry
- First-Class Military Service Medal
H.E. Dr. Ahmed Mohamed Al Ansari
Chief Executive Officer of the National Health Regulatory Authority (NHRA), Kingdom of Bahrain
Dr. Donia Al Bastaki
Dr. Donia Al Bastaki is the head of drug registration department with more than 17 years working experience in the pharmaceutical field, her area of expertise is regulatory affairs and pharmacovigilance where she contributed to the development of drug regulatory framework in Kuwait and GCC.
13 years’ experience in GMP inspection through which she inspected several international, regional, and local pharmaceutical manufacturing companies.
Member of GHC Central Registration Committee since year 2007 till 2018 and contributed to setting the GCC Guidelines for Drug Registration as well as Stability, Bioequivalence and PIL GCC guidelines and others.
Member of the International Society of Pharmacovigilance and Kuwait deputy focal point for Uppsala Monitoring Center /WHO Collaborating Center for International Drug Monitoring.
She was assigned as Kuwait focal point with the League of Arab states in the field of Pharmacy and drugs and participated in the development of the Arab common Bioequivalence Guidelines.
Dr. Donia Al Bastaki
Head of Drug Registration Department, Pharmaceutical and Herbal Medicines Registration and Control Administration at Ministry of Health – Kuwait
Dr. Nisreen Nassr
Dr. Nisreen Nassr is an accomplished pharmaceutical regulatory leader with over 23 years of experience in medicines regulation and public health. She demonstrates strategic leadership in shaping pharmaceutical regulatory frameworks and advancing regulatory modernization in the Sultanate of Oman.
Dr. Nisreen’s expertise spans marketing authorization, GMP compliance, pharmaceutical inspections, regulatory policy, medicines lifecycle management, and stakeholder engagement. She has a proven track record in leading transformative initiatives that strengthen regulatory governance, enhance transparency and operational excellence, and align national regulatory systems with international best practices. She is committed to fostering innovation, safeguarding public health, and ensuring access to safe, effective, and quality medical products.
Dr. Nisreen Nassr
Director of Medicine Registration – Ministry of Health, Oman
Mr. Khalid Al Sudais
Healthcare and regulatory affairs with extensive experience in pharmaceutical regulation, policy development, and international regulatory collaboration.
plays an active role in advancing regulatory harmonization initiatives across the Gulf region.
Mr. Khalid Al Sudais
Director of Centralized Products, Gulf Health Council
Dr. Shaikha Al Mazrouei
Director of Reference National Laboratory, Drug Department, Emirates Drug Establishment (EDE)
Dr. Nabeela Ahmed Memon
Nabeela Ahmed Memon regulatory affairs pharmacist in the Kingdom of Bahrain with nearly a decade of progressive experience at the National Health Regulatory Authority (NHRA).
Currently serves as Head of Registration & Pricing and holds the additional responsibility of Chief of Pharmacy & Pharmaceutical Products Regulation department, leading national oversight of medicine registration, pricing, and regulatory compliance.
Leads national operations for pharmaceutical product registration and pricing, overseeing innovative, generic, and non-registered medicine portfolios in alignment with GCC and international standards.
Spearheaded the digital transformation of medicine registration through full implementation of the “Adweya” system, reducing review timelines by 35% and enhancing regulatory efficiency.
Deputy Chairperson of the Pharmaceutical Products Licensing Committee and represents Bahrain in regional GCC regulatory harmonization and GMP initiatives.
Recipient of the prestigious Prince Salman bin Hamad Medical Merit Award in recognition of her leadership and outstanding contribution during Bahrain’s national COVID-19 response.
Dr. Nabeela Ahmed Memon
Acting Chief, Pharmacy and Pharmaceutical Products Department, National Health Regulatory Authority, Bahrain
Dr. Abdulrahman Aloumi
Dr. Abdulrahman Aloumi is an accomplished pharmaceutical professional and academic researcher with extensive experience spanning clinical, community, and regulatory pharmacy. He holds an MSc in Pharmaceutical Analysis and Quality Control and a PhD in Pharmaceutical Science, both from King’s College London, and has experience teaching at the post-graduate level. In 2021, Dr. Aloumi transitioned into the regulatory sector, and since 2023, he has served as the Head of the Pharmaceutical Pricing Department within the Kuwait Ministry of Health’s Pharmaceuticals and Herbal Medicines Registration and Control Administration.
In this capacity, Dr. Aloumi contributes to national policy-making and strategic regulation. He serves as an active member of several key regulatory bodies, including the Kuwait Pricing Committee, the Gulf Health Council (GHC) Pricing Committee, and the Pharmaceutical Products Classification Committee. Additionally, Dr. Aloumi is dedicated to supporting the institutionalization of Health Technology Assessment (HTA) frameworks, advocating for data-driven, pharmacoeconomic models that comprehensively evaluate the clinical, economic, and social value of innovative medical technologies to balance sustainable healthcare funding with optimal patient access.
Dr. Abdulrahman Aloumi
Head of Pharmaceutical Pricing Department, Ministry of Health - Kuwait
Dr. Faiza Alsharji
Dr. Faiza Alsharji is a pharmacist at the Medicines and Biologicals Department, Drug Safety Center, Ministry of Health, Sultanate of Oman. She has professional experience in pharmaceutical regulation, drug safety, pharmacovigilance, and healthcare quality. Her work focuses on ensuring the quality, safety, and efficacy of medicines and biological products, while supporting patient safety and regulatory excellence initiatives. She is passionate about strengthening healthcare systems, advancing regulatory practices, and promoting public health through evidence-based approaches.
Dr. Faiza Alsharji
Pharmacist, Medicines and Biologicals Department, Drug Safety Center, Ministry of Health of Oman
Ph. Manal Salim Sulaiyam Al Bousafi
Variation Task Lead, Pharmaceutical and Biological Product Section, Ministry of Health Oman
Dr. Shatha Ziad Al-Quraan
Dr. Shatha Ziad Al-Quraan holds a Master’s degree in Pharmaceutical Sciences, now she is the Head of the Chemical Drugs Registration Department at the Jordan Food and Drug Administration (JFDA). She has held several leadership positions within JFDA, including Head of the Medical Devices Registration Department and Head of the Scientific Advice Unit.
Dr. Al-Quraan represents JFDA in the International Council for Harmonisation (ICH) and previously represented the agency in the International Medical Device Regulators Forum (IMDRF) and the Global Harmonization Working Party (GHWP). She is a member of several technical committees responsible for the development, enhancement, and updating of pharmaceutical regulations, guidelines, and policies in alignment with international standards.
She also serves as the JFDA Topic Leader in the ICH Q3E Expert Working Group
Dr. Shatha Ziad Al-Quraan
Head of the Chemical Drugs Registration Department, Jordan Food and Drug Administration (JFDA), Jordan
Dr. Anees Puthan Veettil
Dr. Anees Puthan Veettil is a senior regulatory affairs professional with over 21 years of experience across regulatory authorities and the pharmaceutical industry. He currently leads the Technical Evaluation and Compliance Unit at the Emirates Drug Establishment, overseeing the scientific assessment of clinical, non-clinical, and CMC regulatory dossiers and supporting evidence-based regulatory decision-making.
His expertise encompasses Regulatory Affairs, GxP compliance (GMP, GCP, GLP), clinical research, biologics, advanced therapies, and regulatory policy development, with extensive knowledge of ICH, WHO, EMA, FDA, and GCC regulatory frameworks. Prior to joining EDE, he held leadership roles in multinational pharmaceutical companies and CROs, gaining broad experience in R&D, quality, clinical operations, and regulatory compliance.
Dr. Anees is an active speaker, trainer, and advisor, contributing to regulatory capacity building and the advancement of global regulatory excellence.
Dr. Anees Puthan Veettil
Head, Technical Evaluation and Compliance Unit Emirates Drug Establishment (EDE), UAE
Mr. Sultan ALGhamdi
Sultan ALGhamdi is a senior healthcare and pharmaceutical affairs leader with 11+ years of experience across Public affairs, regulatory affairs, and scientific office leadership in Saudi Arabia.
He currently serves as Director of Public Affairs & Scientific Office at STADA, where he leads strategic engagement with government stakeholders, oversees regulatory and policy priorities, and drives cross-functional initiatives that support business growth and long-term healthcare objectives. In his role, he works closely with key healthcare and regulatory stakeholders to foster collaboration and advance initiatives aligned with the evolving healthcare landscape in Saudi Arabia.
Mr. Sultan ALGhamdi
Director of Public Affairs & Scientific Office, STADA
Dr Paulyne Wairimu
Paulyne Wairimu, Chair of the African Medical Devices Forum (AMDF) under the African Medicines Agency, also serves as the Head of the Medical Devices and IVD
Cluster at the Pharmacy and Poisons Board, Kenya’s National Regulatory Authority. With extensive experience in regulatory systems development and health systems
strengthening with Specialized Expertise in Medical Technologies, Public Health, and
Global health diplomacy; Paulyne is a dedicated advocate for regulatory harmonization and convergence across Africa and globally.
Dr Paulyne Wairimu
Head of the Medical Devices and IVD Cluster, Pharmacy and Poisons Board, Kenya
Dr. Yasmine Hisham
Dr. Yasmine Hisham is a Regulatory Affairs professional and Manager of Human Pharmaceutical Regulatory Affairs Administration at the Egyptian Drug Authority.
Dr. Yasmine has solid experience in the assessment of small molecule pharmaceuticals, with a focus on dossier evaluation, lifecycle management, and regulatory compliance. In her role, she contributes to enhancing review efficiency and supports regulatory initiatives aligned with international best practices.
Dr. Yasmine is particularly interested in regulatory harmonization and reliance approaches to improve timely access to safe and effective medicine.
Dr. Yasmine Hisham
Manager of Human Pharmaceutical Regulatory Affairs Administration, Egyptian Drug Authority
Dr. Alaa Awamleh
Dr. Alaa Al-Awamleh is a distinguished Regulatory Affairs Specialist and Doctor of Pharmacy with over a decade of experience in pharmaceutical regulation. Since November 2024, she has served as the Section Head of the Originator Drugs Unit at the Jordan Food and Drug Administration (JFDA), where she leads the Committee of Post-Approval Changes for Originator Drugs and chairs the Local Generics Drug Registration Committee. She also acts as the Focal Point of Contact representing the JFDA Marketing Authorization function in the WHO Global Benchmarking Project, contributing to the authority’s ongoing efforts to achieve Maturity Level 3.
Prior to her current role, Dr. Alaa served as a Senior Regulatory Affairs Specialist at the JFDA from March 2016, where she was responsible for reviewing and assessing electronic Common Technical Dossier (eCTD) files for drug registrations and evaluating post-approval changes of registered drugs. She played an active role in the development and issuance of reliance regulations and guidelines adopted by the JFDA, while conducting thorough assessments of medicine profiles to ensure compliance with safety and efficacy standards.
Dr. Alaa holds a Bachelor of Doctor of Pharmacy from the University of Jordan and built her foundational expertise through clinical roles in hospital and community pharmacy settings between 2012 and 2016. Committed to public health excellence, she continues to drive regulatory efficiency, provide strategic guidance to stakeholders, and ensure that only safe and effective medicines reach the Jordanian market.
Dr. Alaa Awamleh
Section Head, Originator Drug Sector, Jordan Food & Drug Administration
Hebatalla Ibrahim
Hebatallah Ibrahim Abd El-Salam is a senior regulatory affairs expert with over 15 years of professional experience at the Egyptian Drug Authority (EDA). She currently serves as General Manager of the General Administration of Biological Products within the Central Administration of Biological and Innovative Products, where she leads national regulatory oversight for biological products.
She has extensive expertise in the regulation of vaccines, biotechnology products, and other biological products, with a strong background in regulatory evaluation decision-making, and policy development.
She plays an active role in international regulatory harmonization, serving as an independent technical expert and advisor with several global and regional initiatives. she contributes to the African Medicines Regulatory Harmonization (AMRH) program through regulatory capacity development activities. She was a member of the Regulatory Capacity Development Technical Committee and was serving as Chair of the Vaccine Subcommittee.
She is also a member of the International Council for Harmonisation (ICH) Expert Working Group, contributing to the development of the ICH Q5E guideline annex for advanced therapy medicinal products (ATMPs).
She holds a Bachelor’s Degree in Pharmaceutical Sciences from Cairo University, a Master of Business Administration (MBA) and is currently a Doctorate program candidate in Quality Management.
Hebatalla Ibrahim
General Manager of the General Administration of Biological Products, Egyptian Drug Authority
Dr. Areej Jawad
Dr. Areej Jawad is a Prime Pharmacist at the Ministry of Health, Iraq, where she serves as Head of the First Registration Committee within the Registration Department, Directorate of Technical Affairs. She has recently been appointed Manager of the Pharmacy Department within the same directorate, further strengthening her leadership role in regulatory and pharmaceutical oversight.
Dr. Areej Jawad
Prime Pharmacist | Manager of Pharmacy Department, Iraq Ministry of Health
Dr. Dana Samih Ahmad
Dr. Dana Ahmad is a Clinical Pharmacist at the Jordan Food and Drug Administration (JFDA), currently serving in the Biologicals, Sera and Vaccines Registration Department. With a Master’s degree in Clinical Pharmacy and a strong background in pharmacovigilance from her previous role within JFDA’s Rational Drug Use and Pharmacovigilance Department, she plays an active role in national regulatory initiatives and committees dedicated to advancing the regulation, safety, and oversight of biological medicines and vaccines in Jordan.
Dr. Dana Samih Ahmad
Clinical Pharmacist, Biologicals, Sera and Vaccines Registration Department, Jordan Food and Drug Administration (JFDA)
Arda Arat
Arda Arat is the General Manager for Haleon Gulf & Near East (GNE), leading operations across a diverse cluster of markets in the Middle East.
A strategic leader with over two decades of experience in finance and business leadership, Arda has played a key role in driving growth, profitability, and innovation across the region. Prior to his current role, he served as Business Unit Finance Head for Middle East & Africa, where he led major initiatives including market expansion, pricing optimization, and strategic transformation programs.
In his current role, Arda is focused on advancing Haleon’s purpose of improving everyday health with humanity, with a strong emphasis on self-care, health literacy, and access to healthcare. He has been a visible advocate for building collaborative healthcare ecosystems working with government, academia, and industry partners to empower individuals to take greater control of their health.
Arda is particularly passionate about driving the shift toward preventative health and self-care, recognizing its role in improving health outcomes, increasing productivity, and reducing pressure on healthcare systems. His leadership is centered on delivering sustainable impact for consumers while contributing to the broader economic and social development of the region.
Arda Arat
General Manager, Haleon Gulf & Near East (GNE)
Dr. Samia Saad
Dr. Samia is Senior Advisor to the CEO and Strategic Lead for Climate and Health at the Coalition for Epidemic Preparedness Innovations (CEPI). Previously Samia was Executive Director of Resource Mobilisation & Investor Relations responsible for the strategic engagement with sovereign governments, philanthropic foundations, multi-lateral development banks and a wide range of other stakeholders to ensure CEPI’s sustainability. Prior to taking on her roles at CEPI, Samia was the Bill & Melinda Gates Foundation (BMGF) representative on the CEPI Investor Council and observer to the Board.
During the previous seven years, Samia developed and lead BMGF’s Global Health R&D and Epidemic Preparedness Policy, Advocacy and Communications strategy. Prior to that, Samia spent many years as a technical advisor to EU donor governments and multi-lateral health agencies, defining science and research priorities and conducting policy analysis for better access to medicines and vaccines in low-income countries.
Samia has also worked as a medicines policy analyst at the WHO in Geneva and Cairo and as Strategy Manager at the UK BioIndustry Association (BIA) where she led initiatives that focused on securing an enabling research policy and financing environment in the EU, fostering global bioscience partnerships and developing research & innovation strategies. Samia holds a BSc. (Honours) in Biochemistry from Imperial College, London and an MSc. in International Health Policy & Health Economics from the London School of Economics & Political Science and spent several years as biomedical researcher conducting doctoral studies at King’s College London and post doctoral studies Harvard Medical School.
Dr. Samia Saad
Senior Advisor to the CEO and Strategic Lead for Climate and Health, Coalition for Epidemic Preparedness Innovations (CEPI)
Dr. Ahmad Elkhatib
Ahmed Yasser is the Global Regulatory Affairs Manager at SPIMACO with more than 19 years of experience in the pharmaceutical industry. He has extensive expertise in regulatory affairs, regulatory strategy, product lifecycle management, and market access across the Gulf region and international markets.
Throughout his career, Ahmed has led regulatory initiatives supporting the registration, approval, and lifecycle management of a broad portfolio of pharmaceutical products. His experience spans new product registrations, renewals, variations, regulatory intelligence, compliance management, and the development of regulatory strategies that support business growth and timely patient access to medicines.
In his current role at SPIMACO, Ahmed provides regulatory leadership for international markets, overseeing regulatory activities across multiple regions and working closely with health authorities, industry partners, and cross-functional teams to navigate evolving regulatory requirements and support successful product registrations and lifecycle management initiatives.
A strong advocate of regulatory innovation and digital transformation, Ahmed played a leading role in supporting the early implementation of eLabeling initiatives within the GCC region. His efforts have focused on facilitating the transition toward modern labeling solutions, promoting regulatory efficiency, and enhancing access to accurate and up-to-date product information for healthcare professionals and patients.
Ahmed is passionate about advancing regulatory excellence, fostering collaboration between industry stakeholders and health authorities, and supporting initiatives that strengthen regulatory systems and improve patient access to quality medicines across international markets.
Dr. Ahmad Elkhatib
Global Regulatory Affairs Manager, SPIMACO
Ramez Sawiris
Ramez Sawiris serves as the R&D Head for Haleon Middle East and Africa and is the Vice Chair of MENAP-SMI (Middle East, North Africa, Pakistan Self Medication Industry), where he has played an important role in leading discussions on self-care in the region. With over 20 years of experience in the pharma and consumer healthcare industries, Ramez oversees the research and development activities across the MEA region, ensuring the delivery of innovative and high-quality products that align with consumer needs and local regulatory standards.
Ramez holds a robust background in regulatory affairs, regulatory strategy development, pricing, and external engagement. Through his leadership, Ramez has built and maintained strategic partnerships with key stakeholders including government agencies, industry associations, and healthcare professionals, reinforcing Haleon’s commitment to deliver better everyday health with Humanity across MEA. Ramez also holds an MBA in Management from the University of Bradford, UK and a Bachelor of Pharmacy and pharmaceutical science from Cairo University.
Ramez Sawiris
Vice President, R&D Middle East & Africa (MEA), Haleon
Dr. Fatima Zaid Abu Zanat
Dr. Fatima Zaid Abu Zanat is a pioneering leader in pharmaceutical and healthcare industries, with over 17 years of experience ensuring timely patient access to innovative therapies in some of the world’s most dynamic emerging markets. As Regional Director of Regulatory Affairs & Scientific Office at Ipsen Pharma, she blends scientific rigor with strategic leadership, while passionately championing the evolution of regulatory affairs professional into a creative, purpose-driven business partner within Ipsen, partners and beyond.
A pharmacist by training and R&D scientist by education, Dr. Abu Zanat holds three international research publications, two of which are based on her groundbreaking MSc Pharmaceutical Technology thesis on a novel co-drug for dyslipidemia. She also holds the prestigious RAPS Dual Regulatory Affairs Diploma and Certificate. Her contributions to the broader industry include active roles with associations such as RAPS, PhRMA MEA and formerly Mecomed. Her voice and vision continue to be sought after at major, regulatory forums, where she regularly contributes as a speaker and panel moderator.
Her exceptional contributions have earned her prestigious accolades, including the most recent Award of 2025 Global Women Power Leaders for the category of Regulatory Excellence Across Borders, 2023 GCC Regulatory Affairs “Women of the Middle East” Award, 2022 nomination among Ipsen’s top Women of the Year and DUPHAT 2012 3rd Best Professional Poster Award. As a mentor and recognized leader, Dr. Abu Zanat continues to shape the future of regulatory affairs – empowering the next generation to lead with purpose, innovation and integrity.
Dr. Fatima Zaid Abu Zanat
Regional Director of Regulatory Affairs & Scientific Office – Middle East, Turkey & Africa, Ipsen Pharma
Dr. Salmine El Naggar
Salmine El Naggar is a Regulatory Affairs & Launch Excellence Lead at Sanofi with over 9 years of experience driving regulatory innovation and shaping regulatory strategies across diverse therapeutic areas in the Greater Gulf region. She led a diverse portfolio spanning multiple therapeutic areas in specialty care and vaccines playing a key role in bringing innovative therapies across the Greater Gulf countries.
In her current role, Salmine leads end-to-end development and execution of regulatory strategies, driving regulatory launch excellence throughout the product development lifecycle and ensuring alignment of the regional priorities with corporate strategies while navigating the evolving regulatory landscape across the Greater Gulf. In this role, she leads initiatives that strengthen the regulatory ecosystem, identify strategic opportunities, and accelerate patient access to innovative medications.
She also leads transformational initiatives focused on digitalization, process optimization, and the adoption of digital tools within Regulatory Affairs strengthening operational effectiveness and enabling more agile regulatory decision-making.
Salmine is committed to advancing patient access to life-changing therapies through fostering collaboration between the industry and regulators to advance and shape the regulatory landscape, advance innovation, and accelerate patient access to breakthrough medications.
Dr. Salmine El Naggar
Regulatory Affairs & Launch Excellence Lead, Sanofi
DR. RAWYA KREDLY
Dr. Rawya is a clinical pharmacist with broad Medical and Pharmaceutical knowledge, experience in various aspects of the Pharmaceutical Industry especially Medical Affairs, Regulatory Affairs and Pharmacovigilance, as well as knowledge and experience in the research field. She has a M.Sc. Clinical Pharmacy (with Distinction) – Queen’s University, UK.
Dr. Rawya began her career at Hikma Pharmaceuticals, Jordan since 1998 till 1999, and she is currently the Regulatory Affairs & Medical Affairs Director at Gulf Pharmaceutical Industries (Julphar), Ras Al Khaimah, United Arab Emirates since 2020 – to the present date.
In her role in Regulatory affairs, she displays and actions leadership in all aspects of Regulatory Affairs for company product portfolio of generics and novel products, including product development and submissions.
She is also an expert in defining the strategic regulatory direction for pipeline development and global launch excellence for a significant dedicated R&D budget. In addition, Dr. Rawya is knowledgeable of partnering with R&D and Global Strategic Marketing leaders as well another functional leader to develop and implement strategy for pipeline development and global launch excellence.
DR. RAWYA KREDLY
Medical and Regulatory Affairs Director - Gulf Pharmaceutical Industries (Julphar)
Dr. Priti Baijal
Dr. Priti Baijal is a physician and regulatory affairs leader with extensive experience across the Middle East, Türkiye, Eurasia, and Africa. As Head of Regulatory Affairs META at Galderma, she leads regulatory strategy and portfolio management and multicultural teams across diverse and evolving markets.
With a background spanning Regulatory Affairs, Medical Affairs, Policy engagement, Business Development, and Commercial Strategy, she has successfully supported market expansion, regulatory transformation, and patient access to innovation.
Known for her strategic mindset and collaborative leadership, Dr. Priti is passionate about transforming regulatory affairs into a strategic business enabler. She is also a strong advocate for self-care and healthcare innovation, helping organizations drive growth while delivering better outcomes for patients and consumers.
Dr. Priti Baijal
Head of Regulatory Affairs META, Galderma
Dr. Yousra Farid
Yousra a Regulatory Affairs and Commercial & Distribution Quality Assurance Head with over 16 years of diversified experience from various leadership positions in Regulatory Affairs and Quality Assurance within Health Authority as well as multinational organizations at both regional and local levels.
Yousra is currently leading Abbott-Gulf & Emerging Markets Regulatory Affairs & Quality Assurance. In her role in Abbott Established Pharmaceutical Division. Yousra is responsible for setting Regulatory Strategies for New Product Introduction, Geo-expansion, Licensing & Acquisition, Localization, Life cycle management, enhancement of promotional model, as well as RA risk mitigation and regulatory compliance.
Yousra has set effective regulatory strategies of external engagement including Health authorities, local distributors, trade associations and Third-Party Manufacturers. This is in addition to her Quality Assurance responsibilities of establishing and embedding Quality Management System within GEM. Institute of Technology, USA which upgraded her strategic thinking and enhanced her development.
Yousra is holding a bachelor of Pharmaceutical sciences from Cairo University and RAPS-DPC certification/USA-UAE and She has also completed the “New Leadership Program (NLP)”, by Harvard Business School and is currently enrolled in “Professional Diploma in Business Planning and Strategy”, by Rochester Institute of Technology, USA.
Dr. Yousra Farid
Regulatory Affairs & Quality Assurance Director, Strategic Project Lead Gulf, Levant & EM, Abbott
Dr. Sarah El Masry
Dr. Sarah El Masry is Regulatory Affairs and Pharmacovigilance leader at Novo Nordisk in the Gulf region. She brings over 17 years of experience in regulatory affairs and pricing, complemented by strong expertise in pharmacovigilance and quality assurance.
Dr. El Masry is actively engaged in regulatory advocacy, contributing to discussions aimed at strengthening regulatory frameworks and enhancing collaboration across the Gulf region. Her areas of interest include innovative medicines, biologics, and the optimization of regulatory processes to support timely patient access.
She holds a Bachelor’s degree in Pharmacy, along with postgraduate qualifications in Health Economics and Total Quality Management.
Dr. Sarah El Masry
Head of Regulatory Affairs and Pharmacovigilance, Novo Nordisk
Dr. Sarah El Samad
Dr. Sarah El Samad has nearly 20 years of experience in dermatology and biologics across global and regional role with previous experiences at MSD, Abbvie and Sanofi.
Dr. Sarah now heads the medical strategy for Galderma across the META region bringing deep expertise in biologics and innovation, KOL engagement and evidence generation.
Dr. Sarah El Samad
Head of Medical Affairs META, Galderma
Dr. Mariem Emad Mesiha
Dr. Mariem is a Regulatory Affairs professional with over eight years of experience in the pharmaceutical and consumer healthcare industries across the Middle East, currently based in the United Arab Emirates. Her work focuses on regulatory strategy, product registrations, and health authority engagement across GCC and emerging markets.
Throughout her career, Dr. Mariem has managed regulatory submissions, supported product launches, and worked closely with cross-functional teams including R&D, quality, and commercial to ensure compliance and timely market access.
Prior to her current role, she gained valuable experience at Johnson & Johnson and Channel, devloping strong expertise in regulatory processes across both pharmaceutical and consumer healthcare sectors. Dr. Mariem is passionate about enabling access to safe, high-quality products while navigating complex regulatory environments across the region.
Dr. Mariem Emad Mesiha
Senior Regulatory Affairs & Scientific Office Manager, Deputy QPPV UAE, Procter & Gamble
Dr. Ahmed Salah
Dr. Ahmed Salah is the Regional Patient Safety Manager for Novartis Pharma, leading pharmacovigilance and patient safety operations across the Middle East and Africa. With extensive experience spanning multiple countries, he plays a key role in ensuring compliance, quality, and operational excellence in safety processes across the region.
He collaborates closely with global and regional stakeholders to drive strategic initiatives, optimize safety systems, and strengthen regulatory oversight for diverse across the Middle East and Africa.
With a strong background in pharmacovigilance systems, audit readiness, and risk management, Dr. Ahmed is recognized for his leadership in building robust safety frameworks and advancing a culture of patient safety. His career reflects a consistent focus on continuous improvement, governance, and delivering high-quality outcomes in complex, multi-country environments
Dr. Ahmed Salah
Regional Patient Safety Manager, MEA, Novartis Pharma
Dr. Dana Al Rashaideh
Dana is the Head of Regulatory Affairs for MENAP and KSA at Kenvue, bringing over 18 years of extensive regulatory affairs experience across Europe, the Middle East, Levant, GCC, Africa, Asia Pacific, and Latin America. Throughout her career, Dana has held pivotal roles, including serving as the Regulatory Affairs Director for Europe and International at Procter & Gamble (P&G) in Germany.
She has also held senior regulatory leadership positions at Merck Consumer Health, Boehringer Ingelheim, and Hikma Pharmaceuticals. These experiences have allowed her to deepen her expertise in various areas, including medicinal products, medical devices, food supplements, and consumer healthcare products. Dana holds a Bachelor’s Degree in Pharmaceutical Sciences from the Jordan University of Science and Technology in Jordan.
Dr. Dana Al Rashaideh
Head of Regulatory Affairs MENAP and KSA, Kenvue
Dr. Rasha El Masry
With over 20 years of experience in the pharmaceutical industry, I began my career in regulatory affairs in 2010. I have held leadership roles overseeing regulatory operations in the Gulf and Saudi Arabia, Currently, I serve as the Regulatory Affairs Head for the Gulf at Merck, where I play a strategic role in ensuring compliance and fast access of medication across the region. My expertise spans multiple functions, having started in commercial before transitioning
Dr. Rasha El Masry
Head Of Regulatory Affairs for Gulf - Merck
Mr. Ajay Punjabi
Ajay is the Deputy General Manager-Procurement heading Group Procurement at Aster DM Healthcare, one of the GCC’s largest integrated healthcare providers. With over 20 years of leadership experience across the pharmaceuticals, FMCG, and healthcare sectors, he has built a reputation for driving procurement transformation, operational excellence, and resilient supply chain strategies across complex, multi country environments having an experience in 11 countries.
A Chartered MCIPS professional, Ajay has overseen end to end procurement for hospitals, clinics, and pharmacies across the GCC, leading strategic sourcing, supplier governance, cost optimisation, and cross border supply chain operations. His expertise spans category strategy, risk management, digital procurement enablement, and sustainable sourcing frameworks.
Throughout his career, Ajay has partnered with global suppliers, regulators, and healthcare operators to strengthen procurement maturity, embed compliance, and deliver measurable value in high stakes, fast growing markets. Known for his structured thinking and collaborative leadership style, he plays a pivotal role in shaping procurement strategy that supports Aster’s clinical, operational, and expansion priorities.
Ajay frequently contributes to industry discussions on healthcare supply chain resilience, procurement digitisation, ESG integration, and talent development, bringing a practitioner’s perspective grounded in real world execution.
Mr. Ajay Punjabi
Deputy General Manager, Group Procurement, Aster DM Healthcare
Dr. Mona Al Moussli
Dr. Mona Al Moussli is the Co-Founder and Managing Director of PRA Consultancy, with over 20 years of expertise in pharmaceutical and medical device regulatory affairs. She has led key initiatives like the GCC Regulatory Affairs Summit and the AfriSummit and developed the GCC Regulatory Affairs Course. Dr. Al Moussli also serves on several advisory boards, contributing to healthcare advancement and regulatory excellence in the region.
Dr. Mona Al Moussli
Chairman of GCC Regulatory Affairs Summit
Dr. Hanan Sboul
Dr. Sboul is the Group Lead of Pharmaceutical Industry as part of the National Team responsible for developing Jordan’s Economic Modernization Vision 2023-2033, she is also a member of the Board of Jordan Food and Drug Administration JFDA, a member of Hashemite University Board of Trustees, the Vice Chair of the Steering Committee for the Jordan Pharmaceutical Center of Excellence, member of the Advisory Council of Pharmacy School at Jordan University of Science & Technology.
Dr. Sboul has also served as a Member of several Boards, including the Higher Education Council and The Higher Committee for Drugs & Pharmacy, the Scientific Research Support Fund, the Fund for Employment, Technical, Vocational Education & Training (E-TVET Fund), the University of Science & Technology Council, the Council of Pharmacy School at Jordan University.
At international level, Dr. Sboul was the Chair of the International Generic & Biosimilar Medicines Association IGBA in 2020. She was also a member of the USP Council of Convention, the Chair of the USP Convention Membership Committee & the Chair of USP MENA Regional Chapter. In her current and previous roles, Ms. Sboul is actively engaged in enhancing the regulatory landscape for pharmaceuticals to improve access to quality, safe & effective medicines and support local pharmaceutical industry.
Dr. Sboul received her MBA from Jordan University in 2000 and received her B.A in Pharmacy from Yarmouk University. She was the first Association Executive from Jordan to receive the Certified Association Executive Certificate from the American Society for Association Executives in 2005.
Dr. Hanan Sboul
Secretary General of The Jordanian Association of Pharmaceutical Manufacturers (JAPM)
Ms. Riya Cao
Riya Cao is an award-winning executive with 25 years of distinguished experience spanning technology, pharmaceuticals, healthcare, and government sectors. A recognized authority in traceability and supply chain management, she brings deep expertise in cost-effective compliance, operational automation, and big data analytics.
Riya is the visionary founder and CEO of LSPedia, an Inc. 5000 company and global leader in traceability solutions and Supply Chain Cloud technology. Under her leadership, LSPedia serves a diverse range of clients — including manufacturers, wholesale distributors, third-party logistics providers, health systems, and retail pharmacies — helping them navigate the complex regulatory landscape with confidence and efficiency.
Before founding LSPedia, Riya served as Head of Life Sciences at QAD and held senior leadership roles at Ferndale Labs, TRW, and United Technologies, building a career defined by innovation and cross-industry impact.
Riya is also one of the most influential voices in drug supply chain compliance. Her widely read blogs on DSCSA and pharmaceutical serialization have cultivated a following of more than 10,000 professionals who turn to her for regulatory clarity and actionable industry guidance.
A sought-after speaker, thought leader, and trusted advisor, Riya Cao continues to shape the future of supply chain traceability on a global scale.
Ms. Riya Cao
Chief Executive Officer, LSPediA
Mr. Varma Bhupathiraju
With over 23 years of experience in the biopharmaceutical industry, Varma Bhupathiraju is a recognized leader in global regulatory affairs, specializing in the development and approval of biologics. He has played a pivotal role in securing approvals for multiple biological products, including biosimilars and vaccines, across key global markets such as LATAM, MENA, CIS, AFRICA, and APAC. Notably, he pioneered the first-ever US FDA approval for a vaccine candidate from an Indian manufacturer.
Varma has successfully obtained regulatory approvals in over 100 countries and secured GMP accreditations from leading regulatory agencies, including ANVISA-Brazil, COFEPRIS-Mexico, ANMAT-Argentina, ISP-Chile, SAHPRA-South Africa, NPRA-Malaysia, DAV-Vietnam, EDA-Egypt, NAFDAC-Nigeria, TMDA-Tanzania, NDA-Uganda, MCAZ-Zimbabwe, WHO, ensuring alignment to facilitate market access. Additionally, he has been instrumental in streamlining regulatory approval processes in India.
Currently, Varma leads the regulatory team for Emerging Markets and India, driving the company’s mission to expand patient access to affordable biologics.
Mr. Varma Bhupathiraju
Associate Vice President - Global Regulatory Affairs, Biocon Limited
Dr. Abeer Khriesha
A pharmacist and data expert with an MSc in Clinical Pharmacy from the University of Jordan. She currently serves as the Regulatory & Clinical Data Content Lead at Pi Pharma, where she has spent the past four years guiding a high-performing team to deliver credible, evidence-based content across the healthcare and pharmaceutical space. With an earlier four-year tenure in academia across universities and colleges, Abeer brings a rare blend of scientific rigor and real-world industry insight. Her work centers on transforming complex clinical and regulatory information into actionable, data-driven insights that support smarter decisions, compliance, and improved healthcare outcomes. Passionate about quality, analytics, and clarity, she builds content frameworks that align regulatory standards with practical stakeholder needs bridging science, policy, and patient impact.
Dr. Abeer Khriesha
Content Team Leader, Pi Pharma Intelligence
Mr. Marwan Zeidan
Mr. Marwan Zeidan is leading EVOTEQ’s business development and client relationships, responsible to drive growth while maintaining client satisfaction.
He has over 25 years of rich experience that has encompassed various disciplines in business development, sales and delivery across complex IT/OT digital solutions, public sector offerings, and smart buildings/cities. Prior to joining EVOTEQ, he was leading TASMU, Qatar’s national smart city platform within the Ministry of Communications and Information Technology.
He held various roles in Schneider Electric, supporting customers in their digital transformation, leveraging the best in Operational Technology solutions with advanced Information Technology. He was also an Associate Partner with IBM leading Watson IoT Services for MEA, and a Senior Manager with Cisco Systems leading consulting and solution selling for Smart Cities in Europe and MEA. He also held positions with consulting companies that include Accenture and Deloitte & Touche.
Mr. Marwan graduated from the American University of Beirut with a degree in Computer and Communications Engineering.
Mr. Marwan Zeidan
VP of Business Development and Customer Servicing, EVOTEQ
Mr. Görkem Aydin
Mr. Görkem is the Chief Marketing Officer at VISIOTT, specializing in Track and Trace solutions and Vision Inspection systems. With a fervent enthusiasm for data analytics and international trade, he thrives in fostering global partnerships and driving tangible results. He brings a wealth of experience to his role and is committed to pushing the boundaries of innovation in his field.
Mr. Görkem Aydin
Chief Marketing Officer, VISIOTT
Mr. Zeeshan Ahmed
A true innovator in pharmaceutical serialization, Mr. Zeeshan launched CosmoTrace in 2018 and has since positioned the company as an industry frontrunner. Under his guidance, CosmoTrace addresses the critical need for comprehensive IT solutions by delivering tailored services and solutions that meet global serialization and traceability regulations.
Join us as Mr. Zeeshan explores the evolving landscape of pharmaceutical compliance and the transformative impact of advanced IT solutions in achieving traceability and operational excellence.
Mr. Zeeshan Ahmed
Founder & CEO, CosmoTrace
Mr. Marc Chaillou
Marc Chaillou is Head of Sales at Schlafender Hase. He has been working for the Pharmaceutical & Medical Devices industries for the last 13 years. Marc specialises in Regulatory Labelling and specifically how processes & technologies can reinforce, or compromise patient safety.
Mr. Marc Chaillou
Head of Sales Europe & Global Strategic Projects, Schlafender Hase
Mr. Martin Schmid
Mr. Martin Schmid is the Chief Operating Officer (COO) of cormeo and the CEO of EXTEDO GmbH. With more than 15 years of leadership experience in the life sciences industry, he has played a key role in shaping strategies, driving digital transformation, and encouraging organizational growth.
Before joining EXTEDO, Mr. Martin held several management and consulting positions in the technology and services sectors, where he focused on process optimization, operational excellence, and business transformation. His broad experience across industries allows him to combine strategic foresight with practical implementation skills.
Mr. Martin is passionate about building sustainable, efficient organizations that balance innovation, quality, and human collaboration. He regularly shares his insights on leadership, transformation, and the future of operations at industry events and conferences.
Mr. Martin Schmid
COO of cormeo and CEO of EXTEDO
Aditya Tallapragada
Aditya Tallapragada is the President of AKT Health, a global life sciences strategy and operations organization with a presence across India, Japan, the United States, and the UAE. With over a decade of leadership in the life sciences sector, Aditya has built AKT Health into a trusted partner for pharmaceutical, biotechnology, and medical device companies navigating complex multi-market regulatory and commercial environments.
Under his leadership, AKT Health has developed an integrated operational framework spanning Clinical & Regulatory Operations, Pharmacovigilance, Health Economics & Outcomes Research (HEOR), Market Access, and Medical Affairs with a particular focus on GCC market entry and compliance with regional authorities including SFDA and MOHAP. The organization’s proprietary digital platforms, Datakapt and Vigil, reflect Aditya’s commitment to embedding technology at the core of life sciences operations to drive faster, more evidence-based decision-making. Aditya’s strategic vision centers on translating global clinical and commercial intent into locally executable market strategies enabling clients to move from regulatory complexity to sustainable growth. His approach prioritizes capability transfer, ensuring that partner organizations build long-term internal competency rather than ongoing dependency. Recognized for his ability to bridge scientific rigor with commercial pragmatism, Aditya continues to shape AKT Health’s expansion as the GCC life sciences landscape evolves toward unified HTA frameworks and the 2030 cross-border dossier recognition goal.
Aditya Tallapragada
Founder & Chief Executive Officer, AKT Health
Mr Ahmed Ezz
Ahmed Ezz is Managing Director of Neuraxpharm Middle East, where he leads the company’s entry and affiliate build-out across the GCC and wider MENA region. He is responsible for establishing Neuraxpharm’s regional presence, from corporate setup and regulatory and market access strategy through partner engagement, portfolio registration, and the launch of the company’s CNS-focused portfolio in the Middle East.
Ahmed brings nearly two decades of pharmaceutical industry experience across MENA, with a track record of bringing innovative specialty therapies to GCC markets in collaboration with global partners including AbbVie, Kyowa Kirin, UCB, Chiesi Global Rare Diseases, Juvisé, Serb, Sunovion, Abiogen, Illumina, and Veracyte.
Prior to Neuraxpharm, he served as Senior Director and Group Therapy Area Director for GI, Metabolic, and Rare Diseases at NewBridge Pharmaceuticals, where he led a cross-functional team of across 10 markets and managed a portfolio of nine specialty brands, including multiple FDA- and EMA-approved products.
Earlier in his career, he led NewBridge’s regional CNS franchise, overseeing the launch of neurology and psychiatry portfolio across the region.
He holds an MBA with Distinction from the University of Leicester, a Diploma in Strategic Management and Leadership from the Chartered Institute of Management in London, and a Bachelor of Pharmaceutical Sciences with Honors from Ain Shams University, Cairo.
Mr Ahmed Ezz
Managing Director, Neuraxpharm Middle East
Dr. Samar Abdalhalim
Dr. Samar Abdalhalim graduated with a bachelor’s degree in Pharmaceutical Sciences in 2007.
With over 18 years of dedicated experience in the pharmaceutical and personal healthcare industry, Samar Abdalhalim has had the privilege of making significant contributions to the regulatory field. She has been at the forefront of shaping the regulatory landscape and ensuring compliance within the P&G Health organization.
Dr. Samar has held various positions at leading companies such as Johnson & Johnson and, Procter & Gamble , where she honed her expertise in regulatory & medical affairs , research & development , product research and strategic planning.
Dr. Samar Abdalhalim
Director of R&D ,Regulatory & Medical affairs for Middle East & Africa at Procter & Gamble Health
Dr. Reem Fada
Dr. Reem Fada is the Director of Regulatory Affairs for the Gulf and Near East at Haleon and the Scientific Office Manager for Haleon UK Export Limited. With more than two decades of experience in the pharmaceutical and consumer healthcare sectors, she leads regulatory strategy, compliance governance, and market access initiatives across the region.
A pharmacist by training, Dr. Fada is widely recognized for her deep regulatory expertise and strong influence within the regional regulatory community. She has successfully overseen high‑impact product registrations, regulatory negotiations, and lifecycle management activities, consistently enabling timely and compliant access to innovative consumer health and OTC products.
Renowned for her strategic leadership and strong connectivity with regulatory authorities and industry partners, Dr. Fada plays a key role in shaping regulatory dialogue, fostering collaboration, and supporting the evolution of science‑based regulatory practices across the Gulf and Near East.
Throughout her career, she has championed regulatory excellence, integrity, and innovation, ensuring alignment with public health priorities while enabling sustainable business growth. As a respected regional expert, Dr. Fada continues to represent Haleon in major healthcare and regulatory forums, contributing thought leadership to advance regulatory development in the region.
Dr. Reem Fada
Director Regulatory Affairs, Gulf & Near East, Haleon
Mr. Mina Samir Fakhoury
Mina Samir Fakhoury is a Pharma and Healthcare Strategy Consultant with over 20 years of experience in multinational pharmaceutical organizations across the UAE, GCC, and North Africa. He specializes in commercial strategy, tender management, market access, business development, and go-to-market execution, helping healthcare companies achieve sustainable growth and expand their regional presence. His expertise combines strategic insight, operational excellence, and deep knowledge of the healthcare landscape.
Mr. Mina Samir Fakhoury
Commercial Market Access Expert, Independent
Dr. Khaled Rozza
Dr. Khaled Rozza is the Regulatory Affairs Lead for Gulf in Arcera life sciences, based in Cairo, Egypt having more than 20 years’ experience in Regulatory Affairs in different regions including GCC, Middle East & Africa.
Having started his career in Quality Assurance & Validation in a local manufacturing site in Egypt, Dr. Khaled shifted to Regulatory Affairs & has since worked for multiple local & multinational companies including Novartis, Pfizer, NewBridge before joining Arcera in 2019.
Dr. Khaled Rozza
Regulatory Affairs Lead, Gulf, Arcera Life Sciences
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