Linda has spent the last 30 years in regulatory strategy, policy, and intelligence roles at Seagen, Sanofi, Bayer, and GSK. She most recently was Chief of Staff, Pfizer Oncology Regulatory Strategy, a role she also had at Seagen. She has also been an Assistant Adjunct Professor in the Temple University RAQA graduate program since 1998. Linda attained Regulatory Affairs Certification for the US, Canada and Europe and was inducted into the 2011 Class of RAPS Fellows. Linda was honored with the RAPS 2020 Founder's Award and the DIA 2012, 2019, and 2022 Excellence in Volunteer Leadership Awards. She is immediate past chair of the DIA Regulatory Affairs Community and founded the DIA Regulatory Intelligence Working Group.

Vicki Burk is the Sr. Director R&D Quality Assurance Clinical QA Program Management, Combination Products and Medical Devices and the Comprehensive Quality Strategy at AbbVie. She leads teams responsible for Clinical QA across all stages of development and Combination Product/Medical Device Design Quality Assurance. Vicki is also the business process owner for the R&D Comprehensive Quality Strategy, a cross-GxP framework used to manage Quality Risks Throughout the Development Life Cycle. Vicki has held several positions at AbbVie in a broad range of quality, technical and operations disciplines.

Nancy Dreyer is Chief Scientific Advisor to Picnic Health and Adjunct Professor of Epidemiology at the University of North Carolina. Recently retired from full-time employment as Chief Scientific Officer at IQVIA Real World Solutions, she maintains an active career consulting, publishing and teaching for the International Society of Pharmacoepidemiology (ISPE). She is a Fellow of DIA and a member of DIA's Scientific and Policy Advisory Council, a Fellow of the International Society for Pharmacoepidemiology and a member of the ISPOR RWE leadership team. She has helped advance global use of real-world evidence by medicinal product regulators, with her work cited in guidelines in the US, Europe, and China.

João Duarte is currently Director, Business Planning & Operations at Alexion, AstraZenenca Rare Disease. João serves as Chief of Staff to the Head of Regulatory & Quality Affairs and leads regulatory policy activities within the team. He held several roles since 2012 in Regulatory Intelligence & Policy, notably at Lundbeck and Takeda, where he worked to help colleagues to better understand the shifting regulatory environment and to support drug development in several therapeutic areas globally. João also worked briefly in the generics industry in Portugal and at the European Medicines Agency as a trainee.

Tim Grey joined AbbVie in December 2013. He is currently Senior Director of Research and Development Quality Assurance leading the Quality Systems and Support Services team which includes Quality Systems, Documentation Management, training, QKM, QRM, CAPA, Qualification and Validation activities. Tim has spent his career developing, applying, and implementing quality systems principles across the GxP product development lifecycle. Before joining AbbVie, he was with Eli Lilly and Company in various Quality Assurance positions, including the role of a Lean Six Sigma Black Belt. Early in in his career he had the opportunity to work in the Aerospace industry at Rolls Royce Aerospace where he developed his passion for quality.

Alberto Grignolo, Ph.D. FDIA formerly served as Corporate Vice President, Corporate Strategy and Thought Leadership at Parexel, and established the Company's Japan Regulatory Consulting Services during a two-year assignment in Tokyo. He is a champion of Diversity, Equity and Inclusion within and outside Parexel. Dr. Grignolo served as Chairman of the Regulatory Affairs Professional Society, and as President of FIDIA Pharmaceutical Corporation. He is a DIA Fellow, the Editor-in-Chief of DIA's digital magazine Global Forum, and served for two decades on the faculty of DIA's Regulatory Affairs: The IND, NDA, and Post-Marketing Training Course, which he taught in Japan, China, Korea, Europe, and the US.

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.

Mike Laddin is the principal and owner of ResultsMatter. ResultsMatter provides leadership development workshops, strategic consulting, and executive coaching and management team assessments to clients worldwide. The premise of ResultsMatter’s work is that management is a science – where the specific skills and abilities to lead/manage can be defined and developed. Mike has over 20 years of senior management experience with 7 years of health care marketing experience negotiating HMO and PPO contracts, General Manager of a publishing firm and CFO/COO with an international pharmaceutical research association. Mike has a BS in Psychology and Chemistry, an MS in Clinical Psychology and Mathematics, and an MBA with an emphasis in Finance.

Daniel Liu, PhD, has served for more than two decades in global clinical research departments, in both management and operations, for such multinational drug companies as Novartis, Pfizer, Sanofi, Schering-Plough, Johnson & Johnson, and Medidata. Dr. Liu has served as Core Expert of the NMPA CDE clinical data standardization Committee, and as Vice Chairman of the China Clinical Trial Data Management Group, an advisory member of DIA China committee, and a part-time professor of the NMPA Institute of Exceutive Development, a part-time professor of China Pharmaceutical University. He has taught more than 60 clinical research courses at home and abroad. He earned his PhD from the University of Illinois School of Pharmacy.

Dr. Kelci Miclaus is Senior Director of Veeva Stats, head of product and engineering for the Veeva Systems statistical computing environment solutions. Previously, she helped create, develop, and manage the JMP Genomics and JMP Clinical software solutions as Advanced Analytics Sr. Manager for the JMP Life Sciences division at SAS Institute. She holds a PhD in Statistics with biomedical and genomic concentrations from North Carolina State University. Kelci is a recognized thought-leader and subject matter expert around the role of software, data platforms, and analytics/visualization in advancing and operationalizing discoveries with genomic, translational, and clinical data lifecycles in the life sciences domain.

Gerrit Nijveldt is currently Labeling consultant with Opus Regulatory. Gerrit has more than 25 years of experience in Global labeling. He has a broad experience in developing and maintaining Company Core Data Sheets, US Prescribing Information and EU Summary of Product Characterisation, including the labeling for multiple development products (early phase to approval) and labeling for devices. Gerrit was also an associate adjunct professor for Temple University School of Pharmacy teaching Global Labeling in the RA/QA Master’s Program till 2022. Gerrit earned his MSc in Medical Biology from University of Utrecht in the Netherlands

Lisa helps development teams to align strategically and communicate persuasively with global regulators and payers. She empowers teams to create and deliver clear, consistent, and convincing messages to critical audiences and decision-makers. She has coached hundreds of individuals and provided presentation, Q&A and facilitation training to teams in pharma, and biotech, and has helped 45+ teams prepare to present and defend their positions at FDA Advisory Committee meetings and EMA Oral Explanations. Lisa also creates and leads dynamic workshops to empower teams to communicate complex science with clarity.

Rodrigo Perez, based in Mexico City, has more than 14 years of experience in clinical research working for Sanofi’s Clinical Study Unit (CSU) in different roles (CRA, Study Manager, and Operations Manager, among others). Graduated from Universidad La Salle, Rodrigo has a bachelor’s degree in Pharmaceutical Chemistry. Since 2016 Rodrigo took a partial role of Risk-Based Monitoring (RBM) Project Leader, which evolved to Risk Management and Monitoring Lead full-time role. In this capacity, Rodrigo is currently working to align the global implementation of RBM in the CSU. He is the main point of contact to facilitate RBM adoption by mobilizing local study teams in stretch communication with global departments, ensuring processes harmonization.

Dr Yoshiaki Uyama is currently Associate Executive Director, Pharmaceuticals & Medical Devices Agency (PMDA) of Japan. He is responsible for regulatory science reserach in the agency. He has many experiences in new drug evaluation and real world data utilization, including the ICH E15, E16 and E17 Expert Working Groups, and Pharmacoepidemiology Discussion Group. He is also served as a visiting professor in Chiba University and Nagoya University.

Joachim Vollmar, a trained mathematician and certified bistatistician, has more than 40 years of experience in preclinical and clinical research and development of drugs, biologics, medical devices and diagnostics. After 22 years in the pharmaceutical industry, and 12 years with a CRO, he has been involved in innumerable projects, acting as chairman and member of Data Monitoring Committees, serving as an executive statistical, drug safety, scientific and management consultant for the health care industry in North America and Europe. He founded International Clinical Development Consultants (ICDC), an independent consultancy and co-founded PRESCOS, a preclinical research and scientific consulting services organization.

Richard C. Zink is Vice President of Data Management, Biostatistics, and Statistical Programming at Lexitas Pharma Services, Inc. He was the 2019 Chair of the Biopharmaceutical Section of the American Statistical Association, and is currently host of the Biopharmaceutical Section Statistics Podcast and Associate Editor for the DIA journal Therapeutic Innovation & Regulatory Science. Richard is author, editor, and contributor to 8 books on statistical topics in clinical trials and clinical research. He holds a Ph.D. in Biostatistics from the University of North Carolina at Chapel Hill, where he serves as Adjunct Professor of Biostatistics. Richard was named a Fellow of the American Statistical Association in 2020.

Brian D. Bradbury is Vice President and Head of the Center for Observational Research (CfOR) at Amgen, Inc. He leads a global team of epidemiologists, data scientists, programmers and operations professionals who generate real-world evidence (RWE) to support the development and continuous benefit:risk assessment of Amgen's medicines. Brian also holds an Adjunct Professor of Epidemiology appointment at the University of California, Los Angeles. He received his DSc in Epidemiology from Boston University and a MA in Education and Psychology from Pepperdine University. He has authored/co-authored 80+ peer-reviewed publications in the areas of pharmacoepidemiology, cancer, kidney, cardiovascular and bone disease.

Samantha qualified as a pharmacist and has worked in the pharmaceutical industry in varying roles and countries for over 20 years. She moved back to South Africa in 2014 and transitioned in to clinical research where she lead local clinical operations for both GSK and Amgen. She has been actively involved in the local pharmaceutical industry chairing research associations and committees. Samantha is a member of the Transcelerate RBM working group and for the last 3 years has been focusing on evolving the risk-based monitoring model at Amgen.

Kassa Ayalew, M.D., M.P.H. is a Director of the Division Clinical Compliance Evaluation in the Office of Scientific Investigation at Center for Drug Evaluation and Research (CDER) in FDA. He is a practicing pediatric infectious disease specialist with several years of clinical and regulatory medicine experience.