Pharmacovigilance & Drug Safety

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical- scientific department of a medium-size CRO in Rotterdam.

Clinical Drug Safety, clinical practice,Pharmacovigilance

John received a BS in biochemistry from Albright College and his Ph.D. in synthetic organic chemistry from Brown University. After completing a Postdoctoral Fellowship at the Sloan-Kettering Cancer Institute in NYC in the departments of Positron Emission Tomography and Neurology, he joined the Medicinal Chemistry Discovery group at Johnson Matthey Biomedical. There he worked on Pt-based antitumor drugs and peptide-based diagnostic radio-imaging agents. After nearly a decade in drug Discovery, he later moved on to drug development, in positions of increasing responsibility at J&J and Sanofi-Aventis. For the past 15 years he and his teams have specialized in drug delivery and pharmaceutics, focused at the interface of drug discovery and development. His specific expertise in drug delivery lies in the area of enhancing the solubility of insoluble compounds, where he has successfully introduced a wide range of methods into drug discovery space. His research also spans specific areas such as targeted prodrugs and new functional excipients. He currently is a Senior Principal Scientist and Network Technology Lead of the Discovery Pharmaceutical Sciences department at Merck Research Labs. He is co-inventor on 13 US Patents and author of many diverse publications and book chapters in the fields of organic, solid state & medicinal chemistry as well as drug delivery

Organic, solid state & medicinal chemistry and drug delivery

Shawn (Xiaotian) Yin received his Ph. D. in Solid-State Chemistry from University of Waterloo, Canada. He then completed his Post Doctoral fellowship at Department of Materials Sciences and Engineering, Cornell University. Currently, Dr. Yin is a Senior Principal Scientist at Bristol-Myers Squibb Company. His research interests include amorphous and nanomaterials for drug delivery, pharmaceutical polymorphic form studies, API crystal form in drug product, physical characterizations of pharmaceutical substances and powder X-ray diffraction applications in pharmaceutical sciences.

Formulation, Drug Delivery, Drug Development

Doctor Antonio Steardo specialized in Pharmacology and graduated in Pharmacy and Pharmaceutical Chemist. He has now gained years of experience since 2002 in the pharmaceutical products trade sector as he could have been behind the counter of the Steardo pharmacy from an early age. Already in elementary school, the curiosity for chemistry manifests itself during his games and continues lectures at the department of science at the University of Salerno. Therefore, during the cycle of studies, he prefers biochemistry and biochemistry of drug action, graduating in July 2007 with a thesis on the functioning of the endocannabinoid system on Alzheimer’s disease in pharmacology. Following the beginning of his pharmaceutical chemistry studies, he stopped for a competition as a postgraduate in pharmacology at the University of Rome La Sapienza in July 2014. Expecting constant improvement as a professional update, he enrolled in the continuing professional training department at the University of Oxford to follow courses in Experimental and Translation Therapy and on Medical Research. His desire to improve leads him to attend international conferences and seminars.

biochemistry and biochemistry of drug action

Dr. Mayada Alkhakany has more than 15 years of experience working within various sectors of the pharmaceutical industry having worked across a range of key areas including clinical operation, medical affairs, and pharmacovigilance functions. She was the head of pharmacovigilance in Middle East, Turkey, and Africa (2014-2019) in Boehringer Ingelheim. She was an associate director of pharmacovigilance in Merck Sharp & Dome (2010-2014). She’s pharmacovigilance, policy making and leadership consultant. Dr. Mayada is a member of ISoP (International Society of Pharmacovigilance), founder and co leader of ISoP patient engagement group. Co-founder and ex-president of ISoP Middle East chapter (2015-2020). She was the chair of local organizing committee of the annual meeting of ISoP 2021. She conducted many training programs under the umbrella of ISoP Middle East Chapter and in collaboration with Arab Health Authorities. She has been invited as a speaker in many conferences both international and regional.

Pharmacovigilance

Mircea Ciuca, MD is currently Global Head of Medical & Clinical Drug Safety at Vifor Pharma in Switzerland. He is leading a team of scientists and physicians involved in all aspects of pharmacovigilance, in both development and post-marketing settings. Mr. Ciuca has about 13 years of experience in drug safety. Prior to join Vifor Pharma he held various positions (Deputy QPPV, Senior Pharmacovigilance Medical Manager, Drug Safety Advisor) at large pharmaceutical companies in The Netherlands, after successfully establishing and leading the medical- scientific department of a medium-size CRO in Rotterdam

Pharmacovigilance

Prof Mohamed Eddouks has received his PhD in University of Liege, Belgium during the period of 1990-1993. Currently, he/she is working as Professor in Moulay Ismail University. He has successfully completed her Administrative responsibilities as founding Dean of Polydisciplinary Faculty of Errachidia. His research has included antidiabetic and antihypertensive medicinal plants. Based on this research and fellowship training he has received several awards and honors, such as The first Prize of Scientific Research in 2008 by the Moroccan Association of Research and Development. He is serving as an editorial member of several reputed journals like Evidence-based Complementary and Alternative Medicine, International Journal of Pharmacy and Pharmaceutical Sciences, Asian Journal of Pharmaceutical and Clinical Research, Metabolic and Functional Research on Diabetes, Pharmacology and Pharmacy, Research Journal of Pharmacology, Pharmaceutical Regulatory Affairs…etc & expert Reviewers for journals like Journal of Cardiovascular Pharmacology, Journal of Pharmacy and Pharmacology, Journal of Food Biochemistry, Plant Foods for Human Nutrition, Diabetes Research and Clinical Investigation, Journal of Herbal Pharmacotherapy, Evidence Based Complementary and alternative Medicine, Journal of Herbs Spices and Medicinal Plants, Life Sciences, Biophysica Biochemica Acta, Phytotherapy Research, Journal of Ethnopharmacology and Journal of Medicinal Plants Research….etc. He has authored more than 70 research articles and 3 books. He is a member of American Diabetes Association, American Stroke Association, the Scientific Council for High Blood Pressure, Research and European Institute for the Ambulatory Study of Obesity and Diabetes.

Obesity, Diabetes, Pharmacology, Food Biochemistry

Dr. Ashok Srivastava is Chief Executive Officer and Chief Medical Officer of Cure Pharmaceuticals, and ClinFomatrix Oncology CRO, He was founder, Chief Executive Officer and Chief Medical Officer of CareBeyond - A Radiation Therapy Cancer Center, New Jersey. USA. He has more than 15 years of experience in drug development, medical affairs and commercialization of cancer drugs including radiopharmaceutical and supportive care; Phase 1 – 4, and marketing commercialization of Hematology, Oncology and radio-immuno-oncology drugs in USA, EU and Japan.

Biopharmaceutical Science, Pharmacovigilance, Drug Safety, Drug Delivery

Dr. Robert L. Barkin is Professor of Anesthesiology, Pharmacology, and Family Medicine at Rush University Medical College in Chicago, Illinois. He is also a clinical pharmacologist in a collaborative practice with 5 physician pain specialists at the NorthShore University Health System Department of Anesthesiology Pain Center’s of Skokie and Evanston Hospitals in Illinois. Dr. Barkin’s extensive daily practice is both outpatient and in-patient. Dr. Barkin designs patient specific pharmacotherpeutic treatment plans.

Pain – Acute and chronic, Postoperative pain, fibromyalgia, migraine headache, Neuropathic & nociceptive pain, Psychopharmacology

Dr. Lopez-Ruiz has completed his Ph.D. from Valencia University and postdoctoral studies from CEU Cardinal Herrera Health Sciences Faculty. She obtained her doctorate in Medicine with the doctoral thesis on “Analysis of the use of medication in the paediatric population that visit accident and emergency department” with summa cum laude. She has achieved the qualification of “University Expert in Neonatology” from the Catholic University of Valencia and “Master’s Degree in Neonatology (from de SENeo -Neonatology Spanish Society-)”. She is Medicine Degree Coordinator in CEU Cardenal Herrera University since 2015. She is the director of the “Master’s degree in Neonatal Intensive care and Neonatal Nursing”. She has attended to International Congresses of Pediatrics as a keynote speaker and she has been part of the Organizing Committee member for the 12th International Conference on Pediatric Pathology and Laboratory Medicine, and she has published in reputed international journals.

Pediatrics, Neonatology, Human Anatomy, Pharmacology

Dr. Tirotta is a member of numerous professional societies and has served on a number of hospital committees, including the Heart Program Executive Committee. He previously served as the Co-Chair of the Miami Children’s Hospital Physician Hospital Organization. He is also responsible for giving numerous medical lectures nationally and internationally and is actively engaged in clinical research. He has been the Principal Investigator on a number of clinical drug/device trials, including on the ONQ Pain Buster, the muscle relaxant Zemuron, the procoagulant RiaSTAP, the Cardiotronic NICOM device and the ClearLine. He will also be the Principal Investiagator in Merck’s Sugammadex pediatric trial and Pacira Pharmaceuticals pediatric Exparel trial.

Pediatric Cardiac Surgery Patients, Clinical Anesthesia, clinical drug/device trials , Pharmaceuticals pediatric Exparel trial,

Richard H. Parrish II is Director and Chief Pharmacist at St. Christopher’s Hospital for Children in Philadelphia, Pennsylvania, USA and President and Executive Officer at Meds4Kids RESEARCH COLLABORATIVE, LTD, (M4KRC) a think-tank of concerned clinical pharmacists and pediatricians devoted to the creation of safer medication management systems designed for children and their families. All other authors are members of the Board of Advisors for M4KRC

Pediatric pharmacotherapy and Clinical Pharmacy.

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