22 - 23 April 2026<br />
GCC PHARMACOVIGILANE TRAINING
24 April 2026<br />
GCC QUALITY CONFERENCE

eCTD Training

22-23 June 2026

GCC REGULATORY AFFAIRS PHARMA SUMMIT 2026 – DUBAI

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.

Dr. Nabeela Ahmed Memon

Position: Acting Chief, Pharmacy and Pharmaceutical Products Department, National Health Regulatory Authority, Bahrain
Categories: Speakers 2026

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. Donia Al Bastaki

Position: Head of Drug Registration Department, Pharmaceutical and Herbal Medicines Registration and Control Administration at Ministry of Health – Kuwait
Categories: Speakers 2026

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. Yasmine Hisham

Position: Manager of Human Pharmaceutical Regulatory Affairs Administration, Egyptian Drug Authority
Categories: Speakers 2026

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

Position: Section Head, Originator Drug Sector, Jordan Food & Drug Administration
Categories: Speakers 2026

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

Dr. Mona Al Moussli

Position: Chairman of GCC Regulatory Affairs Summit
Categories: Speakers 2026

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

Position: Secretary General of The Jordanian Association of Pharmaceutical Manufacturers (JAPM)
Categories: Speakers 2026

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)

Dr. Fatima Zaid Abu Zanat

Position: Regional Director of Regulatory Affairs & Scientific Office – Middle East, Turkey & Africa, Ipsen Pharma
Categories: Speakers 2026

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

Mr. Varma Bhupathiraju

Position: Associate Vice President - Global Regulatory Affairs, Biocon Limited
Categories: Speakers 2026

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. RAWYA KREDLY

Position: Medical and Regulatory Affairs Director - Gulf Pharmaceutical Industries (Julphar)
Categories: Speakers 2026

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)

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