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

LCDR Scott Janiczak, PharmD, MPH, BCPS, is a pharmacy officer in the U.S. Public Health Service, who serves as a Team Leader in the Division of Pharmacovigilance-I (DPV-I) within FDA’s Center for Drug Evaluation and Research. In this role, he leads a multidisciplinary team reviewing post-market drug safety across therapeutic areas. Previously, he served as a safety evaluator in DPV-I (2020-2024) and regulatory affairs pharmacist in FDA’s Office of Generic Drugs (2014-2020). LCDR Janiczak earned his PharmD from Midwestern University, completed a PGY-1 residency at Franciscan Health (Dyer, IN), and is board certified in Pharmacotherapy. He frequently presents on FDA drug safety initiatives at national conferences and academic institutions.

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.

Bethany Van Veen has focused her entire career on pharmacovigilance (PV). In 2017, she founded Perspective Pharmacovigilance, a think tank of PV experts. PPV’s global staff of industry leaders, former PV department heads, and ex-regulators, design innovative solutions to a rapidly changing PV landscape. Bethany is passionate about cultivating PPV’s unique environment where the global team can do the work they love with people they trust. Bethany is also an adjunct professor at San Francisco State University teaching the Safety Monitoring Course for the Clinical Trials Design and Management Certification.

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 studies.

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.

Balmeet Gurm is an accomplished physician with extensive experience in the pharmaceutical industry, specializing in oncology and cardiovascular therapeutic areas. Currently serving as Executive Director, Therapeutic Area Lead in Patient Safety at Bristol Myers Squibb (BMS), Balmeet brings a wealth of expertise in pharmacovigilance, risk management, and drug development. Balmeet transitioned to the pharmaceutical industry after practicing medicine for a few years and has held critical leadership roles in safety and pharmacovigilance across multiple organizations. Throughout a distinguished career, Balmeet has contributed significantly to advancing patient safety, regulatory compliance, and the successful development of innovative therapie

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.

Stephanie is the Deputy Director of Benefit Risk Evaluation II in the Safety and Surveillance group at the MHRA. Prior to her current role she held a variety of management and assessor positions in the Agency. She has a masters degree in Clinical Pharmacology and a PhD in Cell Biology. She joined the Agency following a career in academia and has now over 20 years experience in drug regulation with particular experience in post-authorisation procedures and pharmacovigilance.

Kal Elhoregy is an accomplished healthcare industry executive with 25+ years’ experience focused on implementation of Risk Minimization Programs, Quality Management Systems and Pharmacovigilance Quality and Compliance for companies within the pharmaceutical industry. As a strategist and accessible leader with experience in Pharmacovigilance and Quality Risk Management within the pharmaceutical industry, Kal has developed the infrastructure for managing all REMS programs and RMPs in collaboration with multiple disciplines. Kal believes in leadership and teamwork and focuses on what is important to achieve successful results in ensuring patient safety and regulatory compliance.

Jamie Wilkins, Pharm.D. is an experienced pharmacist and former regulator currently responsible for partnering with internal and external stakeholders on delivering innovative, strategic global safety and risk management excellence for Pfizer’s drug and biologics portfolio. Prior to her role at Pfizer, Jamie served as the Deputy Director for the Division of Risk Management (DRM) at the US FDA. She is a two-time recipient of the FDA Francis O. Kelsey drug safety award, and has a deep passion for safety, and risk management science.

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

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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 20 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 aggregate safety assessment plans, internal data monitoring committees, and IND aggregate safety reporting procedures. In addition, she co-leads Workstream One of the American Statistical Association's Biopharma Safety Working Group.

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.

Sorcha McCrohan is a Senior Scientific Project Manager for Global Science at DIA. In her current role, she focuses on content development and strategy for DIA's meetings to improve and facilitate innovation in clinical research, drug development, and the fields of devices and diagnostics. Before joining DIA, she conducted COVID-19 research in Chiapas, Mexico, and worked in marketing within Pfizer's Global Vaccines franchise. Sorcha holds a BA in Sociology from Mount Holyoke College and an MSc in Global Health, Disease Prevention & Control from Georgetown University.

Dr. Vassileva has decades of experience with managing complex multi-stakeholder biomedical research programs. She spent most of her career in the nonprofit sector, leading the Science Team at the Arthritis Foundation, and working at the Foundation for NIH and the American Association for the Advancement of Science. She was also on the leadership teams of two health research organizations, serving as project director on multiple government contracts. Her areas of expertise include musculoskeletal, metabolic, immunity and inflammation disorders, as well as patient engagement. She received her PhD in Biochemistry and Cell Biology from Johns Hopkins.

Dr. Gita Toyserkani is Founder and Principal Consultant of DelMetrik, advising life sciences companies on drug safety, benefit–risk assessment, and risk management strategies. She is the former Associate Director at the U.S. FDA’s Office of Medication Error Prevention and Risk Management, with over 20 years of regulatory experience in pharmacovigilance and risk management. At FDA, she led development of the REMS Logic Model guidance, created the REMS Public Dashboard, and advanced REMS design and evaluation. Her expertise includes applying implementation science to translate strategies from pre-approval to real-world practice. She has authored 30+ publications and delivered many talks on risk management and regulatory science.

A graduate in medicine from Universidad Autonóma de Madrid, Spain, postgraduate studies in pharmacoepidemiology at Macgill University, Montreal, Canada and in pharmaceutical medicine (combined Strasbourg, Basel and Freiburg universities) Dr Arellano has more than 20 years of experience in the safety and pharmacovigilance (PV) field in the pharmaceutical industry. A senior executive having worked in global roles for top 10 pharma in PV of medicines, consumer products, devices and vaccines Dr Arellano is Global Head of Safety Risk Management at F Hoffmann La Roche, Switzerland. With a career spanning all elements of PV Dr Arellano is committed to excellence in medical compliance and innovation in safety science to create value for society.

Dr. Robert Califf is an Adjunct Professor of Medicine at Duke University and a practicing cardiologist. He served as FDA Commissioner (2016–2017) and Deputy Commissioner for Medical Products and Tobacco. At Duke, he was Vice Chancellor for Clinical and Translational Research and founding director of the Duke Clinical Research Institute. A globally recognized expert in cardiovascular medicine and clinical research, he has over 1,200 peer-reviewed publications. Dr. Califf is a member of the National Academy of Medicine and has served on numerous FDA and NIH advisory boards. He co-founded the Clinical Trials Transformation Initiative and led several national research infrastructure programs.

Delese Mimi Darko graduated as a pharmacist with an MBA. She has a 28-year career in regulation of food and health products. She rose through the ranks of the Food and Drugs Authority to become its first female Chief Executive Officer in 2017. She led FDA’s designation as a Regional Center of Regulatory Excellence in Medicines Safety, Clinical Trials and Drug Registration. She contributed to the growth of research and of the local manufacturing industries in Ghana Mimi Chairs the Steering Committee of WHO African Vaccines Regulatory Forum and serves on several international and local expert committees. She has received several awards for her exemplary work. She is a devout Christian and married with two children.

Andrej Segec is a pharmacist by training (Comenius University, Bratislava, Slovakia) with an MSc in Epidemiology (London School of Hygiene and Tropical Medicine, London, UK). He has worked for the European Medicines Agency since 2008, in pharmacovigilance/signal management, monitoring of the EMA pharmacovigilance system, in surveillance and epidemiology, as committee manager for the operations of the Pharmacovigilance Risk Assessment Committee (PRAC) and as a risk management specialist for anti-infective therapies and vaccines during the COVID-19 pandemic.Currently, Andrej’s focus is on the generation and use of RWE in regulatory decision making and the establishment of the DARWIN EU®.

Dr. Waksman is the president of Pharmasec, a drug safety consulting company. He is also the Head of Drug Safety at Centessa Therapeutics. He has 15 years of experience in drug safety/pharmacovigilance, holding various leadership roles, including leading drug safety teams. Dr. Waksman specializes in Internal Medicine and Medical Toxicology, with expertise in hepatotoxicology and Drug-Induced Liver Injury. He is also a Fellow of the American Academy of Clinical Toxicology. Before joining the industry, Dr. Waksman was the director of the Medical Toxicology Practice at the University of Colorado and is currently on the clinical faculty of UCSF. He was a member of the CIOMS DILI work group and hepatic committees.

Andrew is VP and Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Leadership team. Previously Andrew was in the Epidemiology Leadership team at Pfizer for a decade. Prior to joining Pfizer, Andrew was at the Uppsala Monitoring Centre for more than 12 years, where he led the Research function. Andrew is an Honorary Professor of Epidemiology at LSHTM. Andrew has and does contribute to several international initiatives and has been a member of the Transcelerate Intergrated Leadership Team, and PV Steering Committee since 2020.

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.

Kate Gofman, MD, Ph.D., is currently working as a Global Patient Safety Physician at AstraZeneca. She has been with AstraZeneca for more than five years delivering global safety strategy and oversight for various compounds. Kate serves as an industry expert for automation & digital innovation. Before working with AZ, she practiced as a cardiologist and worked in various clinical leadership roles. Kate is a change agent and a blockchain enthusiast and has business education from Oxford and Stanford.

Deirdre is a Senior Program Officer and Pharmacovigilance Lead at the Gates Foundation, overseeing grants that support the African Union’s first continental safety surveillance platform for the African Medicines Agency. With over 20 years of PV experience across regulatory, industry, and non-profit sectors in the EU, US, and Latin America, she brings a global perspective to post-marketing safety, compliance, and global health. She has lectured at Tufts University and is a Fellow of the International Society of Pharmacovigilance (ISoP).

Simone Pinheiro is Head of the Pharmaco-Epidemiology Center of Excellence at AbbVie, leading experts in regulatory pharmacoepidemiology, data science, and analytics to drive real-world evidence across the enterprise. With 15 years’ experience—including leadership roles at FDA/CDER—and Doctorate and Master’s degrees from Harvard, she is recognized for advancing RWE in regulatory decision-making and product development and shaping best practices in the field.

Ed Whalen has worked in the industry for 31 years and partially focused on safety related questions both at the project level and in general for the last 15 years. His background has covered drug development primarily in CNS and pain with some prior experience in anti-infectives, oncology and cardiovascular.

Priya Bahri, RPh, PostGradDipEpi, PhD, at EMA since 1996, is now EMA's Lead Pharmacovigilance and Risk Management Guidance and Policy. In this role, she also instigates research and regulatory frameworks for risk communication, stakeholder engagement for pharmacovigilance and implementation of risk minimisation in healthcare. Pro bono, she is active in the learned societies ISoP and ISPE and as associated researcher at Utrecht University. She is the editor of the Springer textbook "Communicating about Risks and Safe Use of Medicines - Real Life and Applied Research".

Dr. Andrea Best is an Executive Medical Director in Pharmacovigilance and Patient Safety at AbbVie in the suburbs of Chicago where she is responsible for Clinical Trial Safety Excellence and International Product PV. Andrea has over 20 years of experience in academia and industry across a variety of roles (clinical development, medical affairs and pharmacovigilance) and spanning numerous therapeutic areas including oncology, immunology, anti-infectives, renal, anesthesia, general medicine and devices. She has led discussions with global regulatory authorities on a variety of issues and has participated on several external collaborations related to regulatory system strengthening and pharmacovigilance in developing countries.

Renee Breed is an Independent Pharmacovigilance Consultant located in San Francisco, California with more than 23 years of experience in case management, global safety reporting, safety science, quality management, and safety systems. Prior to starting her consulting business in January 2025, Renee was most recently Vice President, Medical Safety Operations (Vincerx Pharma) and previously held positions as Head of Medical Safety Operations and Excellence (Acerta Pharma/AstraZeneca), Head of Drug Safety Operations (Onyx/Amgen), Head of Pharmacovigilance (Sunesis), and Head of Drug Safety Risk Management Operations (InterMune/Roche). Renee holds a BS in Biology from the University of Wisconsin at Madison.

Richard Forshee is the Associate Director for Benefit-Risk Assessment in the FDA Center for Drug Evaluation and Research, Office of Surveillance and Epidemiology. His portfolio includes benefit-risk assessment, real world evidence, pharmacoepidemiology, and artificial intelligence for regulatory science. He has won several awards including the FDA Award of Merit. Before joining the FDA, he was the Director of the Center for Food, Nutrition, and Agriculture Policy at the University of Maryland, College Park.

Dr. Rodriguez-Watson is focused on continuously developing and enhancing a portfolio of work that leverages real-world data and experiences to inform and conduct clinical and post-market drug safety and effectiveness studies to improve population health. Key projects bring together communities of experts to develop and advance frameworks and tools to systematically describe and improve data sources and methods for use in pre- and post-market studies of product safety and effectiveness. Such efforts serve to operationalize regulatory guidance and support practical interpretation in a collaborative environment. Dr. Rodriguez-Watson brings her extensive background in public health, epidemiology, and health outcomes research to this work.

Dr. Achanzar is currently the Nonclinical Safety Therapeutic Area Head for the Cardiovascular and Neuroscience at Bristol-Myers Squibb, where he oversees the nonclinical safety strategy for all assets in these disease areas. He received his PhD in Molecular and Cellular Biology from the University of Arizona. After graduating, he trained in toxicology as a postdoctoral fellow at the National Cancer Institute with Dr Michael Waalkes. He joined BMS in 2003 as a junior toxicologist and, over the past 22 years, has acted as the toxicology lead for a number of early- and late-stage drug development programs across multiple disease areas and modalities, including oligonucleotides.

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.

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