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.

Pharmacist with >20 years’ experience in pharmacy & pharmaceutical business, started as clinical pharmacist in Cairo Univ. Med-School Teaching Hospital integrating with top HCPs of different specialties where safety monitoring is an integral part of clinical practice. Using her expertise, she joined the pharmaceutical industry working in RA & regional positions before focusing on Pharmacovigilance. Actively working in PV Reg-Intel in a role enabling her to interact with industry colleagues and Competent Authority PV departments. Contributed to several international initiatives and partnerships to support patient safety & improve drug safety monitoring. She’s an active ISOP member collaborating in the initiation of the Global PV Certificate.

Dana is a pharmacist, with more than 10 years of experience in regulatory affairs and pharmacovigilance in big Pharmaceutical Companies. Dana’s broad pharmacovigilance experience has been gained in Bristol Myers Squibb as being responsible for the Pharmacovigilance activities in Middle East and Africa Region. Dana is a member of the EFPIA International Pharmacovigilance Group and part of the Middle East and Africa sub-teams.

Dr S Pal has a Masters in Pharmacy with a PhD in Pharmacology. Been with WHO for nearly 2 decades, and leads the Medicines Safety Programme in WHO, to support pharmacovigilance activities in low and middle income countries and in priority programmes such as HIV, TB, malaria. WHO representative in platforms such as ICH, CIOMS, ICMRA, and a Deputy Board Member of the Uppsala Monitoring Centre, Sweden.

Hadir holds B.Sc. Clinical pharmacy, a Certificate in Executive Management from Harvard School of Public Health USA and Clinical Pharmacy Diploma from Cambridge Regional College UK. She has 19 years experience at the Egyptian Pharmaceutical Authority. On 2009 she was assigned to be a co-founder of The Egyptian Pharmacovigilance Center (EPVC) and the national pharmacovigilance system On 2016 she has been promoted to be the Head of EPVC with a mission to strengthen Pharmacovigilance practice in Egypt. She is also a member in National PV committee and Non-reference medicinal products evaluation Committee. She is a principal contributor in issuing the “Good Pharmacovigilance Practice guidelines in Arab Countries” (GVP-Arab)

18 years working in pharmacovigilance, of which 10 have been as a director of pharmacovigilance for the affiliates at MSD. In his current role, Sean provides pharmacovigilance support to primarily the Eastern Europe, Middle East and Africa regions. Responsible for Pharmacovigilance activities in the EEMEA region as well as global PV Intelligence and Operational activities within the International PV organization. Sean supports the development of local PSMF’s at MSD, which are legislatively required or requested pre-inspection. Sean is a chairperson of two EFPIA PV working groups, (Africa and the Middle East).

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

Served as the Pharmacovigilance Representative for multinational Bio Pharmaceuticals companies. Professional familiarity with the Middle East Pharmacovigilance environment from industry perspective especially in the Arab countries where I served in Egypt, Saudi Arabia and UAE. Speaker at the Regional and international Pharmacovigilance congresses. Member of PHAME Group (Regional Pharmacovigilance industry group based in Dubai)

Amal Arafah is a pharmacist and holding a Master of public health in health systems and quality management. Amal started her career in 2013 as in/out-patient pharmacist between privet\ government hospitals and top of that she worked as medication safety officer for one year. At the end of 2017, she joined Eli Lilly company as the qualified person responsible for pharmacovigilance. Now Amal is working with Saudi Food & Drug Authority in Pharmacovigilance inspection department. She participated in 52 inspection and re-inspection visits over pharma companies in Saudi Arabia.

Holder of Pharmacy diploma, and Master in EU and International Regulation and Healthcare Laws. Currently heading the regulatory department for MENA region in Novartis. She has 15 years’ experience and expertise in the European and Emergent markets regulations; worked for various MNCs. Inas is an active member in the EFPIA Middle East Regulatory Network group, and of the Programme Committee of the MERC and DIA Middle East since 2008. She has participated as a speaker in several international and regional conferences. Inas is a member in the MEA Regulatory Working Group, under the PhARMA association umbrella. Her focus and interest is the healthcare reforms and legislations to accelerate patient access to innovative medicines.

Sultana Essa Bin Haider is a Pharmacovigilance Officer and Manufacture Inspector in MOHAP who studied at Dubai Pharmacy college in Dubai UAE and graduated in 2018 (zayed year). She is currrently pursing her Masters of Pharmaceutical Product Development.

Pfizer Arab League QPPV & Cluster Safety Lead for North West Africa & ME region, Marouane is a Pharmacist by training University of UCAD in Dakar and holds a university Diploma in pharmaceutical quality assurance from Pharmacy and Medicine University (Rabat). Before joining Pfizer, occupied various positions in pharmaceutical industry, Pharmacovigilance and safety training, quality assurance, and regulatory. Marouane is also a Board member of the Moroccan society of pharmacovigilance, with the society and the support of Morocco WHO CC, he participated to development of several pharmacovigilance training courses to support local & regional pharmacovigilance understanding and development across the North West African region.

Dr. Mohammed Serve as Head of signal detection section at Saudi food and drug authority. In this role, he has several initiatives to enhance the drug safety regulation in the kingdom of Saudi Arabia. In 2008 Dr. Fouda received his bachelor’s degree in pharmaceutical sciences from king Saud university he also awarded his doctor of pharmacy degree in 2014 from Massachusetts College of Pharmacy and Health Sciences University. Dr. Fouda is currently a member of several international reference groups.

Peter Pitts is President and co-founder of the Center for Medicine in the Public Interest. Prior to founding CMPI, Pitts was a Senior Fellow for healthcare studies at the Pacific Research Institute. Peter was FDA’s Associate Commissioner for External Relations, serving as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management. He served on the agency’s obesity working group and counterfeit drug taskforce.

A doctor graduated from the University of Algiers, holding a Diploma of Advanced Studies from the Faculty of Medicine of Paris (France), a university degree in pharmacovigilance from the university Claude Bernard of Lyon and a doctoral thesis in clinical pharmacology at the Faculty of Medicine of Besançon. She took part in the creation of the CNPM with its founder Professor A Helali in 1998. Since 2016, she has introduced the concept of Phytovigilance, Réactovigilance, Cosmetovigilance, in addition to the vigilance of the drug, the medical device and the vaccine already established. Teacher at the Faculty of Medicine of Algiers. Editor of the independent Medical journal "la Revue Prescrire" since 2007.

Previously served as Senior Vice President and Managing Director for DIA Europe, Middle East, and Africa (EMEA) in addition to corporate international public affairs and as consultant for Amgen, Merck KGaA, and Biogen, working across market access, government affairs, public affairs, health policy, corporate communications, and patient advocacy to bring medicines to patients. Mr. Bols has held board positions for Europabio, the European Confederation of Pharmaceutical Entrepreneurs, and other associations, and chaired various regulatory and access working groups within the European Federation of Pharmaceutical Industries and Associations. Mr. Bols earned his post-graduate degree in European Law from the University of Amsterdam.

Monica is a pharmacist by training, with more than 20 years of experience in pharmacovigilance and has been manager for teams at UMC who are supporting member countries of WHO in reporting, signal detection and analysis, and other PV related questions. She was Product Manager for systems provided to the WHO PIDM (VigiFlow, eReporting and VigiLyze) for 6 years, including gathering & prioritizing requirements from users, working closely with engineering and support. Since 2018, she has been Head of PV Collaborations, coordinates activities with WHO and the WHO Collaborating Centres in PV, and with other stakeholders. 1999 to 2009; observer in WHO working group on ATC and DDD classifications. July 2019 – ongoing; PAVIA advisory board member.

PhD and master’s degree in clinical pharmacy. She trained and has a wide range of experience. 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 board member, FIP and ISOP Middle East chapter scientific committee member. She had authored more than 20 articles in different drug safety related subjects.

Dr. Laila has been working with the Ministry since 2004 as a pharmacist in the Drug department. In 2008, she has set up the Pharmacovigilance section within the department. She has placed the Pharmacovigilance work plans and initiated the implementation of the UAE National Pharmacovigilance Program. She has coordinated & managed the UAE PV higher committee involving all national regulatory authorities & concerned parties. Dr Laila is a member of the unified Gulf Cooperation Council (GCC) PV center. She is a member of the organizational committee of the International Conference on Falsified & Substandard Medical Products.