Pharmacovigilance Training 2026
GCC QC

eCTD Training

24-25 June 2026

GCC PHARMACOVIGILANCE
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. Mariem Emad Mesiha

Position: Senior Regulatory Affairs & Scientific Office Manager, Deputy QPPV UAE, Procter & Gamble
Categories: Speakers 2026

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. Lateefa Jamal Abdulla Al Marzooqi

Position: Section Head of Pharmacovigilance and Drug Education, Department of Health, Abu Dhabi
Categories: Speakers 2026

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

Position: Director of Drug Inspection Administration | Pharmacovigilance Superintendent - Ministry of Health, Kuwait
Categories: Speakers 2026

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

Position: Director of Pharmacovigilance, National Agency for Food and Drug Administration and Control, Nigeria
Categories: Speakers 2026

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

Position: Senior Pharmacist, National Health Regulatory Authority (NHRA), Bahrain
Categories: Speakers 2026

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. 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. Maha El Temamy

Position: Regional Pharmacovigilance Hub Head - CEETRIS, Middle East, and Africa, Roche
Categories: Speakers 2026

Maha Eltemamy is a pharmacist and patient safety advocate with nearly two decades of experience across the pharmaceutical industry in CETRIS, Middle East and Africa. Throughout her career, she has remained driven by a single purpose: strengthening trust in medicines by ensuring that patient safety remains at the center of healthcare systems.

Maha joined Roche in 2008. Starting in commercial roles, she gained a unique perspective on the real-world challenges patients and healthcare providers face when accessing and using medicines. This early exposure shaped her belief that the true value of innovation lies not only in discovery, but also in the responsible monitoring of medicines once they reach patients. In 2011, Maha transitioned into pharmacovigilance, dedicating her career to advancing drug safety systems and strengthening collaboration between industry, healthcare professionals, and regulators. Over the years, she has played a key role in developing regional pharmacovigilance
capabilities across diverse healthcare landscapes, supporting the evolution of safety systems in both emerging and mature markets.

Today, Maha leads a Regional Pharmacovigilance Hub responsible for safety oversight. In this role, she champions a forward-looking vision for pharmacovigilance – one that moves beyond compliance to embrace innovation, data-driven insights, and stronger partnerships to better detect, understand, and manage medicine-related risks.

Maha is particularly passionate about empowering teams and fostering a culture where patient safety is a shared responsibility. She actively advocates for greater transparency and accessibility of safety information, believing that patients and caregivers should be equipped with the knowledge that supports confident and informed treatment decisions. Through her leadership and advocacy, Maha continues to contribute to the transformation of pharmacovigilance into a more connected, proactive, and patient-centered discipline – one that ultimately strengthens public trust and improves outcomes for patients worldwide.

Dr. Maha El Temamy

Regional Pharmacovigilance Hub Head - CEETRIS, Middle East, and Africa, Roche

Dr. Sara Thomas

Position: Pharmacovigilance Manager META, QPPV UAE and Oman, Arcera Life Sciences
Categories: Speakers 2026

Dr. Sara Thomas is a seasoned pharmacovigilance professional with over a decade of experience in drug safety, risk management, and regulatory compliance across global and regional markets. Currently the PV Manager for the META region and QPPV for UAE and Oman, overseeing PV systems, ensures regulatory compliance, and act as the primary contact for health authorities.

Dr. Sara holds a Master of Pharmacy in Pharmacology and Toxicology from India. Her academic background is complemented by research experience in oncology and metabolic disorders, along with teaching experience in pharmacology and related disciplines.

Throughout her career, Dr. Sara has contributed to both generic and innovator pharmaceutical environments, with expertise spanning PV system establishment, ICSR management, signal detection, risk management planning (RMPs), periodic safety reporting (PSUR/PBRER), system integration, and regulatory submissions.

Particularly interested in emerging trends in drug safety, digital transformation in PV systems, and global harmonization of safety practices.

Dr. Sara Thomas

Pharmacovigilance Manager META, QPPV UAE and Oman, Arcera Life Sciences

Mrs. Anam Mukhtar

Position: Senior Regulatory Intelligence and Content Specialist, RegAsk
Categories: Speakers 2026

With over 13 years of international regulatory affairs experience across pharmaceuticals, nutraceuticals, and cosmetics, spanning the GCC, EU, CIS, EAEU, Africa, and Southeast Asia, Anam offers a distinctive combination of regulatory expertise and technological proficiency within the Regulatory Intelligence and Pharmacovigilance space.

She began her career in pharmaceutical regulatory affairs, developing deep expertise in CMC and lifecycle management. Having established regulatory pathways for multiple first-time product launches, Anam now serves as a GCC Expert and content specialist for an Agentic AI platform that enables end-to-end regulatory intelligence and workflow orchestration. Her work focuses on helping compliance teams stay ahead of regulatory change and turning regulatory data into actionable insights.

Mrs. Anam Mukhtar

Senior Regulatory Intelligence and Content Specialist, RegAsk

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.

Feedback from our Attendees