eCTD Training
GCC Pharmacovigilance Training: Collaborative PV Excellence across the GCC Region
The GCC Pharmacovigilance Training is a specialized regional platform designed to strengthen drug safety practices and advance pharmacovigilance systems across the Gulf. The training brings together regulatory authorities, PV leaders, and industry professionals to explore the latest GCC pharmacovigilance requirements, safety reporting expectations, signal management strategies, and compliance updates.
Attendees will gain clear, practical insight into the evolving pharmacovigilance landscape, learn best practices for maintaining an inspection-ready PV system, and understand how to enhance risk management, benefit–risk evaluation, and safety oversight within Marketing Authorization Holder (MAH) operations.
This training supports teams in building stronger, more compliant PV frameworks aligned with regional and global standards.
Evaluate the role and responsibilities of the QPPV within a company’s pharmacovigilance system, including oversight, governance, and regulatory expectations.
Understand the unique challenges faced by QPPVs in small and medium-sized enterprises (SMEs) and when operating under contractual arrangements with CROs or external partners.
Equip QPPVs to clearly articulate their role within their organization to secure senior management awareness, alignment, and support for PV activities.
Learn from GCC’s QPPV best practices, gaining practical insights and real-world experience to better understand how to fulfil and manage the QPPV function effectively.
Strengthen knowledge of legal obligations and liability considerations for QPPVs, including the essential documentation and agreements required for compliance.
Explore strategies to advance and elevate the QPPV position across the GCC and Middle East, contributing to stronger, more mature pharmacovigilance systems in the region.
Where
Mövenpick Grand Al Bustan – Dubai, UAE
When
22- 23 April 2026
SPEAKERS
20+ Expert Speakers
SEATS
100+ Seats Available
Speakers 2025
The GCC Pharmacovigilance Training brings together distinguished safety leaders, regulatory officials, and PV experts to share insights on GCC pharmacovigilance requirements, drug safety practices, compliance expectations, and the evolving PV landscape across the Gulf region.
Dr. Reem El Essa
Dr. Reem Al-Essa has a PhD in Pharmaceutical Regulations, MBA General and Strategic Management, MSc in PV and Pharmacoepidemiology, MSc Health Economics and Pharmacoeconomics and BSc. Pharmacy (Honours), with a long and diversified experience in both government and private sectors in Kuwait.
She started her career in Kuwait Ministry of Health, Drug and Food Control, Pharmaceutical and Herbal Medicines Registration and Control Administration, holding the position of Drug Registration Superintendent. She was appointed in the position of Coordination and Development Superintendent at the Pharmaceutical Services Administration and then became the Director of Drug Inspection Administration (DIA) in addition to holding her role as a Pharmacovigilance Superintendent in Kuwait Office for Pharmacovigilance Surveillance (KOPS).
Dr. Reem El Essa
Director of Drug Inspection Administration | Pharmacovigilance Superintendent - Ministry of Health, Kuwait
Dr. Noura Abdelaal
She is a qualified professional with 7 years of experience in the Drug Department, having worked across multiple functions, including the regulation of Narcotics, Psychotropics, and Precursor Chemicals. Her expertise extends to conducting GMP audits both locally and internationally, monitoring drug quality and safety, and investigating malpractice within the industry, all with a focus on ensuring the safe use of medicines across the country.
She has played a pivotal role in strengthening MOHAP’s partnerships with other federal entities, including the Ministry of Interior, the Federal Customs Authority, and the Weapons and Hazardous Substances Office, as well as collaborating with international organizations such as the World Health Organization (WHO) and the International Narcotics Control Board (INCB).
Dr. Noura Abdelaal
Head of Regulating Controlled Substances & Products, & Precursor Chemicals Section, & Head of Pharmacovigilance Section - Emirates Drug Establishment (EDE), UAE
Dr. Katya Nabeel Ailabouni
Dr. Katya Nabeel Ailabouni is a Clinical Pharmacist with extensive experience in the UAE Ministry of Health. She holds an M. Pharm. in Clinical Pharmacy (2024, Al Ain University, UAE) and a B.Sc. in Pharmacy (1999, Philadelphia University, Amman, Jordan).
Since 2004, Dr. Katya has worked with the Ministry of Health’s Registration and Drug Control Department. From 2005-2008, she served as a Registration Officer, handling New Drug Applications, renewals, and manufacturing facility registrations. Since 2008, she has been a Pharmacovigilance Officer and a reporter for the UAE National Pharmacovigilance Committee.
Earlier in her career, Dr. Katya was the Pharmacist-in-Charge at Al Nahdha Pharmacy, Abu Dhabi (2002-2003), and a Pharmacist at Mermaid Pharmacy, Abu Dhabi (1999-2001).
Dr. Katya Nabeel Ailabouni
Clinical Pharmacist & Pharmacovigilance Officer - Emirates Drug Establishment (EDE), UAE
Dr. Mais Al-Khreishah
Dr. Mais al-khreishah, Senior specialist pharmacist in Jordan food and drug administration Currently hold head of lab affair and follow up department position, she has studied pharmacy at Jordan university worked in import and export department, pharmaceutical and herbal product unit, registration department and royal medical service.
She participated in a number of committees in JFDA, Currently Chairman of the LAB Affair Committee and member in post marketing surveillance committee and specification of secondary packaging material committee.
Dr. Mais Al-Khreishah
Head of Lab Affair & Follow Up Department – Jordan Food & Drug Administration
Ph. Taqwa Maqatef
Pharmacist Taqwa is a head of pharmacovigilance devision in rational drug use and pharmacovigilance department with 15 years experince in clinical studies and pharmacovigilance. Ph. Taqwa holds a Mater degree in clinical pharmacy from the university of jordan. My responsibilities include the oversee adverse event reporting, risk management strategies and ensuring compliance with regulatory requirements to maintaining the highest standards of patient safety and fostering cross-functional collaboration to achieve organizational goals.
Ph. Taqwa Maqatef
Head of Pharmacovigilance Division in Rational Drug Use and Pharmacovigilance Department - Jordan Food & Drug Administration
Dr. Doaa Soliman
Dr. Doaa Soliman holds a B.Sc. in Pharmaceutical Science, an Egyptian Board of Healthcare Management certification, and a master’s in healthcare quality management.
With 10 years of experience in the healthcare sector, Doaa has worked as an inpatient and community pharmacist, as well as in supply chain management, specializing in pharmacovigilance (PV). As an Administrative Manager, she oversees three units: PV Training, PV Inspection, and Pharmacovigilance System Master File (PSMF) Assessment.
She has contributed to the Egyptian Drug Authority’s (EDA) global benchmarking program with the World Health Organization (WHO) and led PV inspections across Egypt, ensuring compliance with safety standards along with providing PV training programs to stakeholders.
Dr. Doaa Soliman
Accreditation and development Administration Manager, Pharmacovigilance General Administration - Egyptian Drug Authority (EDA)
Dr. Heba Khalil Mohamed
General Manager of General Administration of Clinical Trials - Egyptian Drug Authority (EDA)
Dr. Mona Al Moussli
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.
Dr. Mona Al Moussli
Chairman of GCC Regulatory Affairs Pharma Summit
Mr. Syed Zaferuddin
An accomplished Pharmacovigilance professional with over a decade of experience in Drug and Device vigilance and regulatory compliance. Currently serving as a Global Vigilance Manager and QPPV at Gulf Pharmaceuticals – Julphar, Syed has expertise in signal management, safety database administration, and global pharmacovigilance system oversight.
Syed Worked for Organizations like Jamoom Pharma, TCS (Roche), Cognizant (Novartis), Parexel, Clinovo Research lab previously.
Notable achievements include developing and validating Implementing AI based PV tools like RI, MedDRA, Literature PV tools, implementing comprehensive training programs for thousands of professionals, and authoring critical safety reports such as PSURs and RMPs. Recognized for exceptional contributions as a speaker at global platforms like the World Drug Safety Congress, Syed is a trusted partner to regulatory authorities across the GCC region.
Certified in advanced pharmacovigilance systems, ISO standards, and biosimilars, Syed thrives on building robust safety systems that ensure patient welfare worldwide.
Specialties:
Signal Management | ICSR Processing | Regulatory Inspections | Risk Minimization | Aggregate Reporting | Training and Development | PSMF Management | GCC PV Compliance
Mr. Syed Zaferuddin
Global Vigilance Manager and QPPV at Gulf Pharmaceuticals – Julphar
Who Will Attend?
The training is essential for professionals involved in drug safety and pharmacovigilance within the GCC pharmaceutical industry, including:
QPPVs and Local Safety Officers
Pharmacovigilance Managers, Specialists, and Associates
Drug Safety & Medical Information Teams
PV Operations and Compliance Professionals
Regulatory Affairs teams supporting PV submissions and requirements
Medical Affairs professionals with safety responsibilities
Quality Assurance personnel overseeing PV systems and audits
Pharmacovigilance consultants, CROs, and safety service providers
MAH representatives responsible for PV compliance and reporting
Participants will benefit from updated regulatory insights, structured PV methodologies, and actionable best practices to strengthen their organization’s pharmacovigilance capabilities and ensure continuous compliance across the GCC.
