Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTM, Stella studied medicine at Cambridge and Guys, working in hospital medicine before joining the pharma industry. She has worked in PhV and pharmacoepi for 35 years: in industry (11+ years) as a regulator (16+ years) and CRO (9 years). Following her MSc in Epidemiology from LSHTM, she co-developed their course in PhV and Pharmacoepi. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU strategy and policy on risk management, was lead writer on the EU guidelines on this and was part of the core team implementing the 2010 PhV legislation and ENCePP. She is/was on the CIOMS IX/XI/XIII working parties and is a member of the CIOMS Executive Committee.

Mariette Boerstoel-Streefland, MD, MBA, MSc(epi), has been in the pharmaceutical industry for 30 years, and is currently SVP, Worldwide Patient Safety Officer at BMS. Mariette joined pharma industry from clinical practice in 1989 and held various leadership positions in drug safety at Organon (now Merck), Mayne Pharma (now Hospira/Pfizer), Forest Labs (now Abbvie). In 2014 she joined Baxter to establish a new safety organization for Baxalta, and upon the acquisition by Shire led the new combined safety organizations. In 2018 she moved to Alexion and with the acquisition by AZ was appointed Chief Safety Officer, SVP Global patient safety. In August 2023 she joined BMS. Mariette has an MD degree from the University of Utrecht, a MSc Pharma

Gerald J. Dal Pan, MD, MHS currently serves as the Director of the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research, where since 2005 he has been responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. In this capacity, he is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics, and in the implementation of the drug safety provisions of the Food and Drug Administration Amendments Act and other initiatives.

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

E. Stewart Geary, MD, is Global Safety Officer at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Board for the Journal of Pharmaceutical Medicine. A member of CIOMS XII, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII on Signal Detection, CIOMS on Standardized MedDRA Queries, CIOMS IX on Medicinal Product Risk Management and CIOMS Working Group on Drug-Induced Liver Injury. Dr. Geary is a DIA Fellow, a Fellow of the Academy of Physicians in Clinical Research and an IFAPP Global Fellow in Medicines Development. He earned a BA from Harvard and MD from Stanford Medical School.

He received formal training in infectious diseases and molecular mechanisms of pathogenesis and has more than 15 years of experience directing global product development and registration programs. He also has extensive experience in pharmacovigilance and health informatics as well as the evaluation and exchange of safety data. He has served with other experts and senior scientists on many consensus panels, including ICH, CIOMS, ISO, and HL7.

Lisa Harinstein is a Team Leader in the FDA-CDER Division of Pharmacovigilance. She received her Doctor of Pharmacy degree from the University of Michigan and completed a Pharmacy Practice and Critical Care Residency at the University of Pittsburgh Medical Center. She worked as a Surgical ICU Clinical Specialist at Cleveland Clinic prior to working at the FDA.

Steve received his MD from the University of Newcastle Upon Tyne, UK and worked in the UK National Health Service for 17 yrs. He joined Halozyme in 2018 as Vice President, Drug Safety & Pharmacovigilance and became Chief Medical Officer in January 2020, with responsibility for Drug Safety, Medical and Regulatory. Prior to this, Steve worked at Eli Lilly for 16 years, 12 years of which was in drug safety in various roles of increasing responsibility involving safety operations and drug safety surveillance

Barbara Morollo has over 20 years’ experience in the biopharmaceutical and medical device industry with specific focus on the Pharmacovigilance and Risk Management challenges in the clinical development of rare disease, gene therapy and advanced therapeutics. As a practicing registered nurse, her prior clinical experience encompassed a broad range of critical care settings. She is currently Head, Pharmacovigilance at Corbus Pharmaceuticals, a clinical-stage company focused on treating inflammatory and fibrotic diseases by targeting the endocannabinoid system.

Simone Pinheiro is the Head of the Pharmaco-Epidemiology Center of Excellence (PECOE) in Global Epidemiology at Abbvie. The PECOE brings together experts in regulatory pharmaco-epidemiology, data science and data analytics and serves as a strategic resource for real-world data, analytics, and regulatory pharmaco-epidemiology expertise for the enterprise. Dr. Pinheiro has 15 years of regulatory pharmaco-epidemiology experience. Prior to joining AbbVie, she was the Director of the Division of Epidemiology-I at the Office of Surveillance and Epidemiology at CDER/FDA. Dr. Pinheiro has Doctorate and Master degrees in Epidemiology from the Harvard School of Public Health.

Michael Richardson has many years of global management experience in research based life Sciences companies. He has worked in major multinational companies’ across the globe both at a Regional management level and heading up Research and Development in Asia. Currently Head of Bristol Myers Squibb’s Pharmacovigilance Function. Prior to this role he headed BMS and Eli Lilly’s Development and Medical Organization across Asia Pacific. Before joining Lilly he worked in a joint venture in Japan, Fujisawa-Fisons setting up their development and quality control organisations and prior to that with Organon laboratories in the UK as Medical Director.

Dr. Annette Stemhagen is an epidemiologist, with >30 years of public health research experience, including 20+ years in the biopharmaceutical industry. She provides strategic consulting in epidemiology, pharmacovigilance, and risk management. She develops and implements creative and innovative epidemiologic study design solutions. She also has extensive expertise designing and implementing risk intervention programs, risk management evaluation studies, Risk Evaluation and Mitigation Strategies (REMS), and risk minimization programs for EU Risk Management Plans for more than 120 products. She was appointed as the first Industry Representative to the FDA Drug Safety and Risk Management Advisory Committee.

Lesley Wise has over 20 years of experience in pharmacovigilance both in medicines regulation at the MHRA, and in the pharmaceutical industry as vice-president and global head of Risk Management Centre of Excellence and Pharmacoepidemiology where she worked closely with colleagues to ensure a companywide approach to Benefit - Risk Management and to maintain compliance with regulatory requirements. Lesley has been working as an independent consultant to the pharmaceutical industry for the last seven years and has liaised regularly with regulators, including meetings with PRAC, CHMP and FDA.

Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while in academia. He continued his research in industry before moving over to clinical development and eventually Medical Affairs. Bruce has held various positions in industry, including Head of Drug Safety at Genentech and now Senior Group Director of Pharmacovigilance Innovation Policy in Global Regulatory Affairs. In this role, Bruce focuses on current challenges in pharmacovigilance, such as predictive drug safety and quality of safety data sources.

Dr. Eichler is responsible for coordinating activities between the European Medicine Agency's (EMA) scientific committees and giving advice on scientific and public health issues. Prior to joining EMA, Dr. Eichler was professor and chair of clinical pharmacology and vice-rector at the Medical University of Vienna. Other positions held include President of the Vienna School of Clinical Research and co-chair of the Committee on Reimbursement of Drugs of the Austrian Social Security Association.

Dr. Khozin is the Chief Executive Officer of CancerLinQ, LLC, and Executive Vice President of ASCO. He has more than a decade of leadership experience in health technology, regulation, clinical research, and data science, including the application of artificial intelligence and machine learning in biomedical research, therapeutic development, and care delivery.

Christine McSherry is the executive director of Jett Foundation, a non-profit dedicated to Duchenne muscular dystrophy, and the co-founder of Casimir Trials, a CRO that designs patient, caregiver, and observer reported outcomes that support regulatory approval and reimbursement. Christine began working in rare disease in 2001 when her son, Jett, was diagnosed with Duchenne muscular dystrophy, and has become an advocate for including the patient voice in every stage of drug development.

Dr. Sandra A. Mitchell is a Research Scientist and Program Director in the Outcomes Research Branch in the Healthcare Delivery Research Program. Her work focuses on the measurement of symptoms and impairments in physical functioning, and the testing of interventions to improve these outcomes, especially in vulnerable populations, including older adults and patients with multimorbidity. Dr. Mitchell serves as the NCI Scientific Director for the development and testing of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is a new measurement system designed to integrate patient-reporting of symptomatic adverse events into cancer clinical trials.

Eric is currently Chief Science Officer at Datavant, an innovative new company with the mission to organize the worlds healthcare data. Eric is also Visiting Scientist in the Department of Biomedical Informatics at Harvard Medical School and a frequent volunteer advisor to Médecins Sans Frontières and other international aid and relief NGOs. Most recently Eric was Senior Vice President and Head of the Takeda R&D Data Science Institute where he built an integrated institute of more than 165 multi-disciplinary data scientists serving all aspects of biopharmaceutical R&D and digital health.

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.

Amanda Roache, MPP, is a Senior Director in PhRMA’s Science and Regulatory Advocacy Department. She leads PhRMA’s work under the International Council for Harmonisation (ICH) as well as key science and regulatory activities related to international regulatory policy, advocacy in regional platforms such as APEC, and international priority markets.

Dr. Shinobu Uzu is the Senior Executive Director, PMDA and in charge of the Safety offices, Office of International Programs, and Regulatory Science Center since April 2020. He took Ph.D. in Pharmacy from the graduate school of the University of Tokyo and has over thirty years of experience in MHLW, PMDA. He worked for new drug review as Director of the Office of New Drug I and Associate Executive Director for new drug review, PMDA and safety management for drugs and medical devices as Chief Safety Officer, PMDA and Director of Safety Management, MHLW. He also worked for international affairs as ICH steering committee member on behalf of MHLW and 1st Secretary of the Embassy of Japan in Indonesia.

Gary Zammit, PhD, is the President & CEO of Clinilabs, a full-service CRO that provides clinical drug development to industry, focusing on CNS therapeutics. He also is an Associate Clinical Professor of Psychiatry, Icahn School of Medicine at Mount Sinai (New York, NY), where he provides physician education in the field of sleep medicine.Dr. Zammit earned a Ph.D. degree in clinical psychology from the University of Toledo (Toledo, OH), where he won both the Turin Service Award and the Leckie Scholar Award. He completed an internship and clinical research fellowship in the Department of Psychiatry at the New York Hospital - Cornell University Medical College (White Plains, NY), where he won the Alumni Award for Excellence.

Jaspal (JP) Ahluwalia is a physician working on post marketing safety within FDA CBER. He also reviews pharmacovigilance plans for new BLAs. His professional career began with an eight-year stint in the US Army where he served as a medical officer at the Defense Department’s premier biological research facility at Ft. Detrick, Maryland. Dr. Ahluwalia received his undergraduate and medical degrees from The Ohio State University and his Masters in Public Health from Johns Hopkins University. He is currently an officer in the US Public Health Service and has attained the rank of Commander (O-5).

Steven Anderson, Ph.D., M.P.P., is currently the Director of the Office of Biostatistics and Epidemiology (OBE) at the FDA Center for Biologics Evaluation and Research (CBER). He provides leadership for all CBER statistical, epidemiological and risk assessment programs. He was previously the Associate Director for Risk Assessment and established a program in quantitative risk assessment for biologics and has led numerous risk assessment projects and epidemiological studies.

Robert Baker is a VP of Eli Lilly and Company and leads several groups within its Medicines Development Unit: Global Patient Safety, Clinical Development Design Hub, and Clinical Pharmacology Medical/Design Group. Robert has been at Lilly for 18 years in various roles across Drug Discovery, Drug Safety, and Medical Affairs. Prior to joining Lilly he was an Academic Psychiatrist studying schizophrenia and substance abuse. Robert completed medical school at Northwestern University and psychiatry training at the University of Pittsburgh.

Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior, Melissa worked for several years within the pharmaceutical industry. At Health Canada she has been a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within the Marketed Health Product Directorate (MHPD), as well as a member of the core team for the Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Since 2018 she has held the position of Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Pharmaceutical Drugs Directorate.

Jeremy Jokinen is the Vice President and Head, Safety Evidence and Sciences at Bristol Myers Squibb. In this role, he leads a global team of risk management, epidemiology, and safety science experts responsible for insights, evidence generation, and risk minimization programs ensuring the safety of patients worldwide. Jeremy has led numerous cross-industry pharmacovigilance workgroups and initiatives for DIA, TransCelerate, and ICH, and is a frequent speaker at industry conferences. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, medical device, and patient safety research. He holds MS and PhD degrees in quantitative psychology from Ohio University

Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including for breakthrough therapies, expedited reviews and safety. In the OCE, Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH.

As COO of Accelerated Cure Project, Sara Loud ensures delivery of research resources to scientists studying multiple sclerosis. Passionate about the integration of people into “people-powered” research, Sara combines a love of technology, business expertise, and social enterprise into her work, most recently focusing on the development of iConquerMS, a people-powered research network. Sara holds a BS/MS in electrical engineering from Northeastern University and a MBA from Babson College.

Dr. Jacques P. Tremblay received a PhD in Neuroscience from the University of California at San Diego in 1974. Since that time, he has been at Laval University as a postdoctoral researcher, Professor and Director of the Department of Anatomy. He is currently Full Professor in the Department of Molecular Medicine. He has published over 250 scientific articles on hereditary diseases. He has worked specifically on myoblast transplantation as a treatment for Duchenne muscular dystrophy. For the last 3 years he also worked on gene correction with the CRISPR/Cas9 technology for Duchenne muscular dystrophy, Friedreich's Ataxia and Alzheimer’s disease.

Dr. Ellis Unger is a Principal Drug Regulatory Expert at Hyman, Phelps & McNamara. A cardiologist with 24 years of FDA experience in drug regulation, safety, clinical trial design, and analysis, he started as a Medical Officer in CBER, ultimately serving 8 years as the Director, Office of Drug Evaluation-I, and, after the 2020 reorganization, as Director of the Office of Cardiology, Hematology, Endocrinology, and Nephrology in CDER’s Office of New Drugs. He played major roles in developing several FDA Guidances and ICH Guidelines, including ICH E2F (DSUR), E2C(R2) (PBRER), and E19 (Safety Data Collection). Before joining FDA, Dr. Unger led a translational research effort on angiogenesis in the National Heart, Lung, and Blood Institute, NIH.

John Barlow Weiner is the Associate Director for Policy in the Food and Drug Administration's Office of Combination Products, which is tasked with ensuring the sound and consistent regulation of combination products and also with the classification and assignment for regulation of medical products (drugs, devices, biological products, and combination products).

Jeffrey Anderson, MD-PhD, leads the global clinical development for Immuno-Oncology agents in gastrointestinal tumors at Bristol-Myers Squibb.He is also a core member of the BMS Medical Surveillance Team, which is responsible for the pharmacovigilance and safety signal detection in ongoing clinical trials.Jeffrey has been involved in early and late-stage clinical development in Virology and Immuno-Oncology with the goal of helping patients prevail over serious diseases.Jeffrey received his MD-PhD from West Virginia University. He completed Internal Medicine residency training at University of Michigan and Infectious Diseases fellowship training at UNC Chapel Hill.

Dr. Comfort is a Principle Scientific Enablement Director for Roche in Science Enablement and Processes, leading innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 20 years combined biopharma industry/regulatory experience. Dr. Comfort’s current work focuses on developing machine-learning models to evaluate Drug-Adverse Event causality and predict Project/Phase Probability of Success. Recently he published his first book focused on using mathematical estimation in healthcare: How Much Is that Cure in the Window? Simple Math Solutions for Complicated Problems in Biology, Medicine, and Healthcare.

Dr Adrian Dana is the VP of Global Patient Safety and Risk Management for Aimmune, a leader in the development of treatments for food allergies. In this role, she is building an innovative safety organization to support the development of these new therapies. Her past positions include VP of Global Patient Safety and Risk Management at Alnylam, where she built the safety organization to support the development of innovative RNA interference therapies. Prior to that she was VP, Safety Science Oncology at Genentech/Roche, and spent 10 years at Merck in Clinical Safety and Risk Management. Her experience includes multiple therapeutic areas encompassing vaccines, infectious diseases and oncology. Adrian is a pediatric infectious disease MD

Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.

Qualified as a pharmacist in 1981 and started her career in hospital pharmacy. In 1983 she specialised in Drug Information Services and moved to Kuwait to set up and run the first National Drug Information Centre. On her return to the UK, Vicki spent the next four years in community pharmacy. In 1996 Vicki joined GlaxoWellcome and started her career in pharmacovigilance. In 2002 she moved to AstraZeneca UK Ltd as the Drug Safety Manager moving on to become Head of Drug Safety & Medical Information. Vicki joined Abbott in 2005 as European Qualified Person for Pharmacovigilance (EU QPPV). In 2013 moved to AbbVie as EU QPPV and Head of Affiliate Safety Excellence (ASE) and is now VP, Pharmacovigilance Excellence and I-QPPV.

Simon Johns has over 25 years of experience supporting global pharmaceutical customer projects. As Director of Medical Information (MI) and Marketed Product Safety at IQVIA, he manages global MI projects focused on process optimization and technology enablement to drive enhanced efficiency and customer engagement. Simon is a member of the European DIA Medical Information and Communications Training Team, advising pharmaceutical companies on best industry practices, innovation and automation. He speaks regularly on topics ranging from combined human and AI conversational agent models for MI to the benefits and increased value of integrating MI and pharmacovigilance.

Sadiqa Mian MD MPH currently works as an Executive Medical Director, heading Safety Management Team in Global Patient Safety Department at Amgen. Her current areas of responsibilities include Signal and Benefit Risk Management, Medical Review and Aggregate Reports. She has been at Amgen for 4 and half years. Prior to Amgen, her industry experience includes working at Geznyme, Sanofi and Boston Scientific.

John R. Peters, MD graduated from the George Washington University School of Medicine. He is a Family Physician certified in Forensic Medicine with a Certification in Public Health from Georgetown University. He practiced Family and Emergency medicine in MN, later joining the US Army FP residency teaching staff at DeWitt Army Hospital Ft Belvoir and Uniformed Services University of Health Science. In 1992 he moved to the FP residency program of Georgetown University. He has been Director of Managed Care and Associate Director of an MCO. In 2006 he joined the FDA 2009 where he is currently the Deputy Director of the Office of Generic Drugs.

Peter Verdru, MD was trained as neurologist and joined UCB in 1997. He is heading the global Patient Safety team since 2015. Prior to his current role, Peter was heading the Therapeutic Area CNS in Medical Affairs and Clinical Development.

Elenee is an attorney with 15 years experience in biopharmaceutical commercial leadership roles spanning COPD, Type II Diabetes and Atrial Fibrillation. Elenee leads Watson for Patient Safety (WPS), a solution that applies cognitive computing and the Watson Platform for Heath to pharmacovigilance to add speed, consistency and insight to adverse event processing. She is also guiding the development of signal detection and advanced causality solution using several big data sets including EHR and administrative claims data.Elenee is also the Watson Health Life Sciences Academic Collaborations Lead where she has forged novel partnerships to pilot and evaluate Watson Life Sciences Solutions.

Dr. Bano is the Vice President of Combination product Quality at Amgen. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and a certified coach. Khaudeja has more than 25 years professional experience, including patient care. She has held several global safety positions at Guidant, Abbott (multiple divisions like Vascular, Diagnostics, and Established Pharma), and AbbVie Inc. She currently serves as the working group chair of the Combination Product Coalition's Post-marketing Safety Reporting team.

Ms. Bulliard has over 20 years’ experience in conducting real-world & late-phase studies, patient registries, safety studies, and other specialized real-world programs for orphan drugs, disease and medical device studies including studies measuring effectiveness of risk minimization measures. With an extensive global portfolio, specialising in post-authorisation safety studies, she has conducted many large and successful programs for a wide range of life science and healthcare organizations. Michelle is responsible for real-world evidence program strategy translating evolving methodological observational research standards into effective delivery strategies.

Dr. Chazin joined FDA in 2002 and has held several leadership positions related to clinical policy and safety of new drugs, biologics and generics. He is the Director of the Division of Clinical Safety and Surveillance in the Office of Generic Drugs' Office of Safety and Clinical Evaluation. He leads several multidisciplinary teams of physicians, pharmacists, nurses, and data analysts tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products and addressing all Risk Evaluation and Mitigation Strategies for generic drugs. He also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.

Graduated from Russian Medical University, specialized in medicinal biophysics. Have a PhD scientific work on human brain with a morphometric studies of brain cortex (speech-motor areas), with 8-year experience in light microscopy in National Brain Research Institute (Moscow, Russia). Have a 15-year experience in pharmaceutical industry, working in clinical studies (Novartis), Drug Safety and Medical Quality Oversight (Pfizer). Now as a Drug Safety Unit Head, EAEU/Ukraine QPPV (Pfizer), with oversight on countries under the Eurasian region (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) and CIS countries not included in the EAEU (Azerbaijan, Georgia, Mongolia, Uzbekistan, Turkmenistan, Tajikistan).

Dr. Simmons is currently Senior Medical Fellow (formally the EU QPPV) in Global Patient safety for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focused her career drug safety through senior management positions in Glaxo/Glaxo Welcome and Eli Lilly and Co. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Expert Working Group, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug and biologic product safety and effectiveness using Real World Evidence, including managing the Sentinel System.