Dr. Sameh Al-Zubiedi is an associate Professor of Pharmacology and Therapeutics at the School of Pharmacy, University of Jordan and is the founder and acting director of the University of Jordan Pharmacovigilance office. He is currently a member of the national Pharmacovigilance and Adverse events following immunization (AEFI) review committee in Jordan. He has contributed to several committees at Jordanian Food and Drug Administration (JFDA) such as health hazard evaluation committee, re-registration committee, and clinical studies committees. He is a member of ISOP Middle East Chapter Scientific committee, ISOP 2021 Annual meeting local organizing committee, and WHO Global Patient Safety Network.
Dr. AlZubiedi holds a bachelor degree in pharmacy from Jordan University of Science and Technology (JUST), a master degree (medical sciences) in Clinical Pharmacology from the University of Glasgow and a PhD in pharmacology and Therapeutics from the University of Liverpool funded by UK department of Health. Dr.Al-Zubiedi was a Postgraduate research scientist at Department of Pharmacology and Therapeutics (The University of Liverpool) and the Royal Liverpool and Broadgreen University Hospital NHS Trust.
Dr. Al-Zubiedi was awarded the Daniel Turnberg Traveling Fellowship from UK Academy of Medical Sciences which he spent at the Wolfson Centre for Personalized Medicine, University of Liverpool. Also he was awarded an Erasmus
+ mobility grant from the University of Bath UK and the Menarini Foundation travel fellowship from Italy. Dr-Al.-Zubiedi has participated in several national, regional, and international meetings, workshops, and conferences.
His area on research interests includes pharmacogenetics, pharmacovigilance and medication safety in special population.
Dr. Appelskog is heading the EU QPPVs and Consulting Services at TFS, focusing on the strategic initiatives, innovation and integrated management system within PV. She has about 20 years of experience in Pharmacovigilance combined with 8 years of experience in cancer and diabetes research.
Julia was leading global pharmacovigilance teams as Head of PV QMS and Policy as well as Head of PV Strategy at Merck. For almost four years she was Head of Pharmacovigilance and EU QPPV and at Bluefish Pharmaceuticals. In previous roles at MSD, Johnson & Johnson she was leading Nordic hubs and at Sanofi Pasteur MSD, besides Pharmacovigilance, she was also responsible for management of epidemiological and Clinical Trials, Quality Assurance, Regulatory Affairs and Medical Information.
Dr. Appelskog has accomplished a PhD Thesis in cell biology and diabetes at the Karolinska Institute (Sweden) in 2001, followed by a postdoctoral fellow position at the Department of Clinical Neuroscience at Karolinska Institute, conducting research on epigenetic mechanisms, modification of DNA and its associated proteins in tumor cells.
Julia was an active member of EMA EudraVigilance Working Group (EWPWG), EuropaBio, International PV Working Group (IPWG) at EFPIA, TransCelerate, AESGP, Medicine for Europe and the Chairman of PV Working Group at Swedish Generic Medicines Association (FGL).
|Sep 1976 – Avr. 1983||Medical doctor|
Faculté de Médecine et de Pharmacie Rabat-Maroc
|Sep 1983 – Fév. 1987||Fundamental and clinical pharmacology|
Faculté de Médecine Montpellier-France
|Sep 1983 – Fév. 1987||Certificates and Diplomas: Physiology, Biochemistry, Pharmacovigilance, Clinical Research Methodology and Neuropsychopharmacology.|
Facultés de Médecine de Montpellier, Lyon et Marseille-France
|Sep 1997 – Juil. 1997||Leadership capacity Building in Public Health|
Institut National d’Administration Sanitaire Rabat-Maroc
|June 1987 –May 1988||Medical Director|
· Development of medical department for pharmaceutical industry,
· Implementation and follow up of Clinical trials
|Juil. 1989 – Aujourd’hui||Director|
Centre Anti Poison et de Pharmacovigilance du Maroc, Ministère de la Santé Rabat-Maroc
· National organization of Vigilances (Pharmacovigilance, Toxicovigilance);
· Drug Information;
· Toxicological Screening and monitoring of drugs;
· Centre of Excellency for capacity building in Clinical Pharmacology and toxicology.
|Fév. 1987 – Aujourd’hui||Professor of clinical Pharmacology|
Faculté de Médecine et de Pharmacie, Université Mohamed V Rabat-Maroc
· Teaching of clinical Pharmacology for medical, pharmaceutical and dentistry students;
· Coaching students for research and thesis;
· Funder of Pharmacovigilance diploma.
|Nov. 2011 – Aujourd’hui||Director|
WHO Collaborating centre for strengthening Pharmacovigilance Practices, Rabat-Maroc
· To conduct and facilitate regional and national PV training courses, specifically for Francophone, Eastern Mediterranean and Arab countries
· To support the WHO normative functions related to PV for medical products (MP) and promote patient safety
· To assist WHO in the PV assessments and in the provision of technical support to Member States in strengthening PV systems for MP in order to increase quality care to patients
· To develop and manage a Vigilance Platform for sharing information among Francophone and EMR Arabic-speaking countries on safety of MP between Member States in the EM Region
|Competences & Activities|
|Compétences||Management, training and human resources development;|
Pedagogical and oratory skills;
Drug and Patient safety;
Drug Marketing authorizations;
Risk Management Plan;
Health vigilance systems.
|Langues||Arabic, French, English.|
|Member of Commissions and Societies|
|· Vice President of « La Commission de la Transparence » (Rabat Morocco) ;|
· Advisory Committee for Safety of Medicinal Products OMS member (ACSoMP, Geneva, Switzerland) ;
· Uppsala Monitoring Centre board ember (Uppsala, Sweden) ;
· President of “La Federation Maghrèbine de Toxicologie”;
· Coordinator for the European project on managing medication errors (2009-2013);
· Founder and president of “Association Marocaine pour l’usage rationnel des medicaments et pour la sécurité du Patient”
· Founder and former president of The Moroccan Society of Pharmacovigilance;
· Founder and former president of The Moroccan Society of Clinical and Analytical Toxicology;
· Member of numerous scientific, administrative and regulatory committees;
· Founder and President of The African Society of Pharmacovigilance (ASoP);
· Member of numerous scientific and regulatory committees (Morocco);
· Reading committee member for major international Pharmacovigilance and Toxicovigilance magazines.
|Profile as of January 2018 (Click here to see full profile)|
· RG Score : 44.06
· Publications : 930
· Reads : 47,391
· Citations : 1,201
|Appointment in research bodies|
|· Consultant or international scientific expert;|
· Guest speaker at internationally renowned meetings and conventions;
· Reviewer of international peer-reviewed journals;
· Member of research institutions national or international faculty;
· Awards and research grants jury member;
· Member of project selection committees with international donors.
|Experience in Developing Pharmacovigilance systems|
|All the activities listed below were carried out personally or in team with the staff of the Centre Antipoison et de pharmacovigilance du Maroc|
|Guidelines||Acting as a secretary, co-author, reviewer and/or translator of the following pharmacovigilance guidelines (non-exhaustive list) :|
· WHO: “WHO pharmacovigilance indicators: a practical manual for the assessment of pharmacovigilance systems;”
· WHO: “Surveillance de la sécurité d’emploi des medicaments – Guide pour la création et le fonctionnement d’un centre de pharmacovigilance”;
· WHO: “The importance of pharmacovigilance. Safety Monitoring of medicinal products”;
· WHO: “The safety of medicines in public health programs. Pharmacovigilance an essential tool”
· WHO: “Reporting and learning systems for medication errors: the role of pharmacovigilance centers”;
· The Arab League: “Guideline on good pharmacovigilance practice for Arab countries”.
|Annual French Pharmacovigilance training course|
|Pharmacovigilance course developed annually since 2007:|
· To provide participants with basic knowledge, tools and practical skills to develop a PV centre;
· To put in place an operational action plan to create or strengthen a national PV system;
· To initiate strategic reflection on the pertinence and the practicability to create a PV centre;
· To manage ADRs and related problems;
· To manage ADRs and related problems.
|Trainings for developing Pharmacovigilance systems||Individual or group training in Morocco, in countries or at regional levels|
Since the 90s, I have been asked by international organizations or by countries themselves to support the countries in evaluating and developing their pharmacovigilance system, or to conduct workshops and training seminars (in Africa, Asia and Arab countries).
|Training on specific items||· VigiFlow, causality assessment|
· Case to case Signal detection
· Medication errors
· Pharmacovigilance in pregnancy
· Pharmacovigilance of herbal medicines
· Pharmacovigilance of vaccines
· Patient safety and Medication Errors
|Organization Participating to national and regional trainings|
Medical doctor, graduated from Rabat University School of medicine, Morocco. Specialized in pharmaco-toxicology. She has a PHD in Health Vigilances field.
She began her career as practitioner during 4 years before integrating the WHO Collaborating Centre: Moroccan Poison Control Centre and Pharmacovigilance Centre, in 2007.
Since 2007: working in pharmacovigilance activities, focusing on cases analysis, causality assessment, signal detection and risk minimization actions.
Since 2008: Involved in different training and pharmacovigilance development projects in collaboration with the World Health Organization, Monitoring Medicines Project, Uppsala Monitoring Centre and the Moroccan Pharmacovigilance Centre, to promote Pv in Africa and MENA region and to develop new tools to manage ADRs.
Since 2014, She is member of ATC-DDD WHO Working group.
Helena is the VigiBase manager at Uppsala Monitoring Centre; a registered pharmacist with experience from information management and development of FASS.se (Swedish drug formulary) at the Swedish Association of the Pharmaceutical Industry and retrieving information from databases at the Swedish Medical Products Agency at the information department. Always with an eager interest for databases, she found her place at the Uppsala Monitoring Centre in 2007, where she started out with signal detection work, moved on to software development and database management before taking on the VigiBase manager role in 2013. Today her responsibility is to ensure that the information that is collected in VigiBase on behalf of the WHO Programme for International Drug Monitoring (PIDM) is useful and used in accordance with WHO policies. A main driver is to improve UMCs offerings to the member countries of the WHO Programme to support efficient pharmacovigilance processes
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 be the Regional PV Lead for TMEA region in March 2017 and relocated to Dubai in Dec 2017.
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.
Dr. Rouba Eid experience in the region dates back from 2013 when she joined the industry after a career path at the US FDA. Her experience since focuses on pharmacovigilance systems setup, merges/integrations of PV systems, audit/inspection preparedness and PV operation in Middle East and Africa.
Dr. Eid received her Bachelor of Pharmacy degree from the Massachusetts College of Pharmacy in Boston, USA and her Doctorate in Clinical Pharmacy from Midwestern University in Illinois, USA. She obtained a Diploma in Epidemiology from the University of Bordeaux, France and completed a fellowship in the US FDA, Office of Compliance in Washington DC where she subsequently worked till 2013 . Prior to this, Dr. Eid served as the Associate Dean and Founder of the School of Pharmacy at the Lebanese International University of Beirut where she obtained 10 years’ experience in higher education management, training and curriculum development
Shahinaz Badr is currently holding the role of Regional Pharmacovigilance Manager-AfMET in NewBridge Pharmaceuticals. She has contributed to several regional and international pharmacovigilance and medical safety activities. Shahinaz, B.Sc. Degree in Pharmacy, has long diversified experience in Pharmacy extending to 19 years’, starting her career as a pharmacist in Cairo University Medical School Teaching Hospital integrating with top HCPs of different specialties in interdisciplinary healthcare system where safety monitoring is an integral part of clinical practice. Leveraging on her expertise and connections of Near East countries, she worked in Regulatory Affairs and Tender Business in a role which enables her to integrate with regulators knowing the difficulties faced to allow the healthcare products to exist safely in their market. Furthermore, working on a project in a multinational company added to her expertise through actively interacting with global teams and learning directly from regulatory experts who are overseeing the project globally has been a milestone in her career development. Shahinaz has a network of strong relationships with regulatory agencies who are encouraging to actively engage in pharmacovigilance, putting the focus and interest on helping patients overcome their health challenges
Shabana has a wealth of experience in pharmaceutical care in different health institution in Muscat governorate since 2003; with a highly experienced in the development & training programs.
She worked as an auditor for different health center & polyclinics in different health authorities.
She held several senior roles in multiple areas in Muscat governorate as section head of medical store& head of pharmacy.
She started her PV career in national PV center in Sultanate of Oman, in 2019, after one year, she was selected to be the section head pharmacovigilance human medicine
Dr. Anwar is a professional business partner, with strong scientific & medical background, brings up 20 years of experience in the pharmaceutical industry.
Dr. Anwar obtained a bachelor’s degree in veterinary medicine and post graduate Microbiology diploma focusing on Immunology, Bacteriology, Virology and Mycology from Cairo University, Egypt.
Dr. Anwar started the career in 2001 as a medical representative in Egypt and then relocated to UAE in 2007, where she held several seniors roles in different top multinational pharmaceutical companies,” Novartis, GSK, Allergan and Abbvie”.
Dr. Anwar accomplished high level of business acumen with diversified roles in Medical affairs, clinical trials and Pharmacovigilance, within diversified geographical areas
• Ahmed is a Physician by education and holds a Master’s degree in Pharmaceutical Medicine (First Class Honor).
• He holds certificates on programs or courses from The George Washington University, Columbia University, Royal College of Physicians and Hibernia College.
• He attended many trainings in leadership, strategic thinking, decision-making, brand planning, building efficient teams, performance, accountability, communication skills, and persuasion and selling skills.
• Moreover, He attended courses in Outcome Research and Health Economics, Drug discovery and development, Ethics, Biostatistics, Research Methodology, Regulatory Affairs, Medical Affairs, and Pharmacovigilance.
• He attended numerous conferences and events.
• Ahmed received various awards and recognitions in innovation (Upjohn Award), achievements and others.
• He has some international publications in international journals.
• He was invited as a speaker for hundreds of local or regional, international events and on TV programs.
• He Possess strong medical knowledge in various therapeutic areas and many product portfolios
• He was a member of the ISoP and was a committee member of the ISoP Middle East Chapter.
• He owns 24 years of wealthy experience in Pfizer and Merck in different functions and regions.
• His latest position was head of Global Patient Safety of Africa, Middle East, Turkey, Russia & CIS countries.
• Currently he is a Consultant for Pharmacovigilance and Medical Affairs and is the Managing Director of PVigilaint Health.
Holds PhD and master’s degree in Clinical Pharmacy. She laid the establishment and the expansion of the Iraqi pharmacovigilance system. On the national level, she represents Iraq in the WHO International Drug Monitoring Program, currently a member in many committees including; Biologicals and Biosimilars registration, Iraqi Clinical Pharmacy Advisory Board, Pharmaceutical Ethical Promotion, the Central Committee for Containing Antimicrobial Resistance and many others. On the international level, she is an ISoP Advisory Board member and represents ISoP in CIOMS WG XI to develop a guideline on “patient participation in the development and safe use of medicines. ISOP Middle East chapter vice president, ISoP Pharmacovigilance Professional Qualification Framework SIG member and a member of DSRU MEP International Working Group on Signal Detection and Management in Pharmacovigilance. She had authored more than 20 articles in different drug safety-related subjects.
Dr. Reem Al-Essa has a PhD in Pharmaceutical Regulations and an EU2P MSc in PV and Pharmacoepidemiology, with a long and diversified experience in both government and private sectors in Kuwait.
She started her career in Kuwait Ministry of Health, Drug and Food Control, Pharmaceutical and Herbal Medicines Registration and Control Administration. She then moved from there to work at a community pharmacy in the private sector. She decided to move back to MOH to work in the Drug Inspection Administration carrying out the role of pharmacy licensing and inspection in addition to her role as a PV focal point in Kuwait
Dr. Al-Essa has been recently promoted as The Coordination and Development Superintendent at the Pharmaceutical Services Administration, Ministry of Health. This position is an excellent opportunity to develop, promote and manage pharmacovigilance and ADR reporting in the government hospitals and primary healthcare clinics.
Ministry of Health /registration and Drug Control Department
Jan 2005 Dec 2008: Registration Officer (New Drug
Application, Renewal Of registration, Minor variation,
manufacturing facilities registration and Local
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 and trainee at Mermaid Pharmacy Abu Dhabi