Speakers

Dr. Ruqaya Al Bastaki is an accomplished pharmaceutical leader with over two decades of experience in the pharmaceutical and medical devices industries. With a deep understanding of the sector’s complexities, challenges, and dynamics, she has consistently demonstrated excellence in leadership, regulatory compliance, and operational enhancement. As a results-driven professional, Dr. Ruqaya Al Bastaki is highly regarded for her ability to foster innovation, lead cross-functional teams, and implement strategic initiatives that align with organizational goals.

Currently serving as a Regulating Medical Products at the Emirates Drug Establishment since October 2024, Dr. Ruqaya Al Bastaki brings with her a wealth of experience from her extensive career, including her tenure as Director of the Drug Department at the Ministry of Health and Prevention (MOHAP) from 2017 to 2024.

Career Milestones

Director of Drug Department, Ministry of Health and Prevention (2017–2024)
In her role as Director, Ruqaya oversaw numerous key functions, including the registration and pricing of medical products, ensuring regulatory compliance with international standards for conventional medicines, healthcare products, and medical devices. She was responsible for driving the department’s strategic direction and working alongside domestic and international stakeholders to shape regulatory frameworks for the pharmaceutical industry.

• Strategic Leadership: Developed and implemented strategic initiatives aligned with the MOHAP vision, while also leading and mentoring a team of over 100 employees in the Drug Department.
• Regulatory Compliance: Ensured the highest standards of quality and safety for medical products in the UAE, managing all aspects of medical product registration, pricing, and compliance.
• Cross-Functional Collaboration: Worked closely with global organizations such as the WHO, INCB, PICS, ICH, and the Arab League to advance the objectives of the Arab Drug Agency and improve drug registration processes.
• Clinical Research and Manufacturing Oversight: Administered and supervised all clinical research and local manufacturing facility activities, ensuring compliance with Good Manufacturing Practices (GMP).
• Pharmacovigilance and Narcotics Management: Led initiatives on pharmacovigilance as per WHO standards, and managed the import/export of narcotics and controlled substances in alignment with international requirements, including the International Narcotics Control Board (INCB).

Under her leadership, MOHAP’s Drug Department became renowned for having the fastest drug registration timelines in the UAE and the MENA region, according to IQVIA studies.

Key Achievements and Contributions

Throughout her career, Ruqaya has been at the forefront of pharmaceutical policy development, contributing significantly to the enhancement of intellectual property practices in pharmaceutical licensing. She has also been a main contributor in composing pharmaceutical laws and regulations that govern the industry in the UAE, ensuring that the country stays in alignment with global standards and regulatory requirements.

Her efforts in improving local medical manufacturers’ GMP have resulted in higher quality standards across UAE pharmaceutical production, further ensuring that the country meets international pharmaceutical manufacturing and quality benchmarks.

Ruqaya’s expertise extends beyond her professional roles. She has served as a Member of the Pharmacy Advisory Board at Sharjah University, and she is a member of several committees dedicated to ensuring compliance with MOHAP’s pharmaceutical standards.

Legacy and Future Goals

Ruqaya Aqeel Mohamed is widely recognized for her ability to drive change, enhance operational efficiencies, and ensure the highest standards of regulatory compliance across the pharmaceutical sector. Her legacy includes helping transform the UAE’s pharmaceutical and medical devices landscape, making it more efficient, transparent, and aligned with global best practices.

This biography highlights Ruqaya Aqeel Mohamed’s significant contributions to the pharmaceutical industry, her leadership roles, and the impact she’s made on the development and regulation of medicines and medical devices in the UAE.

Dr. Hanady Yousef Shourrab is a strategic and results-driven Senior Pharmacist with over a decade of experience at the UAE Ministry of Health & Prevention. She has 13 years of experience in retail pharmacy and is known for pioneering digital transformation initiatives in pharmaceutical regulation.

Holding a Master’s in Pharmaceutical Technology and pursuing a Ph.D. in Pharmaceutical Sciences, Dr. Hanady excels in optimizing compliance processes, fostering inter-departmental collaboration, and leveraging expertise in Import & Export, Registration, and Pharmacovigilance. She has a proven track record in representing the department at international conferences and driving performance enhancements.

Dr. Nisreen Mohammad Nassr is a distinguished pharmaceutical executive with over 22 years of expertise in regulatory affairs and strategic leadership. Dr. Nassr holds an MSc in Pharmaceutical Science with distinction from the University of East London, UK, and certified lean six sigma black belt. As the Director of Drug Control at the Ministry of Health in Oman, Dr. Nisreen has demonstrated strong commitment to regulatory compliance and alignment with international standards. She has been instrumental in formulating strategies that optimize market responsiveness and improve medication availability. Her leadership includes oversight of cross-functional teams, risk management, and stakeholder engagement with global regulatory authorities

Ph. Muna Al Saidi stands as a dedicated professional at the forefront of healthcare administration, currently holding the esteemed position of Section Head in the Registration Section of Human Medicine at the Ministry of Health, Oman. With a passion for ensuring the seamless operation of medical registration processes, Muna Al Saidi has become a respected figure in the healthcare sector of Oman.

Known for her strategic vision and meticulous attention to detail, Muna Al Saidi has played a pivotal role in streamlining registration procedures within the Ministry of Health. Her commitment to excellence has not only earned her the trust of her colleagues but has also contributed significantly to the overall efficiency of the healthcare system in Oman.
As a seasoned leader, Muna Al Saidi brings a wealth of experience to her role, coupled with a deep understanding of the complexities involved in managing the registration of human medicine. Her dedication to advancing healthcare services reflects a commitment to enhancing the well-being of the Omani population.

• Msc – Supply Chain & Logistic Management (Glasgow, Strathclyde University, UK)
• Master of Pharmacy (M-Pharm) (Liverpool John Moores University, UK)
• Diploma – Pharmacy (Institute of Pharmacy, Oman)
• Positions
• Regulatory Staff – Drug Control Department – Variation Section (November 2022 onwards)
• Director of Medical Store (Laboratory Materials & Supplies)- Directorate General of Medical Supply )2021-2022 )
• Head of Department of Receiving Section – Directorate General of Medical Supply )2019-2021)
• Pharmacist in Quality Department – Directorate General of Medical Supply )2018-2019)
• Head Of Department of Injection Section – Directorate General of Medical Supply )2017- 2018)
• Acting Head of Injection Section – Directorate General of Medical Supply )2016- 2017)
• Acting Head of Syrup Section – Directorate General of Medical Supply )2015-2016)
• Pharmacist in Directorate General of Medical Supply (2011- 2015)
• Pharmacy In charge – Wilayat Bousher  (2008-2011)
• Pharmacist in Al khuwair Health Center  (2003 – 2008)
• Publications
• Lean Practitioners project (Accuracy in Quantifying the annual requirement of lab disposable items ( February 2022 till June 2022)
• Literature review on statins & rhabdomyolysis published in LENS magazine March 2011 Oman
• Acne (Is isoisotretinion the solution?) – The Reflection (Wilayat Muscat Health services Newsletter) on January 2006

She is a seasoned expert in Pharma Policy, Public Affairs, and Regulatory Affairs, with over 30 years of diverse industry experience. Nadia holds a Bachelor’s degree in Pharmacy from Jordan University, a Master’s degree in Healthcare Management from Zayed University, and a Master’s in Public Health (MPH) with a focus on Leadership & Policy from Johns Hopkins University, USA, she also completed two years of advanced DrPH studies in same University.

Nadia’s illustrious career that encompasses roles in both multinational corporations, such as Pfizer and AstraZeneca, and government regulatory authorities. She notably served as the Head of the Registration & Pricing Department at the UAE Ministry of Health, where she played a crucial role in shaping the GCC-UAE regulatory frameworks. Her international engagements include representing the UAE at esteemed platforms like the WHO and the Gulf Health Council.

As the Managing Director of Stellar Pharma Consultancy, Nadia has been a trusted advisor, leading complex regulatory and policy advocacy projects for top multinational pharmaceutical companies.

Currently, she serves as a consultant for Drugs Regulations & Medical Products at the Department of Health-Abu Dhabi, Life Sciences Sector.

Nadia is passionate about advocating for Regulatory System Strengthening (RSS) among regulatory authorities. She actively promotes Regulatory Active Collaborative models to achieve higher Regulatory Maturity Levels. Her work has been presented at workshops and through policy position papers to Medicinal National Regulatory Authorities in Algeria, Pakistan, the Philippines, Kenya, and Turkey.

Dr. Anees Puthan Veettil is a strategic leader with over 20 years of experience in Drug Development, specializing in pharmaceutical studies and clinical trials. He holds a Pharmacy Post-Graduation in Pharmacology from Dr. MGR Medical University, India, and a specialization in Clinical Research & Regulatory Affairs from York College, Canada.

Dr. Veettil currently leads the Evaluation Unit of Pharmaceutical Studies at the Ministry of Health and Prevention in the UAE. He has expertise in Pharmaceutical Studies Evaluation, Clinical Operations, Regulatory Affairs, Quality Assurance, R&D, GMP Audits, and Project Management, with experience working with global pharmaceutical companies like GlaxoSmithKline.

In addition, he is a visiting faculty member at various research and pharmacy institutes and has trained doctors and ethics committees on clinical research.

Education and experience:

– pharmacist, graduated from Hawler medical university (HMU)

College of pharmacy (2014,2015)

-over 8 years experience in regulatory affairs and registration regulations for pharmaceutical sites and products, ensuring:

1.the compliance with national and international regulations, fostering adherence to healthcare standards.

2.Provided expert guidance to pharmaceutical companies, enhancing their understanding of compliance requirements.

Dr. Ahmed Mohamed Al-Ansari is the CEO of the National Health Regulatory Authority (NHRA) in Bahrain. He has extensive experience in the healthcare sector, contributing to the development and improvement of medical services in the kingdom. He expanded emergency departments, increased operating room capacity, and improved infection control, reducing wait times in hospitals. He also played a key role in developing medical curricula and enhancing medical education in Bahrain, aligning the healthcare system with global standards.

She has graduated from the University of Jordan faculty of pharmacy in 2017, following that in 2018 she joined NHRA as a team leader of the Medicine variation as a primary responsibility.

Through her journey at NHRA, she gained extensive experience and knowledge in e CTD submission, evaluation of the medicine new registration files and safety notification.

Additionally, she is responsible for identifying any safety concerns related to medicine and ensuring that those concerns are addressed to the health care professionals where appropriate.

Hanan Salim is a Senior Specialist Pharmacist with over 15 years of experience in hospital pharmacy, currently serving at Sultan Qaboos University Hospital in Oman. In her role, Hanan excels in supervising clinical pharmacists and providing expert guidance on medication selection and management. She is passionate about training pharmacy and medical students in clinical practices, as well as in medication prescribing and management.

Hanan holds a Master of Science in Clinical Pharmacology from the University of Aberdeen, where her studies included clinical research, drug discovery, and pharmacovigilance. With a strong background in both clinical and research settings, she is dedicated to advancing pharmaceutical care, supporting clinical trials, and ensuring compliance with industry standards. Her extensive experience and leadership significantly enhance patient care and medication safety within her institution.

Dr. Manal Khader holds a master’s degree in clinical pharmacy from Jordan, a Diploma in Pharmaceutical Operations from the UK, and a Diploma in Regulatory Affairs for Drugs and Medical Devices (Jordan, USA, Europe). With over 20 years of experience in the pharmaceutical field, Dr. Khader began her career as a clinical pharmacist in the private sector before joining the Jordan Food and Drug Administration (JFDA) in 2013.

At JFDA, she worked for several years as a pharmacist in the Narcotics, Psychotropic Substances, and Chemical Precursors Department. In 2020, she transitioned to a new career path as a Regulatory Affairs Specialist in the Chemical Registration Department. In this role, she is responsible for receiving, reviewing, and assessing e-CTD drug files for drugs, evaluating post-approval changes of registered drugs, and handling renewals of registered drugs.

Dr. Khader has chaired and been a member of many technical committees at JFDA, including the committee for assessing and re-evaluating chemical drug files submitted for registration, the post-approval changes committee for registered drugs, and the clinical trials committee

A passionate pharmaceutical  regulatory specialist with over 15 years of experience dedicated to advancing healthcare and ensuring the safety of medicines. With a Master’s degree in Pharmaceutical Sciences and a strong academic background, I’ve spent my career at the intersection of research and development, regulation, and innovation. Currently, I work with the Jordan Food and Drug Administration, where I play a key role in evaluating and approving drugs, ensuring they meet the highest standards of quality and safety.

My journey has taken me from formulating pharmaceutical products to teaching the next generation of pharmacists, and now to shaping regulatory policies that impact millions. I’ve also ventured into entrepreneurship, and innovative health solutions that won national recognition.

Beyond my professional life, I find joy in art, drawing, and painting, which keeps me inspired and balanced.

I believe in the power of continuous learning, innovation, and collaboration to drive change. My mission is to contribute to a healthier world, one where science and regulation work hand in hand to improve lives.

Dr. Wael El Sisi Manager of Pharmaceutical Information Systems Department with 20 years experience in pharmaceutical field including 10 years inspection & quality also development Projects and starting from 2014 in digital transformation plan in Egyptian drug authority starting from company profile and drug databases and different automated systems such as Me devices – Egycosm – Evers…etc

Dr. Wael hold master degree of business administration from Arab Academy for Science, Technology & Maritime Transport and Oracle certified professional from Oracle USA.

Iam advocate  for  collaborating in digital transformation activities and AI implementation in Health Sector especially pharmaceutical.

Dr. Reem Eltanahy is the Manager of Biologics Variation Unit at the Egyptian Drug Authority (EDA). With over 13 years of experience in the pharmaceutical and biologics industry, she has held various positions within the regulatory sector.

Dr. Eltanahy earned her Bachelor of Science in Pharmaceutical Sciences from Cairo University and a Master of Business Administration from the Arab Academy for Science, Technology, and Maritime Transport.

At the EDA, she leads her team in regulating post-approval changes to registered biological products. Notably, she played a key role in establishing “the guidelines for regulating post-approval changes to a registered bio-therapeutic product in Egypt.”

Furthermore, Dr. Eltanahy was part of the team that successfully achieved WHO GBT ML3 for vaccines at the EDA.

Dr. Mona Al Moussli is a trailblazer in the field of pharmaceutical and medical device regulatory affairs in the Middle East. With over twenty years of experience, she has firmly established herself as a seasoned professional renowned for her unparalleled expertise in navigating the intricacies of healthcare regulations.

Throughout her career, Dr. Al Moussli has demonstrated an unwavering dedication to upholding the highest standards of ethics and compliance within the industry. In 2013, she co-founded PRA Consultancy, a firm that has since become synonymous with regulatory excellence in the region.

Her impact transcends traditional boardroom boundaries as she actively works to shape the future of healthcare regulation through education and advocacy. Notably, Dr. Al Moussli played a pivotal role in the inception of the GCC Regulatory Affairs (RA) Course, a pioneering certification program designed to nurture the next generation of industry experts.
Fueled by her passion for advancing health and safety standards, Dr. Al Moussli has spearheaded numerous initiatives, including the renowned GCC Regulatory Affairs Pharma Summit and other significant gatherings focused on pharmaceutical-related regulations in the region.

Dr. Al Moussli’s commitment to advancing regulatory standards transcends borders, as evidenced by her initiation of the AFRI Summit. This crucial platform facilitates discussions on pharmaceutical and medical device regulations in Africa, fostering knowledge sharing and collaboration among stakeholders to improve healthcare outcomes across the continent.
Beyond her professional achievements, Dr. Al Moussli remains actively involved in community engagement, serving as an advisory board member at Dubai Pharmacy College and lending her expertise to the Women’s Business Council at the Dubai Chamber of Commerce. In recognition of her outstanding contributions, Dr. Mona Al Moussli was elected as a board member of the Emirates Medical Association – Pharmacy chapter for consecutive terms in 2021 and 2022.

With a PhD in Pharmacy, an Executive MBA from Paris Dauphine, and an International Certificate in Corporate Finance from HEC Paris, Dr. Sarraj brings a unique blend of expertise in regulatory affairs, development, and strategic management.
Currently serving as the Director of Regulatory Affairs, and Pharmacovigilance at SAIPH Group in the Middle East and Africa, he has a proven track record of driving successful projects, partnerships, and regulatory strategies across diverse markets.

Dr. Fatima Zaid Abu Zanat is an accomplished Regulatory Affairs/Quality Assurance (RA/QA) professional with a total of 17 years of experience spanning the medical device, pharmaceutical, and biotech industries across emerging markets. She holds a Master of Science in Pharmaceutical Technology and the prestigious RAPS Dual Regulatory Affairs Diploma and Certificate. Dr. Abu Zanat possesses a strong scientific background in product research and development and is keen on strategic best practices implementation. A distinguished speaker and panel moderator at key regulatory conferences, Dr. Abu Zanat actively contributes to industry-wide, regulatory discussions. Her dedication and contributions have not gone unnoticed, where she was honored by the GCC Regulatory Affairs Award in 2023 for her outstanding achievements and impact in the region as the “Woman of the Middle East”. She is actively engaged in regulatory and industry associations. She is also recognized for her leadership in establishing and managing UAE Scientific Offices, fostering growth, and building strong relationships with regional health authorities. Beyond her professional endeavors, Dr. Abu Zanat has made significant contributions to international publications, highlighting her thought leadership and expertise. Her accolades, including nominations such as the Women of Ipsen Nomination and the DUPHAT 2012 3rd Best Professional Poster Award, underscore her commitment to innovation and excellence.

Meet Gorkem, 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.

Shatha Safi, RA Planning and Labelling Manager who joined the Regulatory Affairs Department at Hikma Pharmaceuticals in 2015. In her current role, she is responsible for the Regulatory Planning and Labelling, where she manages the coordination, organization and implementation of Regulatory Planning and Labelling activities for Hikma’s products throughout their lifecycle in diverse geographies in the Levant and GCC regions. She also has hands-on experience and a proven track record in Project Management and Business Process Automation.

Dr. Safa’ has more than 30 years of experience in research and development, quality and regulatory affairs within the pharmaceutical industry and held several leadership positions in Jordan and Tunisia. She has wide experience in developing and registering new generic products targeting global markets in the USA, Europe and MENA.

Dr. Safa’ is currently heading the Regulatory Affairs activities in the MENA region in Hikma Pharmaceuticals. She is responsible for the development of the regulatory strategies and setting the required implementation plans across more than 16 countries in the region. She works closely with health authorities to help in shaping the regulatory environment in the region.

Dr. Safa’ has:

BSc in Pharmacy from University of Jordan

MSc in Drug Analysis from Monastir University, Tunisia

PhD in Pharmaceutical Sciences from University of Lille, France

Dr. Safa’ is an active member of the Jordanian Association for Pharmacists JAP – Registration Committee. She delivers lectures in different Jordanian universities on regulatory affairs and other pharmaceutical industry topics. In 2019, she received an appreciation and recognition award from the association for her significant contribution to the development of the pharmaceutical industry in Jordan.

She is also an active member in the scientific committee of the AUPAM (Arab Union for Pharmaceutical Manufactures) and the scientific committee of the Charity Medicine Bank in Jordan.

A results’ driven professional with an interest in entrepreneurship and innovative technology, industrial engineer with a recent graduate degree in International Production Management from Hamburg University of Technology, having strong academic records and a profound operations and corporate management experience across healthcare and pharmaceuticals industries, mainly in emerging markets. Leading an interdisciplinary projects portfolio covering; organizational and business development, new product development, and technology transfer. Certified PMP®, professional in business analysis (PMI-PBA®), and associate consultant in SAP ERP applications.

Dr. Fokion Sinis is a Greek-Canadian Pharmacist and Health Economist with extensive experience in the pharmaceutical industry, spanning government, NGOs, and industry roles across seven countries.

He is currently the Head of International Business at SPIMACO. Previously, he was the General Manager for Sanofi Vaccines in the Greater Gulf region, where he oversaw a €100M business with leadership in paediatric, meningitis, and influenza vaccines.

Prior to that, he served as Commercial Head for Sanofi in the Greater Gulf, managing portfolios across Specialty Care, General Medicines, Vaccines, and Consumer Healthcare. His career began in Brussels as a lobbyist for the Pharmaceutical Group of the EU, followed by a role at the European Medicines Agency in London. He later worked in Pricing and Market Access at Novartis Oncology (Basel) and Novo Nordisk (Denmark), where he held various leadership positions in Global Pricing, Market Access, Business Development, and Marketing across Africa and Europe.

Dr. Fokion is passionate about public health and is dedicated to improving access to medicines and vaccines.

Dr. Mohamed Larbi Jelassi holds a PharmD with a specialty in Industrial Pharmacy from Monastir University and Paris Descartes University, as well as a master’s degree in Management in Health Care from Paris Sud University. With 17 years of experience in the pharmaceutical industry, he has developed expertise in Market Access, Regulatory Affairs, Corporate Affairs, and Marketing across the Middle East and Africa.

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.

Work Experience:
Haleon
– Head of R&D MEA (July 2022 to Present)
– GlaxoSmithKline Consumer Healthcare

Present
– R&D Senior Director, MEA (2021- July 2022)
– Regulatory Affairs Director -MEA (2014-2021)
– Regulatory Affairs & Quality Director Middle East (2011-2014)
– Regulatory Affairs Director MEPITEL (2003-2008)

Eli Lilly
– Sales, Regulatory and Marketing roles Saudi & Gulf (1994 – 2003)

Education:
– MBA Management (1998-1999) – University of Bradford – United Kingdom
– Bs Ph, Pharmacy (1988-1993) – Cairo University – Egypt

Arda Arat is currently serving as the General Manager for Haleon Gulf & Near East (GNE). He is a strategic leader with over two decades of finance experience. Having previously served as a Business Unit Finance Head for Middle East Africa (MEA) at Haleon, Arda has successfully led and supported multiple initiatives to drive growth, profitability, and innovation across the MEA region, such as launching new products, expanding into new markets, optimizing pricing strategies, executing mergers and acquisitions, and implementing process improvements. Through his role at Haleon, Arda’s mission is improve the health and well-being of millions of people in MEA and beyond.

Dr. Reem Fada, Director Regulatory Affairs and the scientific office manager at Haleon with over 20 years of experience in the pharmaceutical industry.

Holding a bachelor’s degree in pharmacy, she has a deep understanding of regulatory landscapes and has successfully led numerous high-profile product registrations across the Gulf region.

Throughout her distinguished career, Reem has been instrumental in driving compliance strategies that have facilitated the swift introduction of innovative OTC products to market. Her expertise in navigating complex regulatory environments has earned her recognition as a leader in the field, where she is known for her collaborative approach to building strong relationships with regulatory authorities and key industry stakeholders.

Her participation as a panellist at the upcoming summit underscores her commitment to advancing the industry and addressing the evolving challenges in OTC regulations.

Since 2017 Michael supports the EXTEDO team as Business Consultant, focusing on drug regulation and registration. He is active in EXTEDO’s Regulatory Competence Center, where he monitors regulatory standards worldwide. His focus regions are Europe, EAEU, Asia, and the Middle East including GCC countries.

Michael is a professional regulatory and software trainer for EXTEDO’s customers globally. He manages customer projects, provides advanced regulatory customer support, and publishing services. He has more than six years of experience with regulatory and technical, tool-specific consulting on EXTEDO’s product portfolio in projects with industry and agency customers worldwide.

With over 20 years of distinguished experience in the pharmaceutical industry, Dr Shaimaa has built a robust career specializing in regulatory affairs, pharmacovigilance and quality assurance. She has successfully navigated the complexities of pharmaceutical operations, contributing to the success of both national and international companies.

With her extensive experience across multiple regions and companies has equipped her with a unique perspective and adaptability, making her a trusted leader in pharmaceutical affairs. With a focus on innovation, compliance, and patient safety, Dr. Shaimaa continues to drive excellence in the ever-evolving pharmaceutical landscape.

Dalia Fouad, the head of regulatory and policy at Sanofi, is a seasoned professional with a strong background in pharmaceutical regulation and policy development. With extensive experience in the healthcare industry, Dalia has demonstrated exceptional leadership skills and a deep understanding of regulatory frameworks. She is known for her strategic thinking and commitment to excellence, driving impactful regulatory initiatives at Sanofi. Dalia’s visionary approach and effective communication skills have played a key role in shaping regulatory policies and advocating for patient-centric healthcare solutions.

With a passion for innovation and ethical standards, Dalia continues to lead Sanofi towards regulatory excellence and positive health outcomes for patients worldwide. As the head of regulatory and policy for Sanofi for more than 15 years, she brings a wealth of experience and expertise to this role. With a background in Pharmacy, she has demonstrated strong leadership skills and a deep understanding of regulatory policies. She has achieved several accomplishments in innovative access to medications as well as policy shaping in the region through driving regulatory compliance, shaping impactful policies, fostering collaboration.

Anna Mansurova is a Managing Director at Hellmann Calipar Healthcare Logistics, a specialized logistics and supply chain solution provider for the Healthcare industry.  Based in Dubai, Mrs. Mansurova heads company strategy, solution development and healthcare operations in the United Arab Emirates.

With 17+ years of experience, her healthcare journey started in operations in 2010 when Hellmann established its first regional Healthcare Distribution centre in Dubai.  Today, Hellmann Calipar Healthcare is a market leader in the regional Healthcare logistics with highly qualified and knowledgeable team and is a trusted partner in the healthcare community, offering tailored solutions that leverage compliant systems, advanced infrastructure, and digital innovation.

Anna’s and her team’s commitment to excellence is evident in their ability to manage complex projects and drive innovation, implementing advanced healthcare solutions at high standards of quality for the benefit of the patients in the region.

Hellmann Calipar Healthcare Logistics continues to expand its footprint in the UAE, with the latest addition of the 4^th  state-of-the-art distribution center in Dubai South in November 2023.

Hellmann Worldwide Logistics, a 152-year-old family-owned global logistics provider, established its Healthcare vertical in 2010 in the Middle East. Today, the company operates state-of-the-art healthcare warehouses in the UAE and Saudi Arabia, along with comprehensive freight solutions, ensuring seamless supply chain management.

Mr. Mete Karaca serves as an Executive Board Member at Tiga Healthcare Technologies, where he spearheads Business Development initiatives, driving the company’s growth and strategic partnerships in the healthcare IT landscape. With a robust technical foundation stemming from a bachelor’s degree in Electrical and Electronics Engineering, Mr. Karaca combines analytical precision with innovative problem-solving skills, enabling him to address complex challenges in the ever-evolving healthcare technology sector.

To complement his technical expertise, Mr. Karaca pursued a master’s degree in Engineering Management, where he cultivated advanced project management capabilities and honed his leadership acumen. This multidisciplinary background has positioned him as a dynamic leader who seamlessly integrates technical knowledge with strategic vision, delivering transformative results across a wide range of projects.

Over nearly two decades, Mr. Karaca has led and delivered numerous health IT projects across the globe, with notable experience, especially in national-scale healthcare information systems. His expertise spans key domains such as Healthcare Interoperability, Health Information Exchange, Personal Health Record (PHR), Central e-Prescription, Pharmaceutical Track and Trace System and Hospital Information System (HIS), solidifying his reputation as a trusted leader in transforming healthcare infrastructure on a national level. His work in the GCC region has been particularly impactful, showcasing his ability to manage multi-stakeholder collaborations with public healthcare authorities, regulators and leading organizations. This extensive experience underscores his versatility and expertise in complex, high-impact projects with precision and efficiency.

Mr. Karaca’s profound understanding of the intersection between healthcare and technology has enabled him to advance innovation within the industry. His leadership continues to shape projects that merge cutting-edge technologies with patient-centric solutions, setting new benchmarks for efficiency and effectiveness in healthcare delivery. As a forward-thinking leader, Mr. Karaca remains dedicated to driving progress and fostering meaningful change in healthcare IT worldwide.

He holds a bachelor’s degree in Pharmaceutical Science from Alexandria University Egypt in 2002, as well as a US equivalency from the National Association of Boards of Pharmacy in 2008 same. He has more than 20 years of experience in multinational companies such as MSD, GSK, Novartis, and Lilly, working across different regions such as Egypt, Gulf and US.

He has a strong passion for regulatory affairs, where he spent 15 years of his career. He also led the Regulatory Affairs Working Group Gulf for four years and was involved in the organizing committee, as well as a speaker and moderator, in several DIA meetings. He is a proud father of three children, the eldest of whom is studying pharmacy in the US.

With a PhD in Biosciences, Alessandro has extensive experience in defining and driving regulatory policy strategies to support the development of novel vaccines and medical technologies. Previously, Alessandro worked at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) in Geneva, supporting on global vaccine regulatory policy. Alessandro started his career at GSK, working in various regulatory affairs functions.

Dr. Inas is a holder of Pharmacy diploma, and Master in EU and International Regulations and Healthcare Laws from Paris V University.]

Dr; Inas has 20+ years expertise in the European and Emergent markets regulations; she worked for various MNCs, and currently she is heading the Executive Director- Head of Regulatory and Policy – MEA Region at Novartis.

Her focus and interest are the Healthcare reforms and legislations, policy shaping with main objective to accelerate patient access to innovative medicines.

Dr. Inas chaired EFPIA and PhRMA association groups for 6 consecutive years, and actively participating as speaker in regional and international conferences.

Mr. Brian Savoie is a seasoned association education executive who currently serves as RAPS’s senior vice president, education and international programs. In this role, Brian is responsible for RAPS’s conferences, in-person and online workshops, and credentialing programs. Brian’s passion is to create transformative education experience throughout an individual’s lifetime. He is an award-winning educational producer across a variety of media. Brian has served on numerous board and leadership roles across professional associations. Brian is the current vice president of the Association of Graduate Regulatory Educators and is a past board member of the Producers Guild of America – National Capital Region.

Jacqueline Acquah is a registered pharmacist in Ghana and holds an MPH from the University of Ghana and a certificate in Clinical Vaccine Development and Biomanufacturing from the University of Oxford.

Jacqueline has over 16 years of experience in healthcare, with a significant number of those years being in regulatory affairs.

She currently works as CEPI as Snr. Regulatory Affairs Lead responsible for Middle East & Africa, where she leads regional harmonisation and strengthening efforts to prepare NRAs for pandemic readiness.

She previously worked for Johnson & Johnson as an Associate Director responsible for vaccines regulatory affairs in emerging markets in Eastern Europe, Middle East, and Africa (EMEA). There, she was instrumental in developing strategies in obtaining Emergency Use and Marketing authorizations to potentiate access to J&J vaccines in over 50 LMICs, particularly COVID-19 vaccines, during the COVID-19 pandemic. She was also instrumental in working with the WHO/AVAREF, Africa Vaccines Regulatory Forum during the COVID-19 pandemic, to shape the regulatory ecosystem for emergency use authorizations.

Jacqueline also served as Co-Chair for the Africa Regulatory Network (ARN) of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) and was a member of IFPMA’s Regulatory Science Committee (RSC), the highest regulatory decision-making body of the IFPMA. Together with other industry colleagues, she led the association to work in collaboration with regulatory authorities and the pharmaceutical industry in Africa to encourage greater harmonization of regulatory requirements on the African continent and strengthening of the regulatory ecosystem.

Through the IFPMA, she has supported the work of the AMRH since 2018, sitting on various TCs and contributing to regulatory harmonization on the continent.

Prior to joining J&J, Jacqueline worked with Pfizer, leading corporate regulatory strategy in West and Central Africa.

Jacqueline has also previously worked the 37 Military Hospital and the Pharmaceutical Society of Ghana. Jacqueline has contributed to several regulatory publications on Africa and spoken at various international regulatory affairs fora.

Dr. Mohammad Yousuf obtained a Bachelor’s Degree in Pharmacy from Ajman University, followed by a Master’s Degree in Clinical Pharmacy from Queen’s University Belfast.

He joined Mafraq Hospital in 2009 and later moved to Sheikh Shakhbout Medical City in 2019.

Dr. Yousuf has worked in various areas, including Inpatient and Outpatient Pharmacy, Oncology Pharmacy, the Drug Information Centre, quality and medication safety, and the Clinical Pharmacy Department. Additionally, he has been involved in the Pharmacy and Therapeutics Committee, OFF-label medication, and has led the pharmacy education programme.

Dr. Abla graduated from pharmacy school and began her career as a teaching assistant in the Faculty of Pharmacy. Subsequently, she transitioned to regulatory affairs, where she has accumulated over 20 years of experience. She is currently the Associate Director of Regulatory Affairs – MENA at Hikma Pharmaceuticals.

Madelein Terblanche is a seasoned regulatory affairs and digital transformation expert specializing in eCTD and eSubmission implementation. With extensive experience in training, consulting, and regulatory harmonization, Madelein has played a pivotal role in supporting agencies like SAHPRA and ANMPS in adopting streamlined electronic submission processes.

As a key contributor to eCTD specification authoring, Madelein has developed industry guidelines and validation criteria, ensuring compliance with global best practices. Her expertise extends to document and submission management configuration, optimizing workflows for regulatory agencies and the pharmaceutical industry.

In addition to regulatory consultancy, Madelein is a skilled project manager, successfully leading major initiatives such as national regulatory authority implementations, docuBridge system rollouts, and industry workshops. Her commitment to knowledge-sharing is evident in her role as a speaker and moderator at international conferences, including LORENZ Converge, AfriSummit, and SAAPI.

Passionate about regulatory harmonization in Africa, Madelein actively contributes to the advancement of eCTD adoption across the continent. Her ability to bridge technical expertise with strategic policy development makes her a leading voice in the field of digital regulatory transformation

Dr. Hanan J. Sboul, M.B.A., B. Pharm. Secretary General of the Jordanian Association of Pharmaceutical Manufacturers JAPM, a member of Hashemite University Board of Trustees, Group Lead of Pharmaceutical Industry as part of the National Team responsible for developing Jordan’s Economic Modernization Vision 2023-2033, the Vice Chair of the Steering Committee for the Jordan Pharmaceutical Center of Excellence, a member of the USP Council of Convention for 2020-2025 Cycle, the Chair of the USP Convention Membership Committee & the Chair of USP MENA Regional Chapter.

Dr. Sboul has also served as a Member of the Higher Education Council 2018-2021 & a Member of the Board of Jordan Food and Drug Administration JFDA 2018-2023, and a Member of Higher Committee for Drugs & Pharmacy 2010-2018.

She was also a member of The Fund for Employment, Technical, Vocational Education & Training (E-TVET Fund), a member of the Scientific Research Support Fund, Jordan University of Science & Technology Council, Council of Pharmacy School at Jordan University and Council of Pharmacy School at Jordan University of Science & Technology, and internationally she was the Chair of the International Generic & Biosimilar Medicines Association IGBA in 2020.

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. Before joining JAPM, she worked at JFDA as a Registration & Pricing Officer for more than ten years. She has also worked for Abt. Associates as a Deputy Chief of Party, Senior Pharmacist at Commercial Market Strategies, a USAID funded project for family planning and reproductive health in Jordan.

Dr. Sboul received her MBA from Jordan University in 2000 and received her B.A in Pharmacy from Yarmouk University in 1986. She was the first Association Executive from Jordan to receive the Certified Association Executive Certificate from the American Society for Association Executives in 2005.

She is a seasoned regulatory professional with 20 years of experience guiding pharmaceutical and medical device companies through the complex regulatory landscapes of the MENA and Europe regions. As a Regulatory Intelligence and Market Access Consultant, Rima possesses a deep understanding of regional regulatory requirements, helping numerous companies successfully navigate registration and access processes.

With extensive experience in regulatory, quality, and supply chain management within the medical field, Rima holds two master’s degrees in Public Health and Business Administration, complemented by various national and international certifications. This expertise enables her to contribute meaningfully to regulations revision and setting with authorities for pharmaceutical and medical guidance.

A sought-after expert in regulatory affairs, Rima frequently speaks at industry conferences and contributes to publications on regulatory topics. Leveraging her strong background in regulatory intelligence, market access, medical supply chain, and procurement, Rima brings unique insights to the GCC Regulatory Summit. She shares best practices, helping attendees stay ahead of the curve in medical tendering and AI analytics.

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

He is the Chief Executive officer of EVOTEQ, a UAE-based digital traceability platforms provider. Jihad is a leader in digital transformation, technology and telecom industry in the region, bringing in his wealth of experience and expertise to spearhead the development of advanced technology solutions that increase efficiency, support business growth, and fuel digital innovation. Under his leadership, EVOTEQ has successfully achieved numerous milestones, undertaking several large-scale landmark projects including the most recent track and trace projects in the UAE.

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.

He is a experienced regulatory leader at Sanofi with extensive experience across the GCC and international markets. With a strong background in regulatory affairs, digital transformation, and change management, Passionate about leveraging technology to improve regulatory frameworks and shaping the future of regulatory practices in a rapidly evolving landscape.

An Indian, who continues to be captivated by the vibrance of UAE for the past 20+ years.
Education: Bachelor in Ayurvedic (alternative) medicine from Rajiv Gandhi University of Health Science, Bangalore, India/ MBA in Quality management system from Geneva Business School, Switzerland/ Advance certificate in regulatory affairs from San Diego State university, USA.
20 years of experience in the pharmaceutical industry, including sales and regulatory roles.
Job Profile summary:
Develop and implement regulatory strategies, ensure compliance and continuous access of innovative medicine to patients, within the GEM & Africa cluster, a region with diverse, complex, and rapidly evolving regulatory environment.
Developing external partnerships and building positive relationships with internal cross-functional teams to strategize, execute and drive business growth.
Achievement:
Personal: Becoming the best buddy of my two teenage boys
Professional: Core team member “Regional Distribution Network”, Licensing BMS distribution hub in Dubai,
BMS scientific office licensing.
Core team member “Project Fusion” – process & system integration following company acquisition.
Representing BMS as country network participant in the TransCelerate initiative (TransCelerate initiatives are a long-term industry collaborative effort to design, develop and deliver solutions for more efficient R&D).
My Life’s Mantra: “EKAM SATH, VIPRA BAHUDA VADANTI” – Truth is one, its interpretations are many.

Dr. Deema Musa currently works at Acino MEA, UAE as Regulatory Affairs Manager the Middle East, Turkey and Africa region. She has 11 years’ experience in the pharmaceutical industry in regulatory affairs, she held many regional roles in Regulatory Affairs in Pfizer, Takeda Pharmaceuticals and Acino MEA. Deema is a pharmacist graduated from Jordan University in Jordan.

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.

Shruthi Shankar is a team lead at Biocon Biologics India, leading the Middle east, Africa and North Africa markets. She has over 14 years of experience in the biopharmaceutical industry specializing in the development and global registration of biosimilars. Experienced in the field of biosimilar registration, has engaged with multiple global agencies such as SFDA, EDA, MHRA, EMA and many more. Has secured approvals from multiple agencies enabling product registrations across the globe.

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.

Ms. Soufia Hanna, Regulatory Affairs & Safety Regional Director , Health, Home & Hygiene .for Reckitt Benckiser , with responsibility on AFRICA , Middle East ,West ASEA and Russia-CIS

She has been with Reckitt for over 27 years, developing her experience in different functions including Sales, Marketing, Market access, e-Commerce, Compliance, Quality, Safety and Regulatory & Government Affairs.

Her area of responsibility over the years has included over70- 80 countries in the Middle East, AFRICA, ASEAN (Hygiene), Turkey, West and South Asia.

Sofia’s medical background, MBA and her experience in several different functions has been of great help in developing Reckitt’s Healthcare category in the Middle East.

She is one of MENAP-SMI (ME Self Care association) founder since almost 20 Years ago.

She is also proud of being the FIRST Female to work in medical detailing not only in UAE but in the whole GCC, where she was paving the way for lots of female to follow (now more that 65% of medical detailing are females).

Within her carrier journey she covered multiple categories Regulatory responsibilities as below :

Categories EXPERTISE

She is also very committed to public service, supporting various charity organizations,