Pharmacovigilance Training 2026
GCC QC

eCTD Training

22 - 23 April 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

22- 23 April 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.

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

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. 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

Dr. Sara Bahr

Position: Near East & UAE Patient Safety Lead, Boehringer Ingelheim
Categories: Speakers 2026

As Patient Safety Lead, I have driven high impact pharmacovigilance and patient safety initiatives across Africa, Middle East, Turkey, and supported regions in East and Central Europe. With 18 years of experience in the pharma industry including more than 11 years dedicated to Pharmacovigilance & Patient Safety, I have partnered closely with respected Health Authorities to strengthen drug safety culture and elevate patient safety standards.

My passion lies in building a culture of safety. I have led numerous efforts to increase awareness of pharmacovigilance among healthcare professionals, students, and the wider community, ensuring that safety knowledge extends far beyond regulatory boundaries. Collaboration has been a cornerstone of my work, enabling meaningful progress at local, and regional levels.

Throughout my career, I’ve held key leadership roles at Hikma Pharmaceuticals, Baxter, and Boehringer Ingelheim, with deep expertise in PV and quality management systems, contractual agreements, and license partner management. Each chapter reflects my ongoing commitment to advancing patient safety excellence and supporting the continuous evolution of safer healthcare practices.

Dr. Sara Bahr

Near East & UAE Patient Safety Lead, Boehringer Ingelheim

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. 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. Tarik Messaoud

Position: Medical Director, Drug Safety, Iovance Biotherapeutics
Categories: Speakers 2026

Dr. Tarik Messaoud is a physician, consultant, and speaker at pharmacovigilance conferences in the USA, Canada, Europe and In UEA. He holds a graduate diploma in Clinical Research and Clinical Trial Management from the University of Montreal, Canada. With 15 years of experience in pharmacovigilance, he specializes in oncology drug safety, particularly in immunotherapy and adoptive cell therapy involving checkpoint inhibitors. Dr. Messaoud has worked with prominent pharmaceutical companies in USA and Canada such as Merck/MSD and GlaxoSmithKline, as well as Iovance biotechnologist focused on patient safety. He possesses extensive knowledge of pharmacovigilance regulations from Health Canada, the FDA, ICH, and the European Medicines Agency. Currently, he leads pharmacovigilance training initiatives and mentors students at McGill University and Access Clinical Research while also developing eLearning courses in pharmacovigilance.

Dr. Tarik Messaoud

Medical Director, Drug Safety, Iovance Biotherapeutics

Dr. Shahinaz Badr

Position: Founder and Managing Director, Vigilance Gate FZ LLC
Categories: Speakers 2026

Shahinaz Badr is the Founder and Managing Director of Vigilance Gate FZ LLC, a specialized pharmacovigilance and regulatory compliance consultancy providing strategic and operational support to regional and international organizations.

With over 20 years of experience across Pharmacovigilance (PV), Regulatory Affairs (RA), and Quality Management Systems (QMS), Shahinaz brings extensive expertise spanning the EU, Middle East, Africa, and emerging markets. A pharmacist by background with clinical practice experience, Shahinaz applies a patient-centered perspective to compliance, system design, and regulatory oversight. This foundation is complemented by a Lean Six Sigma Green Belt and certification as an ISO-qualified Lead Pharmacovigilance Quality (PVQA) Auditor, as well as expertise in process risk management and integrated management system auditing (ISO 9001, 14001, and 45001) supporting the development of PV systems that are compliant, sustainable, and inspection-ready. Shahinaz has supported global Marketing Authorization Holders and local distributors in ICSR management, signal evaluation, regulatory submissions, and inspection readiness. A specialist in vendor and distributor oversight, conducted risk-based audits and due diligence across EMEA to proactively mitigate regulatory risk, applying GAMP 5 principles to Computerized Systems Validation (CSV), ensuring PV infrastructures maintain data integrity and regulatory control.

Beyond consultancy, Shahinaz is a prominent contributor to drug and patient safety, authored multiple abstracts published with Springer Nature and currently serve as Co-Chair of the ISoP AI Special Interest Group (SIG), as well as PV Operations Sub-group Lead within the Industry SIG. A frequent speaker at international and regional forums, serving as Program Committee for the DIA Global QPPV Forum, contributing to scientific content development, and mentoring the next generation of pharmacovigilance professionals to strengthen global safety governance.

Dr. Shahinaz Badr

Founder and Managing Director, Vigilance Gate FZ LLC
Joëlle Issa - Blok, MSc, Pharmacist

Dr. Joëlle Issa – Blok

Position: Regulatory Affairs & PV Director Middle East, Turkey & Africa, Arcera Life Sciences
Categories: Speakers 2026

Joëlle Issa-Blok currently works at Acino part of Arcera Life Sciences, UAE as Regulatory Affairs and Pharmacovigilance Director for the Middle East, Turkey and Africa region. She has 20 years’ experience in the pharmaceutical industry in different positions, starting in Regulatory Affairs Europe R&D in the Netherlands, then in various regional roles as Head of Regulatory Affairs and Pharmacovigilance MEA at Astellas where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations. She lived and worked 10 years in the Netherlands where she gained her experience in EU RA & PV regulations. Joëlle is a Pharmacist graduated from the Saint Joseph University in Beirut, in addition she holds a Masters in Pharmaceutical Science degree in Drug Innovation Research & Development from the University of Utrecht in the Netherlands.

Over the past years, Joëlle has been a speaker and lecturer in RA & PV GCC summits as well as various PV certified courses.

Dr. Joëlle Issa – Blok

Regulatory Affairs & PV Director Middle East, Turkey & Africa, Arcera Life Sciences

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