Sigrid Behr, PhD, is a Group Lead within Quantitative Safety and Epidemiology at Novartis, providing strategic leadership for the evaluation, understanding and communication of safety data and benefit-risk to support decision-making at all stages of the drug life-cycle. She has >10 years experience in industry and academia with evaluating the safety of drugs from signal detection to confirmation/refutation using clinical trial, observational and spontaneous reporting data.

Dr Hans Ulrich Burger. PhD in mathematics at University of Freiburg. Since 1992 with Hoffmann La Roche in Basel. Currently global head of Neuroscience and Ophthalmology biostatistis and global head of a small methodology group within biostatistics. Outside the company I was the President of the ROeS 2006-2007 and since two years the president of the BBS (Basel biometrics section of the ROeS).

Professor of Pharmacoepidemiology at the London School of Hygiene and Tropical Medicine & a medical statistician;a member of the EMA’s drug safety committee & the WHO Global Advisory Committee on Vaccine Safety; Immediate Past President of the International Society of Pharmacoepidemiology

Jürgen joined Bayer AG in 1992 as statistician.Jürgen was appointed Head of Global Statistical Science in 2004. Effective September 1, 2005 Jürgen joint Novartis Pharma in Switzerland, where he most recently held a position as Global Head, Statistical Safety Sciences. In November 2011 Jürgen joined CSL Behring where he most recently hold the position of Global Head, Quantitative Safety Sciences. In January 2017 he started his consultancy business.Jürgen has published in statistical and scientific journals, regularly gives scientific presentations and organized various sessions at scientific conferences.

Jim Slattery has worked for the European Medicines Agency for ten years in the Pharmacovigilance Dept. Before that he worked for four years at the Health Technology Board for Scotland as Principal Statistical Epidemiologist and four years at the MHRA where he was a Senior Statistical Assessor. He was also a clinical trials statistician at Edinburgh University Department of Clinical Neurosciences for nearly nine years. He has a degree in mathematics from Cambridge and an MSc from Southampton.

Andrew Thomson is a statistician in the Taskforce dedicated to Data, Analytics and Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas and is the lead scientific secretariat of the Methodology Working Party. He also is the lead of the Statistics subgroup of ICH E11A on paediatric extrapolation, sits on ICH E6 R3 Annex 2 group, and is the Regulatory Chair of both groups. Before joining EMA, he headed the Epidemiology Unit in the Vigilance and Risk Management of Medicines Division of the MHRA, the UK regulator and was also previously a Statistical Assessor within the Licensing Division of the MHRA.

As an Associate Director Epidemiology at Actelion, Mr. Muros-Le Rouzic provides strategic and operational leadership for the design and conduct of observational research in the therapeutic area of rare cardiovascular diseases from early product development and throughout life cycle management. Focuses on registries and other real-world data sources to inform disease epidemiology, support clinical development programs, and understand drug safety and effectiveness in the post-marketing real world setting. Mr. Muros-Le Rouzic has an MSc in Epidemiology and Public Health from the University of Bordeaux, France.

Martin Posch is professor for medical statistics at the Medical University of Vienna. From 2011-2012 he worked as statistical expert at the European Medicines Agency (London, UK) in the Human Medicines Development and Evaluation sector, where he contributed to guideline development and the assessment of study designs. His main research interests are group sequential trials, adaptive designs and multiple testing, focusing on applications in clinical trials. Martin Posch serves as Associate Editor of Biometrics and Biometrical Journal and is Observer at the EMA Biostatistics Working Party. Furthermore, he is member of the EU Patient-centric clinical trial platform IMI EU-PEARL.

Anja Schiel has studied Biology at the Johannes Gutenberg-University, Mainz, Germany. She received her PhD from the Free University in Amsterdam in 2006 and worked several years as Post-Doc before starting at the Norwegian Medicines Agency (NoMA) in 2012. At NoMA she is working as special adviser/Statistician/Methodologist both on regulatory (EMA) and HTA projects. She has been Chair of EMA’s Biostatistics Working Party 2017 - 2019 and just finished her 3-year term as Chair of the Scientific Advice Working Party (SAWP) at EMA. She continues currently as alternate member of the SAWP and is Member of the new Methodology Working Party (MWP) recently established at EMA. She also leads the international HTA team at NoMA.

Rob is a partner at Consilium, a consultancy partnership between Rob Hemmings and Tomas Salmonson, both long-standing contributors to the EU regulatory network. Consilium supports companies in the design of clinical development programmes, the design, analysis and interpretation of clinical trials, regulatory strategy and regulatory interactions. Previously Rob worked at AstraZeneca and then for 19 years at the MHRA, during which time he served as CHMP member at EMA for 11 years and chaired the Scientific Advice Working Party at EMA. Rob has co-authored multiple regulatory guidance documents and continues to work on any and all aspects of evidence generation and regulatory policy in respect of medicine’s development.

Olaf Klungel is Professor of Pharmacoepidemiologic Methods at the division of Pharmacoepidemiology & Clinical Pharmacology. He was trained as a pharmacist and epidemiologist. His main research area is the development, improvement and evaluation of innovative methods of observational drug research. Main applications are in the post-registration phase of drug development. He is (co-)author of over 200 papers in peer reviewed journals, book chapters and research reports.

Dr Mario Ouwens is Statistical Science Director Health Economics, Payer Models and Real World Data at the Statistical Innovation department of Astrazeneca, chairing the Global Medical Affairs Committee of Purpose within Biostatistics and Informatics. He is first author on the AZ pragmatic clinical trial guideline, related to reducing costs, improving pace, while maintaining sufficient quality and acceptability. He developed trainings for the Medical Academy within AZ.

Carol Reid has over 18 years of experience in the pharmaceutical industry and has worked in all phases of clinical development across several therapeutic areas. She is currently a Biostatistics Manager at Roche in the UK supporting projects in neurosciences.

With 34 years of experience as a statistician focusing on non-RCT research, the last 14 years with Eli Lilly and before then working in the NHS. As a principal research scientist in the international business unit my work has focused on the use of Real world evidence to support the launch of new medications. Projects external to Eli Lilly include the IMI projects “GetReal” and the Alzheimer’s disease focused projects “ROADMAP” and “MOPEAD”.

PD Dr. Christoph Gerlinger is Bayer’s Expert Statistician for Health Technology Assessment and Women’s Health. He is the regulatory chair of the European Federation of Statisticians in the Pharmaceutical Industry (EFSPI) and a WP leader for the IMI BigData@Heart project. Christoph worked as statistician over 25 years in the industry and (co )authored over 75 papers in peer-reviewed scientific journals. In his spare time he teaches as “Privatdozent” at the University Medical School of Saarland.

Mark Levenson is currently the Director of the Division of Biometrics VII in the Office of Biostatistics/Office of Translational Sciences/Center for Drug Evaluation and Research of the US Food and Drug Administration (FDA). At FDA, he has been the primary reviewer or secondary reviewer on many major pre-market and post-market drug safety problems. He contributes to statistical policy and guidance development in the areas of drug safety, real-world data, and regulatory evidence. He is a member of the CDER Medical Policy Program Review Committee and the FDA Real-World Evidence Committee. Dr. Levenson received a Ph.D. in Statistics from the University of Chicago and a B.A. from Cornell University in Mathematics.

Nicolle Gatto, PhD, MPH, is a Group Lead with the WSS Epidemiology Group at Pfizer, providing strategic leadership, oversight of comprehensive epidemiology strategies to examine the safety of medicines, consultation on design of pragmatic trials, and expertise on methods-related epidemiologic issues. She has designed and implemented primary and secondary data collection observational studies and pragmatic trials. Nicolle is also an Adjunct Assistant Professor of Epidemiology at Columbia University and Tulane, teaching courses in pharmacoepidemiology, causal inference and confounding control methods.