Dr. med. Brigitte Keller-Stanislawski is Consultant Clinical Pharmacology. Since 2003 she is Head of the Department Safety of Medicinal Products and Medicinal Devices in the Paul-Ehrlich-Institut, Langen. This also includes the responsibility for Hemovigilance in Germany.
Appointments to relevant regulatory committees include: Member of the European Hemovigilance Network (EHN), Co-opted Member as scientific expert of the PRAC, expert of the Vaccine Working Party of the CHMP, Extraordinary Member of the Committee of Medicines of the German Medical Association (AKDÄ), Member of the Adverse Drug Reaction Working Group of the German Medical Association (UAW-Ausschuss der AKDÄ), Steering Committee Brighton Collaboration. She is PEI Representative in the German Standing Vaccination Committee (Ständige Impfkommission) and the Subgroup Look Back of the “Arbeitskreis Blut” (German Blood Working Group).
Chonlaphat Sukasem is the Associate Professor in Clinical Pathology and Pharmacogenomics at the Department of Pathology, Faculty of Medicine Ramathibodi Hospital, Mahidol University, Thailand. He has been appointed to be Head of the Division of Pharmacogenomics and Personalized Medicine. He also serves as Chief of Laboratory for Pharmacogenomics, Somdech phra Debaratana Medical Center (SDMC). He currently functions as the Program Director of the MS. and Ph.D. of Clinical Pathology. He has a background in pharmacological science and pharmacogenomics. His research interests center on pharmacogenomics of drug induced-severe cutaneous adverse drug reactions, antipsychotics used in autistic children and schizophrenic patients, antiretroviral and antifungal, anti-cancers, drug used in childhood acute lymphoblastic leukemia, statin induced rhabdomyolysis and the influence of race/ethnicity on drug response etc. He primarily aims how to translate the pharmacogenomics knowledge into clinical practices including pharmacogenetic testing, TPMT enzyme activity and therapeutic drug monitoring for the precision medicine.
Dr David J Lewis
Dr Dave Lewis joined Patient Safety at Novartis Pharmaceuticals in the UK in March 2007. He was EU QPPV for Novartis Pharmaceuticals AG from April 2009 and became Global Head of Pharmacovigilance Systems and Data Management. He was promoted to Global Head of Pharmacovigilance in February 2011. Dr Lewis has experience of working in country affiliates (UK, Ireland) and in a variety of global safety and risk management functions with both investigational and marketed products. During the last three decades, he has also worked in roles dedicated to safety IT systems and pharmacovigilance processes. Previous experience was gained at Shire Pharmaceuticals and at GSK. Dr Lewis is the author of papers on various aspects of the safety of human medicines, as well as research papers on neuropharmacology. He has a number of academic links, including being named Senior Visiting Research Fellow, Department of Pharmacy, Pharmacology & Postgraduate Medicine, University of Hertfordshire. Dr Lewis is Project Coordinator for the IMI WEB-RADR project (http://www.web-radr.eu). Outside of his scientific work Dave runs a smallholding and maintains an interest in retaining his advanced driving licence. He actively participates in a number of sports, having played cricket and hockey at representative level. Last but not least he enjoys reading (history, archaeology and science fiction) and music (ranging from Baroque to current releases, including an eclectic mix exemplified by Byrd, JS Bach, Pink Floyd, New Order, Warpaint, The XX and London Grammar).
Gianluca Trifiró is MD, PhD working as Clinical Pharmacologist and Assistant Professor of pharmacoepidemiology with tenure track at both University of Messina (Italy) and as honorary Assistant Professor at the Erasmus Medical Center (NL). In the last years, he was involved in scientific coordination of several international projects evaluating drug use and safety in real life using multiple European healthcare databases. Currently, he is coordinating an Italian Health Minister-funded project assessing post-marketing benefit-risk profile of biosimilars in Italy through distributed database network. He is member of the Sicilian Regional Drug Formulary and Committee on Biosimilar use and secretariat of pharmacovigilance at the Italian Drug Agency. He is member of the Steering Group of the European Network of Center for Pharmacoepidemiology and Pharmacovigilance (ENCePP) at the European Medicine Agency. Authors of more than 130 scientific peer-reviewed publications in international journals.
Professor Guruprasad P. Aithal
Professor Guruprasad P. Aithal is the Professor of Hepatology and the Head of the Nottingham Digestive Diseases centre, University of Nottingham. He leads the Gastrointestinal and Liver Disorder Theme of National Institute for Health Research Nottingham Biomedical Research Centre. He has over 150 publications with H index of 46 currently. His landmark study on warfarin pharmacogenetics (Lancet 1999) catalysed the field, leading the US Food and Drug administration (FDA) to recommend (2007 & 2010) genetic testing during warfarin dosing and its wider application in practice. He also led an international expert panel to establish phenotypic standardisation in drug-induced liver injury (DILI) (Clin Pharmacol Ther. 2011). He co-chaired international DILI consortia to conduct a seminal genome-wide association studies identifying key associations with key polymorphisms in HLA and other genes with DILI (Nat Genet. 2009, Gastroenterology 2017).
Prof Aithal is the Deputy Director of the Medical research Council (MRC) Nottingham Molecular Pathology Node. He contributed critically to the evaluation of the Enhanced Liver Fibrosis panel (Hepatology. 2008, Hepatology. 2013), the only non-invasive marker set recommended for clinical use by National Institute for Health and Care Excellence, UK in the draft NICE guidance (2015) on NASH and cirrhosis. He also evaluated piogltazone (Gastroenterology. 2008) and liraglutide (Lancet 2016) in phase II trials to demonstrate efficacy in NASH.
Prof Aithal has led the development of fast, and inexpensive magnetic resonance imaging (MRI) method to estimate the degree of inflammation and fibrosis within the whole liver (NMR Biomed. 2015). Recently, he used this method to estimate portal pressure (J Hepatol 2016), showing that it correlates with hepatic venous pressure gradient measurements – the current gold standard but invasive and expensive test, only available in selected centres. This technique will revolutionise the stratification of patients with chronic liver disease, making it available to all.
Henk-Jan Guchelaar, PharmD PhD
Henk-Jan Guchelaar studied Pharmacy at the Rijksuniversiteit Groningen (RuG) and specialized as a hospital pharmacist and clinical pharmacologist. Since 2003, he is employed as a clinical pharmacist and clinical pharmacologist and professor of clinical pharmacy and chair of the department of Clinical Pharmacy & Toxicology at Leiden University Medical Center.
Since october 2008, he is also appointed professor of Clinical Pharmacy at the Faculty of Science, Leiden Academic Center for Drug Research, University Leiden and chair of the Leiden University focus area ‘Translational Drug Discovery and Development’.
Pharmaceutical patientcare in oncology is his main area of clinical interest. He is program leader of the research program ‘Personalised Therapeutics’ investigating interindividual variability of drug response with an emphasis on pharmacogenomics. He is founder and board member of the Leiden Network for Personalised Therapeutics (www.lnpt.nl). He is (co-)author of more than 500 (Web of Science indexed) articles (Pubmed: 310) in international peer reviewed scientific journals, more than 100 articles in Dutch journals and 20 (chapters in) books.
From 2010-2016 he was a member of the national Central Committee on Research Involving Human Subjects, from 2003, he is vice-chair of the Dutch Society for Clinical Pharmacology and Biopharmacy, and since 2016 he is member of the Dutch Medicines Evaluation Board. Since 2017, he is member of Council for Medical Sciences of the Royal Dutch Academy of Science. Henk-Jan is founder of the new Master of Pharmacy, Leiden University Medical Center, University of Leiden.
Dr Jeffrey Aronson
Dr Jeffrey Aronson [MA, DPhil, MBChB, FRCP, HonFBPhS, HonFFPM] is a Clinical Pharmacologist working in the Centre for Evidence Based Medicine in the University of Oxford. He is President Emeritus, an Honorary Fellow, and Vice-President Publications of the British Pharmacological Society and an Emeritus Fellow of Green-Templeton College, Oxford. His research interests include all aspects of clinical pharmacology (especially adverse drug reactions and interactions and monitoring therapeutic interventions), medical history, and philology.
Other current and recent activities include:
- Editor-in-Chief, Meyler’s Side Effects of Drugs—The International Encyclopedia of Adverse Drug Reactions and Interactions (16th edition, 2015) and of its annual update volumes (Side Effects of Drugs Annuals 15-35)
- Co-editor (with John Talbot), Stephens’ Detection and Evaluation of Adverse Drug Reactions: Principles and Practice. 6th edition. (Wiley-Blackwell, 2011)
- Member of the Advisory Board of the British National Formulary and the British National Formulary for Children
- Chairman, British Pharmacopoeia Commission’s Expert Advisory Group on Nomenclature
- Associate Editor, BMJ Evidence Based Medicine
Jeremy A. Rassen ScD.
Jeremy A. Rassen, ScD is Co-Founder, President and Chief Scientific Officer at Aetion, Inc., a healthcare technology company that provides real-world evidence (RWE) analytics solutions to healthcare companies. At Aetion, Dr. Rassen leads the effort to design, scale and communicate scientific methodologies for obtaining valid and timely medical evidence from real-world data, focusing on questions of safety, effectiveness and value. Dr. Rassen was formerly an Assistant Professor of Medicine at the Brigham and Women’s Hospital and Harvard Medical School, where he focused on methodology for improved validity and reach of pharmacoepidemiology and comparative effectiveness research. His published work includes numerous papers on propensity score and instrumental variable methods, as well as methods for pooling data across databases and preserving privacy. Before coming to Harvard, Dr. Rassen worked in Silicon Valley in a variety technology companies, including Hewlett-Packard and Epiphany, Inc. His focus was on high-performance software for the creation and analysis of large marketing databases. Dr. Rassen received his bachelor’s degree in Computer Science from Harvard College and his masters and doctorate degrees in Epidemiology from the Harvard School of Public Health.
Judith (Judy) Zander M.D.
Judy Zander is the Director of the Office of Pharmacovigilance and Epidemiology (OPE), in the Office of Surveillance and Epidemiology (OSE), in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA). In this capacity, she oversees the Divisions of Pharmacovigilance 1 and 2, the Divisions of Epidemiology 1 and 2, including drug safety epidemiology activities and pharmacovigilance programs
Judy joined FDA in January 2017. She has more than 20 years of pharmaceutical industry experience in drug safety, and risk management. She has experience with branded and generic products, from clinical development through post market use, in all therapeutic areas.
Prior to joining FDA, Judy was the Vice President of medical scientific strategy in Global Pharmacovigilance.
Judy held prior positions with increasing responsibility at AstraZeneca, Novartis, and Johnson and Johnson. . She has supported and lead internal and external pharmacovigilance activities, including being a member of the CIOMS IX Expert working group regarding the application of Risk Management Tools.
Judy is a licensed and board certified internist.
She earned her medical degree from New York Medical College and a bachelor’s degree in chemistry from Brooklyn College.
In her free time, Judy enjoys biking and spending time with her family.
Dr. Kin-Wei Chan
Dr. Chan is a physician epidemiologist with almost 30 years of global research experience in academia and private sector, with a primary focus on post-marketing evaluation of pharmaceutical agents and vaccines. He received medical training at National Taiwan University (MD-equivalent, 1987) and advanced training in epidemiology at Harvard School of Public Health (Doctor of Science, 1992). He has served on the faculty at National Taiwan University (NTU) and Harvard School of Public Health and joined the private industry in 2005, subsequently became the Chief Scientist of the Epidemiology Unit at Optum.
Dr. Chan returned to NTU in 2013 and is currently a professor at NTU College of Medicine, Director of the NTU Health Data Research Center, and Director of Medical Research Department at NTU Hospital. In addition to scientific research, he has provided consulting input to Taiwan Food and Drug Administration and related health authority for more than 20 years. Dr. Chan has authored or co-authored more than 100 peer-reviewed articles and co-edited one of the two widely used English textbook on pharmacoepidemiology.
Laura M Yates MBChB DRCOG MRCPCH PhD
Dr Laura M. Yates is Head of Teratology for the UK Teratology Information Service (UKTIS), Newcastle upon Tyne, UK and a Consultant in Clinical Genetics at the Institute of Genetic Medicine in the Newcastle Hospitals NHS Foundation Trust. Her research interests are in developmental genetics and teratology.
Maja Mockenhaupt, MD, PhD,
Maja Mockenhaupt, MD, PhD, started her work on severe cutaneous adverse reac-tions 1990 as a research fellow at the department of dermatology at the university of Freiburg, Germany. She was involved in various epidemiologic studies in this field, e.g. SCAR and EuroSCAR, both large scale case-control studies, as well as the on-going RegiSCAR-project and the German Registry of severe skin reactions. After her PhD in 2007 she received a personal grant for clinical research by Else Kroener-Fresenius-Foundation.
She received her training as a dermatologist at the department of dermatology at the University of Freiburg, Germany, and passed her board examination in 1996. She has since worked in different clinical units of the department and serves as a senior dermatologist with teaching obligations (since 2000) and holds the position of a pro-fessor at the medical faculty of the university (2011).
She also serves as the head of the German Registry and the coordinator of the mul-tinational RegiSCAR-study.
Michael Dougan is Professor of Law at the University of Liverpool.
Niklas Norén is the Chief Science Officer and Head of Research of the Uppsala Monitoring Centre, and is responsible for the scientific direction of the centre. He holds a PhD in Mathematical Statistics from Stockholm University in 2007 and a Master’s degree in Engineering Physics from Chalmers University of Technology in 2002. Niklas has worked in various positions at the Uppsala Monitoring Centre and affiliated organizations since 2002. He has published more than 30 peer-reviewed papers on exploratory analysis of observational medical data, including internationally awarded research of methods for duplicate detection and subgroup discovery in large data sets.
Peter Pitts is President of the Center for Medicine in the Public Interest. A former member of the United States Senior Executive Service, 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 and as a Special Government Employee (SGE) consultant to the FDA’s Risk Communications Advisory Committee. He is a Visiting Lecturer at the École Supérieure des Sciences Économiques et Commerciales (Paris and Singapore), and has served as an adjunct professor at Indiana University’s School of Public and Environmental Affairs and Butler University.
Professor Philip A Routledge
Phil Routledge graduated in Medicine (MB BS and MD) from the University of Newcastle upon Tyne and trained in general internal medicine and clinical pharmacology and toxicology in the UK and USA before being appointed Senior lecturer in Clinical Pharmacology in Cardiff University School of Medicine and honorary consultant physician and clinical pharmacologist in Cardiff and Vale University Health Board (based at University Hospital Llandough) in 1981.
He is presently Clinical Director of the All Wales Therapeutics and Toxicology Centre in Cardiff and Vale University Health Board and Emeritus Professor of Clinical Pharmacology in Cardiff University. From 2006 until 2014, he chaired of the All-Wales Medicines Strategy Group (AWMSG) which advises Welsh Government, particularly in relation to the introduction of new medicines and medicines policies in Wales. Since 2005, he has been Chair of the UK Herbal Medicines Advisory Committee at the MHRA. In 2008, he was awarded an OBE for services to Medicine.
MPharm, RNDr, Principal Scientific Administrator
Surveillance and Epidemiology Service, Pharmacovigilance and Epidemiology Department, European Medicines Agency (EMA)
Sabine Brosch obtained a Master Degree in Pharmacy and a Doctor of Natural Sciences Degree in pharmacology from the University of Vienna, Austria. She worked as Assistant Professor at the Department of Pharmacology and Toxicology at the University of Vienna from 1988 to 1992 and thereafter in the Department of Pharmacovigilance at the Ministry of Health in Vienna, Austria.
She joined the EMA in 1996 and works as Principal Scientific Administrator at the Pharmacovigilance and Epidemiology Department.
Dr Shanthi Pal
Dr Shanthi Pal is the Group Lead for Medicines Safety in the Safety & Vigilance Team in WHO, Geneva. She holds a M Pharmacy degree with a PhD in Pharmacology. Her current responsibilities in WHO include promoting global exchange of information on medicines safety, coordinating the work of the various WHO Collaborating Centres for Pharmacovigilance, building partnerships for pharmacovigilance with Global Health Initiatives such as Global Fund, Medicines for Malaria Venture (MMV), the Bill and Melinda Gates Foundation; mobilizing resources for pharmacovigilance in LMIC and driving harmonization and methodological innovations in pharmacovigilance in low and middle income countries . Dr Pal is the Secretary to the Annual Meetings of National Pharmacovigilance Centres participating in the WHO Programme for International Drug Monitoring and represents WHO on the board governing the activities of the Uppsala Monitoring Centre, Sweden. Prior to her present position, Dr Pal was a Reader in Pharmacology in India.
Dr Sherael Webley
Dr Sherael Webley is the Programme Leader for the MSc Pharmacovigilance programme and a Principal Lecturer, in the School of Life and Medical Sciences at the University of Hertfordshire (UH). Since 2009 she has been the Subject Director (Pharmacovigilance Regulations) for the Eu2P Masters programme, an EU grant award winning European Academic/Industry collaboration. Sherael has been Chair of several Pharmacovigilance Development Committees responsible for development of new post-graduate pharmacovigilance courses in both developing and developed countries. Prior to joining UH she worked in collaboration with industry within clinical trials studying efficacy and toxicity of new chemical entities. In addition to her role at the University, Sherael maintains her links with the operational aspects of pharmacovigilance practice through her consultancy work, focused on the writing of documents legally required by regulatory bodies. As the Pharmacovigilance Group Lead at UH, Sherael has an interest in a range of drug safety research areas including spontaneous ADR reporting and pharmacovigilance training and education.
Simon Maskell is a Professor of Autonomous Systems at the University of Liverpool. Simon has a strong track record of developing efficient solutions to difficult algorithmic problems. Prior to 2013, Simon worked for the defense and security company, QinetiQ, where he was a technical manager for an interdisciplinary team of 130 staff focused on researching, developing and supporting the operational use of tools that enable data to support decision making. Since joining the University of Liverpool in 2013, Simon has attracted funding from EPSRC, EU, Innovate, Industry and UK Government to grow a team of 8 PhD students and 5 post-docs working on projects spanning, for example, bioinformatics, cyber security and defense. The unifying theme is the use of Bayesian machine learning to manage risk (e.g., with one paper cited over 10,000 times) and the projects include one investigating how social media analysis can support the detection of drug safety issues.
Professor Dame Valerie Beral, DBE, AC, FRS
Professor Dame Valerie Beral, DBE, AC, FRS is an epidemiologist, academic and a preeminent specialist in breast cancer epidemiology. She is Professor of Epidemiology, a Fellow of Green Templeton College, Oxford and has been the Head of the Cancer Epidemiology Unit at the University of Oxford since 1989.
After achieving a first class honours degree in Medicine at the University of Sydney, Professor Beral pursued her quest for answers to the bigger questions about public health. She has led pioneering research into the causes of cancer and effects of the contraceptive pill.
Professor Beral is the leader of the Million Woman Study which started in 1996, and has recruited more than 1.3 million UK women over 50 via the NHS breast screening centres. The study is investigating how a woman’s lifestyle and behaviour can affect women’s health, with a particular focus on the effects of hormone replacement therapy (HRT). It is the largest such study in the world with one in four of UK women in the target age group participating.