Essam GHANEM is an experienced physician and Qualified Person for Pharmacovigilance with almost 25 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organisations. Around 8 years working experience as EUQPPV and as consultant Safety physician in the Pharmaceutical Industry.Essam Ghanem is the founder of the pharmacovigilance consultation company Vigi-Care BVBA. At present time, Essam Ghanem is the head of Drug Safety and Pharmacovigilance at Keyrus Biopharma (BE, FR, CA, LEB)(*). Membership owner of European society of CRO Federation (EUCROF).

Pharmacovigilance,clinical Research and Drug Development

Giovan Giuseppe Mattera graduated as MD at the School of Medicine of the Pisa University in 1988. In 1992 achieved the PhD in Clinical Pharmacology. From 1989 to May, 1993 he worked as Scientist in Hemodynamics Lab - Department of Pharmacology- Guidotti SpA. In this role he was involved in project on the research of new inhibitors of Angiotensin and Endotelin Converting Enymes. In June 1993, he joins Sigma tau SpA where he serves as Head of New Experimental Model Lab (from 1993- to 1998) and Head of Cardiovascular Pharmacology Lab. - General Pharmacology Dept – R&D Area (from 1998 to 2002). Head of Cardiovascular Pharmacology and Safety Lab. – C&PNS and General Pharmacology Area (from 2002 to 2011) and Head of Pre-clinical Safety Lab. – General Pharmacology Area – Corporate R&D (from 2011 to 2013). In this period his principal research’s interests were: Pharmacology of Carnitin System; Physiopathology of Endothelium; Cardiovascular Diabetic Complications; Cardiac Insufficiency and research of new inotropic agents; Set up of the laboratories for C.V. Safety study in large animal and telemetric methods. Several studies of the effects on QT/QTc duration, of different class of New Chemical Entity under development. From May 2013 to now, he moved to Clinical Research Dep. of Sigma tau Corporate R&D as Head of Human Safety Unit. Moreover, from 2016, he serves also as Medical Qualified Person of Pharmacovigilance for Alfasigma SpA, the new group born from ST and Alfa Wasserman joining. In those positions, he prepare the clinical trials Safety Monitoring Plans, assures the safety monitoring and evaluation of IMP in clinical studies; supporting Clinical Research to define risk / benefit profile of IMPs. He exerts other Pharmacovigilance activities as Signal Detection and periodic safety reporting.

Pharmacovigilance,Clinical Trials and Safety Reporting

Toxicologist with more than 15 years working in the field of nonclinical toxicology and safety assessment. Experiences in Pharma Company and Contract Research Organization. Senior Toxicologist involved in Pharmacovigilance to support the efficacy, safety and well-use of medicines of our Company. Experience as Medical Adviser in dermatological area. Medical-Scientific support worldwide to the medicines of our Company. Study director, design, conduction and preparation of final reports of in vitro and in vivo toxicological studies in drug development, drug-candidate selection. Experience in toxicological data interpretation, preparation of nonclinical toxicology-safety report, reviews and summaries of safety of new drugs to support clinical studies.

Nonclinical Toxicology,Safety Assessment and Pharmacovigilance

Dr. Roger M. Leblanc received a B.Sc. degree in Chemistry from Université Laval in 1964, followed by a Ph.D. in Physical Chemistry in 1968. Then, he obtained a postdoc position at the Royal Institution of Great Britain for two years before moving to the University of Québec, Trois-Rivières, Canada, where he spent 20+ years of studying photobiophysics. He moved his research to the University of Miami in 1994. Dr. Leblanc is Professor and Chair of Chemistry Department at University of Miami. And his research interests are centered on biophotophysics, spectroscopy and surface chemistry and he has published more than 500 research articles related to these topics and has guided more than 100 Ph.D. and M.Sc.

Biophotophysics,Spectroscopy and Surface chemistry

Mirko Diksic is a scientist who has successfully used his abundant experience in basic sciences and applied that knowledge to neurobiological and neuropharmacological research. After joining the Montreal Neurological Institute in 1979 Mirko Diksic, along with a research group, devised and set up the first medical cyclotron facility in Canada designed exclusively for medical research. He made a substantial contribution to the development of the methods for the synthesis of radioactive labeled compounds used medical research. At the same time, Mirko Diksic established a radiochemical laboratory to prepare biologically active molecules marked with the short living 18F md 11C radioisotopes. These labeled molecules have been used in investigations of processes in the human CNS in vivo using PET. He made a significant contribution to oncological brain research. Mirko Diksic was first to demonstrate that the effects of BCNU depend on its routes of administration. A great deal of Mirko Diksic's scientific work is connected to studies in the control of the synthesis rate of the neurotransmitter (serotonin) in the CNS. He is one of the first scientists to determine the rate of serotonin synthesis in the human brain in vivo, using 11C-alpha-methyltryptophan synthesized in his laboratory. The most significant contribution of this study was the finding that the rate of serotonin synthesis in healthy male and female brains is differently affected by mild 'stress' produced by lowering body tryptophan.

Oncological Brain Research

principal investigator in London, Birmingham, and Manchester attached to Renal Unit Royal

DR. EMMANUEL O. AKALA completed his Ph.D. in Pharmaceutics from University of Manchester, England and did his NIH Postdoctoral Fellow in Pharmaceutics and BioEngineering from University of Utah. He is currently teaching in Howard University and the courses includes Pharmaceutical technology, Physical Pharmacy, Pharmaceutical Mathematics, Biopharmaceutics and Applied Pharmacokinetics.

His research interests includes Controlled Drug Delivery and Drug Targeting, Drug Formulation and Stability Studies, Pharmacokinetics in Pharmaceutical Dosage Form Design, Pharmacokinetics in Pharmaceutical Dosage Form Design, Drug Formulation and Stability Studies, Biomaterials, Biopharmecutical Application of Nanotechnology.

Dr. Susan Welsh is the Chief Safety Officer and Head of Global Pharmacovigilance & Epidemiology at Sanofi. She has 27 years of broad management experience in both R&D and commercial sectors of the global pharmaceutical industry, preceded by 10 years experience in direct patient care as a physician. Susan has 15 years’ experience in PV/Risk Management, overseeing drug safety directly or managing safety as part of clinical development/medical affairs roles. Prior to joining Sanofi, Susan held global leadership roles in PV at BMS and Pfizer. During her years at BMS and Pfizer, she has had increasing PV responsibilities for a broad array of small molecules and biologics across the product lifecycle. Susan has worked in numerous therapeutic and product areas e.g. oncology, haematology, immuno-therapies, rheumatology, genetically defined diseases, neuroscience, vaccines, generics, over-the-counter and mature products. Susan received her Medical and Bachelor of Science degrees from the University of Leeds, UK. She earned a Master's in Information Management from Washington University, St. Louis and an MBA from the University of California at Berkeley, USA. She is a Fellow of the Faculty of Pharmaceutical Medicine, Royal Colleges of Physicians (UK), a Member of the Royal College of General Practitioners (UK), a Member of the Royal College of Psychiatrists (UK), a Diplomat of the Royal College of Obstetricians and Gynaecologists (UK) and Member of the American College of Physicians. Before joining industry, Susan practiced medicine for 10 years in Great Britain. During this time she served for 6 years as an officer in Britain's Royal Air Force.

Pharmacovigilance/Risk Management, Clinical development and Medical Affairs

Dr. Rathinavelu received his Ph.D., M. Phil., M.S., and B.S. from the University of Madras in India and conducted his Post-Doctoral work at Purdue University. He joined NSU’s College of Pharmacy in 1992 and he is currently the Executive Director of the Rumbaugh Goodwin Institute for Cancer Research of NSU. Dr. Rathinavelu has been involved in cancer research for more than two decades with great interest and expertise in drug discovery, pharmacogenomics, signal transduction, gene expression and natural products research. Dr. Rathinavelu holds 5 new patents for the discovery of novel anti-angiogenic compounds that are nearing completion of pre-clinical testing. Dr. Rathinavelu serves on the Governmental Affairs Committee of Bio Florida and was a member of the Center of Excellence for Marine Biology and Biotechnology consortium that included scientists from NSU, Florida Atlantic University and Florida International University. Dr. Rathinavelu has published, co-authored, and reviewed research articles and textbooks extensively. Dr. Rathinavelu is the recipient of the ‘Fulbright Award for Excellence in Teaching and Research’ for the year 2015 from the Council of the International Exchange of Scholars of the United States of America (USA) and the ‘Distinguished Professor of the Year’ Award from 2016 from NSU

Drug Discovery, Drug screening, Pre-clinical testing, Natural Products research, Genomics and Biotechnology. Rathinavelu's work also includes identification of gene defects, studying the effect of tumor micro environment on gene expression pattern and cellular mechanisms that enhance angiogenesis, cancer metastasis and drug resistance.

Gamal El-Sokkary has completed his PhD at the age of 35 years from Assiut and Texas Universities (member of joint supervision mission). He is the Professor of Cell Biology. He has published more than 42 papers in reputed journals and has been serving as an editorial board member of repute. He has supervision on more than 8 Ph.D. thesis and 7 masters in Egypt and other countries. He got Best Research Award of the Faculty of Science (Zoology) 5 times.

His research interests are melatonin as an antioxidant and free radical scavenger, effect of oxidative stress on DNA synthesis, cell proliferation, and cell cycle duration and the protective role of melatonin.

Mohamed Eddouks is Professor at Moulay Ismail University, Faculty of Sciences and Techniques Errachidia, Morocco with a Master Degree from University of Paris 6, a specialized certificate from Paris 7 and PhD degree from University of Liege, Belgium and post-doctoral fellowship at Faculty of Medicine of Montreal, Canada. His contribution to the field of phytotherapy of diabetes and hypertension includes four international books and more than 90 peer-reviewed articles. He has been honored with many national and international awards. He has been the founder Dean of Polydisciplinary Faculty of Errachidia.

Ethnopharmacology, Diabetes, Hypertension

Manish Mahajan completed his MD in Biophysics from All India Institute of Medical Sciences, New Delhi, India, holds a Post Graduate Diploma in Pharmaceutical Marketing and a certified Business Analyst. He has published various papers in reputed national and international journals and serving as member of reviewer panel of a reputed journals. His areas of expertise and interests are Therapeutic Lead and Target identification; Biosimilar Pre and Clinical development, Medical Education, Regulatory Affairs for Drugs and Nutrition and Health Economics.

Key research areas are Biologics similarity, In vitro diagnostics, Pharmaco-economics and Public Health Policy

Essam GHANEM is an experienced physician and Qualified Person for Pharmacovigilance with almost 25 years of experience in clinical research and drug development in academic institutes, Pharmaceutical Industry and Clinical Research Organisations. Around 8 years working experience as EUQPPV and as consultant Safety physician in the Pharmaceutical Industry.Essam Ghanem is the founder of the pharmacovigilance consultation company Vigi-Care BVBA. At present time, Essam Ghanem is the head of Drug Safety and Pharmacovigilance at Keyrus Biopharma (BE, FR, CA, LEB)(*). Membership owner of European society of CRO Federation (EUCROF).

Pharmacovigilance,clinical research and drug development

Manish Mahajan completed his MD in Biophysics from All India Institute of Medical Sciences, New Delhi, India, holds a Post Graduate Diploma in Pharmaceutical Marketing and a certified Business Analyst. He has published various papers in reputed national and international journals and serving as member of reviewer panel of a reputed journals. His areas of expertise and interests are Therapeutic Lead and Target identification; Biosimilar Pre and Clinical development, Medical Education, Regulatory Affairs for Drugs and Nutrition and Health Economics.

Key research areas are Biologics similarity, in vitro diagnostics, Pharmaco-economics and Public Health Policy.