Hussain Al Ramimmy is a Senior Specialized Pharmacist with over 25 years of experience. He is currently the director of Pharmacovigilance and Drug Information at the Drug Safety Center, Ministry of Health, Oman. Al Ramimmy obtained his bachelor’s degree in pharmacy from Strathclyde University, Glasgow in 1998 and the master’s degree in pharmacology from Glasgow Caledonian University in 2011.

• PhD Pharmaceutical Regulations
• MBA General and Strategic Management
• MSc PV and Pharmacoepidemiology
• Has a long experience in the regulatory and inspection practice
• As well as the community pharmacy and pharmaceutical services in Kuwait.
• Currently, has research interest in the field of health economics and Pharmacoeconomics and the economic value of PV.

Dr. Abeer Zeitoun is a skilled specialist in Medication and Patient Safety with extensive experience in the field of public safety. Currently, Dr. Zeitoun holds the position of Clinical and Technical Manager at the Lebanese National Pharmacovigilance Program. She has more than 15 years of educational expertise, having held the role of Clinical Pharmacy Assistant Professor at the Lebanese American University (LAU). Her academic background includes a Pharm D degree from the Lebanese American University, complemented by a Master’s degree in Patient Safety from Massachusetts College of Pharmacy and Health Sciences. Additionally, Dr. Zeitoun is credited as an author in numerous publications.

Dr. Rita Karam, a Pharmacist with a Ph.D. in Pharmaceutical Sciences, is a Professor at the Lebanese University and holds key roles in healthcare governance as the Director of Quality Assurance of Pharmaceutical Products Program (QAPPP) and National Pharmacovigilance Program Coordinator. She is an active member of ISoP (International Society of Pharmacovigilance), and chairs the ISPOR-Arabic Network (The Professional Society for Health Economics and Outcome Research). With more than one hundred scientific articles and reports, her contribution span various fields in healthcare, including Health Technology Assessment, Health Economics, and Pharmacovigilance. This extensive body of work establishes her as a significant figure in academia and public health.

Bachelor’s degree in Pharmaceutical Sciences, and Master of Business Administration (MBA) Candidate-Arab Academy for science, technology and Maritime transport (AASTMT).

Previously:

• Deputy Manager of Pharmaceutical Vigilance General administration
• Manager of Pre- Marketing Vigilance Regulatory Affairs Administration
• Pharmacovigilance committee rapporteur
• PV specialist. – Egyptian Drug Authority (EDA)

Walaa Ebrahim, is an Administrative Manager with thirteen years of experience working within regulatory authorities. Walaa specializes in pharmacovigilance and is responsible of Supervising and management of pre marketing & post marketing administrations regarding  Human, Biological, Herbal, Medical devices,  Veterinary & Biocides safety units, Supervising the development of policy proposals, Regulatory and executive regulations for pharmaceutical vigilance, Supervising the evaluation of risk-benefit balance and risk management plans for pharmaceutical products and for medical devices,

Achievements

• A representative of EDA in WHO regulatory training in swissmedic & many other training and scientific events.
• Actively participated in EDA global benchmarking program conducted by the World Health Organization (WHO)
• Principle contribution in the issuance and reviewing of the updated guideline on pharmacovigilance practice in Egypt (GVP)
• Develop an appropriate Administrative & technical Manual on Pharmacovigilance practice regarding Human & Biological products illustrating the responsibilities of Marketing Authorization Holders.
• Participated in the Pharmacovigilance inspections on marketing authorization holders.
• Conducted advanced-level pharmacovigilance training sessions for pharmaceutical companies and their respective teams.
• Participate in many EDA twining projects with other regulatory authorities.
• Principle contribution in developing many EDA guidelines and polices.
• Prepare and review the Standards Operating Procedures (SOPs) of whole Pharmacovigilance processes and continuously update them as appropriate.
• Manage the Pharmacovigilance Committee and prepare safety issues to be discussed by the Committee as appropriate.
• Takes/ recommends the appropriate regulatory actions where necessary based on the continuous monitoring of the safety profile for pharmaceutical products available in Egypt.
• Develop work strategies &plans, delegate tasks & monitor the performance.

Dr. Hayaa Banat is a senior pharmacovigilance specialist and the Head of pharmacovigilance section at Jordan Food and Drug Administration (JFDA). Dr. Hayaa has more than 11 years’ experience in the field of Pharmacovigilance including ADR processing and assessment, Risk management, inspection and quality management.

She has participated in publishing many scientific articles in the areas of pharmacovigilance and antimicrobial resistance.

Eman has a wealth of experience in PV since 2012, with a strong network with 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 the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.

After Abbvie’s acquisition of Allergan in May 2020, Eman supported the global and affiliate PV integration workstreams and subsequently was appointed on May 2021 as the Lead of the Middle East & Africa PV hub, the largest PV hub in Abbvie.

She also has a vast experience in delivering trainings to multiple pharmaceutical companies in Egypt on Arab GVP and her trainings were accredited and acknowledged by the Head of Egyptian Pharmaceutical Vigilance Center in Egypt.

Lastly, Eman has participated in GCC PV trainings that took place in Dubai, UAE, in years 2019 and 2020, 2021 and her sessions were widely recognized and got excellent feedback from the audience and regulators as well.

She also has 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 International Society of Pharmacovigilance ISoP, ISoP Middle East Chapter and the Country Representative in United Arab Emirates.

20 experience in Pharma Industry.

15 years experience as Qualified Person Responsible for Pharmacovigilance/Local Safety Responsible, Quality Assurance Responsible Person.

Qualified International Trainer by International College in London.

Owner & Founder of State Of Practices Consultancy Center.

Dr. Michelle Gebara holds a Doctorate of Pharmacy degree from the Saint Joseph University of Beirut, Lebanon.

Throughout her journey in diverse regional and global pharmacovigilance roles within multinational pharmaceutical companies, she developed and enriched her passion for patient safety through multidisciplinary, innovative, and patient-centric approaches.

Dr. Raghda has rich experience in Pharmacovigilance and Patient Safety since 2011 when she starts establishment new pharmacovigilance system in Middle East and North Africa at Eli-Lilly from scratch.

she was working hand by hand with regulatory authority bodies within Middle East and North Africa region to implement and execute Arab Guidelines for Pharmacovigilance GVP first version.

She has several senior regional roles in multinational companies like Eli Lilly, Shire and now Takeda where she got diversified experience in Patient Safety in different geographical regions including not only Middle East and Africa but also some European countries like Greece, Portugal, Israel, Spain and Italy by which has been exposed to different experience that she builds on her area of expertise in Middle East and Africa region.

Dr. Raghda has passionate to Promote for Patient Safety in general and to optimize patient Safety awareness in specific within all health community sectors.

She is active member in different regional PV associations, and she is active moderators for DIA forums and different Global Pharmacovigilance events.

Dr. Reem AbdelJawwad Mahmoud Yasin, the head of Quality Assurance and Pharmacovigilance in Hawkary Pharmaceuticals co., one of the top and leadings pharmaceutical’s companies in Iraq.

Dr. Reem AbdelJawwad Mahmoud Yasin, the head of Quality Assurance and Pharmacovigilance in Hawkary Pharmaceuticals co., one of the top and leadings pharmaceutical’s companies in Iraq.
She is a pharmacist graduated from University of Jordan and worked as lecturer there in the College of Pharmacy.

Dr. Reem has over 10 years of experience in the field of Integrated Quality Management, legal agreements and Pharmacovigilance in Jordan, Iraq, GCC and Europe.

Currently, she is a member of ISOP and member in Arab Quality consultants’ union (AQCU).

Certifications:

• Certified ISO QMS consultant
• German board in good manufacturing practices in pharmaceuticals industry
• Certified in Pharmacovigilance professional
• Certified with mini-MBA
• Certified in Risk management professional
• Certified Trainer

Ms. Alina holds a bachelor’s degree in pharmacy from the University in Moscow, MBA and Msc in Pharmacovigilance from the UK Universities.

Ms. 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 freelancer in Pharmacovigilance, Regulatory Affairs and Quality improvements initiatives. Ms.  Alina covers GCC, LATAM and CIS regions for regulatory submissions while working with UK, US and EU companies on PV projects.

She is a highly skilled Pharmacovigilance Lead for Gulf and Levant at Organon. Rania started her career as a Global Drug Safety Specialist Intern at MSD Americas. Her passion for drug safety and her exceptional skills helped her to climb the ladder of success.

Today, she leads the Gulf and Levant region in Pharmacovigilance, ensuring the safety and regulatory compliance of all drug-related activities at Organon. With a background in clinical pharmacy and a master’s degree in business management and marketing, Rania brings a unique and valuable perspective to her role as a Pharmacovigilance Lead.

Dr. Darshi Shah is a pharmacist by profession. She has multi-functional working experience in Pharmacovigilance, Regulatory Affairs and Quality since 2013.

With over 10 years’ experience in various local and multinational Pharma companies, Darshi has been involved in shaping various Health Authority Legislations across different countries, shaping Quality Management Systems for Regulatory Affairs, Quality and Pharmacovigilance. She has proven capabilities in affiliate and regional PV governance as well as being savvy in audits and CAPA implementation.
Dr. Darshi believes that Patient Safety is a vital function and is everyone’s responsibility.

Mohamed Abdel Hady is an accomplished pharmacovigilance professional with extensive experience in drug safety and regulatory compliance. With a background in pharmaceutical sciences, Mohamed has contributed significantly to the field through his work in adverse event reporting, risk assessment, and Industry groups across the GCC in well reputed Biotechnology companies.

Mohamed Abdel Hady holds a Master’s degree in Pharmacology from Alexandria University. He has worked with leading pharmaceutical companies across the GCC region. His expertise lies in ensuring patient safety by monitoring and evaluating drug safety data, implementing risk minimization strategies, and collaborating with cross-functional teams.

As a dynamic speaker, Mohamed has presented at various industry conferences and workshops including the World Drug Safety congress of Europe, Healthcare Automation and Digitalization Congress, DIA MENA and the Annual Risk Management and Pharmacovigilance Summit. His engaging sessions cover topics such as pharmacovigilance best practices, regulatory updates, and the role of the affiliates to apply the policies of the Pharmacovigilance HQs.

As the Senior Manager of Regulatory Affairs and Pharmacovigilance at Insights Research Organization and Solutions (IROS), Dr Marie leads operations associated with the conduct of clinical trials in accordance with all applicable regulations & study-specific requirements and ensures that research sites are prepared and have the necessary tools needed to start the trial. In addition, her department manages the safety profile of new drugs in clinical trials, oversees case-processing activities through all phases of development, and perform regulatory reporting and medical monitoring tasks.

Dr Marie has over 15 years of experience, the last 8 of which have been in Regulatory Affairs including the regulation of clinical research, continuous education, professional licensing, and auditing of health advertisements.

Prior to joining IROS, she headed the Research and Education Regulation Department at Dubai Healthcare City Authority where she oversaw the regulation of human subject research including non-interventional studies and complex clinical trials. She also sat on the IRB of Mohammed Bin Rashid University of Medicine and Health Sciences as the Regulatory Representative.

Dr Marie graduated with a degree of Doctor of Dental Surgery in 2008 and also holds a Master’s Degree in Healthcare Management and a Postgraduate Diploma in Clinical Leadership and Innovation from the Royal College of Surgeons in Ireland.

Dr. Joëlle Issa-Blok currently works at Acino MEA, UAE as Regulatory Affairs and Pharmacovigilance Director for the Middle East, Turkey and Africa region. She is as well the QPPV for the UAE and Oman.

She has 18 years’ experience in the pharmaceutical industry in different positions, starting in Regulatory Affairs Europe R&D in the Netherlands, then in various regional roles as Head of Regulatory Affairs and Pharmacovigilance MEA at Astellas where she has been building and leading different Regulatory Affairs, Pharmacovigilance teams and organizations.

She lived and worked 10 years in the Netherlands where she gained her experience in EU RA & PV regulations. Joëlle is a Pharmacist graduated from the Saint Joseph University in Beirut, in addition she holds a Masters in Science degree in Drug Innovation Research & Development from the University of Utrecht in the Netherlands.

Dr. Mareez William is Egyptian and has graduated from Faculty of Pharmacy Ain Shams University in 2012.

She is currently working as Regional Pharmacovigilance Manager (META) in Acino Pharmaceuticals from 2019.

She has set up Pharmacovigilance system for Acino in Egypt, KSA & UAE and responsible for PV activities in Middle East and Turkey.

She seeks professionalism in her career life & personal life as well, so Time Management is her KEY in achieving this!  Also, she is glad to join GCC Summit every year as she is passionate about Networking Growth and meeting other PV experts in the region.

Ahmed has more than 12 years of experience in Pharmacovigilance (PV) and Quality Compliance. He started his career in Egyptian Health Authority in Drug Factories inspections, then moved to Pharmacovigilance center before joining the Pharma companies as Qualified Person for Pharmacovigilance since 2015. Ahmed managed to establish and maintain efficient and complaint PV system in more than 21 countries throughout his years of experience in close partnership with Health Authorities and Local License Partners including Angola, Bahrain, Egypt, Ghana, Iran, Iraq, Jordan, Kenya, Kuwait, Lebanon, Libya, Mauritius, Nigeria, Oman, Pakistan, Qatar, Rwanda, Seychelles, Sudan, UAE, Uganda, and Yemen.

In his role as regional Patient Safety and Pharmacovigilance (PSPV) lead for India, Middle East, Turkey, and Africa (IMETA) at Boehringer Ingelheim; Ahmed is leading IMETA OPUs to act as patient ambassadors within the organization so that we can influence the internal and external environment to achieve the safest use of pharmaceutical products.

With a keen eye for detail and a strong history in defense industry bid management, Dolcinea took up the role of Business Development Director with AAICO at the end of 2022, as they relocated their global HQ to Abu Dhabi. At AAICO she leverages her passion for innovation and emerging technologies to successfully drive growth across various verticals.

Dolcinea holds a Masters Degree in Law and a Bachelor of Arts in Communication, which brings a unique perspective to her role. Known for her approachable nature and collaborative spirit, Dolcinea is dedicated to taking others on the journey of discovering the power of artificial intelligence in healthcare.