Pharmacovigilance & Drug Safety

Mario Bertazzoli is a physician and a registered specialist in Human Reproduction Pathology. He received both medical and specialization degrees from the University of Milan, Italy. He worked since 1995 for international pharmaceutical companies as pharmacovigilance and pharmaco-epidemiology physician. He is currently the Head of Corporate Drug Safety and Reference Physician to the EU Qualified Person for Pharmacovigilance for the Helsinn Group. He is founder and treasurer of the International Society of Pharmacovigilance, Swiss-Austrian Chapter.

Worldwide Pharmacovigilance (especially US, EU, Switzerland, China and Japan), Benefit-risk management and Pharmacoepidemiology.

Microbiology, Genetics, Immunology, Virology, Immunopharmacology, Cell Biology

Microbiology, Genetics, Immunology, Virology, Immunopharmacology, Cell Biology,

Saad Shakir qualified in Medicine in 1976 and worked in hospital medicine for eleven years before moving to general practice. He has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially at the Medicines Control Agency (MCA) in the UK then in the international pharmaceutical industry.He was appointed as the Director of the Drug Safety Research Unit (DSRU) in Southampton in 1999. The DSRU is an academic Unit associated with the University of Portsmouth. At the DSRU he leads a research team with an active programme for monitoring and studying the safety of medicines. Saad Shakir is a Fellow of the Royal Colleges of Physicians in Glasgow, Edinburgh and London, a Fellow of the Faculty of Pharmaceutical Medicine, a Fellow of the International Society of Pharmacoepidemiology and a Member of the Royal College of General Practitioners in the UK. He continues to practice clinical medicine part-time. He has worked and advised on many drug safety issues including product withdrawals and major safety hazards. He is an author of many publications in scientific journals on pharmacovigilance and pharmacoepidemiology and is a member of the editorial board of the journals of Pharmacoepidemiology and Drug Safety. Saad Shakir has led, co-ordinated and participated in many postgraduate educational and training programmes. He supervises postgraduate students for higher degrees and has been involved with a number of international initiatives to promote and develop pharmacovigilance and pharmacoepidemiology.

Pharmacovigilance risk management and risk minimisation and its effectiveness

1980 - 1994 Qualified University of London, Guy\\\\\\\'s Hospital Medical School followed by hospital medicine and clinical research: general medicine, 6 years in renal medicine, principal investigator in London, Birmingham, and Manchester attached to Renal Unit Royal Infirmary 1994 -1999 Senior Medical Assessor UK Medicines Control Agency – Senior Medical Assessor in Pharmacovigilance Assessment Group. 1999 - 2005 Senior Medical Director in a global CRO – Parexel Scientific and Medical Services – with responsibilities in pharmacovigilance and clinical trials. 2005 - 2007 Deputy Qualified Person for pharmacovigilance for Janssen Cilag Since July 2007, Dr Edwards has been a Principal Consultant in Pharmacovigilance and Drug Safety with NDA Regulatory Science Ltd based in Leatherhead, Surrey, UK. In addition, he chairs the QA panel overseeing the training of UK pharmaceutical physicians on behalf of the UK Faculty of Pharmaceutical Medicine and he is Director of ISoP Secretariat Ltd, is on the ISoP Executive Committee and is Treasurer as of November 2012. He is also Vice President in the Alliance Clinical Research Excellence and Safety (ACRES). He is co-chair of PharmaHUF in the UK & Ireland.

hospital medicine and clinical research: general medicine

Kieran O’Donnell has over 15 years of PV and since 2006 has been leading European and Global PV operations, gaining broad experience in PV QMS; Benefit-risk management; Signal Detection & Management; PSURs & DSURs; RSI development; ICSR and SUSAR submission; Inspection (MHRA GCP & PV and FDA PV inspections; ISO 9001:2000; and responsible roles such as the RP for EudraVigilance and Deputy QPPV for Pharmacovigilance. In addition to his PgC Pharmacovigilance, he has been a member of the RQA PV Committee since 2008 and is a Fellow of PIPA. He joined TMC in June 2014.

Pharmacovigilance, EudraVigilance, Signal Detection, Benefit-risk management

Marco Manfredi MD, pediatrician and gastroenterologist, is now adjunct professor at Parma University. He carried out his education at Parma University where completed his PhD in Pediatric Gastroenterology in 2004. Currently he is working as Assistant Manager in Pediatric Gastroenterology at “Pietro Barilla” Children's Hospital in Parma, Italy. His main fields of interests are Helicobacter pylori infection, coeliac disease, gastrointestinal infectious diseases, functional gastrointestinal diseases, and Probiotics. Dr Manfredi published more than 75 papers, included chapters of textbooks. He is editor of three textbooks on “Helicobacter pylori infection”, “Gastrointestinal Endoscopy in Children” and on “Probiotics in Children” published by Nova Science Publishers, New York, USA. He is serving as an editorial board member of several reputed journal like “Clinical Microbiology: open access” and “Frontiers in Pediatric Gastroenterology and Hepatology” and expert Reviewer for journals like BMC Gastroenterology, Saudi Journal of Gastroenterology, BMC Case Reports. He is a member of Italian Society of Pediatric Gastroenterology, Hepatology and Nutrition.

Gastroenterology, Hepatology and Nutrition

Uqbah Iqbal is the recipient of Research University Fellowship Scheme, MyBrain 15 (MyPhD) Postgraduate Scholarship Programme, graduate on Time Award, Outstanding Student Award, the Youngest Ph.D. in History Holder and the only Malaysian achieved a Ph.D. in History in conjunction with the 43rd Convocation of the National University of Malaysia. He’s authoring 71 books/ebooks and his 320 articles appeared in international and national journals. In the process, he became Executive Editor, Chief Editor, Associate Editor, Guest Editor, International Advisory Board, Conference Organizer, and Review Committee. He has also reviewed the book Pharmacovigilance and Pharmacoepidemiology, Clinical Research in Psychology. International Journal of Pharmacovigilance, International Journal of Modern Pharmaceutical Research.

Pharmacovigilance, Pharmacology, Neuropharmacology

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