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.

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

Dr. Nahed Yaish

Position: QMS & PV Consultant / QPPV Auditor – Qualified International Trainer
Categories: Speakers 2026

23 year of experience in the Pharma Industry.

18 years of experience as a Qualified Person Responsible for Pharmacovigilance/Local Safety Responsible, Quality Assurance Responsible Person.

QPV Auditor & Qualified International Trainer by International College in London.

Dr. Nahed Yaish

QMS & PV Consultant / QPPV Auditor – Qualified International Trainer

Mrs. Alina Panourgia

Position: PV and Regulatory Affairs Advisor – Composite Pharma, UAE
Categories: Speakers 2026

Alina Panourgia is a pharmacist by training, with a degree from Moscow and further studies in the UK, where she earned both an MBA and an MSc in Pharmacovigilance.

Her career began on the ground, at a manufacturing site in Quality and Regulatory Affairs, where she built a strong foundation in compliance and process. After living and working across Asia and then relocating to the Middle East, Alina shifted into independent consulting. She now leads GxP audits, works closely with global teams, supporting regulatory submissions across the GCC, LATAM and CIS regions; and partners with companies in the UK, US and EU on post-marketing safety and clinical trial oversight.

Alina enjoys connecting the dots between regulations and real-world practice. She’s a frequent speaker at forums, conferences and training programmes, where she shares practical insights drawn from hands-on experience and a few hard-earned lessons along the way.

Mrs. Alina Panourgia

PV and Regulatory Affairs Advisor – Composite Pharma, UAE

Mohamed Abdel Hady

Position: Director, Affiliate Head of Patient Safety at Gilead Sciences
Categories: Speakers 2026

Mohamed Abdel Hady is Director, Affiliate Head of Patient Safety at Gilead Sciences, where he leads pharmacovigilance strategy, inspection readiness, and CAPA excellence across complex regulatory landscapes. He oversees RMP/PSUR programs and risk‑minimization measures and drives cross‑functional collaboration with affiliates and regulators across countries within Eurasia and Middle East.

In addition, Mohamed currently serves as Lead of the PHAME Group (Pharmacovigilance Association for Middle East), a regional industry forum. PHAME spans GCC, Levant, and North Africa, fostering regulatory intelligence sharing and collaborative problem‑solving.

Mohamed Abdel Hady

Director, Affiliate Head of Patient Safety at Gilead Sciences

DR. EMAN GOMAA

Position: International Operations & Capabilities Lead - AbbVie
Categories: Speakers 2026

Eman has a wealth of experience in PV since 2012, with a strong network with decision makers in different health authorities. She held several senior roles in multiple multinational Pharma companies.

She started her PV career in Cairo, in 2012, at the very early beginnings of the Egyptian PV guidelines followed by the Arab GVP implementation in 2015.

She has worked in multiple pharmaceutical companies, from local Egyptian companies to Gilead’s agent in Cairo then joined Allergan as Egypt LSO in March 2016. After one year, she was selected to be the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.

After AbbVie’s acquisition of Allergan in May 2020, Eman supported the global and affiliate PV integration workstreams and subsequently was appointed on May 2021 as the Lead of the Middle East & Africa PV hub, the largest PV hub in AbbVie.

She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.

Lastly, Eman has participated in GCC PV trainings that took place in Dubai, UAE, since 2019, and her sessions were widely recognized and got excellent feedback from the audience and regulators as well.

She also has multiple lectures in the annual PV course arranged by PRA and the Dubai Pharmacy College since 2020.

Eman is now the International Operations & Capabilities Lead in AbbVie and is a member of the International Society of Pharmacovigilance ISoP, ISoP Middle East Chapter and the Country Representative in United Arab Emirates.”

DR. EMAN GOMAA

International Operations & Capabilities Lead - AbbVie

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