DSS Dubai – Drug Safety Symposium
Days
Hours
Minutes
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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

Speakers

Executive Committee Member,ISoP and Founder of InnoVigilance (Canada)

Dr. Omar Aimer

Middle East Africa Hub Lead, Abbvie

Dr. Eman Gomaa

Ministry of
Health/registration
and Drug Control
Department

Dr. Katya Ailabouni

Patient Safety Cluster Lead - Middle East and Turkey, Takeda

Dr. Raghda Hassan

Managing Director,
PVigilant Health

Dr. Ahmed Hegazy

Head of Iraqi Pharmacovigilance Center- (MOH)

Dr. Manal M. Younus

Medical Director,
Iovance Biotherapeutics (San Fransisco, USA)

Dr. Tarik Messaoud

Associate Director - Non Drug Program, Novartis

Dr. Laila Fatima

Associate Director - Global Pharmacovigilance & Business Excellence,
Organon

Rania Haggag

A/Executive Director,
Marketed Health Products Directorate, Health Canada

Dr.Rania Mouchantaf

Regional PV Consultant and PVQA Auditor, PQE Group

Ms. Shahinaz Badr

Director General Technical Assistant / Jordan Food & Drug Administration

Wesal AlHaqaish

Heads Global Pharmacovigilance & Clinical Operations, Arcolab
Dr. Gopal Muralidharan

Regional Pharmacovigilance Hub Head (Middle East, Africa, India Subcontinent & Turkey)

Maha El Temamy

Director General
The National Centre for pharmacovigilance -Algeria

Prof. Nouzha Lazli

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

Media Partners

Pricing

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(Till December 5th)

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USD 1500
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Dubai

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

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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. 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.

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

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.

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.

Manal M. Younus

Head of Iraqi Pharmacovigilance Center- (MOH)

Dr. Manal Younus currently heads the Iraqi Pharmacovigilance Center within the Ministry of Health. With a background as a pharmacist holding a Ph.D. in clinical pharmacy, she led the creation and expansion of Iraq’s pharmacovigilance system. Dr. Younus is an ISoP fellow and serves as an Advisory Board member, leading the ISoP students group as the Students Group coordinator. Additionally, she holds a position on the Executive Committee of the CIOMS organization.

Dr. Younus, co-founder of the ISoP Patient Engagement SIG and vice president of the ISoP Middle East chapter, remains deeply involved in advancing drug safety initiatives. Her contributions extend to include over 40 articles and 3 book chapters authored on various drug safety topics, along with the supervision of many postgraduate students. She serves as a WHO benchmarking assessor and is affiliated with the International Academy of Public Health’s Scientific Council and the AMR Specialty Committee member.

The PSMF organization recently awarded Dr. Younus a fellowship in patient safety, further demonstrating her commitment to raising healthcare standards.

Dr. Tarik Messaoud

Medical Director, Iovance Biotherapeutics (San Fransisco, USA)

Dr. Tarik Messaoud is a physician, consultant, and speaker at pharmacovigilance conferences in the USA 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, he specializes in oncology drug safety, particularly in immunotherapy and adoptive cell therapy involving checkpoint inhibitors.

Dr. Messaoud has worked with prominent pharmaceutical companies such as Merck/MSD and GlaxoSmithKline, as well as biotechnology firms 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.

Dr. Laila Fatima

Associate Director - Non Drug Program, Novartis

Laila brings over 20 years of expertise in the pharmaceutical and healthcare industries, excelling in project management and regulatory strategies. With a proven track record, she led a diverse portfolio of 60+ projects with varying regulatory requirements across multiple countries, ensuring on-time and within-budget delivery. She published 7 international and 2 national research papers, earned a Doctorate in Pharmaceutical Sciences from BITS Pilani, India, and hold certifications including Project Management Professional (PMP), Six Sigma Green Belt, Lean Six Sigma, Agile Foundations, Scrum Basics, and Design Thinking.

Her competencies extend beyond project management to encompass strategic and operational leadership, business transformation, regulatory risk assessment and mitigation, vendor and contract management, stakeholder management, and effective management reporting. She is passionate about driving success in pharmaceutical research and development, and looks forward to contributing my skills and experience to further your organizational goals.

Rania Haggag

Associate Director - Global Pharmacovigilance & Business Excellence, Organon

Rania Haggag is a dedicated and accomplished professional in the field of
pharmacovigilance (PV), known for her commitment to ensuring the safety and efficacy of
medications. Rania began her career as an intern at MSD Americas, working in the Data
Management Center. This early experience ignited her passion for pharmacovigilance and
provided her with a solid foundation in the critical processes involved in monitoring drug
safety.
 
Driven by her enthusiasm and determination, Rania moved up the ranks within MSD. She
joined the Middle East PV office, where her skills and dedication were quickly recognized,
leading to her promotion to Pharmacovigilance Lead. In this role, she demonstrated her
ability to manage teams and streamline processes, ensuring compliance with regulatory
standards and enhancing patient safety.
 
When MSD underwent a significant spin-off, Rania transitioned to Organon, where she took
on the role of PV Lead for the Gulf and Levant regions. Her leadership in this position further
solidified her expertise and influence in pharmacovigilance, as she played a vital role in
implementing effective safety monitoring practices across multiple markets.
 
Rania’s career continued to flourish as she was recently promoted to Associate Director of
Global Pharmacovigilance Business Excellence. In this strategic role, she focuses on driving
operational excellence and advancing pharmacovigilance initiatives on a global scale,
ensuring the organization meets regulatory requirements while prioritizing patient safety.

Dr. Rania Mouchantaf

A/Executive Director - Marketed Health Products Directorate, Health Canada

Dr. Rania Mouchantaf has over 20 years of academic, industry and regulatory experience and, is currently the A/Executive Director at the Marketed Health Products Directorate at Health Canada.  Before entering the public service, she worked in the private sector. However, her interest in drug safety and public health led her to join the federal government at Health Canada in 2006 where she has had the opportunity to take on various challenges and assume different roles in assessment, management and strategic policy development from both a pre and post market perspective in the area of safety, efficacy and quality throughout the drug lifecycle. In addition, Dr. Mouchantaf expanded her public health portfolio by having worked at the Public Health Agency of Canada where her team was responsible for developing evidence-based information that informed on policies related to the COVID-19 border travel testing program.

Her education includes a doctoral degree in Pharmacology and Therapeutics from McGill University, Canada, and a post-doctoral fellowship in the area of oncology and breast cancer research. Her experience also includes a past academic appointment as Associate Professor at the faculty of Pharmacy at the University of Montreal, Canada.

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.

Wesal AlHaqaish - JFDA

Director General Technical Assistant / Jordan Food & Drug Administration

Ms. Wesal AlHaqaish is the Technical Assistant to the Director General at JFDA, Jordan, a position she has held since January 2021,also she is the ICH representative member for Jordan FDA.
Before this, Ms. AlHaqaish served in several key roles within JFDA, Jordan, including Director of the Drug Directorate from July 2017 to January 2021. She has also chaired and vice-chaired multiple committees.
Ms. AlHaqaish, with five years of experience as the Head of the Drug Registration Department, played a crucial role in developing and establishing regulatory instruments through her participation in technical committees. Additionally, she has been a member of the Faculty of Pharmacy Council at several universities in Jordan.
Ms. AlHaqaish holds a Bachelor of Science in Pharmacy from the University of Jordan and a Master of Science in Pharmaceutical Sciences. She has also completed a professional diploma in supply chain management and is a regular speaker at regional and international workshops and conferences.

Dr. Gopal Muralidharan

Heads Global Pharmacovigilance and Clinical Operations, Arcolab

Dr. Gopal Muralidharan heads the global pharmacovigilance and clinical operations team at Arcolab. With over 35 years of experience, he has worked in both pre-clinical and clinical research areas in the USA, for almost 15 years with American Cyanamid (Lederle Laboratories, USA) and Wyeth Research (presently Pfizer, USA). He later returned to India as President and CSO of Lotus Labs, Bangalore. As an entrepreneur, he set up a CRO and
has worked extensively in Clinical, Non-Clinical and bioanalytical areas of drug development programs across various therapeutic areas not only for NMEs (NDAs, including 505b2) but also for Generic molecules (ANDAs), with quality and integrity serving as the cornerstone of his successful contributions. He led the transformation of the pharmacovigilance program at Arcolab.
On the academic front, he served as an Adjunct Faculty at Manipal College of Pharmaceutical Sciences, Manipal University and was also a research guide to post- graduate students at the Rajiv Gandhi University of Health Sciences, Bangalore.
He has made several scientific presentations in national and international forums and has also been involved in several scientific deliberations with regulatory authorities worldwide. He has served as a consultant to the Tropical Disease Research program of the World Health Organization and is a member of several international professional organizations.
Dr. Muralidharan has a Ph.D. in Drug Metabolism and Pharmacokinetics from the University of Saskatchewan, Canada.

Maha El Temamy

Regional Pharmacovigilance Hub Head (Middle East, Africa, India Subcontinent & Turkey)

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. Nouzha Lazli

Director General,
The National Centre for pharmacovigilance - Algeria

Professor Nouzha Lazli is a specialist pharmacist with over twenty years’ experience in various areas of the pharmaceutical sector. She began her career as a university hospital lecturer in 2004, just after obtaining her diploma in specialised medical studies in pharmacology from the Faculty of Medicine in Algiers. Prof. Lazli has accumulated a wealth of experience in a variety of industrial and hospital settings, the first of which was the research and development centre of a public pharmaceutical group, where she took part in several generic drug development projects. In 2011, she joined the national pharmaceutical control laboratory in Algeria, where she was responsible for setting up the immunochemical control of biological medicinal products, taking part in carrying out comparability tests on biosimilars and in the technical evaluation of pharmaceutical dossiers for biological medicinal products. She then joined a major university hospital centre in Algiers in 2016, where she was in charge of the pharmacology unit until the beginning of 2023. The unit’s remit is to ensure the therapeutic drug monitoring of immunosuppressants, antibiotics and anti-epileptics, an activity in which Prof. Lazli has invested a great deal of time and effort, particularly with her doctoral thesis in medical sciences, which focused on the immunomonitoring of calcinein inhibitors.

As soon as Prof. Lazli took over the helm of the CNPM, she set about putting all her knowledge and experience to work to improve patient safety in the use of medicines, vaccines and medical devices, and has been doing so since January 2023.

Her ambitions are clear: to develop the Algerian pharmacovigilance and medical device safety network by including all those involved in pharmacovigilance.

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. 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.

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