Sara is currently Senior Manager, Scientific Programmes at DIA. In the EMEA region, she is responsible for engaging with external stakeholders and advancing the scientific content strategy by creating opportunities to integrate scientific and regulatory changes of interest in DIA initiatives. Additionally, she is responsible for the regional patient engagement and learning design initiatives, being the liason for the Middle East and SEE regions. Previously, she was Public Health Promotion Projects Manager at the Portuguese Pharmaceutical Society. Sara is a Master of Pharmacy since 2015 and a Soft skills Trainer since 2012, having delivered over 300h of Training internationally primarily focused on creating impactful interactions.

Thomas Morel (DrSc) is Director for Patient-Centred Outcomes Research, Global Clinical Development at UCB. Through his role, Thomas ensures that the patient perspective is at the very heart of drug development by promoting the use in clinical trials of PROs and of clinical outcome assessments that are meaningful to patients. Thomas is also Research Fellow at KU Leuven (Belgium) where he conducts academic research on rare diseases, and a member of the Therapies Scientific Committee of the International Rare Diseases Research Consortium (IRDiRC).

Tom Metcalfe graduated in Biochemisty from King's in London and has an MBA from the Open University. He currently works in the Ecosystems team in Roche Pharma's Personalised Healthcare Centre of Excellence. He also represents Roche Pharma in the EFPIA Innovation Board Sponsored Committee. Prior to that he worked for Roche as a Strategic Innovation Leader in Global Development from 2015 to 2018. He served as CEO of Oncotest GmbH, a CRO providing preclinical profiling services in Oncology from 2011 to 2104 and worked for Roche Pharma and Diagnostics in a variety of roles from 1993 to 2011 including as Head of the Personalised Healthcare Portfolio and the Roche Biomarker Program.

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.

Nathalie Bere has a BSc in Psychology and a Master in Public Health. Nathalie has been working with European Medicines Agency (EMA)since 1998 and is currently responsible for its engagement with patients and consumers. Patients bring specific knowledge and expertise from their real-life experience of the condition and its treatment to the scientific discussions, and their contributions lead to better regulatory outcomes. Over the years, Nathalie has tested and implemented methods for the inclusion of the patient’s voice in all aspects of the medicines regulatory lifecycle and she continues to further strengthen these interactions and ensure they are fit for purpose in an evolving health landscape.

Mark is a founder and managing partner at Axian Consulting, where he focuses on improving benefit:risk balance and outcomes for patients through improving communication and adding value using digital approaches. He has a >20 year pharma career which has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI, Foresight, PopeWoodhead, Huron and now is a founder and managing partner of Axian Consulting). He is now focusing on the opportunities presented by improved benefit-risk management approaches to enhance risk management decision-making in development and on adding value to the interactions of industry and customers to maximise B-R balance and improve outcomes in REMS and aRMM programmes.

Aimad Torqui has been the Division Head at the Medicines Evaluation Board since September 2022. His role encompasses overseeing (national)policy and European affairs, regulatory science, representation in EU committees, promoting the better use of medicines and veterinary medicines.

Tom is the Head of Clinical Outcomes Assessment (COA) Strategy and Execution for Roche's Patient-Centered Outcomes Research (PCOR) team. His role is focused on optimizing the development of the company's pipeline through patient-focused outcomes. Prior to joining Roche, Tom worked in academia, clinical practice and consultancy, in roles focused on the development and validation of patient-focused outcomes.

Christina A°kerman, MD, PhD, Executive MBA, is Senior Advisor for EIT Health and Chair of EIT Health High Value Care Forum Advisory Board, Affiliate Faculty at the Dell Medical School at the University of Texas at Austin, and on the Steering Committee of the Coalition for Health, Ethics and Society at the European Policy Center. Until August 2018, she was the President of the International Consortium for Health Outcomes Measurement. She has also served as Director General for the Medical Products Agency in Sweden, been a Member of the Board of the European Medicines Agency and President of AstraZeneca Philippines.

Michelle Campbell is the Associate Director for Stakeholder Engagement and Clinical Outcomes in the Office of Neuroscience, Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Dr. Campbell joined FDA in 2014 and was previously a reviewer on the Clinical Outcome Assessments (COA) Staff and Scientific Coordinator of the COA Qualification Program in OND. Dr. Campbell’s focus is in patient-focused drug development and the use of patient experience data in the regulatory setting.

A hospital pharmacist before becoming inaugural Professor of Pharmacy at Leeds, Theo has 35 years of research improving patient information and ‘user testing’ the information with lay people. This led to forming the spin-out company Luto Research, a leading provider of user testing services. Synergies between the University and Luto underpin recent work, notably how best to present benefit and harm information. Currently he is working in policy and practice on making the new clinical trial ‘layperson summaries’ fit-for-purpose. He has a Lifetime Achievement Award from Fédération Internationale Pharmaceutique.

As Vice President and Global Head of Strategy for the R&D Solutions business unit at IQVIA, Josh Rose is responsible for building the overarching strategy for the clinical development business, establishing and governing strategic initiatives, and leading the identification of acquisition candidates. He focuses specifically on bringing to market new solutions that drive growth and differentiation across the company. He also leads the Virtual Trial service business within the R&DS business unit.

Melanie Calvert, PhD, is Professor of Outcomes Methodology at the University of Birmingham UK. She is Director of the Centre for Patient Reported Outcomes (PROs) Research (www.birmingham.ac.uk/cpror) which aims to optimise the use of PROs in clinical trials and routine care, to improve service delivery, enhance patient care and outcomes and ensure that the patient perspective is at the heart of health research and healthcare decision-making. She has led the development of international guidance for PROs including SPIRIT-PRO and CONSORT-PRO and is a member of the SISAQOL and PROTEUS Consortia.

Francesco Pignatti graduated as Medical Doctor at the University of Rome La Sapienza, Italy. In 1995 he became Research Fellow at the EORTC Data Center in Brussels, Belgium In 1997 he obtained a Master of Science degree in Biostatistics from the University of Limburg, Belgium. In 1999 he joined the European Medicines Agency (EMA) in London, UK. Since 2009, he has held the position of Head of Oncology, Haematology and Diagnostics in the Human Medicines Evaluation Division. In 2023 he was appointed as Scientific adviser for oncology. His main regulatory science interests include cancer clinical trial methodology, benefit-risk analysis, and stated preference studies.

Evelien is a Clinical Neurologist in training who works for NHS Tayside, Scotland. She is currently in post as a Clinical Research Fellow at MEMO Research – Medicines Monitoring Unit & Hypertension Research Centre, University of Dundee. MEMO runs several large-scale randomised clinical trials, including decentralised trials looking at drug safety and efficacy. Trials include FAST, ALL-HEART and the TIME Study.

Elizabeth Scanlan joined the European Medicines Agency in 2016 where she is currently Product Owner for electronic product information (ePI). Prior to joining EMA, she worked in communication roles in the biotechnology industry and not-for-profit sector. Elizabeth holds a PhD in molecular biology from Trinity College Dublin.

Meredith Smith, PhD, MPA, FISPE is Senior Director and Head, Implementation Science team within the Patient-Centered Research group at Evidera, Inc., PPD, a part of Thermo Fisher Scientific. She is a behavioral scientist and health services researcher by training with over 20 years of experience in health outcomes, drug safety and regulatory policy in the pharmaceutical industry. She has served on numerous FDA expert panels, on CIOMS Working Groups VIII, IX and XI, and IMI-PREFER and is an adjunct professor at the University of Southern California School of Pharmacy. She has been a pioneer in the application of Implementation Science methods within the context of drug development and has published widely in the peer-reviewed literature.

Sabrina Conti is Senior Policy and Regulatory Affairs Coordinator at Medicines for Europe. In her role she leads the Digital and Telematics working groups and she is involved in the following topics: EU Digital Health, operational excellence, SPOR IDMP, interoperability and ePI. She is also member of the Regulatory and Scientific Affairs Committee within Medicines for Europe and coordinator in several industry inter-associations groups, such as SPOR - IDMP and electronic product information (ePI) cross-industry taskforces. She actively contributed in the latest Industry report on Multilingual package and modernisation of the Variations system.

Dr. Lievano has extensive experience in medicine, clinical development, risk management, epidemiology, pharmacovigilance at several pharmaceutical companies. Additionally, he worked as a public health expert at WHO European Regional Office and researcher at CDC in Atlanta. He is a physician from Colombia trained in epidemiology at Epidemiology Intelligence Service of the CDC. He manages a large team of scientists (MDs, PhDs, statisticians) in several therapeutic areas mainly Immunology, Oncology and Vaccines. He has authored several papers and abstracts in medical journals and major scientific conferences. In connection with his CDC work he received several awards for distinguished service by the US Secretary of Health and Human Services.

Dan is a Leicester medical graduate with a background in cancer research, histopathology and oncology. His PhD in the field of tumour suppressor genes was awarded from Imperial College London and he holds an MSc in Oncology from the Institute of Cancer Research. He completed higher medical training in the UK in Pharmaceutical Medicine. He joined the Medicines and Healthcare products Regulatory Agency (MHRA) as a Medical Assessor in 2006. He is editor author of the first edition Oxford Specialist Handbook of Pharmaceutical Medicine and he is on the editorial board of the journal Expert Opinion on Orphan Drugs. Dan has special interest in rare diseases, patient engagement and early access.

Beate Wieseler is Head of the Department of Drug Assessment at the German Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). At IQWiG she is responsible for the scientific assessment of pharmaceuticals, the development of assessment methods as well as in the Institute’s collaboration with German and international external parties. Prior to joining IQWiG in 2005, Beate Wieseler worked in clinical research and regulatory affairs for about 10 years. Beate Wieseler holds a Diploma in Biology from the University of Bonn and a Dr. rer. nat. from the University of Freiburg, Germany.

Deborah has been working in the Pharmaceutical Industry for over 25 years. She began her career in Research before moving into Regulatory Affairs. During her tenure at Bayer Deborah worked in the UK affiliate, as an EU liaison, set up a new global RA department focusing on the RA support for Mature products and headed the International RA department before moving to her current position 12 years ago. She is currently VP and Head of Global Labeling at Bayer.

Megan Heath is Efpia Lead in the PILOT study within IMI Trials@Home project. Megan has 25 years of operational experience managing all phases of the drug development process. Megan started her career as a phase I research associate at Inveresk Clinical Research, UK before moving through various clinical operations positions in the industry. Megan joined Sanofi in Medical Affairs Clinical Operations and is currently the Head of Clinical Studies Units European Region. Megan graduated with a Bachelor’s degree in Pharmacology from Glasgow University before completing a PhD in Asthma Pharmacology at University of Manchester.

Tony is the Head of the Regulatory Science and Innovation Task Force (TRS) responsible for providing leadership in the Task Force and the Agency to enable its continuous future proofing through operation of a regulatory science observatory, addressing key scientific and technological trends and their translation through the development of regulatory science strategy, planning and governance. He also provides leadership for supply and availability of medicines under the extended mandate of the Agency.

I am a clinical neurologist who before joining the EMA worked as a consultant neurologist at the Clinic of Neurology, University Hospital – Plovdiv, Bulgaria. I have a PhD in Neurology and hold a position of senior teaching professor of neurology at the Department of Neurology, Medical University of Plovdiv. Currently I lead the office for Therapies for Neurological and Psychiatric Disorders at the EMA. In my career at the EMA, I have been involved in the development of the regulatory guidelines for development of new drugs in the field of Multiple sclerosis, Duchenne Muscular Dystrophy (DMD) and Amyotrophic Lateral Sclerosis (ALS).

Dr. César Hernández MD, PhD. joined the Spanish Agency for Medicines and Medical Devices as a Head of the Human Medicines Department in 2009. Prior to joining, he was the deputy Medical Director of the Hospital Clínico San Carlos in Madrid for three years. He previously worked as rheumatologist at the same Hospital for 16 years also developing functions as associate professor of Medicine and principal and associate investigator in several research projects financed by public and/or private funds in areas such as basic research, clinical research and health care services. He graduated from medicine and surgery, specialist in Rheumatology in 1987 at the Complutense University of Madrid and received his PhD in 1996 at the same university.

Dr. Isaac R. Rodriguez-Chavez is a biomedical and regulatory leader with expertise in Infectious Diseases, Viral Immunology, Viral Oncology, Microbiology, and Vaccinology. His experience covers the entire life cycle of medical products from basic, preclinical, interventional clinical research (phase I – IV), non-interventional clinical research and post-marketing studies.

Antoine is a biostatistician specializing in the analysis of patient-centered outcomes data. Antoine holds a PhD in Applied Statistics from the University Claude Bernard Lyon 1 (France). Over the past 20 years, Antoine developed a combined skillset in psychometrics and statistics that he uses to support pharmaceutical companies with their analysis of patient-centered outcomes data from clinical trials and observational studies in a wide variety of disease areas, including oncology, hematology, neurology and rare diseases. He currently is a member of the Board of Directors of the International Society of Quality of Life (ISOQOL) and has been a member of international research initiatives such as SPIRIT-PRO or NeuroMET-2.