As a Gold Medalist in PharmD and experienced in Pharmacovigilance, I bring a proven track record of enhancing drug safety and regulatory compliance across the pharmaceutical sector. My experience spans strategic oversight of PV activities. Iam passionate about advancing patient safety, fostering a culture of innovation within teams, and leveraging data to improve healthcare outcomes.

Dr. Eugene Zadorin has completed his PhD from Cardiology University. He is the director of NBScience, a premier contract research organization. He has published more than 40 papers in reputed journals and has been serving as an editorial board member of repute.

Graeme has been working as Head of Global Pharmacovigilance and EU QP PV for many large (and small) Pharma, and has been CEO for the last 19 years for PharSafer. He has provided invaluable advice on safety and regulatory strategies for many NCEs and worked in a variety of drug safety areas from medicines; devices; vaccines; cosmetics; advanced therapies; biologics and veterinary. He has also worked on developing new IT systems for Drug Safety and Medical Information databases and enhancing drug safety systems. Graeme is also a member of TOPRA; RQA, PIPA, MAPS and the Institute of Directors and has helped small start up Companies in their planning, growth and been involved in Company acquisitions, due diligence activities for product in-licensing and marketing and development strategies.

Gian Nicola has more than 30 years of experience in the pharmaceutical environment. Since September 2023 he has been working as a Pharmacovigilance Consultant. In addition, he is a Member of the the Italian Society of Pharmaceutical Medicine (SIMeF ETS) – Italy for which he covers the role of Secretary and Member of the Management Board of the Society; he is speaker at seminars, conferences and at master and training in the pharmacovigilanc field. He started as Medical Sales Representative then he joined Chiesi Farmaceutici S.p.A. – Italy (1991-2023). Initially involved in clinical research with responsibility for projects in the fields of osteoporosis, ulcerative colitis/Crohn's disease and post-coronary angioplasty prophylaxis, he dedicated his working life to pharmacovigilance from 1997 to 2023, and for some years to vigilance of medical devices. Former Professor of Pharmacovigilance at the Faculty of Pharmacy of Parma’s University – Italy; former Member of EFPIA Pharmacovigilance Expert Group (2008-2023) and of of Farmindustria’s Pharmacovigilance Working Group/Pharmacovigilance Network (1999-2023).

Dr Carmine Finelli is currently senior registrar of the Department of Internal Medicine, ASL Napoli 3 Sud, Torre del Greco (Naples), Italy and Professor of Internal Medicine at the Federico II University Medical School in Naples, Nursing School, Learning Centre of Nola (Naples). Dr. Finelli is born in Naples (13/06/1974) and obtained his Doctor of Medicine degree in 1999 at the Federico II University Medical School in Naples discussing the thesis: “Prevalence of eating disorders in obese outpatients”. He obtained his PhD in “Clinic and Pathology of Chronic-Degenerative Cardiovascular, Rheumatic and Nutritional diseases” at the Department of Clinical and Experimental Medicine, Federico II University Medical School in Naples in 2004. Research work was carried at the Clinical Nutrition Unit of the same Department. He also obtained his postgraduate degree in Internal Medicine, in 2008, at the Department of Clinical and Experimental Medicine, Federico II University Medical School in Naples. His main research interests are in polymorphism genetic in severe obesity; indicators of the nutritional status; pathogenetic mechanisms of insulin-resistance, hypertension and fatty liver in obesity; physical activity and energy expenditure in human obesity; metabolic and nutritional status in severely obese patients treated with bariatric surgery at short and long-term. He is also author of more than 180 papers, 80 published on peer-reviewed international journals. Dr. Finelli is currently involved in studies on the physiopathology, genetic and treatment of obesity.

Post Doc Researcher (2016-2018, University of Peloponnese, Department of Nursing, Sparta, Greece) Ph.D. in Health Psychology (Panteion University of Social and Political Sciences, Department of Psychology, Athens, Greece) Ph.D. in Personnel Management (University of Peloponnese, Department of Nursing, Tripoli, Greece) M.Sc. Health Services Management (Frederick University, School of Health Sciences and School of Law and Business Administration, Cyprus) M.Sc. Social exclusion, minorities and gender (Panteion University of Social and Political Sciences, Department of Sociology, Athens, Greece) Social Administration - Management of Health Services (National School of Public Administration, Athens, Greece) B.Sc. in Psychology (Panteion University of Social and Political Sciences, Department of Psychology, Athens, Greece) B.Sc. in Social Work (Technological Educational Institute of Athens, Athens, Greece) SCG Lab of Experimental and Applied Psychology; SCG - Scientific College of Greece, Athens, Greece Hellenic Open University, School of Social Sciences, Patra, Greece.

Abdelkrim Hmadcha (AH) has a total of 79 publications (articles, reviews and book chapters) with an h-index of 22 (Web of Science). AH has led/collaborate several research projects, has come to lead a group of more than 20 people (including technician, graduate students predoc and postdocs). He was the researcher in charge of the RETIC group (RD16/0011/0034) of the Cellular Therapy Network (Red TerCel) of the National Institute of Health Carlos III (ISCIII) and of the PAIDI group (CTS-004), and a collaborating researcher in the CB07/08/0006 group of the Spanish Biomedical Research Centre in Diabetes and Associated Metabolic Disorders (CIBERDEM – ISCIII). AH is co-author/co-inventor of 7 patents, AH has directed 6 doctoral theses (University of Seville and University Pablo Olavide), has supervised and tutored student and researcher stays (Juan de la Cierva, Ramón Areces, JAE, final degree and master's papers, stay of national and international foreign students and researchers), has participated as external lecturer in the University Master's Degree in Medical Research: Clinical and Experimental (201314_51270024-M127) at the University of Seville (2014) and has been an external lecturer on the UPO's University Master's in Healthcare Biotechnology since 2011. AH is a Guest Editor for Frontiers and MDPI and a Reviewer in several scientific journals, he is an evaluator of research projects, for the Commission for the Guarantee of the Donation and Use of Human Cells and Tissues of the National Institute of Health Carlos III (ISCIII), and for other entities such as the Spanish Association for Standardization and Certification (AENOR). He served as a Director of the GMP Cellular Production and Clinical Trial Unit of the Andalusian Centre for Molecular Biology and Regenerative Medicine (CABIMER).

With two years of expertise in pharmacovigilance, I have managed end-to-end pharmacovigilance operations, medical assessment, routine safety evaluation, and the establishment of PV system set-ups at both affiliates and global offices. As a people manager, I have led teams to achieve global compliance standards and thresholds. My experience includes handling various safety databases, managing data migrations, conducting database validations, and performing quality reviews of safety medical data. I specialize in managing pharmacovigilance projects for clinical safety, covering innovator biotech products and biosimilars from study initiation to life cycle safety management (phase IV and routine PV activities). I have processed and reviewed Individual Case Safety Reports (ICSRs), and prepared and reviewed aggregate reports (PBRER/DSUR/PADERs/ASSR/ASR/aCO), including Risk Management Plans (RMPs). Additionally, I have conducted signal management activities with a comprehensive understanding of all regulatory classes, facing multiple regulatory inspections and audits. I have conducted several PV audits, including those for vendors, licensing partners, and affiliates. My experience extends to the complete development and maintenance of Pharmacovigilance System Master File (PSMF), Pharmacovigilance System Summary (PSS), and Pharmacovigilance System Specification File (PVSF). I bring expertise from both the pharmaceutical industry (sponsor) and the contract research organization (CRO), managing PV projects from end to end. I am well-versed in LSMV and PV Automation. Highlights of my career include serving as the Qualified Person for Pharmacovigilance (QPPV) and receiving the International Young Scientist Award for 2021. I am a representative from the Middle East for the International Society of Pharmacovigilance (ISoP). Additionally, I am a registered Alternative Medicine practitioner (chiropractor) with registration number MD1162. I am a scientific writing professional with over 15 scientific articles published in international journals.

Professor Dr. Luisa Maria Arvide Cambra, Spanish is now Professor with Chair at the University of Almería (Spain) and she was Assistant Professor and Associate Professor at the University of Granada from 1979 on. Forty four years of the teaching and researching experience. She is the Director of Research Group HUM113-Estudios Filológicos from Program of Research of Andalusian Government, where she has managed and directed several academic and scientific contracts and research projects, as well as a Member of European Scientific Institute (ESI) Team, Athens Institute for Education & Research (ATINER) in Greece, The Academic Genesis Platform (UAGP) in UK&Turkey and Experts of Academic Excellence Research Centre (EAERC), in Jordan; GI Social Sciences Forum (GISSF), in Malaysia; Akademica Nusa International Association of Social Sciences and Humanities, in UAE; Science Research Association (SCIREA); Academic Fora; Foundation for Social Sciences and Education Research (FSSER); etc. She is reviewer and member of the editorial board in several renowned scientific journals as well as member of the organizing, scientific & academic committees at prestigious international conferences.

Prof. Dr. Delia Teresa Sponza is currently working as a professor at Dokuz Eylul University, Department of Environmental Engineering. Scientific study topics are; Environmental engineering microbiology, Environmental engineering ecology, Treatment of fluidized bed and activated sludge systems, Nutrient removal, Activated sludge microbiology, Environmental health, Industrial toxicity and toxicity studies, The effect of heavy metals on microorganisms, Treatment of toxic compounds by anaerobic / aerobic sequential processes, Anaerobic treatment of organic chemicals that cause industrial toxicity and wastewater containing them, Anaerobic treatability of wastewater containing dyes, Treatment of antibiotics with anaerobic and aerobic sequential systems, Anaerobic and aerobic treatment of domestic organic wastes with different industrial treatment sludges, Treatment of polyaromatic compounds with bio-surfactants in anaerobic and aerobic environments, Treatment of petrochemical, Textile and olive processing industry wastewater by sonication, Treatment of olive processing industry wastewater with nanoparticles and the toxicity of nanoparticles. She has many international publications

Dr. Mihail Lucian Birsa is currently a Professor in the Department of Chemistry at the Alexandru Ioan Cuza University of Iasi, Romania. In 2003 he was selected as a member of the Alexander von Humboldt Foundation, working with Professor Henning Hopf in TU Braunschweig - Germany. Since then numerous return fellowships were granted by the Alexander von Humboldt Foundation. He has more than 125 publications in peer-review journals and published +45 books/book chapters (John Wiley & Sons, Thieme etc). Also, is editorial board member in more than 50 journals such as Applied Sciences, Arkivoc, BioChem, Edelweiss Chemical Science Journal, Journal of Medicinal Chemistry and Drug Design, Journal of Fine Chemical Engineering, Modern Approaches in Drug Designing, Pharmaceutical Toxicology.

Dr. Noreddine Bouarroudj serves as Consultant Anesthesiologist and Chief Department of Anesthesiology and Critical Care at the Clinique Maissalyne. After graduating from Constantine University School of Medicine, completed his Anesthesiology Critical Care residency and Emergency fellowship at University Hospital Center of Constantine, joined the Department of Anesthesiology at the University Hospital Center of Batna Algeria in 1997 where he served as head of Critical Care and Emergency and then as head of Anesthesiology and Perioperative Care. Subsequently head of Anesthesiology and Perioperative Care Service at the Clinique Ibn Sina where he implemented Locoregional Anesthesia practice and as medical director at the Naoufel Clinic from 2008 to 2020 where he implemented POCUS, Ultrasound in Critical Care, Emergency Ultrasound and Ultrasound Guided Anesthesia, Interventional Pain Management and Enhanced Recovery after Surgery. Since 2017 he is the Director of the Masterclass of Ultrasound Guided Anesthesia and POCUS for anesthesiologists and Director of Anesthesie Club. He is Editor Board Member at Signa Vitae Journal (Journal of Anesthesia, Intensive Care, Emergency and Pain Medicine) and Co-Editor-in-Chief at UJAAC Universal Journal of Anesthesia and Critical Care (Editorial Board) and has been invited as a conference speaker and workshop trainer on regional anesthesia locally and internationally. In 2023 he occupies a new position as Director of Continuing Medical Education for French Speaking Countries in AFSRA (African Society of Regional Anaesthesia) and the Book Author of Pocus in Critical Care Anesthesia and Emergency Medicine. Research interest: Pocus Ultrasound; Eras Enhanced Recovery after Surgery; Ultrasound Guided Anesthesia; Obstetrics and Gynecology Anesthesia; Orthopedic Anesthesia; Pediatric Anesthesia; General Surgery; Anesthesia for Urology; Anesthesia for ENT Surgery