Dr. James Buchanan is presently an independent drug safety consultant. Dr. Buchanan began his industry career at Genentech where he worked for 9 years in the areas of medical information and drug safety. He subsequently established the drug safety departments at Gilead, Tularik and Nuvelo. Dr. Buchanan next served at BioSoteria as the head of the medical and safety consulting group. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service. He is also a co-lead of the American Statistical Association Biopharmaceutical Safety Working Group Interactive Safety Graphics taskforce that is developing novel, open-source interactive graphical tools to identify and evaluate safety issues during drug development.

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

Dr. Barbara Hendrickson is a former Vice President of Pharmacovigilance and Patient Safety at AbbVie. She is currently on faculty at the University of Chicago. Dr. Hendrickson is a physician with subspecialty training in pediatrics and infectious diseases and has 19 years of pharmaceutical industry experience. Dr. Hendrickson has been involved in multiple new product and additional indication submissions. She also has participated in several clinical trial safety initiatives related to implementation of internal data monitoring committees and IND aggregate safety reporting procedures. In addition, she co-leads the DIA-ASA Aggregate Safety Assessment Planning Working Group.

Scott Janiczak a Lieutenant Commander (LCDR) in the U.S. Public Health Service, who serves as a safety evaluator in the Office of Surveillance and Epidemiology’s, Division of Pharmacovigilance at FDA. In this role, he works with multidisciplinary scientific review teams throughout the FDA to evaluate adverse drug events detected during postmarketing surveillance activities. Prior to this position, he served as a regulatory project manager with the FDA's, Office of Generic Drugs for 6 years. LCDR Janiczak obtained his Doctor of Pharmacy from Midwestern University and holds a national board certification in Pharmacotherapy from the Board of Pharmacy Specialties.

Mamiko Kasho is Executive Director of Global Pharmacovigilance Management in Global Safety HQ of Eisai Co., Ltd, and has been involved in global PV area since she joined the company in 2007. Mamiko has been responsible for PV agreements with licensing partners for 15 years and at the same time in charge of establishing, maintaining the quality management system in PV; and continues working on coordinating activities to comply with regulatory requirements across regions. Mamiko has been participating in several task forces of JPMA PV committee as the team leader, focusing on PV requirements in Europe, US, Asia, and other regions. Mamiko is also the member of MedDRA Management Committee since Mar 2020 as the representative of JPMA.

Susan most recently led the patient safety department at Halozyme and supported both the medical and regulatory functions there from March, 2022 to January, 2024. Prior to joining Halozyme, Susan spent 10 years working in Global Patient Safety at Eli Lilly. She used her clinical experience as an OB/GYN while in pharma to aid in the initial stages of the ConcePTION project, as a working group member for PRGLAC, and most recently on a pregnancy-related TransCelerate project. Susan earned her MD from Indiana University and her JD from Indiana University School of Law – Indianapolis. She is currently starting a foundation to support camps for teens across the country who are interested in medicine.

Dr. Mengchun Li is currently working at Merck & Co., Inc. as a Senior Director, Infectious Diseases. Prior to this, Dr. Li worked at TB Alliance and Janssen Pharmaceutical company (J&J) in Drug Safety and Pharmacovigilance, Clinical Development, and Medical Affairs. Dr. Li is now co-leading the DIA-ASA (American Statistical Association) joint safety working group fostering interdisciplinary collaboration to improve safety evaluation in drug development. Dr. Li received her MD from China Medical University and her Master of Public Administration from Columbia University.

Joe obtained his BS degree in Pharmacy at Rutgers in 1983 and initially worked in clinical research in the pharmaceutical industry. After 10 years he obtained his PharmD at the University of Maryland. Since then he has had extensive experience in pharmacy benefits management, as a consultant pharmacist, and clinical pharmacy practice. Joe joined the FDA as a REMS assessment analyst in June of 2020 and has been the lead reviewer of assessment reports, methodology submissions, and assessment plan development for several REMS Programs. In July 2023 he transitioned to Associate Director of Medication Error and Risk Management Initiatives within the Office of Medication Error Prevention and Risk Management.

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.

Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, her current role is the Head of Vigilance Operations, responsible for adverse incident collection & signal management for medicines and medical devices. Sarah is currently leading on the development and transformation of the Agency's vigilance systems for all medicinal product types.

Executive Director head of Individual Case Safety, Medical Review & Aggregate Safety Reporting team, PV responsible person in China.

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

Annette Williams, M.B.A. R.Ph, is Vice President, Global Head of Lifecycle Safety, leading IQVIA’s comprehensive Safety organization, consisting of more than 4,000 professionals worldwide, providing services across the PV spectrum, including: case processing, regulatory reporting, aggregate reporting, signal detection, risk management, medical information, local affiliate PV support and safety systems. Williams oversees the development and adoption of innovative technologies to streamline the management of safety information and subsequent data analytics. Prior to IQVIA, she held leadership positions in both CRO and Pharma fields, including Drug Safety Alliance, Teamm Pharmaceuticals, and GSK.

Catherine Baldridge is the Sr. Director of Global Safety and Pharmacovigilance, Head of Safety, at Fusion Pharmaceuticals. She has more than 20 years of experience and serves as an executive consultant to the industry providing leadership and support in Pharmacovigilance Operations, development, training, regulatory, and inspection readiness. She has a Bachelors degree in Neuro Psychology from Hollins University and a Masters of Science in Clinical Investigation and Patient Research from the University of Virginia. Catherine was a former adjunct faculty member at Temple University, teaching several courses in pre and post marketing safety and Pharmacovigilance, and former chair of the DIA Clinical Safety and Pharmacovigilance Community.

Greg served in the Navy and taught HS math and physics before earning his PhD in biostatistics from the University of Texas. He co-led a crossfunctional company initiative at Merck to develop and implement the Aggregate Safety Assessment Planning (ASAP) process. His research on blinded safety monitoring procedures is being developed in collaboration with statistical and clinical scientists at several pharmaceutical companies (including AbbVie and Merck). Greg co-leads, with Mary Nilsson and Scott Proestel, the PHUSE Safety Analytics working group; he established (with Bill Wang) the ASA Biopharm Safety Monitoring working group; and he pioneered the joint DIA-ASA Interdisciplinary Safety Evaluation (DAISE) scientific working group.

Tamei Elliott, MS, serves as the Associate Director of Scientific Programs for the Americas region at DIA. In this pivotal role, she is responsible for identifying and prioritizing content areas and topics crucial to DIA constituents. Tamei assesses the implications of significant regulatory and health policy changes, seamlessly integrating relevant content into the development and advancement of DIA conferences and courses. Her responsibilities extend to overseeing content development and strategy within the Americas region.

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.

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.

Dr. Yasmeen Abou-Sayed is a Team Leader in the Division of Risk Management in the Office of Surveillance and Epidemiology in the Center for Drug Evaluation and Research at the FDA. She oversees a team of Risk Management Analysts (RMA), to provide expertise on the potential need, development, and modification of risk evaluation and mitigation strategies (REMS). Dr. Abou-Sayed was previously an RMA at FDA and worked 10 years as a staff pharmacist and pharmacy manager for CVS in Maryland and New York. She maintains a part-time role with CVS, working as a community pharmacist and administering vaccinations. Dr. Abou-Sayed received her PharmD from the University of Maryland at Baltimore and completed undergrad at the University of Houston.

Patrick Caubel is Chief Safety Officer and Global Head of Worldwide Safety for Pfizer . Patrick earned his M.D. degree, with specialization in Gynecology, Obstetrics and Oncology, from the University of Paris XIII (France), followed by a Ph.D. in Clinical and Experimental Pharmacology from the University of Paris VII (France) and later a M.B.A from Rutgers University. He worked in positions of increasing responsibility first in academia, and subsequently for Merck KgaA, Johnson & Johnson and Sanofi. Pfizer Worldwide Safety is in charge of safety monitoring and reporting for all Pfizer products around the globe. Patrick has been actively involved in COVID vaccine and antivirals development and safety monitoring during the COVID-19 pandemic.

Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for Advanced Therapy Medicinal Products. Furthermore, he is overseeing the revision 3 update of GVP Module V – Risk Management Systems and is coordinating the Agency’s transparency efforts for RMPs.

As a neurobiologist with a penchant for rebellion, Sibel has committed the past 15 years to progressing patient safety. Now, in her role in WorldWide Patient Safety at Bristol Myers Squibb, she focuses on nurturing an innovative culture, upskilling people, identifying the right problems to solve while seeking to break new ground with data, models and digital health solutions.

Kasia Lobello is a Senior Director and Safety Risk Lead in Pfizer's Safety Surveillance and Risk Management group. Kasia received her undergraduate training in neurobiology from Cornell University, followed by a medical degree from the University at Buffalo School of Medicine and Biomedical Sciences. She completed residency training in Neurology at Duke University. Since joining Wyeth/Pfizer in 2007, Kasia has held a variety of roles in both Clinical Development and Safety, focusing on neurologic disorders.

Sara Lodi is an Associate Professor of Biostatistics at the Boston University School of Public Health. She obtained her PhD in Medical Statistics at the London School of Hygiene and Tropical Medicine in 2009, UK. Her research focuses on causal inference methods for observational studies using big data, methods for causal inference to improve the statistical analysis of clinical trials, and the reconciliation of results from clinical trials and observational studies, mainly in the areas of infectious diseases (HIV, hepatitis C, tuberculosis) and substance use disorder.

Cindy McShea received a BS in Mathematics from East Carolina University in North Carolina, USA and completed an MPH in Biostatistics from the University of North Carolina at Chapel Hill in North Carolina, USA. Cindy is a senior director of Biostatistics at UCB Biosciences where she leads the Safety Statists team within the Biometrics and Quantitative Sciences group. She has over 25 years of experience in the pharmaceutical industry, 20 of which have been spent in statistical and leadership roles within late phase clinical development in neurology and immunology therapeutic areas. She is a contributing member of the Drug Information Association-American Statistical Association Aggregate Safety Assessment Planning Task Force.

Raza Mohammed is a physician by training and represents as Chief Scientific Officer at OrciMed Life Sciences. He is qualified as a diabetologist and pharmacologist and graduated from India. He has 15 years of experience in pharmacovigilance and over 10 years in clinical practice. Raza began his career in the industry with Novartis and later went on to co-establish Vigi Medsafe, a PV service provider company where he worked as the Director of Medical Affairs. He subsequently worked as a Senior Medical Director at PPD. Raza is a subject matter expert, and his experience involves leading and managing medical teams, clinical and post-marketing pharmacovigilance, aggregate reports, risk management plans, signal management, RA queries and audits.

Michael Ybarra, MD, is Senior Vice President and Chief Medical Officer at the Pharmaceutical Research and Manufacturers of America (PhRMA). As an organization, PhRMA advocates for public policies that support the innovative biopharmaceutical ecosystem. Dr. Ybarra oversees coalition building, stakeholder engagement, and strategic partnerships in support of PhRMA’s federal public policy priorities. Dr. Ybarra is an emergency physician and graduate of Stanford University and Georgetown University School of Medicine, where he also completed his residency training. He is an Assistant Professor of Emergency Medicine at Georgetown University School of Medicine where he continues to see patients in the emergency department.

Tracey Boone holds a BS in biology, an MBA and has been an ASCP-certified medical technologist for 30 years. Before joining pharma, she worked in a hospital laboratory for 10 years. Tracey started her pharma career with Pfizer and worked for 11 years in various scientific, technical and management positions in non-clinical R&D. Tracey has been with AbbVie for 13 years, holding positions in Diagnostics, Regulatory Operations, and Pharmacovigilance. For the past 8 years, Tracey has led initiatives to improve efficiency through robotic process automation and AI. Currently, Tracey is the business lead for several proof-of-concepts for the use of AI, ML, and LLMs in aggregate reporting, signal identification, and data review.

Dr. Lyerly is a Professor of Social Medicine, Research Professor of Obstetrics and Gynecology, and Core Faculty in the Center for Bioethics at UNC-Chapel Hill. A board-certified obstetrician-gynecologist, her work addresses morally complex issues at the intersection of ethics, reproduction, and health policy. She has led NIH-funde projects developing ethics guidance for research in pregnancy. She is a former Chair of the ACOG Committee on Ethics, and has served as advisor to US NIH, CDC, FDA and WHO. She is a fellow of the Hastings Center, and a member of the Johns Hopkins Society of Scholars. She has written dozens of articles and book chapters and is the author of A Good Birth, published by Penguin/Random House.

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.

Dr Georgy Genov is the Head of Pharmacovigilance Office, within Quality and Safety of Medicines Department, European Medicines Agency (EMA). The office oversees and manages lifecycle pharmacovigilance activities in the EU, including signal detection and management; evaluates the impact of regulatory interventions and develops pharmacovigilance guidelines and standards; ensures leadership, coordination and clear roles and responsibilities for a quality assured EMA’s and EU pharmacovigilance systems; collaborates closely with EMA scientific committees and working parties, in particular the Pharmacovigilance Risk Assessment Committee (PRAC). Oversees the development and maintenance of IT systems for pharmacovigilance.

Dr. Tarek Hammad, VP & Head of Medical Safety for Marketed Products at Takeda Pharmaceuticals, is a renowned expert in drug safety, benefit-risk assessment, and pharmacoepidemiology. With extensive experience at major pharmaceutical companies like Sanofi and Merck, as well as a distinguished 13-year career at the US FDA, he has received numerous awards for his contributions. Dr. Hammad is a sought-after speaker, actively involved in industry initiatives and has held several academic appointments. He has authored over 80 peer-reviewed articles, book chapters, and letters to the editor, offering valuable insights in the field. Learn more at www.DrTarekHammad.com.

Vivek Rudrapatna is a gastroenterologist and an assistant professor at UC San Francisco. His research focuses on methods for analyzing large clinical datasets to improve decision making in healthcare. He is also a co-director of the UCSF Center for Real-World Evidence. In this role, he facilitates research collaborations between government, industry, and academia, particularly those that involve the analysis of electronic health records data.

Anjali Shah, PharmD has 15+ years experience in the biopharmaceutical industry in a variety of therapeutic, operational and leadership roles across Medical Affairs and Patient Safety. Inspired by the opportunity to enable safe and informed use of medicines, Anjali is currently involved with establishing and growing a new Capabilities and Innovation function within Worldwide Patient Safety at Bristol Myers Squibb to drive the next generation of Patient Safety.

Dr. Hong Yang is a senior advisor for benefit-risk assessment in OBPV/CBER/FDA. She holds Ph.D. degree in Biological Engineering. Dr. Yang has expertise in benefit-risk assessment of biological products and Modeling and Simulation to inform drug development. She has been devoted in regulatory review, as well as research, training and outreach activities for novel approaches to benefit-risk assessment. She led many benefit-risk assessments to inform FDA regulatory decision and participated development of guidance for industry. She is a member of several FDA, HHS, WHO, CIOMS and ASA working groups on benefit-risk assessment of medical products.

Ariela Chick has worked in Pharmacovigilance for over 20 years and has held leadership roles in global safety operations, PV training & compliance, safety vendor management and REMS/PASS program management. She has been a PV Leader at global companies like Amylin, BioMarin, Gilead Sciences and BeiGene and has successfully supported teams with successful global PV & GCP inspections. As a PV Strategic Advisor/consultant for the past few years, Ariela has enjoyed preparing teams for the increased PV demands that accompany entry into the commercial phase. Ariela holds her B.S. degree in Biological Sciences from UC Irvine, and her MPH in Infectious Diseases from UC Berkeley.

Richard Forshee is the Deputy Director for the Office of Biostatistics and Pharmacovigilance in the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration. He works on a wide range of issues related to the risks and benefits of blood and blood products, vaccines, and human cell and tissue products. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.

Currently the Chief Medical Officer, TLR Therapeutics Inc. Israel is a Global Biotech Executive with over 25 years of experience building multi-therapeutic area medical affairs, clinical development, and drug safety. He has been working with multiple companies in many layers of executive management in the areas of Drug development, Risk Management, Artificial Intelligence implementation and PV Strategy. He has provided leadership of multifunctional groups across many companies including PRA Health Sciences, Pharmacyclics, Abbvie, Exelixis, Genentech, Roche Ltd, Celgene, Pharmion Corp, and Mankind corp. He is a Fellow of the Royal Society of Medicine and a Fellow of the Royal Society of Public Health.

Megan McNeal is a Director of Strategic Operations in the Data Sciences, Safety and Medical functions of IQVIA, where she is responsible for Change Management and Lean Six Sigma Process Improvement. Prior to transitioning to this role, Megan spent 18 years in a variety of operational and leadership roles in Data Management, mostly at IQVIA. She leverages her knowledge and experience to drive digital transformation efforts across the organization, all the while supporting their #1 resource - their people. Megan earned her Bachelors of Biology from UMKC, holds a Prosci Change Facilitator certification and a Lean Six Sigma black belt from the University of Kansas.

Captain Christine Olson, MD, MPH, is board-certified in Obstetrics & Gynecology and Preventive Medicine and is a US Public Health Service medical officer in CDC’s Immunization Safety Office. Prior to joining CDC, she was a clinical assistant professor and clerkship director of ob/gyn. She’s worked at the local, state, and international levels of public health in both the infectious and chronic disease areas, including in outbreak and emergency response, immigrant and refugee health, maternal morbidity and mortality prevention, preterm birth and infant health, occupational health, and vaccine safety. Since 2021, she’s led CDC’s COVID-19 Vaccine Pregnancy Registry.

Extensive experience in both post-marketing and pharmacovigilance in clinical trials for over 19 years. In-depth global filing experience as a safety lead for both small molecule and biologics. Instructor in Loyola PV Certificate Course. Co-chair of Cardiovascular Internal Safety Advisory Group at AbbVie. Member of DIA ASA Safety WG (workstream 3). Intimate knowledge of processes and regulations in ICSR, aggregate reporting and signal detection. Current knowledge of PV regulations including EU good pharmacovigilance practices. Comprehensive and current knowledge of Internal Medicine (current Board certification). Comprehensive knowledge of drug development process and conduct and reporting of post authorization.

Phil is the Deputy Director of Patient Safety Monitoring within MHRA’s Safety & Surveillance function and has over twenty years of experience working in pharmacovigilance. Prior to his current role Phil spent fourteen years leading and developing the pharmacovigilance system, including technology, processes, and relevant aspects of Pharmacovigilance Legislation. He is now accountable for Patient Safety Monitoring across medicines, vaccines, devices, defects and blood products. Phil was responsible delivery of MHRA systems for COVID-19 vaccine surveillance and their integration into the healthcare system. For several years he has led international projects to develop and deliver tools for global pharmacovigilance.

Susan is currently at Teva Pharmaceuticals leading its Epidemiology group which provides RWE for Clinical Development, Medical Affairs and PV groups. In 2022, she established a Benefit-Risk Assessment Planning Process at Teva to be used for products from early development stage to post-marketing. Prior to that she was at CSL Behring where she was the Clinical Epidemiology Team Lead and developed an SOP for Benefit-Risk Assessment throughout the drug lifecycle. She has also worked in Epidemiology & Benefit Risk Evaluation and PV groups at Sanofi for over 3 years in rare disease, immunology and neuroscience. She received a Ph.D. in Epidemiology from Univ of Illinois School of Public Health and an MPH from Emory University.

Peg received her MD & PhD (biochemistry) from U Chicago and boards in Oncology and Clinical Pharmacology. A safety executive with over 25 years’ experience in development and PVG in large and small pharma, Peg developed TAP Pharma's safety review process, led the protocol review team, and served on the Am Board of Clin Pharm. For the past 12 years she has led MedAssessment, a small PVG CRO focused on safety in early development.

Dr. Veronica Pei is a board-certified emergency physician and a commissioned officer in the U.S. Public Health Service currently serving as Associate Director (Acting) of Biomedical Informatics and Regulatory Review Science team in the Office of New Drugs (OND), FDA. In this role, Dr. Pei is involved in development, implementation, and support of bioinformatics initiatives within OND. She is the current FDA topic lead for ICH M11 expert working group on the Structure and Content of Clinical Protocols. Dr. Pei is also the current lead for Standard Tables and Figures and Technical Specifications for Submitting Clinical Trial Data Sets for Treatment of NASH guidance.

Dr Richardson (PhD) is the Principal Medical Information Scientist and Data Manager at the UK Teratology Information Service. He has worked at UKTIS since 2009, completing a PhD whilst with the service investigating novel methods of teratogen surveillance. His main research interests include improving teratogen surveillance data collection techniques, international collaborative approaches to data collection and harmonisation through the application of common data models and the development of data collection and reporting standards in pregnancy pharmacovigilance, and risk communication/informatics relating to medication use in pregnancy.

Evgeny Zalmover is an Executive Director, leading a team of patient safety physicians within the Oncology Therapeutic area of the Global Patient Safety and Pharmacovigilance department at Boehringer Ingelheim Pharmaceutical, Inc. since 2022. Evgeny is a medical doctor with 6 years of clinical practice (general and endocrine surgery) and over 17 years of pharmacovigilance experience working on cross functional teams with increasing roles and responsibilities at Schering-Plough, Merck & Co, US (aka MSD) and Sanofi. In his current position, Evgeny holds full medical strategic accountability for the benefit-risk and risk minimization activities for a portfolio of core strategic assets on a global level.

After his training in hospital medicine and clinical research for 14 years, Dr. Edwards joined the UK Medicines Control Agency (MHRA) in 1994 where he had various responsibilities as a pharmacovigilance assessor. In 1999 he joined Parexel to become Senior Medical Director before joining J&J as a deputy QPPV in 2005. In addition he is Director of ISoP Secretariat Ltd, ISoP Board Member and VP in the Alliance Clinical Research Excellence and Safety (ACRES) . He chairs the unique Pharmaceutical ergonomics & human Factors Group in the UK. After 14 years at NDA Regulatory Science Ltd, he has his own pharmacovigilance consultancy Husoteria Ltd

Scott Proestel, MD, is a Senior Medical Officer on the Biomedical Informatics and Regulatory Review Science Team at the US FDA’s Center for Drug Evaluation and Research. He completed his internal medicine training at Johns Hopkins Hospital and obtained his medical degree from Columbia University College of Physicians & Surgeons. He has conducted and supervised clinical pre-market reviews of new drug and biologic applications at FDA, overseen HIV clinical trial conduct as an Office Director at the US National Institutes of Health, and supervised safety surveillance as a Division Director at FDA. His informatics research has included assessing the use of artificial intelligence to evaluate spontaneous safety reports submitted to the FDA.

As a hepatologist and Associate Director in CDER’s Office of Pharmacovigilance and Epidemiology, Dr. Avigan has been an expert consultant for the evaluation of drug-induced liver injury during the life cycle of drugs and biological agents. Earlier on, Dr. Avigan received his MD from McGill University. After his medical residency and GI fellowship, he served as an NIH staff fellow and then on the faculty of Georgetown University where he attended patients and was the principal investigator of NIH-funded grants to elucidate basic mechanisms in cell growth pathways. Dr. Avigan participates in public-private partnerships supporting innovation in the analysis of hepatotoxicity associated with pharmaceuticals and biological agents.

I am Associate Director for DILI at the FDA. I got my BA in microbiology at UCLA and MD at UC San Diego. After residency and gastroenterology training at UC Davis, I completed a research fellowship at the NIH and a transplant fellowship at the University of Colorado. I received an MPH at Saint Louis University, Missouri. In 2006, I became Medical Director of Liver Transplantation at the University of North Carolina serving in that capacity as associate and then full professor before joining the FDA in 2020. My research and publications have focused on drug-induced liver injury for the last 19 years. I was a Co-Investigator for the NIH Drug-Induced Liver Injury Network and remain Co-Chair of the Causality Committee.