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).

> 20 years, global leadership roles outsourcing operations Wyeth/Pfizer. Manager/motivator globally. Implemented governance inspection ready CT. Strategic implementation quality cost effective outsourcing. Establishment of unique Wyeth Accenture strategic alliance.

5 years in hospital IT, designing clinical data bases. 13 years in pharma (sponsor side), mostly focused on EDC: strategy for roll-out, vendor selection, knowledge transfer, eCRF build, system validation, site training, laptop provisioning...

Heike Schoen is the Managing Director of Lumis International, offering start up services for the pharmaceutical and biotech industry in Europe. She has gained over more than 20 years international experience in conducting clinical trials, managing CROs and international teams.

Molecular biologist, started with Organon in 1989, reproductive endocrinology. Global Project Director, worked in the United States in Regulatory Affairs and in Clinical Research. Director of CDM in 2003. Currently head DM group Merck, Sharp & Dohme in Netherlands. Amateur geologist.

An MD by training, Valdo has 30+ years of experience in the pharma industry. After having practiced medicine, he started in the industry as a clinical pharmacologist at Ciba-Geigy. He then founded the 1st European Central Clinical Lab for clinical trials, SciCor (now Covance Central Lab) in 1992. He joined PHT in 2000, and founded its European affiliate in 2001. PHT was the 1st European modern ePRO provider and Dr Arnera is seen as one of the world pioneers in the ePRO/eCOA field. ERT acquired PHT in 2015. Dr. Arnera currently serves as a Scientific Advisor and the General Manager of ERT Geneva. ERT develops products that facilitate data capture in clinical trials, using mobile and web technologies to collect data from patients and doctors.

Gunnar Danielsson has more than 25 years of experience from the field of clinical research within the pharmaceutical industry. He has held various positions covering monitoring, project leadership and auditing as well as process implementation. The work has been carried out both within local Market Companies as well as Corporate Headquarters in Sweden, UK and US. Between 2003 and 2014 he held the position as GCP Inspector at the Swedish Medical Products Agency. During this time Gunnar conducted a vast number of inspections in Sweden and internationally. He has during this time been an active member of EMA GCP Inspectors Working Group and has been directly involved in the development of a variety of guidelines and reflection papers.

Sally Hollis is Head of Statistical Consulting at Phastar, a specialist CRO, and Honorary Professor of Clinical Trials at the University of Manchester. Sally has over 25 years’ experience in a wide variety of roles in medical statistics in the NHS, academia and the pharmaceutical industry. During 12 years at AstraZeneca she held a number of statistical leadership roles in drug development, across phase II and III, and lifecycle management. She is currently co-lead of a special interest group on Clinical Trial Data Sharing including statisticians in industry and academia.

Franz König is Associate Professor at the Section of Medical Statistics at the Medical University of Vienna, Austria. He regularly serves as member of ethics committees and DSMBs. From 2008 till 2010 he was seconded to the European Medicines Agency as statistical expert. His main research interests are multiple testing and adaptive designs. For more information see www.meduniwien.ac.at/medstat

Detlef Nehrdich, Senior Associate, joined Waife & Associates in April 2012 after twenty years in the biopharmaceutical industry. His particular areas of expertise include process improvement, metrics and data management, in addition to his professional background as a biostatistician (MSc in Statistics from the University of Dortmund, Germany). As a senior manager in industry, his leadership positions provided extensive experience in personnel management and acquisitions integration. Mr. Nehrdich also worked in technology planning and the organizational implementation of new technologies and processes. Currently Vendor Management is one of his most frequently requested areas of expertise.

Christine has expertise across the whole clinical product development lifecycle. Working within Company: from Pharmaceutical company, to Clinical research Organisations (CRO) and for the National Health Service in the UK (NHS). Including but not limited to key opinion leader support for advisory boards and endorsement during marketing authorization application and health technology assessment; independent research grant applications; building internal expertise developing/delivering training packages for sales and marketing teams

Dr. Johann Proeve is the Chief Scientific Officer at Cyntegrity, a Risk-Based Quality Management Solutions company. Johann has over 40 years of experience as a biopharmaceutical industry expert, mainly in the former role of VP Global Data Management at Bayer Healthcare. Awarded one of the 2018 MCC Champions by the Metrics Champion Consortium, Johann is widely regarded as the go-to source for Clinical Data Management and RBQM. In this regard, Johann has been invited to speak to clinical organizations worldwide, including regulatory bodies, sponsors, and CROs, at conferences like DIA, SCDM, Phuse and SCOPE. Johann holds a Ph.D. in Zoology/Animal Biology, and he currently lectures at the University of Essen Duisburg / Germany

+35 years experience in academic and clinical research. Currently leads Covance’s Trial Risk Management team and oversees the development of the Xcellerate® Monitoring suite of applications. Previous roles at Covance include leading a team of process improvement experts, and as Executive Director for Biometrics Operations. He has a MSc in Biostatistics, and is a Lean Six Sigma Master Black Belt...

+25 years experience in Drug Regulatory Affairs and Clinical Science. DIA Board Director and chair of the Advisory Committee Europe. Managing Partner at Widler & Schiemann Ltd, Zug, Switzerland

Jude has a Bachelor of Arts degree in Mathematics and a Master of Science degree in Statistics. He has more than 12 years of experience in clinical trial development and execution. He currently manages a team at Eli Lilly dedicated to designing, implementing, and evolving a strategy to manage risk in clinical trials through a risk-based monitoring methodology. His previous roles at Lilly include Biostatistician for late-phase diabetes, Business Support Consultant for statistical applications, and Central Monitoring Consultant. He has been an active member of the TransCelerate RBM working group.

Tony Hewer has an IT career of over 30 years with the past 18 years in the life sciences sector. After his PhD in astrophysics at UCL, Tony moved into software engineering and various IT management roles with business areas. He then moved to a start-up IT consultancy business with specialties on management of projects for establishing new front-office trading rooms as well as information-flow process optimization. In 1997, Tony joined Pfizer for 10 years in various IT management roles globally covering the pre-clinical and clinical application spaces as well as in-company IT infrastructure services. In 2007, Tony became Senior Director of QA with Medidata Solutions Worldwide.

Doris C Schmitt studied pedagogy in Germany and English Language and History in Cambridge, England. She has completed further education in communication and motivational training. She worked as freelance personnel consultant for an Institute for Personnel Training and finally started her own consulting and coaching agency in management training. Today Doris has specialized in improving communication between physicians and cancer patients. She gives lectures for patients on how to deal with cancer therapy in German and English. In workshops and seminars she trains communication skills with doctors and nurses in Europe. As a medical writer she has published numerous articles about doctor-patient-communication.

Nicola Little (nee Schmitt) graduated from Cardiff University with a B.Sc. in Mathematics and from the College of Medicine with an MPhil in Medical Statistics. Nicola worked as a Biostatistician for the NHS and for the Medical Data Research Centre in Portland Oregon. Nicola joined AstraZeneca in 2004. In her current role as Statistical Science Director, Nicola is accountable for the provision of statistical input and strategy to drug development programmes. Nicola has defended pivotal trial designs to worldwide regulatory authorities. Nicola is also the statistical lead for the Risk Based Monitoring programme at AstraZeneca and has been responsible for embedding RBM into study process, training of staff and conducting statistical monitoring

Fergus Sweeney is Head, Clinical Studies and Manufacturing Taskforce at the European Medicines Agency since March 2020, covering Clinical Studies (Clinical Trial Information System), Biological Health Threats and Vaccine Strategy and supports strategy development in manufacturing and personal data protection in health research on medicines. He joined the EMA Inspections Service in 1999, and became Head of Compliance and Inspections (2009) and Head of Division Inspections and Human Medicines Pharmacovigilance in 2013 (including Scientific Committee Services from 2016). He has a BA (Physiology 1979) a Dr de 3eme Cycle (cancer biology 1982), and PhD (Pharmacology 1986). Fergus worked in clinical research mainly in QA from 1982 to 1999.

Bert van Leeuwen is the deputy QPPV of Astellas Pharma in Leiden, the Netherlands. After obtaining his MD he worked in various hospitals for several years. For over 15 years he has been working in Pharmacovigilance. At first as Medical Safety Adviser at Organon. While leading two Therapeutic Areas in a quickly growing PV department, he was closely involved in the implementation of Core Safety Data Sheets, MedDRA and the setup of a Signal Detection system. He was the Medical Safety Adviser for large clinical trials. Then he led the Quality in PV group, implementing a Compliance Monitoring system and the PV Intelligence system and obtained experience in managing regulatory inspections.

Kerstin Koenig, PhD is the Head of Research & Development Quality, Bristol Myers Squibb. In this role, she is responsible for the development and strategic oversight of the world-wide quality assurance and quality management activities in the area of Product Development Quality, GLP, GCP and GVP. Her current work interests are the evolution of QMS e.g., Quality Risk Management, Quality by Design, Quality Culture; the role of technology e.g.; Data Analytics, and Auditing in the future. Kerstin is a member of the board of the German Quality Management Association and a team member of the CTTI Quality by Design Adoption initiative. She represents EFPIA as Topic Lead in the ICH E8 (R1) Expert Working Group.

In his role as VP, eCOA Science & Consulting, Bryan brings extensive experience and expertise to achieve smarter drug development, clinical trial design and execution (including decentralized and remote trials) to vastly expand the reach and access of trials to more patients, provide improved patient experience and data quality to deliver accelerated drug & device development programs. Bryan is a thought leader and recognized strategist & visionary and continues to influence, drive and deliver on the pharma wide industry necessity for smarter drug & device development and life cycle management.

Rebecca Sudlow has worked for over 25 years as a statistician in the pharmaceutical industry. Rebecca has been involved in data transparency, particularly with regard to enabling access to patient level datasets for the last 3 years. She worked very closely with GSK to develop the cross-company patient level data sharing platform “clinicalstudydatarequest.com” which launched 01 Jan 2014.

Isabelle de Zegher, MD, MS, is Founder of b!loba, focusing on personal health data sharing solutions. She used to be Vice President, Integrated Solutions at PAREXEL Informatics, focusing on Big Data, AI and digital solutions. She worked for 10 years at PAREXEL and 14 years in pharma clinical development including Novartis, UCB and Cap Gemini Life Sciences consulting. Before that she worked for 10 years in Health Care IT at Cap Gemini and in a Belgium SME. She has extensive experience in health information technology, data standards, data integration, semantic interoperability and application of AI in clinical research.

Erik holds a bachelor degree in Computer Science and a master degree in Biostatistics. He has more than 10 years of experience in the life science industry. Erik has spent the last 5 years at developing methodology and technology for central statistical monitoring. Erik has co-authored a number of papers in the field of clinical research and application of statistics for data quality assessment. Erik is currently leading the product development of the CluePoints' RBM platform