Currently working in the area of Regulatory Affairs for Novartis, Scott has over 20 years of industry experience from both the CRO world and within Pharma, in roles focusing on Data Management, Data Standards and Digital Innovation. Prior to his current role in Regulatory Affairs Policy, Scott led several of Novartis’s digital innovation projects. Since his transition into Regulatory, Scott continues to advise digital program teams internally in areas such as eConsent, eSource, Decentralized Clinical Trials, Blockchain & AI, and collaborates externally in several cross-industry initiatives.

After working for Lilly and Merck, Francesca Cerreta joined the EMA in 1996. There, she has set up the parallel scientific advice programme with FDA, worked in CNS and Scientific Advice, and coordinated the PRIME scheme, the digital therapeutic matrix, and the geriatric medicines strategy activities.

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around signal and benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

Kolasa has more than 20 years of academic and occupational experience in the healthcare sector. Her practical skills in the field of health economics were developed during six years employment contract at the Kalmar County Council in Sweden. For the last four years she has been developing experience with the pricing & reimbursement challenges in the field of medical devices. She holds a PhD degree in health economics and is an author of scientific IF publications in the field of health technology assessment and pharmacoeconomics. Nominated by the Ministry of Science to represent Poland in the COST Action CA17117, COST Association. Since Jan 2019, she is co-chair of Global Special Interest Group for Digital Health establish at ISPOR.

Rebecca Stanbrook has worked in the pharmaceutical industry, as a regulator at the MHRA and at various pharmaceutical companies for over 30 years. Her main areas of interest are clinical trials and pharmacovigilance. She is a pharmacist by profession and holds a Diploma in Research Quality Assurance. Rebecca is thrilled to be a member of the ICH E6(R3) Expert Working Group. Currently Rebecca works as GCP Strategic Lead in Process & Risk Surveillance, in the Strategy, Portfolio and Programme Operations Group of Development in Novartis Pharma AG. She is based in Basel.

Mr. Davis is the Chief Operating Officer of Analytics 4 Life¬ (A4L). The company is pioneering digital health using artificial intelligence to develop novel diagnostic solutions for heart disease. Prior to joining A4L, Mr. Davis was the Founder & CEO of The MedCelerate Consulting Group and the CEO of Tryton Medical, a ventured-backed, coronary stent, start-up company. Earlier Mr. Davis was president of Guidant Japan with P&L responsibility for the company’s $225 million cardiovascular business. Mr. Davis holds a B.S. in mechanical engineering from the University of Minnesota and a M.B.A. from the University of Michigan.

Ian Rentsch has over 25 years’ experience in Multinational Corporate Affairs, Outsourcing Management & Clinical Research Development working in large multinational companies including large biopharma and Contract Research Organizations Globally and in Emerging Markets. Most recent roles include General Executive Management, Leadership of regional clinical teams, Business Operations and Strategic Business Development in the Contract Research Industry & Clinical Technology.

Background and experience in the clinical field and afterward in research and devel-opment of pharmaceuticals in the Biotech and Pharmaceutical Industry for 17 years with a long list of publications in high-impact journals. 4 years as Director of Division responsible for Medical Evaluation and Biostatistics – both Human and Veterinary Medical Evaluation, Danish Medicines Agency. As of 1st of January 2021 Director of Division responsible for Medical Strategy and Innovation, Danish Medicines Agency. Co-Chair of the joint HMA/EMA Big Data Steering Group. Member of the Board of Directors, Copenhagen Centre for Regulatory Science, University of Copenhagen Member of the Scientific Advisory Board, EHDEN, European Health Data Evidence Net

A Medical Doctor focused mainly in dermatology & autoimmune diseases, as well as 4 years of residency. She earned a scholarship for the IWI at MIT and for Clinical research from Harvard Medical School. She sees herself as lucky to have earned a few international prizes being the last one the global impact challenge from singularity which made her last startup, SkinSoul, kick off in Silicon Valley. She has been president of IT commission of Health Parliament Portugal, Medical officer at Patient Innovation and member of the National Commission of the Medical Council on Information Technologies. Currently managing two Lusíadas Clinics in Lisbon. She was also invited to be part of the women Leaders global forum, last year.

Andy Fischer studied medicine before graduating in specialist studies in surgery and emergency medicine and was a physician in the Swiss emergency helicopter service (REGA) until 2006. In 1999 Andy Fischer founded Medgate and has led the entire Medgate group since then as CEO. Andy Fischer is President of the International Society for Telemedicine and eHealth (ISfTeH). He has been lecturing in Telemedicine at the University of Zurich since 2008.

Christian is leading the Digital Biomarker department in Roche’s Research and Early Development Informatics (pREDi) organization. His team leverages smartphones, wearables and other remote monitoring technologies to collect objective, sensitive and continuous sensor data and drive the development of novel endpoints. Together with cross-functional Roche-teams, they create innovative remote monitoring concepts, implement them, deploy them in clinical trials, develop outcomes with the data, and seek community- and regulatory acceptance. Christian had joined Roche as Director Emerging Technologies - identifying game changing trends in the pharma Omics & Digital Health space and developing strategies to act on those. Now he is implementing them.

Francesca Mazzi is an Early Stage Researcher in a Ph.D. project about the challenges deriving from the 4th industrial revolution from a patent law perspective, with a focus on the pharmaceutical sector, between Queen Mary University of London and Maastricht University within EIPIN innovation Society, funded by the European Commission’s Marie Sklodowska-Curie Actions. Francesca holds a master’s degree in law from Luiss University of Rome. In 2017 she obtained an LL.M. in Computer & Communication Law at Queen Mary University of London, specializing inter alia in Data Protection and Information Security. In 2018 she got the CIPP/E certification by the International Association of Privacy Professionals. She is a qualified lawyer in Italy.

Senior Legal Counsel at Bayer AG, based in Berlin, joined the pharmaceutical industry in 2006 (Solvay, Boehringer Ingelheim, Bayer). Advising colleagues from Bayer’s global pharma divisions’ functions on legal matters relating to regulatory, development, data privacy , clinical trial transparency and general pharma law related topics. Before joining the industry, legal consultant and manager of Ethics Committee of University of Goettingen (Germany). Worked as judge and public prosecutor in Lower Saxony (Germany) at the beginning of her career. Member of Data Governance Working Group at EFPIA. Member of Data Protection Working Group at German Pharma Association VFA.

Dr. ElZarrad is the Director of the Office of Medical Policy (OMP) at FDA’s Center for Drug Evaluation and Research (CDER), where he leads the development, coordination, and implementation of medical policy programs and strategic initiatives. Dr. ElZarrad currently leads multiple projects focused on exploring the potential utility of real-world evidence, innovative clinical trial designs, and the integration of technological advances in pharmaceutical development. He earned a doctoral degree in medical sciences with a focus on cancer metastases from the University of South Alabama, as well as a master’s degree in public health from the Johns Hopkins Bloomberg School of Public Health.

Also affiliated researcher at Karolinska Institutet, Stockholm. He is a physician, health economist, previously held positions at European & U.S. based consultancies in Health Economics & Outcomes Research. Focused on health technology assessment & economic evaluation in a range of disease areas including neurology, psychiatry and oncology. Recently his research interests include value of innovation in health care with focus on digitalization of health care systems as well as neurodegenerative disorders. Chairman of the board for Swedish Institute of Health Economics, served as advisor to the National Board of Health & Welfare for the development of national treatment guidelines. Author of 90+ original publications, reviews & book chapters.

Kath joined AstraZeneca as Director, Programme Lead for GCP within the audit team. Prior to that she was a Senior GCP inspector at the MHRA. Since joining the Agency in 2005, she has led a variety of National and EMA inspections, attended the EMA GCP Inspector Working Group and sat on several EMA sub-groups. In addition, Kath was one of the authors of the recommendation document ‘Risk proportionate approaches in Clinical Trials’ in relation to the CTR 536/2014 and has posted blogs on the same topic on the MHRA inspectorate blog. As part of the drive to share knowledge and best practice in inspections, Kath participated in the GCP PIC/s programme. She has over 13 years’ clinical research experience within the pharmaceutical industry.

Foteini Orfaniotou is leading the Neuroscience and Rare Disease Digital Health team in the Product Development Medical Affairs organization. Her team leverages technologies to advance patient outcomes. Working cross-functionally, the focus is to implement solutions in the clinical practice setting that will advance early patient identification, disease monitoring and capturing outcomes that will inform clinical decisions and access to care. Foteini is a neuroscientist by training and her passion is to leverage technologies to advance care to patients with neurological diseases.

Multiple award-winning patient advocate Trishna Bharadia raises awareness & improves support for people affected by chronic illness. She aims to put the patient voice into the entire healthcare journey. She collaborates with organisations globally, including from industry, the third sector, and HCPs, to improve support, services and patient engagement. She writes, reviews content & is a highly sought after speaker. She advises on patient centricity & diversity issues, and is a media contributor on health. She's also a patron/ambassador for several health-related and disability-related charities and sits on various advisory committees. Awards include being a "Points of Light" recipient from the UK Prime Minister's Office.