Arab Pharma

	Syed Rizwanuddin Ahmad M.D., M.P.H., F.I.S.P.E., F.C.P. Public Health Consultant MOH Egypt I am trained in drug regulatory science, pharmacovigilance, pharmacoepidemiology, and clinical pharmacology with over 25 years of work experience at the U.S. Food and Drug Administration (FDA), United States Pharmacopeia, and non-profit groups. I consult in drug regulatory science, pharmacovigilance, and pharmacoepidemiology, on issues related to access to medicines; drug approval; benefit-risk assessment; risk management plans; risk communication; generic drugs; product quality including counterfeit/substandard drugs; poison and drug information center; medication errors; medicines policy; essential medicines; rational use of medicines; antimicrobial resistance; and global health. Areas of interest include active pharmacovigilance and anti-TB/HIV/AIDS/malaria drugs; causality assessment; signal identification, detection and management; training, capacity building in pharmacovigilance and strengthening of FDA-like agencies in resource-limited countries. I have provided technical assistance to national medicines regulatory agencies/Ministries of Health in countries in Asia and Africa. I have an academic appointment (Assistant Professor) at Georgetown University School of Medicine; and (Associate Professor) at Rutgers School of Public Health. I have been invited to give lectures/workshops at several international meetings. For 15 years (1998-2013), I worked for the U.S. FDA, and served as a consultant to the review divisions of the Center for Drug and Evaluation and Research (CDER) and reviewed safety data in the pre- and the postmarketing phases of drug development and helped the Agency make informed decisions regarding drug approval, benefit-risk assessment, risk management plans, and risk communication. I have analyzed data from a wide and complex range of sources and produced clear scientific reviews/reports that have assessed the safety and effectiveness of several FDA regulated therapeutic products. On several occasions, I have synthesized the recommendations from my reviews into plain language that has shaped the final labeling of the products and has been used for wider dissemination such as in the Agency's Drug safety communications. At the FDA, I was an active member of the Committee on Advanced Scientific Education (CASE) whose mission is to promote excellence in advanced scientific education, and assist FDA reviewers to maintain a high level of competency in regulatory and scientific knowledge. As a member of the CASE, we organized seminars; workshops; courses and training sessions for FDA scientists. I was instrumental in the launch of CDER’s first Epidemiology for Non-Epidemiologist course. While at the FDA, I was the scientific lead of several projects involving collaboration with various disciplines within and outside the Agency. I am active in the International Society for Pharmacoepidemiology (ISPE) and serve in the Education; and Global Development Committees. In 2014, I conceived the idea for the first Vaccine Safety course that was offered at ICPE Boston in August 2015. In 2006, in recognition of my scientific contributions and service to the society, I was inducted as a Fellow in ISPE. In 2009, I was conferred Fellowship of the American College of Clinical Pharmacology. I have many publications to my credit including 5 book chapters on pharmacovigilance; and one on the evolution of the FDA drug approval process.

	RANIA TAYSEER AL DWEIK Medical Director Ask Health CORP., Ottawa, Ontario, Canada Rania Al Dweik is a PhD candidate in Public Health, University of Ottawa, Canada.Her qualifications include Bsc in Pharmacy and Msc in Toxicology and Forensic Medicine. Currently, she is working as a Research Assistant at the School of Health Science at University of Ottawa, Canada. Rania has over 19 years experience in pharmacy and patient safety field. For the last three years she has been working as researcher in the field of public health and health science. Her researches have focused on different disciplines in public health include patient safety, poverty and drug regulations. She developed experience working with complex survey data and using different research methods including qualitative and quantitative methods which enriching her experience in the researching field.

	Dr. Mohammed Abuelkhair Pharmacovigilance Expert He founded the Pharma/Medicine and Medical Product Department at the Health Authority in Abu Dhabi. He was the Head of Drugs and Medical Products Regulation Section and Chair several committees including Abu Dhabi Pharmacy and therapeutics Committees;Continuing Pharmacy Education Committee and Alternative and complementary committee,Pharmacy Council, Vaccine Committee and Allergy and Asthma committee. He founded the drug information and poison control center in Abu Dhabi. Dr.Mohammed won the ArabHealth Award in 2005 for excellence in pharmacy services. His major area of research is in drug safety and rational drug use. He is a frequent speaker at national and international conferences.

	Amr Abdel Moneim Abdel Rahman Saad Associate Minister of Health and Head of the Egyptian Pharmaceutical vigilance Center and the Head of the Arabic higher technical committee for medicines Dr Amr Saad got his Ph.D. in Epidemiology from The University of Manchester in UK in 2009. He participated in more than 200 national and international conferences where he published many scientific researches all of which are abstracted in the PubMed, and more than 50 posters and countless numbers of speeches in national and international events. He is a well-known worldwide figure in the field of Pharmacovigilance and drug safety monitoring. Currently he is the Associate Minister of Health and Head of the Egyptian Pharmaceutical vigilance Center (EPVC) at the Central Administration for Pharmaceutical Affairs (CAPA). Very recently, he was appointed as the Associate Minister of Health for the pharmaceutical sector. His delegated responsibilities include the reform of the whole sector with increasing capacity and establishing the Egyptian Drug Authority. Before that, he worked very hard to unify guidelines and performance across the Arab world in the field of Pharmacovigilance. This resulted in the issue of a common decree from the Arab ministers of health [(number 7) in their 37th regular meeting in March 2012] to unify PV guidelines in all Arab World. Thus, "‘The Higher Technical Committee for Medicines" was established with representatives from all Arab countries, to create these common Arab guidelines in pharmacovigilance, and in bioequivalence. This committee elected Dr Amr Saad to lead the committee across all its rounds. The committee finished the final drafts of the two common guidelines which were submitted to the 41st regular ministers meeting, and which has been approved by them. He is also a Lecturer of clinical pharmacy at Future University of Egypt (FUE), Misr International University (MIU), Cairo University & Ain Shams University where he is involved in the construction of the course content, scheduling the content, lecturing, and student evaluations (written and oral). He is also a founding member in the Egyptian Clinical Pharmacy fellowship. His responsibilities included the constructing the course content, facilitating the infrastructure, scheduling the content, lecturing, and co-ordinating with other international bodies for the recognition of the fellowship (university college cork (UCC) in Ireland). He is also a member in some Scientific and Technical Committees within the Egyptian Drug authority like: Pharmacovigilance, Non-Referenced Products, Essential Medicines List, Life Saving medicines, Non-Prescription Medicines, Pharmaco-economics, SSFFC. Being the Head of the Egyptian Pharmaceutical vigilance Center (EPVC), His responsibilities included the construction of a national center to monitor adverse drug reactions (ADRs) from scratch. This included the recruitment of personnel; training and educating them; setting the work plan; defining guidelines and SOPs; structuring the time plan; establishing the national yellow card system; constructing the website; developing the national database for ADRs; conducting awareness campaign in universities, hospitals and for health care professionals (HCPs); and registering and reporting to the WHO-Uppsala Monitoring Center (WHO-UMC). These included working in Five main dimensions to establish the culture of Adverse Drug Reactions (ADRs) reporting in Egypt from scratch. The first dimension was awareness campaigns and training to Health Care professionals (HCPs; Physicians, Pharmacists, Dentists, Physiotherapists, Corners and nurses) on pharmacovigilance through series of waves of workshops, conferences and trainings that included more than 6000 professionals during the years 2011/2012. The second dimension was introducing the teaching of this new science in the curricula of faculties of medicines, pharmacies and nurses via co-ordination with the supreme council of higher education. It is now being delivered to undergrads and postgraduates in 12 different universities. I was also involved in the direct teaching of this science in three different universities under the departments of clinical pharmacy. The third dimension was securing the legal frame work and obligations within the ministry of health that necessitates the presence of pharmacovigilance infra structures and dedicated departments in all pharma-companies and Marketing Authorization Holders (MAHs) working in Egypt to maintain their license and keep the registration of their products. The fourth dimension was enforcing the involvement of Egypt in the global networking of Pharmacovigilance and the International WHO Program for Adverse Drug Reactions Monitoring. Introducing Egypt as one of the active members in the international society was a challenge that has been met successfully. The fifth dimension was the establishment, maintaining and running the national regulatory pharmacovigilance committee, and he currently is the head of this committee that meet on a weekly basis to discuss safety issues and propose regulatory actions that ranges from amending the SPCs up to conducting Post Authorization Safety Studies (PASS). Very recently, he is working on establishment of a nationwide network of satellite centers for Pharmacovigilance working under the umbrella of the main Center at the regulatory authority. Current chosen governorates that were selected are: Alexandria, Monofya & Cairo.