19-20 February 2025

GCC PHARMACOVIGILANCE
TRAINING

19-20 February 2025

GCC Pharmacovigilance Training 2025

Join GCC Pharmacovigilance Training to enhance your skills in pharmacovigilance. Aimed at GCC professionals, this training focuses on monitoring, evaluating, and reporting adverse drug reactions, ensuring medication safety.

Gain knowledge on regulatory frameworks, risk assessment, and best practices. Be a part of patient safety and meet the growing demand in the GCC. Elevate your expertise and qualification in pharmacovigilance

Evaluate the place of the QPPV in the pharmacovigilance system of a company.

Share experiences from the EU QPPV to learn better how to fulfil and deal with the role of the QPPV.

Understand the challenges of being a QPPV for small & medium enterprises and contractually within CROs.

Advance understanding of the legal and liability aspects for the QPPV and what documents need to be in place

Enable QPPV(s) to articulate their role in the company in order to promote senior management understanding and support

Design initiatives to move the QPPV position forward successfully in the GCC & Middle East

Where

Movenpick Grand Al Bustan – Dubai, UAE

When

19-20 February 2025

SPEAKERS

20+ Speakers

SEATS

100 Seats

Speakers 2025

The GCC Regulatory Affairs Pharma Summit 2025 gathers experts to explore regulatory updates, compliance, and pharma innovations in the Gulf.

Dr. Reem El Essa

Position: Director of Drug Inspection Administration | Pharmacovigilance Superintendent - Ministry of Health, Kuwait
Categories: speakers 2025

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

Position: Head of Regulating Controlled Substances & Products, & Precursor Chemicals Section, & Head of Pharmacovigilance Section - Emirates Drug Establishment (EDE), UAE
Categories: speakers 2025

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

Position: Clinical Pharmacist & Pharmacovigilance Officer, - Emirates Drug Establishment (EDE), UAE
Categories: speakers 2025

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

Position: Head of Lab Affair & Follow Up Department – Jordan Food & Drug Administration
Categories: speakers 2025

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

Position: Head of Pharmacovigilance Division in Rational Drug Use and Pharmacovigilance Department - Jordan Food & Drug Administration
Categories: speakers 2025

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

Position: Accreditation and development Administration Manager, Pharmacovigilance General Administration - Egyptian Drug Authority (EDA)
Categories: speakers 2025

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. Mona Al Moussli

Position: Chairman of GCC Regulatory Affairs Pharma Summit
Categories: speakers 2025

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

Position: Global Vigilance Manager and QPPV at Gulf Pharmaceuticals – Julphar
Categories: speakers 2025

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

Dr. Nahed Yaish

Position: General Manager of State of Practices Consultancy Center & Quality Pharmacovigilance Consultant, Qualified International PV Trainer
Categories: speakers 2025
  • 21 years of experience in the Pharma Industry
  • 16 years of experience as Quality Assurance Responsible Person, Qualified Person Responsible for Pharmacovigilance/Local Safety Responsible
  • 6 years of experience as a Consultant for Quality Management Systems (QMS), Business Development focusing on Quality and Regulatory Affairs (RA), and Quality Pharmacovigilance
  • Specializes in creating QMS documentation compliant not only with Good Manufacturing Practice (GMP) and Good Storage and Distribution Practice (GSDP) requirements, but also with Good Pharmacovigilance Practices (GVP) to meet Quality PV standards
  • Holds a Diploma in Pharmacovigilance Auditing/Lead Auditor from UK
  • Holds a Diploma in Pharmaceutical QMS Auditing/Lead Auditor from UK
  • Certified GSDP Pharmaceutical Quality System Auditor and Quality Pharmacovigilance Auditor
  • Qualified International Trainer accredited by the International College in London
  • Owner and Founder of the State Of Practices Consultancy Center (SOP Center)

Dr. Nahed Yaish

General Manager of State of Practices Consultancy Center & Quality Pharmacovigilance Consultant, Qualified International PV Trainer

Who Will Attend?

The GCC Regulatory Affairs Pharma Summit 2025 gathers experts to explore regulatory updates, compliance, and pharma innovations in the Gulf.

PV professionals including PV and local safety officers

Qualified persons for pharmacovigilance.

Deputy qualified persons for pharmacovigilance.

Pharmacovigilance regulators & inspectors.

CRO & consultants providing QPPV services.

Feedback from our Attendees