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At Eminence, we catalyse a dynamic exchange of insights and innovations.
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Key Highlights

Interactive Hands – On Workshop
Pharmacovigilance Best Practices

  • Global Pharmacovigilance Trends and Strategies
  • Signal Detection and Management

Regulatory Compliance in Drug Safety

  • Navigating Complex Regulatory Frameworks
  • Good Pharmacovigilance Practices (GVP): An Overview

Regulatory Compliance and Reporting

  • FDA and EMA Regulations: A Comparative Analysis
  • Efficient Adverse Event Reporting

Emerging Trends in Drug Safety

  • Innovations in Pharmacovigilance: Harnessing Data and Technology
  • Artificial Intelligence and Machine Learning in Pharmacovigilance
  • Digital Health and Real-World Evidence

Functional Collaboration

  • Clinical Trials and PV Intervention
  • Ensuring Data Integrity and Quality Assurance in PV Operations
  • Drug Labelling and Communication

Ensuring Patient Safety Through Quality Assurance

  • The Role of Quality Assurance in Drug Safety
  • Implementing Quality Control Measures for Drug Manufacturing

Navigating PV Audits: Best Practices, Do's, and Don'ts for Success

  • Innovations in Pharmacovigilance: Harnessing Data and Technology
  • Artificial Intelligence and Machine Learning in Pharmacovigilance
  • Digital Health and Real-World Evidence

Case Studies in Pharmacovigilance and Adverse Event Reporting

  • Clinical Trials and PV Intervention
  • Ensuring Data Integrity and Quality Assurance in PV Operations
  • Drug Labelling and Communication


Hands-On Signal Detection and Risk Management

  • The Role of Quality Assurance in Drug Safety
  • Implementing Quality Control Measures for Drug Manufacturing

SPEAKERS

Head of National Medical Product Vigilance Section - Center of Crisis Management & Drug Security Emirates Drug Establishment

Dr. Katya Ailabouni

Managing Director,
PVigilant Health

Dr. Ahmed Hegazy

Head of Pharmacovigilance Hub at Roche CEETRIS,

Middle East & Africa, ROCHE

Maha El Temamy

Program Director & Professor at College of Pharmacy,

Dubai Medical University

Prof. Mirza R. Baig

Medical Director, Drug Safety

Lovance Biotherapeutics

Dr. Tarik Messaoud

Co-Founder & Consultant

Composite Pharma

Alina Panourgia

CEO & Owner
Pharsafer

Dr. Graeme Ladds

Global Patient Safety Director MENA Region.
AstraZeneca 

Abdelhamid Shalaby

 

Director, Affiliate Head of Patient Safety,

UAE and Russia

Gilead Sciences 

Mohamed Abdel Hady

 

Global Director of Pharmacovigilance, Medical Affairs & Compliance 
Jamjoom Pharma

Dr. Muhammad Ashar Naeem

Pharmacovigilance Manager and QPPV
Vieco Pharmaceuticals

FZCO

Mina Masrour Gergis

Director, Pharmacovigilance
& UK QPPV

Ipsen Ltd.

Pav Rishiraj

 

Egyptian Drug Authority

Dr. Israa Gamal Abdel Nasser

Interim Head of Patient Safety & Pharmacovigilance IMETA

Boehringer Ingelheim

Dr. Zakaria Thamri

Regional QPPV
Accord Healthcare MENA

Dr. Ritu Pahuja

 

Senior Director PV
Thrana Tech

Vasanthi Shimoga Eswarappa

Past Speakers

Ministry of
Health/registration
and Drug Control
Department

Dr. Katya Ailabouni
General Manager Advisor - Regulatory And Pricing Affairs, Jordan Food And Drug Administration
Dr. Esraa A. Zoubi
Senior Pharmacy Specialist, Kuwait Drug and Food Control Admin
Dr. Hamza Garashi
Head of Pharmacovigilance India, Middle East, Turkey,
and Africa, Boehringer Ingelheim*
Ms. Gozde Olkay

Founder CEO, PVpharm (Madrid)
Mr. Jose Alberto Ayala Ortiz
Executive Committee Member,ISoP and Founder of InnoVigilance (Canada)
Dr. Omar Aimer
Chief Executive Officer QbD International (India)
Dr. Ranjit Barshikar
Group Chief Quality Officer, Klybeck Life Sciences,KSA
Dr. Upendra Quenim

Managing Director,
PVigilant Health

Dr. Ahmed Hegazy
Middle East Africa Hub Lead, Abbvie
Dr. Eman Gomaa
Regional PV Consultant and PVQA Auditor, PQE Group
Ms. Shahinaz Badr
Patient Safety Cluster Lead - Middle East and Turkey, Takeda
Ms. Raghda Hassan

Global Vigilance Manager

Julphar Pharma

Mr. Syed Zafeeruddin
Regulatory Affairs PV, Quality Assurance Expert
Ms. Alina Panourgia

QA Compliance, Jamjoom Pharma, Jeddah, KSA
Dr Izhar Ahmed Mansuri

Pharmaceutical Quality Control Quality Assurance
, Aster Pharmacy
Mr. Ali Ridha AlQafshat

Director - Pharmacovigilance and Drug Information Department, Ministry of Health, Oman
Mr. Hussain Al Ramimmy
Founder & Managing Partner Gazelles Management Consultancy Dubai, United Arab Emirates
Sweta Pandey

Speakers

Ministry of
Health/registration
and Drug Control
Department

Dr. Katya Ailabouni

General Manager Advisor - Regulatory And Pricing Affairs, Jordan Food And Drug Administration

Dr. Esraa A. Zoubi
Senior Pharmacy Specialist, Kuwait Drug and Food Control Admin
Dr. Hamza Garashi
Head of Pharmacovigilance India, Middle East, Turkey, and Africa, Boehringer Ingelheim*
Ms. Gozde Olkay
Founder CEO, PVpharm (Madrid)
Mr. Jose Alberto Ayala Ortiz
Executive Committee Member, ISoP and Founder of InnoVigilance (Canada)
Dr. Omar Aimer
Chief Executive Officer QbD International (India)
Dr. Ranjit Barshikar
Group Chief Quality Officer, Klybeck Life Sciences, KSA
Dr. Upendra Quenim

Managing Director,
PVigilant Health

Dr. Ahmed Hegazy
Middle East Africa Hub Lead, Abbvie
Dr. Eman Gomaa
Regional PV Consultant and PVQA Auditor, PQE Group
Ms. Shahinaz Badr
Patient Safety Cluster Lead - Middle East and Turkey, Takeda
Ms. Raghda Hassan
Global Vigilance Manager Julphar Pharma
Mr. Syed Zafeeruddin
Regulatory Affairs PV, Quality Assurance Expert
Ms. Alina Panourgia
QA Compliance, Jamjoom Pharma, Jeddah, KSA
Dr Izhar Ahmed Mansuri
Pharmaceutical Quality Control Quality Assurance, Aster Pharmacy
Mr. Ali Ridha AlQafshat

Director - Pharmacovigilance and Drug Information Department, Ministry of Health, Oman

Mr. Hussain Al Ramimmy
Founder & Managing Partner Gazelles Management Consultancy Dubai, United Arab Emirates
Sweta Pandey

Event Partners

Thought Leadership Partner

PharSafer is a Global CRO specialising in all aspects of Clinical & Post Marketing Safety; Medical Affairs; Regulatory Strategy; Auditing; Training; IT Informatics & Development. Established for over 20 years; PharSafer has a wealth of experienced individuals in the Company able to help clients in all areas of vigilance – from case processing to signal detection and from drugs to devices to vaccines; biologics; advanced therapies and cosmetics.

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Katya Nabeel Ailabouni

Head of National Medical Product Vigilance Section - Center of Crisis Management & Drug Security , Emirates Drug Establishment

Katya Nabeel Ailabouni is a dedicated clinical pharmacist with a Master’s in Clinical Pharmacy from Al Ain University, UAE (2024), and a Bachelor’s in Pharmacy from Philadelphia University, Jordan (1999). Currently, she serves as a Pharmacovigilance Officer and Import/Export Inspector at the UAE Emirates Drug Establishment (EDE). With over 20 years of experience at the Ministry of Health, she has excelled in drug registration, regulatory affairs, and pharmacovigilance. Katya’s commitment to ensuring drug safety and her expertise in managing national PV processes make her a valuable asset to the UAE’s healthcare sector.

Dr. Ahmed Hegazy

Founder, Pvigilant Health - Dubai

Dr. Ahmed Hegazy is a seasoned physician and pharmaceutical medicine expert with over 27 years of extensive experience across sales, medical affairs, marketing, training, and pharmacovigilance in the pharmaceutical industry. He holds a Master’s degree in Pharmaceutical Medicine with First Class Honours for his thesis on Adverse Drug Reactions in the Middle East—recognized with distinction, presented at ISoP 2017, and published in Drug Safety.

His academic journey is enriched with certifications from prestigious institutions including George Washington University (Neurology), Columbia University (Immunology and Transplantation), the Royal College of Physicians (GCP & Clinical Research), Uppsala Monitoring Centre (Pharmacovigilance), and more. He also holds a Mini MBA, and diplomas in Medical Quality and Hospital Management. Additionally, he is an ISO 9001:2015 Lead Auditor (IRCA-accredited) and a Lean Six Sigma Green Belt holder.

Dr. Hegazy served as Head of Global Patient Safety at Merck for seven years, overseeing PV operations across 82 countries with a team across eight nations. His Medical Affairs leadership spans 12+ years across various therapeutic areas, including neurology, oncology, endocrinology, immunology, and infectious diseases.

He is currently the Founder of Pvigilant Health, based in Dubai, and operates as an Executive Consultant in Medical Affairs and Pharmacovigilance for local and global firms. A respected thought leader, he regularly chairs, moderates, and speaks at conferences and trains regulatory bodies, academic institutions, and industry professionals worldwide.

Drug discovery and development, Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance. His current position is Head of Global Patient Safety for Intercontinental Region (Africa, Middle East, Turkey, Russia and CIS) at Merck. I am based in Dubai, UAE and my team members are based in 7 hubs / locations across the region.

Maha El Temamy

Head of Pharmacovigilance Hub at Roche CEETRIS, Middle East & Africa, ROCHE

Maha Eltemamy, a pharmacist by training, brings 19 years of diversified experience in pharmacovigilance, healthcare compliance, clinical operations, sales, and marketing across both regional and local landscapes.

Maha’s career began with Sanofi-Aventis in 2006 in sales, subsequently joining Roche Egypt in 2008. Her initial roles in sales and marketing provided her with unique insights into patient needs and healthcare system gaps. In 2011, Maha transitioned into pharmacovigilance as a Local Safety Responsible, marking the start of her dedicated journey in ensuring patient safety.

As the current Regional Pharmacovigilance Hub Head, Maha has been instrumental in the creation and growth of the Middle East PV Hub. She is passionate about developing high-performing teams who are purpose driven and has played a crucial role in establishing a connected global PV Hub community. Her leadership in various strategic PAN PV Hub initiatives has been pivotal over the past few years.

Maha’s recent focus has been on shaping the future of a PV-centric ecosystem. She contributed significantly to the co-creation and evolution of Roche International Patient Safety and PAN PV Hubs strategy. Additionally, she has held a prominent leadership role where she was key in the design and realization of the Imagine Safety initiative.

Maha strongly believes that patients and caregivers have the right to get access to the information that influences their treatment journey. Her unwavering commitment to enhancing drug safety underscores her passion for making a meaningful difference in patient care.

Prof. Mirza R. Baig

Program Director & Professor at College of Pharmacy, Dubai Medical University

Prof. Dr. Mirza R. Baig is currently working as an Associate Dean- Clinical Affairs at Dubai Pharmacy College for Girls. He did his PhD in Clinical Pharmacy from University Science Malaysia (USM), Malaysia. He worked in Malaysia, India and have international teaching and research experience of about 22 years. He has been named among top scientists in the world in the scientific index 2024-25. He has one German patent 2022 and two US patents 2024, in collaboration with King Abdul Aziz University, Saudi Arabia. He published six books as co-author, related to Clinical Pharmacy and recent one as an editor in Springer publication April 2024 on Drug Development. He published more than 120 research articles in International Journals with a recent paper published in Jan 2025. He has been invited as a chairperson, speaker and moderator to many international conferences and seminars. He is on the editorial board in various international journals, including reviewer for couple of Elsevier journals. He supervised numerous master and PhD students for their research projects. He also reviewed several Master and PhD thesis for Indian and foreign universities as an external examiner. He received many awards in his career, a few of it as, the Distinguished Alumnus Award 2024 from KLE University, India, Best Research Project 2023, in a conference held in Al Ain University, Best Research Project 2019, in a conference held in University of Sharjah, Best Professor in Clinical Pharmacy in Middle East Educational Awards 2018, Best oral presentation in DUPHAT Dubai 2017, Best Quality Poster in 2016 in DUPHAT Dubai, an Outstanding scientist by a research foundation in India 2016, Best oral presentation in Dubai 2015 & 2014, young scientist award in Malaysia in 2013, Best presentation award in IPC, Chennai 2003, in India. His area of research is Pharmacoepidemiology, Drug safety and efficacy, Drug Utilization Studies, Pharmacovigilance, and Public health.

Dr. Tarik Messaoud

Medical Director, Drug Safety Physician - ClinoSphere Inc.

Dr. Tarik Messaoud is a physician and international consultant, advisor, and speaker in pharmacovigilance, regularly contributing to major drug safety congresses in the United States and Canada. 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 across Canada and the United States, he specializes in oncology drug safety, particularly in immunotherapy, adoptive cell therapy, and checkpoint inhibitor–based cancer treatments. His career includes medical and safety leadership roles at Merck/MSD, GlaxoSmithKline, and Iovance Biotherapeutics focused on patient safety.

Dr. Messaoud brings extensive expertise in global pharmacovigilance regulations, including Health Canada, FDA, ICH, and EMA guidelines.

Alina Panourgia

Co-Founder & Consultant, Composite Pharma
Alina is an experienced Quality Assurance Auditor and Regulatory Affairs professional who worked across the EU, US and APAC regions.
Since moving to the Middle East from Asia, Alina has worked as a Regulatory, PV and Quality freelancer. Alina covers MENA, LATAM and CIS regions for regulatory submissions while working with UK and EU companies on PV projects.
Alina is due to complete her Thesis in Pharmacovigilance on “Post-authorisation safety studies in EU and MENA regions”.

Dr. Graeme Ladds

CEO & Owner, Pharsafer.

Dr. Graeme Ladds has been involved in Drug Safety for the last 35 years holding senior positions in a number of top ten Pharma. As CEO of PharSafer Graeme has established a global Company looking after the safety of many different client product types and has overseen over 100 Regulatory Inspections globally, and understands intimately the requirements for operating a compliant safety system in order to protect patients properly and quickly satisfying the regulations.

Abdelhamid Shalaby

Global Patient Safety Director MENA Region, AstraZeneca.

Abdelhamid Shalaby is the Global Patient Safety Director for the MENA Region at AstraZeneca, bringing extensive experience in pharmacovigilance, regulatory compliance, and patient safety across diverse markets. Based in the United Arab Emirates, he has held senior roles focused on ensuring the effective implementation of safety processes, oversight of adverse event reporting, and alignment of safety systems with evolving regional and global regulatory expectations.

With a strong foundation in medical and patient safety management spanning the Gulf, Pakistan, and broader MENA territories, Abdelhamid combines strategic leadership with practical insights into safety governance and risk minimization. His work emphasizes cross-functional collaboration, robust safety data analysis, and proactive responses to emerging safety signals.

Abdelhamid’s regional expertise equips him to navigate the complexities of local regulatory frameworks while advancing patient safety initiatives that align with global best practices.

Mohamed Abdel Hady

Director, Affiliate Head of Patient Safety, UAE and Russia, Gilead Sciences

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.

 

Dr. Muhammad Ashar Naeem

Global Director of Pharmacovigilance, Medical Affairs & Compliance, Jamjoom Pharma

Dr. Muhammad Ashar Naeem is a distinguished leader and expert in the field of pharmacovigilance and pharmaceutical compliance. He currently serves as the Global Director of Pharmacovigilance, Medical Affairs & Compliance at Jamjoom Pharma in Jeddah, Saudi Arabia. In this pivotal role, Dr. Naeem is responsible for steering the company’s global drug safety strategies, ensuring stringent adherence to regulatory guidelines imposed by international and local health authorities, including the Saudi Food and Drug Authority (SFDA).

An acclaimed international speaker, Dr. Naeem is a recognized authority on navigating the complexities of pharmacovigilance systems within the Middle East and North Africa (MENA) region. He frequently shares his expertise at global industry conferences, such as the World Drug Safety Congress Europe, where he contributes to critical discussions on adverse drug reaction (ADR) reporting and maintaining comprehensive compliance across diverse markets.

With a strong educational foundation from institutions like Hamdard University, Dr. Naeem’s career is dedicated to enhancing patient safety through robust monitoring systems and effective medical affairs leadership. His leadership is crucial in fostering a culture of regulatory excellence and patient-centric drug safety within Jamjoom Pharma’s operations. His work ensures that the company remains at the forefront of ethical pharmaceutical practice and regulatory compliance on a global scale.

Mina Masrour Gergis

Pharmacovigilance Manager and QPPV
Vieco Pharmaceuticals FZCO

Mina Masrour Gergis, Pharmacovigilance Manager and QPPV at Vieco Pharmaceuticals FZCO, and a recognized expert in establishing robust, compliant Pharmacovigilance systems for emerging markets.

With over seven years of progressive pharmacovigilance expertise, he is recognized for pioneering the establishment of the entire PV function from the ground up at Vieco Pharmaceuticals FZCO, including the comprehensive PV system and the Pharmacovigilance System Master File (PSMF). This foundational work ensures strategic safety oversight across the Middle East with a clear roadmap for future global markets.

During his tenure at Novo Nordisk Egypt, he served as the Egypt QPPV, accountable for the strategic oversight and operational integrity of the PV system. He achieved outstanding GVP compliance results in global audits and successfully navigated an official inspection by the Egyptian Drug Authority (EDA) for both global and local systems with excellent results. His performance, which drove significant GVP compliance and process excellence, was formally recognized with the prestigious Novo Nordisk Grow Award in 2023.

He holds a Diploma of Pharmacovigilance from the Faculty of Pharmacy, Cairo University, where he has also been an invited expert speaker for the “Pharma Compass” seminar, guiding students on Pharmacovigilance career pathways.

Mr. Pav Rishiraj

Director, Pharmacovigilance & UK QPPV, Ipsen Ltd | ABPI Board SG Member & PV Expert Chair

Pav Rishiraj is a globally recognised healthcare leader in Pharmacovigilance and Patient Safety with over 25 years of experience.  Currently, Director of Pharmacovigilance & UK QPPV at Ipsen Biopharma. Additionally, he serves as Chair of the UK ABPI Pharmacovigilance Expert Network, leading industry-wide collaboration and innovation in patient safety. 

Pav is also an active member of the International Society of Pharmacovigilance (ISoP), contributing to the advancement of global PV practice. Recognised as a key thought leader, he is widely respected for his ability to translate complex regulatory science into impactful, engaging insights. Through key chairing roles, international forums, and close collaboration with health authorities, Pav continues to shape global pharmacovigilance policy and plays a pivotal role in influencing the UK PV landscape post-Brexit. Known for his compelling keynote delivery and empowering leadership style, Pav inspires audiences to focus on what truly matters within the discipline.

Dr. Israa Gamal Abdel Nasser

Egyptian Drug Authority

Dr. Israa Gamal Abdel Nasser is a pharmacist, MBA holder, and experienced regulatory professional with deep expertise across national medicines regulation, pharmacovigilance, and international cooperation. A graduate of the Faculty of Pharmacy, Cairo University, she is also a Francophone professional, enabling effective engagement across regional and global regulatory platforms.

Dr. Israa has held multiple senior technical and advisory roles within the Egyptian Ministry of Health and Populationand the Egyptian Drug Authority (EDA). Her experience spans key regulatory functions including pharmacovigilance operations, vaccine safety (EPI ICSR management), medical inserts and scientific references, promotional materials oversight, and pharmaceutical practice governance.

She has served as a member of the Chairman’s Technical Office at the Egyptian Drug Authority, supporting portfolios related to pharmaceutical products, foreign affairs, international cooperation, and regulatory communications. Currently, she is a senior member of the Technical Office of the Central Administration of Pharmaceutical Care, with responsibility for pharmacovigilance-related matters and follow-up of the national pharmacovigilance committee.

In addition, Dr. Israa contributes to global regulatory collaboration as a member of the EDA internal taskforce for the ICMRA Working Group on Rare Diseases. Her profile reflects a strong blend of regulatory strategy, PV execution, and cross-border collaboration, making her a valuable voice in regional and international drug safety discussions.

 

DR. ZAKARIA THAMRI

INTERIM HEAD OF PATIENT SAFETY & PHARMACOVIGILANCE IMETA, BOEHRINGER INGELHEIM

Dr. Zakaria holds a Doctoral degree in pharmacy from Algeria and a Pharmacovigilance certificate from France.
He started his career in Pharmacovigilance at Roche Pharmaceutical, where he has also served in different roles in Medical Affairs and Products Quality.

Dr. Zakaria joined Boehringer Ingelheim 2019 as Pharmacovigilance Manager for the North-West Africa Region, in 2021, he moved to Dubai as regional Pharmacovigilance Lead for the IMETA region (India, Middle East, Turkey, and Africa) based in Dubai-UAE. In August 2025, Zakaria has been appointed as the interim Head of Patient Safety & Pharmacovigilance IMETA.

Dr. Ritu Pahuja

Regional QPPV - Accord Healthcare MENA

Dr. Ritu Pahuja is a seasoned pharmaceutical leader with over 16 years of experience across Pharmacovigilance (PV), Regulatory Affairs (RA), and regulatory compliance in the EU, MENA, and Asian regions. She currently serves as the Regional QPPV for Accord UK Products, where she oversees all PV operational activities and acts as the Regional QPPV for Accord Healthcare products, ensuring strong safety governance and regulatory excellence across all MENA markets.

A PhD holder and postgraduate from AIIMS, New Delhi, India’s premier medical institution, and an MBA holder from Middlesex University, Dr. Pahuja has contributed to complex therapeutic portfolios including oncology, biosimilars, and medical devices. Her career spans several leading multinational companies such as Johnson & Johnson, Astellas, Covidien, Medtronic, Boston Scientific, Aspen Healthcare, and others, where she strengthened PV systems, regulatory frameworks, and compliance operations. She has also collaborated directly with the EMA on the EudraVigilance project, contributing to global safety surveillance standards.

In addition to her PV leadership, she is responsible for setting regulatory strategy, registering pharmaceuticals, and leading product launches across MENA, ensuring timely access to high quality medicines. She brings proven expertise in building and executing PV QMS, establishing regional and affiliate governance models, and leading audits, inspections, and CAPA implementation. Known for her strong performance and ability to build high performing teams, she consistently delivers operational and compliance excellence.

Dr. Pahuja is deeply passionate about drug safety, a commitment that has shaped her career since her early academic years. Alongside her industry roles, she has served as an Adjunct Assistant Professor at Dubai Pharmacy College, where she taught Pharmacovigilance to postgraduate students for nearly seven years. Her academic contributions reflect her dedication to nurturing the next generation of safety and regulatory professionals and advancing PV education in the region.

Beyond her technical and academic leadership, she is a certified Mental Health First Aider, committed to fostering psychological safety, compassionate leadership, and well being within the healthcare community.

Her work embodies a holistic approach to patient safety- strengthening systems, empowering people, and elevating healthcare standards across the MENA region and beyond.

Vasanthi Shimoga Eswarappa

Senior Director PV, Thrana Tech.

Vasanthi is an accomplished professional with nearly 27 years of experience, bringing extensive expertise in Medical Safety projects, delivery management, client engagement, and people management. Successfully trained over 800 professionals in handling safety data for clinical trials and marketed products, including pharmaceuticals, nutrition, cosmetics, medical devices, clinical data management, and toxicology. Highly skilled in managing adverse event (AE) and serious adverse event (SAE) case reports across multiple clinical trials and post-marketing studies, ensuring timely submission to global regulatory authorities. Vasanthi has proven ability to identify and resolve pain points related to drug and device ICSR case processing within stipulated timelines. She has led various leadership roles during her tenure at different multinational contract research organizations and Pharma companies.

Dr. Esraa Al-Zoubi

Middle East & Africa MEA Hub Lead, Abbvie
Dr Esraa obtained her bachelor’s degree in pharmacy from Jordan University of Science and Technology in 1999; she was involved in the Professional Training Program in Regulatory Affairs of Drugs and Medical Devices Submission.
Dr. Esraa has over 20 years of experience in the field of pharmaceutical practice & regulatory affairs, she started her career in the private sector in the year 2000 and then moved to JFDA in 2008 where she is currently working as a consultant in the Regulatory and Pricing Pharmaceuticals Affairs. She has also served as Head of GMP inspection & Information Department and chaired many technical committees at JFDA and MOH.
She was also a board member of the Jordan Pharmacy Association (JPA) and represented JFDA & JPA as a speaker at many National and International conferences.
Dr. Esraa is highly committed to her profession and prides herself on her attention to detail. She uses her positive attitude and energy consistently to encourage others in her team to work hard and succeed.

Dr. Hamza Garashi

Senior Pharmacy Specialist, Kuwait Drug and Food Control Admin
Jan 2004 Till Date: Ministry of Health /registration and Drug Control Department as Follow:
Jan 2005 Dec 2008: Registration Officer (New Drug Application, Renewal Of registration, Minor variation, manufacturing facilities registration and Local manufacturer registration). Dec 2008-date: Pharmacovigilance officer (Reporter of the UAE national Pharmacovigilance Committee). Jul 2002-May 2003 Pharmacist in Charge: Al Nahdha Pharmacy Abu Dhabi Nov 1999-Dece 2001 Pharmacist: Mermaid Pharmacy Abu Dhabi

Ms. Gozde Olkay

Head of Patients Safety and Pharmacovigilance of India Middle East Turkey and Africa region

Gozde Olkay, is currently working in Boehringer Ingelheim as a Head of Patients Safety and Pharmacovigilance of India Middle East Turkey and Africa region, with coverage of 36 countries.  

She is a proud graduate of
 Istanbul University Faculty of Pharmacy, and then completed her master degree in business administration. She has been working multinational pharmaceutical companies as an expat, over the last 25 years. She had global roles in Germany, Vienna, Istanbul and finally in Dubai.

Prior to her current role, she was leading Emerging Markets in Research and Development Unit of BI, conducting the early phase trials in different therapy areas.

She has moved to PV function in 2019 and became a member of Regional Leadership Team of BI PSPV. She is a true believer in the partnerships and collaborative work and effort which need to be spent collectively with academia, HAs as well as pharmaceuticals in order to leverage the PV understanding and importance within the region.

Gozde is a mother of a 10 years old boy, passionate about cooking, travelling and cinema.

Mr. Jose Alberto Ayala Ortiz

Founder & CEO, PVpharm
José Alberto Ayala Ortiz (M.Sc. Pharm. and M.Sc. IT) has more than 20 years of experience in Pharmacovigilance and Drug Safety. He has experience from the Regulatory (Danish Medicines Agency) and the Pharmaceutical Industry in clinical safety and PV. Besides his day-to-day Pharmacovigilance work as a consultant, he is an active trainer of pharmacovigilance and GVP, the EVWeb and XEVMPD training courses since 2003, and the DIA Signal Management, PSMF, and Quality Management in PV training courses. He also provides EU QPPV services and local QPPV services in Spain and other EU countries for Pharmaceutical Companies and other consultancies through PVpharm, where he is the founder and CEO. He is also an expert PV Auditor. He has been awarded the Honorific Mention from the Faculty of Pharmacy at the University of Granada.

Dr. Omar Aimer

Pharmacovigilance and drug safety specialist
Omar Aimer has more than 18 combined years of experience in Pharmacovigilance, Quality Assurance and Risk Management in Pharmaceutical Industry, regulatory authority and Hospital environment in Europe and North America. He has also more than 11 years of experience in parallel as a lecturer on Pharmacology and Clinical Research.
Omar holds a Degree in Pharmacy from the University of Oran (Algeria), PhD in Pharmacology from Algiers University (Algeria), a Master in Pharmacovigilance and Drug Safety from Paris Descartes University (France) and a Certification on Improving Global Health with a Focus on Quality and Safety from Harvard T.H. Chan School of Public Health.
He has previously worked as Safety Officer at Pfizer and Pharmacovigilance Specialist at Sanofi in Montreal, Canada.
Omar is a member of the International Society of Pharmacovigilance (ISoP), Leader of the Medical Device Safety – Special Interest Group (SIG) and served on the Executive Committee as the Coordinator of Membership at North American Chapter of ISoP.
He has presented in multiple scientific forums and contribute in several per reviewed publications with interest in new technologies, regulation, and the improvement of pharmacovigilance around the world.

Dr. Ranjit Barshikar

Chief Executive Officer
QbD International
With a 50-year career, Dr. Barshikar brings extensive expertise in Quality Management, R&D, and Regulatory affairs. Currently, serving as a “Quality by Design/cGMP consultant” and “Quality Expert,” he advises prestigious institutions including Emerson Process Management, World Bank, and PwC, alongside numerous Indian companies. Specializing in “Quality by Design” implementation, he has served as a United Nations Geneva as an MPP Adviser.

Dr. Upendra Quenim

Pharmaceutical Quality Control & Quality Assurance, Aster Pharmacy
With over 39 years of experience in Quality Control/Assurance, Regulatory Affairs, and R&D in the pharmaceutical sector, Dr. Upendra Quenim has made a lasting impact globally. Holding key roles at Flamingo Pharmaceuticals, Macleods Pharmaceuticals Ltd., and Geltec Pvt Ltd., he has worked across India, Saudi Arabia, Oman, and Switzerland. Currently serving as Chief Quality Officer at Klybeck Life Sciences Group, Saudi Arabia, Dr. Quenim oversees six manufacturing plants, ensuring successful SFDA audits. His achievements include setting up global standards at Klybeck and leading Swiss Garnier Genexiaa to a 100% success rate in quality audits, and attracting contracts from top pharmaceutical companies. Recognized for outstanding leadership at the Health 2.0 Dubai Awards 2023 and awarded Pharma Ratna Universe 2023, Dr. Quenim’s leadership embodies technical expertise, crisis management, and strategic vision, making him a sought-after speaker at industry events.

Dr. Eman Gomaa

International Safety Operations and Capabilities Lead
Eman has had a wealth of experience in PV since 2012, with a strong network of 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 acquired Allergan in May 2020, Eman supported the global and affiliate PV integration workstreams and subsequently was appointed in May 2021 as the Lead of the Middle East & Africa PV hub, the largest PV hub in Abbvie.
She also has vast experience in delivering training to multiple pharmaceutical companies in Egypt on Arab GVP and her training was accredited and acknowledged by the Head of the Egyptian Pharmaceutical Vigilance Center in Egypt.
She also has had multiple lectures in the annual PV course arranged by PRA and the Dubai Pharmacy College since 2020.
Eman is now the Middle East & Africa MEA Hub Lead in Abbvie and is a member of the International Society of Pharmacovigilance ISoP, ISoP Middle East Chapter, and the Country Representative in the United Arab Emirates.

Shahinaz Badr

Pharmacovigilance Consultant and PVQA Lead Auditor- EMEA- Pharma Quality Europe Group
Shahinaz, pharmacist with more than 20 years’ experience in pharmacy and pharmaceutical business, currently working as Pharmacovigilance Consultant and lead auditor for global service provider-PQE Group covering the Europe Middle East Africa Region. Started her career as a clinical pharmacist in Cairo University Medical School Teaching Hospital integrating with top HCPs of different specialties in interdisciplinary healthcare systems, where safety monitoring was always an integral part of clinical practice, she then promoted to be internal auditor for the organization stores, supplies, and pharmacy units. Leveraging on her expertise, Shahinaz joined the pharmaceutical industry in Regulatory Affairs at local level then regional position before focusing on Pharmacovigilance for the wider EMEA region. Actively participating in pharmacovigilance regulatory Intelligence in a role enabling her to interact with industry colleagues and Competent Authorities Pharmacovigilance departments. Recognized for building effective PV QMS, and for PV training. Shahinaz is an active member in the ISOP Special Interest Group collaborating in the initiation of the GPPC (Global Pharmacovigilance Certificate), and PV Quality certification. She has contributed as a speaker and program committee member to several international conferences, initiatives and partnerships to help support patient safety and improve monitoring of drugs safety.

Raghda Mohamed

Patient Safety Cluster Lead - Middle East and Turkey / Global Patient Safety Evaluation at Takeda
Raghda Mohamed Hassan, a Pharmacist by Education, Pharmacovigilance Lead for the Middle East & turkey Cluster. She has over 12 years of experience in the regional Pharmacovigilance field through different pharma industries, Eli-Lilly, Shire, and now Takeda. She has successfully worked on different strategic models in Pharmacovigilance. Getting the opportunity to establish a PV system on a local level, leading integration of two PV systems and re-shaping Patient safety mindset. I have years of experience managing diversified geographical and cultural territories to optimize PV excellence. Active member in Pharmacovigilance Public Association, EFPIA, and PHAME.

Syed Zafeeruddin

Global Pharmacovigilance Manager
Julphar
With over 15 years of experience, Syed Zafeeruddin is a subject matter expert for Pharmacovigilance & Clinical trial domains. He is involved in the interface with legal and regulatory health authorities, and facilitates auditing health authority for clinical and pharmacovigilance aspects.
His expertise lies in US-FDA, EMEA, MHRA audit inspection for Pharmacovigilance and Clinical trial along with preparing, analyzing, and following-up of AE and SAE reports in compliance with Julphar’s SOPs and applicable guidelines.

Dr Izhar Ahmed Mansuri

QA Compliance, Jamjoom Pharma, Jeddah, KSA
With 25 years of expertise in Quality Management, Dr. Izhar Ahmed Mansuri excels in enforcing cGMP, quality, and regulatory compliance standards. As QA Compliance professional at Jamjoom Pharma, Jeddah, KSA, he adeptly manages various aspects, including change control, deviations, product complaints, CAPA, audits, training, and SOPs. Dr. Mansuri played a pivotal role in securing ISO 9001, ISO 13485, and CE mark certifications for medical devices, serving as the Person Responsible for Regulatory Compliance. His proficiency extends to conducting supplier, distributor, and regulatory audits, such as USFDA, MCC, EU MDR, and Saudi FDA. Having diverse experience in contract manufacturing with multinational giants like Schering-Plough and Pfizer, he has successfully implemented Pharmacovigilance processes and led SAP system validation using GAMP 5 protocols. Driven by a passion for digitalization trends, he applies technology to address evolving quality challenges.

Mr. Ali Ridha AlQafshat

Pharmaceutical Quality Control & Quality Assurance, Aster Pharmacy
As a seasoned Quality Control and Quality Assurance professional, Ali Ridha AlQafshat excels in coordinating QA activities, demonstrating attention to detail, and leveraging advanced technologies to ensure top-notch product quality. With a PharmD degree from Batterjee Medical College and pursuing a Master’s Degree in Pharmaceutical Quality Control & Quality Assurance from King Saudi University, Ali has contributed significantly to renowned companies. In his current role as Pharmacist I at Aster Nahdi Medical Company, Riyadh, he oversees retail store operations and provides healthcare advice. His impactful tenure at Tabuk Pharmaceutical Company as a Senior Medical Sales Representative reflects achievements in product promotion, market share growth, and fostering strong customer relationships.

Mr. Hussain Al Ramimmy

Director - Pharmacovigilance and Drug Information Department, Ministry of Health, Oman
Jan 2004 Till Date: Ministry of Health /registration and Drug Control Department as Follow:
Jan 2005 Dec 2008: Registration Officer (New Drug Application, Renewal Of registration, Minor variation, manufacturing facilities registration and Local manufacturer registration). Dec 2008-date: Pharmacovigilance officer (Reporter of the UAE national Pharmacovigilance Committee). Jul 2002-May 2003 Pharmacist in Charge: Al Nahdha Pharmacy Abu Dhabi Nov 1999-Dece 2001 Pharmacist: Mermaid Pharmacy Abu Dhabi

Sweta Pandey

Founder & Managing Partner Gazelles Management Consultancy Dubai, United Arab Emirates
Sweta Pandey is the Founder & Managing Partner of Gazelles Management Consultancy in Dubai, UAE. She’s a first-generation entrepreneur, innovator, coach, and facilitator with 18 years of expertise in transforming organizations. She specializes in areas such as business strategy, change management, innovation management, project management, organization development, and operational excellence.
She is also known for her pioneering work in Lego Serious Play methodology and enhancing experiential learning in various domains. As an assessor and jury member of prestigious awards and groups, she actively promotes a quality-based culture in the UAE. She is also involved in developing innovative products like “OPEXMS” for operational excellence and “OPEXEDU,” an edtech platform focused on upskilling youth in life skills