


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
24-25 june 2026
SPEAKERS
20+ Expert Speakers
SEATS
100+ Seats Available
Speakers 2026
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. Lateefa Jamal Abdulla Al Marzooqi
Lateefa Jamal Abdulla Al Marzooqi is a pharmacovigilance leader and regulatory pharmacist based in Abu Dhabi, United Arab Emirates. She currently serves as Section Head of Pharmacovigilance and Drug Education at the Department of Health – Abu Dhabi, where she leads strategic initiatives to strengthen medication safety and pharmacovigilance systems across the emirate.
With extensive expertise in drug safety surveillance, Lateefa oversees the monitoring and regulatory assessment of adverse drug reactions, adverse events following immunization, medication errors, and medical device vigilance reports. She has played a pivotal role in shaping Abu Dhabi’s pharmacovigilance ecosystem, including establishing the Abu Dhabi Pharmacovigilance Network (ADPVN) and leading the development of key regulatory policies related to safety alerts, recalls, and vigilance reporting standards.
Lateefa also led the establishment and management of a 24/7 Poison and Drug Information Service in Abu Dhabi and supervised national vaccine safety surveillance during the COVID-19 pandemic through the creation of a dedicated AEFI call center . Her work focuses on strengthening data-driven safety monitoring systems and integrating digital reporting tools to enhance regulatory decision-making and patient safety outcomes.
She holds, bachelor’s degree in pharmacy from Dubai Pharmacy College and postgraduate diplomas in Regulatory Affairs and Clinical Research, Drug Safety and Pharmacovigilance from the Academy of Applied Pharmaceutical Sciences in Toronto, Canada, she was a fellow in ISMP Canada , hold Johns Hopkins Patient Safety Certificate Program and master certificate in healthcare management and services.
Lateefa is actively engaged in international medication safety collaborations and contributes to global pharmacovigilance discussions with regulatory and patient safety networks.
Dr. Lateefa Jamal Abdulla Al Marzooqi
Section Head of Pharmacovigilance and Drug Education, Department of Health, Abu Dhabi
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. Uchenna G. Elemuwa
Dr. Uchenna Elemuwa is the Director of Pharmacovigilance at Nigeria’s National Agency for Food and Drug Administration and Control (NAFDAC). In her role, she oversees the implementation of the National Pharmacovigilance Policy, coordinating medicine safety activities in Nigeria. Dr. Elemuwa obtained a Ph.D. in Clinical Pharmacotherapy from the University of Benin. She earned her Bachelor of Pharmacy (BPharm) from the University of Jos. She holds a Master’s Degrees in Clinical Pharmacy and Bio-pharmacy, and Industrial Labour and Relations. She is a fellow of the West African Postgraduate College of Pharmacists.
Under her leadership, NAFDAC’s Pharmacovigilance Directorate has strengthened national systems for monitoring adverse drug reactions (ADRs) and adverse events following immunization (AEFIs). Dr. Elemuwa also leads collaborations with international partners, including the Uppsala Monitoring Centre, a WHO Collaborating Centre for International Drug Monitoring. She has been instrumental in expanding pharmacovigilance outreach through zonal centers in tertiary hospitals across Nigeria and training healthcare providers on medicine safety practices.
Dr. Elemuwa was the Chairperson Expert Working Group (EWG) on Clinical Trial, Pharmacovigilance, and Medicine Safety for the ECOWAS Medicine Regulatory Harmonisation Programme from 2016 to 2022. She is the current Chairperson for the EWG on Pharmacovigilance and safety monitoring from 2023 to date, and the Lead for the African Union Smart Safety Surveillance (AU 3S) Project in Nigeria. She is a Member of the National Coordinating Committee of the National Expert Committee on Adverse Events following Immunization (AEFI) Causality Assessment in Nigeria. She also leads the Saving Lives and Livelihood Pharmacovigilance Project sponsored by Mastercard through the African Centre for Disease Control.
She is instrumental to Nigeria achieving Maturity Level 3 during the WHO Global Benchmarking Assessment covering the Pharmacovigilance indicators.
Dr. Uchenna G. Elemuwa
Director of Pharmacovigilance, National Agency for Food and Drug Administration and Control, Nigeria
Ms. Fatema Abdulaal
Fatema Abdulaal is a Senior Pharmacist at the National Health Regulatory Authority (NHRA) in the Kingdom of Bahrain, where she has served since 2021. She works within the Medicines Registration and Pricing group, contributing to a wide range of regulatory activities related to the evaluation and oversight of medicinal products. Her responsibilities include the scientific assessment of New Drug Applications (NDAs) and post-approval variations, as well as the classification of medicinal products and evaluation of classification and resubmission applications for alternative and complementary medicines.
Fatema currently leads the national pharmacovigilance initiative in Bahrain, overseeing the establishment and implementation of the country’s pharmacovigilance system. Her work includes developing regulatory frameworks, operational procedures, and reporting infrastructure to support effective monitoring of medicine safety and align national practices with international standards, including the WHO Programme for International Drug Monitoring.
Prior to joining NHRA, Fatema served at King Hamad University Hospital (KHUH) from 2014 as an inpatient pharmacist and later as a Quality and Safety Coordinator. During this time, she gained extensive experience in pharmacy practice, medication safety, healthcare quality improvement, and hospital regulatory compliance, contributing to initiatives aimed at enhancing patient safety and optimizing medication use.
Fatema holds a Bachelor of Science (BSc) in Pharmaceutical Sciences and a Master of Science (MSc) in Quality and Patient Safety in Healthcare Management from the Royal College of Surgeons in Ireland (RCSI). She is professionally committed to strengthening regulatory systems, advancing pharmacovigilance, and promoting medication safety and healthcare quality at the national level.
Ms. Fatema Abdulaal
Senior Pharmacist, National Health Regulatory Authority (NHRA), Bahrain
Dr. Mariem Emad Mesiha
Dr. Mariem Emad Mesiha 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, Dr. Mariem gained valuable experience at Johnson & Johnson and Channel, developing strong expertise in regulatory processes across both pharmaceutical and consumer healthcare sectors. Dr. Meriem 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. 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. Michelle Gebara
Dr. Michelle Gebara holds a Doctorate of Pharmacy degree from Saint Joseph University of Beirut, Lebanon. As Patient Safety Lead for the UAE and Gulf countries at Roche, she drives patient safety and risk management strategies that promote patient protection, regulatory excellence, and improved healthcare outcomes.
Drawing on extensive regional and global pharmacovigilance experience, Dr. Gebara is passionate about advancing patient-centric care and strengthening a culture of patient safety across the healthcare ecosystem.
Dr. Michelle Gebara
Patient Safety Lead for UAE & Gulf Countries, Roche Pharmaceuticals
Dr. Marwa Zaki
Dr. Marwa Zaki is a pharmacist with extensive expertise in pharmaceutical regulatory affairs, medical device regulatory affairs, pharmacovigilance, and medical device vigilance across the Middle East and GCC region. She earned her Bachelor’s Degree in Pharmaceutical Sciences in 2006 and has developed a distinguished career dedicated to regulatory compliance, patient safety, quality systems, and healthcare product lifecycle management.
Dr. Zaki completed advanced professional studies in Regulatory Affairs, Pharmacovigilance, Pricing, and Market Access through Harvard Medical School, Boston, USA. She also holds a Medical Devices Regulatory Affairs Certification from the Regulatory Affairs Professionals Society (RAPS) and has been a Certified Qualified Person for Pharmacovigilance (QPPV) since 2016 through the Arab Union of Pharmaceuticals and Medical Appliances (AUPAM).
She is currently pursuing a Master’s Degree in Pharmacovigilance and Pharmacoepidemiology at the University of Bordeaux, France, where her research focuses on strengthening pharmacovigilance oversight and patient safety systems within the healthcare sector.
In recognition of her contributions to medicine safety and pharmacovigilance, Dr. Zaki received the GCC Pharmacovigilance Excellence Award in 2023.
Currently serving as Cluster Expert – Middle East at Fresenius Medical Care, Dr. Zaki possesses a rare combination of expertise spanning three highly specialized disciplines: pharmaceutical regulatory affairs, medical device regulatory affairs, and pharmacovigilance/medical device vigilance. Throughout her career in the dialysis industry, including leading global healthcare organizations, she has managed regulatory, quality, and safety activities for both medicinal products and medical devices across numerous countries in the GCC, Levant, and wider Middle East region.
Dr. Zaki is passionate about advancing patient safety, strengthening healthcare regulatory systems, promoting effective risk communication, and supporting innovation while ensuring the highest standards of quality, compliance, and public health protection.
Dr. Marwa Zaki
Cluster Expert - Middle East Regulatory Affairs and Post Market Surveillance, Fresenius Medical Care
Dr. Eslam El Berry
Dr. Eslam El Berry is a Global Safety Senior Manager at Amgen with over 24 years of experience in the pharmaceutical and healthcare industry, including more than 18 years in pharmacovigilance. He currently leads safety activities across the Middle East and Africa region for Amgen, where he is recognized as a key safety responsible person, ensuring compliance with global standards and local regulatory requirements.
Dr. Eslam has built a distinguished career across leading multinational organizations, including Amgen, Pfizer, and Takeda, working across diverse markets in the Middle East and Africa. Throughout his career, he has played a pivotal role in shaping pharmacovigilance systems, strengthening regulatory compliance frameworks, and driving operational excellence in safety processes.
He is widely recognized as a subject matter expert in pharmacovigilance, leading global and regional initiatives, including risk management programs, safety process optimization, and audit and inspection readiness. Eslam has also been actively engaged with health authorities and has been invited multiple times to speak at pharmacovigilance conferences, contributing to the advancement of the safety landscape in the region.
A strong advocate for patient safety, Dr. Eslam is passionate about building high-performing teams and fostering a culture of trust, collaboration, and continuous development. His leadership has been instrumental in mentoring teams, driving innovation, and enhancing the overall quality of safety operations.
Dr. Eslam holds a Master’s degree in Pharmacovigilance and Pharmacoepidemiology from the University of Bordeaux, France, and brings a strategic, patient-focused approach to advancing drug safety and public health
Dr. Eslam El Berry
Global Safety Senior Manager, Amgen
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.









