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.

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.

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

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.

 

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.

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.

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.

 

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. 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.