DSS Dubai – Drug Safety Symposium
Drug Safety Symposium 2025
Dubai Chapter

February 12th – 13th, 2025
Advancing Excellence in Pharmaceutical Vigilance, Regulatory Affairs and Quality Assurance.

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Enhancing Quality Assurance

At Drug Safety Symposium 2024, we are at the forefront of ensuring drug safety through the rigorous practices of pharmacovigilance, regulatory compliance, and quality assurance. Our premier gathering provides a dynamic platform where attendees can explore the latest industry trends, stay updated on regulatory changes, and discover innovative solutions that drive the pharmaceutical industry forward. We are committed to excellence and facilitating meaningful discussions, knowledge sharing, and collaboration.

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Why Drug Safety Matters

In an ever-evolving pharmaceutical landscape, the importance of drug safety cannot be overstated. Each day, countless lives depend on the efficacy and safety of pharmaceutical products. Our mission is to advance the critical mission of ensuring that every drug is not only effective but also safe for consumption.

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A Uniquely Engaging Event

What sets Drug Safety Symposium 2024 apart is our unique approach. We combine insightful knowledge sharing with interactive workshops and networking opportunities, all in an atmosphere of camaraderie and fun. It's not just an event; it's an experience that empowers you to make informed decisions and contribute to the highest standards of drug safety and quality.

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Hours
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Our Commitment

At Eminence, we catalyse a dynamic exchange of insights and innovations.
What makes us unique?
  • Global Thought Leadership
  • Interactive Learning: We don't just talk; we engage
  • Pre-Event Online Preparatory Meeting
  • During the Event - Keynotes, Workshops, and More
  • Post-Event Follow-Up Session
  • MENA Regional Focus
  • Cutting-Edge Technology
  • Regulatory Insights
  • Dubai as Your Host

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

Cross 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

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

Past Partners

By partnering with us, you can position your brand at the forefront of the pharmaceutical landscape and gain invaluable exposure to a highly targeted and influential audience.

Media Partners

Pricing

Early Bird

(Till December 15th)

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VIRTUAL
Early Bird

(Till December 15th)

USD 1000
Standard
USD 1200
In-person
Early Bird

(Till December 15th)

USD 1500
Standard
USD 1800
Contact for group discount
Include Price 5% Vat
Standard
VIRTUAL
Standard
USD 1200

+5% VAT

In-person
Standard
USD 1800

+5% VAT

Contact for group discount
Include Price 5% Vat
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Dubai

Venue: Holiday Inn & Suites Dubai Science Park, an IHG Hotel, Dubai, UAE.

What Can You Do In Dubai

22.2 KM Distance
Burj Khalifa
12.7 KM Distance
Explore the Desert
22 KM Distance
Museum of the Future
19.3 KM Distance
Dubai Aquarium
15 KM Distance
Palm Jumeirah
18 KM Distance
Atlantis Dubai
26 KM Distance
Dubai frame
103 KM Distance
Ferrari World
2.6 KM Distance
Dubai Miracle Garden
15 KM Distance
Burj Al Arab
15 KM Distance
Skydive Dubai
25 KM Distance
World Trade Centre
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Katya Nabeel Ailabouni

Pharmacist
Education:
Qualification: B.SC Pharmacy, 1995-1999 Philadelphia University/ Amman Jordan
Current title:
Pharmacovigilance Officer, UAE MOH Import /Export Inspector, UAE MOHAP
Professional experience:
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

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 Pharmacovigilance India, Middle East, Turkey, and Africa, Boehringer Ingelheim*
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

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. Ahmed Hegazy

Managing Director,
PVigilant Health
With over 3 decades of experience, Dr. Hegazy has a diverse experience in the pharma industry including Pfizer and Merck. He has received various awards and recognitions in innovation (Upjohn Award), achievements and others. A Physician by education, he also holds a Masters degree in Pharmaceutical Medicine and Pharmacovigilance (PV).
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.

Dr. Eman Gomaa

Middle East & Africa MEA Hub Lead, Abbvie
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.

Ms Alina Panourgia

Alina holds a bachelor’s degree in Pharmacy from the University in Moscow and MBA degree from Nottingham University, UK.
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 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