Hadir Rostom
(Chair of the Local Organizing Committee)
Pharmacovigilance consultant,
Lecturer at MSA University
Pharmacovigilance consultant, Lecturer at MSA University, member of the WHO Advisory Committee on Safety of Medicinal Products (WHO-ACSoMP), Lead Senior PV auditor, President of Egypt Chapter of ISoP, Member in ISoP Scientific Board.
She has 24 years experience in the Pharmaceutical sector, including 14 years extensively in pharmacovigilance domain. She is Co-founder and former head of the Egyptian Pharmacovigilance Center. Hadir has also contributed significantly to the development of Good Pharmacovigilance Practice guidelines in Arab countries. She acted for integrating PV teaching in Academia in Egypt, supervised several PV research projects and has a list of publications in the pharmacovigilance and drug safety. Her most notable contributions to pharmacovigilance on the international level include serving as a WHO consultant in Regulatory System Strengthening. In this role, she has supported regulatory authorities in various countries to establish and enhance their pharmacovigilance systems in alignment with the WHO Global Benchmarking Tool. Additionally, as an independent pharmacovigilance consultant and lead auditor, she evaluates the compliance of pharmacovigilance systems within the pharmaceutical industry to ensure adherence to applicable regulations across different countries.
Heba Ibrahim
Regional Support & Consultant MedDRA MSSO
Heba Ibrahim is the regional support and consultant for Africa and the Middle East at the MedDRA Maintenance and Services Organization (MedDRA MSSO). She is a pharmacist with over 14 years of experience as a regulator in the Egyptian Drug Authority (EDA) where she played several roles including 6 years in the Egyptian Pharmaceutical Vigilance Center (EPVC). She established EPVC’s Signal Management Unit in September 2020 and headed it until June 2023. She has also volunteered and contributed to various international pharmacovigilance activities and initiatives. She has also updated the Signal Management Module of the Egyptian-GVP guidelines, issued in June 2023. Heba served as a member of the WHO global benchmarking tool (GBT) National Working Group for Vigilance function for 2021/2022 where EDA achieved maturity level 3 (ML3) and was designated as a WHO-Listed Authority for vaccine regulation in March 2022. She holds a Master’s and PhD degrees in the field of pharmacovigilance with a focus on data mining and machine learning in detecting safety signals. Her research studies have been published in ScienceDirect journals. She is also a peer reviewer of several prestigious scientific journals (Q1 & Q2).
Christina Saad
Pharmacovigilance Manager Middle East & Deputy QPPV Egypt-Bayer
Christina Saad is a distinguished pharmacovigilance expert with over 14 years of experience in the healthcare sector, known for her extensive contributions to regulatory authorities and multinational pharmaceutical companies. She has
played an instrumental role at the Egyptian Pharmacovigilance Centre and has held key positions in leading pharmaceutical organizations. Christina earned her Bachelor of Science in Pharmacy from Ain Shams University and has since become a well-respected figure in the field.Throughout her career, Christina has held several pivotal roles, including PV Committee Rapporteur, Deputy Head of the National Pharmacovigilance Center, and Deputy Head of the PV Cluster at Bayer, where she was instrumental in advancing pharmacovigilance practices and ensuring the highest standards of drug safety. Her leadership in these roles has helped shape policies and practices that prioritize patient safety. As an active member of the International Society of Pharmacovigilance (ISoP), Christina collaborates with peers from around the globe to enhance safety standards and improve global pharmacovigilance practices. She is also dedicated to training and mentoring teams within regulatory authorities and marketing authorization holders. Christina has represented her organizations at numerous national and international events, where she has shared her expertise and insights. Her commitment to drug safety, regulatory excellence, and her broad industry experience have made her a leading voice in the evolution of pharmacovigilance worldwide.
Mohamed A. Elhawary
Vaccine Safety Officer & General Secretary of ISoP Egypt
Ministry of Health & Population (MoHP)
Mohamed is an expert in medication and vaccine safety with extensive experience in pharmacovigilance and regulatory affairs. He previously served as a Medication Safety Officer at the International Committee of the Red Cross (ICRC), where he focused on promoting the safety monitoring of medicinal products in resource-limited settings. Mohamed also worked as a Pharmacovigilance Coordinator & Instructor at the Central Administration of Pharmaceutical Affairs at Egypt's Ministry of Health & Population (MoHP), contributing to the enhancement of the country’s pharmacovigilance systems and he training of key personnel. Currently, Mohamed is a Vaccine Safety Officer with the Expanded Program of Immunization (EPI), where he ensures the safety and effectiveness of immunization programs. He has developed protocols, standard operating procedures (SOPs), and reports, and has presented scientific and regulatory data at both departmental and national meetings. In addition to his professional roles, Mohamed serves as the General Secretary of the ISoP Egypt Chapter, further supporting the growth and development of the pharmacovigilance in Egypt. He has also authored multiple publications in respected scientific journals, contributing to advancements in the field of medication and vaccine safety in Egypt.
Gehan El-Hefney
Medical Affairs General Manager MUP - Medical Union Pharmaceuticals
Gehan is a distinguished medical professional with extensive experience in the field of medical affairs. Currently serving as the Medical Affairs General Manager at MUP, she plays a key role in shaping the strategic direction and operational excellence within the organization. Her academic journey reflects a deep commitment to medical education and specialized training. Gehan earned her MBBCh degree from Ain Shams University in 1998, followed by a Master’s in Hematology from the same institution in 2005. Her passion for nutrition and healthcare is evident from her ESPEN Diploma in Nutrition obtained in 2012, which further complements her comprehensive knowledge. Gehan is a certified trainer with a TOT (Trainer of Trainers) Certificate from Missouri University, USA, as well as an International Business Driving License (IBDL) certification, also from Missouri University. Her commitment to continuous professional development is evident in her specialized training in Pharmacovigilance from the University of North Carolina, USA. As a Board Member of ISoP Egypt Chapter, Gehan plays a vital role in advancing pharmacovigilance and promoting the safe use of medications within the region. Her expertise, combined with her strong leadership skills, makes her a respected figure in both the medical and pharmaceutical sectors. Gehan is a passionate advocate for education, patient safety,and healthcare innovation, continually contributing to advancements in the medical community.
Senior Advisor and Solution Architect
Personalized Medicine Coalition
Denny Van Liew is a seasoned life sciences leader with extensive experience in global pharmacovigilance, regulatory affairs, and corporate transformation. He has held key roles at major US/EU-based pharmaceutical companies, advisory firms, and contract service organizations, driving performance improvements across drug safety, regulatory, and R&D functions. At Pfizer, Denny led the Safety and Regulatory Affairs Project Management Organization and Contracts & Outsourcing team, managing partnerships with top biopharma sponsors. He played a pivotal role in integrating drug safety and regulatory functions following the acquisitions of Warner-Lambert, Pharmacia, and Wyeth. His expertise extends to strategic initiatives, operational excellence, and stakeholder engagement, ensuring seamless global collaboration in complex regulatory environments. Denny has a proven track record in optimizing pharmacovigilance and regulatory frameworks, enhancing compliance, and modernizing operating models. He has led the integration of two top-20 pharma regulatory and safety organizations and spearheaded large-scale transformation projects in clinical development, medical affairs, and health systems digitization.
Amira Shehata
Country Safety Lead - Pfizer
Amira Shehata is a highly experienced Pharmacovigilance (PV) expert with over 12 years of experience at Pfizer, where she has played a key role in managing PV operations across Egypt, Levant, and Iraq (ELI) countries. She currently serves as the Qualified Person for Pharmacovigilance (QPPV) for Egypt and other countries, in addition to acting as the Arab League QPPV back-up. Throughout her career, Amira has held several pivotal roles, including Saudi QPPV back-up, Interim Gulf Country Safety Lead, and back-up to the UAE QPPV. Amira is an active member of the International Society of Pharmacovigilance (ISOP) Egypt Chapter and was previously elected as Chair of the PV group in the PhRMA association, where she contributed to shaping PV strategies and regulatory discussions. Her deep understanding of global pharmacovigilance regulations and local requirements has made her a trusted leader in the field. Amira holds a Bachelor's degree in Pharmacy from Cairo University. Her career in the pharmaceutical industry spans multiple roles that have strengthened her expertise in drug safety, regulatory compliance, and risk management. With her extensive knowledge and leadership in PV, she continues to drive high standards of patient safety and regulatory excellence across the markets she oversees.
Ahmed Hegazy
Managing Director
PVigilant Health
Dr. Ahmed Hegazy is a physician with a Master’s degree in Pharmaceutical Medicine (First Class Honor). His thesis on ADRs in the Middle East was presented at ISOP 2017. He holds certifications in Medical Quality Management, Hospital Management, and Mini MBA, along with specialized courses from esteemed institutions like George Washington University, Columbia University, and the Royal College of Physicians. He has expertise in medical affairs, clinical research, pharmacovigilance, health economics, and more. Dr. Hegazy holdscISO 9001-2015 Quality Lead Auditor Certification and is a Lean and Six Sigma Greenbelt holder. He has been awardedcfor innovation (Upjohn Award) and has numerous scientific publications. With over 27 years of experience in thecpharmaceutical industry, he has held key roles in sales, training, medical, marketing, and pharmacovigilance.cHe spent 12+ years in medical affairs and 7 years as Head of Global Patient Safety for Merck in Africa, the Middle East,cTurkey, Russia, and CIS countries. Currently, Dr. Hegazy is an Executive Consultant for Medical Affairs and Pharmacovigilance, Founder of Pvigilant Health in Dubai, and an international speaker and trainer. He chairs and moderates global, regional, and local events, and serves as a senior auditor for international firms.
