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.

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.

Beth has more than 20 years of experience in pharmaceutical product safety based on monitoring adverse event data from use in medical practice for both clinical investigations and postmarketing. Her experience includes extensive industry-based global pharmacovigilance with both CROs and sponsor-based companies where her focus has been operational efficiencies, risk management, and data visualizations for signal detection. She completed her BS in Pharmacy and Doctorate in Pharmacy at UNC’s School of Pharmacy in Chapel Hill, NC.

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

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.

Sudip S. Parikh, PhD, serves as Senior Vice President and Managing Director for DIA Americas. He previously served as Vice President and General Manager of Health & Consumer Solutions at Battelle, leading its Healthcare Improvement, Public Health Research, and Consumer, Industrial, and Medical Technology Development teams in R&D supported by government and commercial clients. Dr. Parikh is a board member of Research America, the Friends of Cancer Research, and the Food Innovation Center. He was a Presidential Management Fellow at the National Institutes of Health, and was awarded a National Science Foundation Graduate Research Fellowship while earning his PhD in Macromolecular Structure and Chemistry from The Scripps Research Institute

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. 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.

Reema Mehta, PharmD, MPH is Head of the Risk Management Center of Excellence at Pfizer, Inc. She is responsible for providing strategic guidance, innovation and research, and defining best practices for risk management planning. Prior to joining Pfizer, Dr. Mehta worked at the US FDA for the Division of Risk Management, where she provided oversight and expertise for regulatory requirements and appropriate risk mitigation measures as they related to risk evaluation and mitigation strategies (REMS). Dr. Mehta also worked at Johnson and Johnson in pharmacovigilance and served as adjunct faculty at the University of Florida and at Rutgers University.

A healthcare industry senior executive and clinician with broad experience in the clinical development of new therapeutic methodologies. These include research and clinical practice, pharmaceutical, biologic products, medical devices, genetic modification of living organisms and immune modulation therapy. He has extensive clinical and product development experience in start-up, mid-size and large corporate settings. In addition, he has had continuous experience with FDA, European authorities (CHMP, EMA and country authorities), Japan Authorities as well as many other regulatory country agencies and maintains credibility with these regulatory worldwide groups.

Sanjay K. Sahoo MS. MBA. Food and Drug Administration. FAERS Expert and Business Owner, Regulatory Science, OSE/CDER/FDA Mr. Sanjay K. Sahoo has over 18 years of demonstrated achievements, across FDA, NIH, and Bio-Pharma companies, impacting public safety through alignment of policies, regulations and innovative healthcare informatics solutions with strategic objectives. Now in Office of Surveillance and Epidemiology at CDER, Mr. Sanjay as FDA Adverse Events System (FAERS) expert and business owner provides expert advice and technical direction on regulatory science of exploring and developing new tools, data sources, standards, methods and approaches to assess safety, efficacy, quality, and performances of all FDA-regulated products.

Dr. Wolpert joined the Lilly Cambridge Innovation Center in July 2016 after 25 years on the faculty at Joslin Diabetes Center/Harvard Medical School where his clinical and research activities focused on the use of technology in diabetes management. In addition to being PI in several major multi-center randomized trials evaluating the use of technology in diabetes care, he is author of a book on insulin pump therapy published by the American Diabetes Association (ADA), lead author of the section on continuous glucose monitoring in the Endocrine Society Clinical Practice Guidelines, and editor of the 2016 edition of the ADA book on Intensive Diabetes Management.

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. Burkhart received his medical toxicology training at the Rocky Mountain Poison Center in Denver. He received his Emergency Medicine training at the University of Cincinnati. He is the former Medical Director of the Penn State Poison Center. Clinical care has been provided at the PinnacleHealth Hospital. He is a co-editor of Critical Care Toxicology. He performs mechanistic-based biological plausibility consults for drug safety issues using cheminformatic and bioinformatic tools. Natural Language Processing is used to analyze the OVERDOSAGE Section of drug labels. Data mining is used to analyze real world evidence.

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.

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.

Campbell Hutton, MSPH, is Senior Director, Regulatory Affairs and is responsible for JDRF’s interactions with regulatory agencies, including the U.S. Food and Drug Administration. In this capacity, she oversees the regulatory affairs team to develop and implement JDRF’s overall regulatory strategy. Ms. Hutton joined JDRF in 2009 in a newly created position, Director, Regulatory Affairs – Medical Devices. Prior to joining JDRF, Ms. Hutton was Vice President, Strategic Consulting Group at Becker & Associates Consulting, a boutique scientific consulting firm in Washington, D.C.

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.

A patient who personally balances benefits & risks of treatments for four chronic conditions. Also, as founder of Seaton Associates, LLC, Think Training, Inc. and Communications Development Service, a learning professional who helps NGOs, communities, non-profits, State & Federal agencies, and corporations gather information, manage risks and develop/execute strategic responses more effectively when facing complex personal, group and community/organizational challenges of all sorts.

Sonja Brajovic is a Medical officer in the Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordination of projects related to the Medical Dictionary for Regulatory Activities (MedDRA), including monitoring MedDRA coding quality of reports in the FDA Adverse Event Reporting System (FAERS). Sonja represents FDA on the International Conference on Harmonisation (ICH) MedDRA Points to Consider workgroup. Sonja obtained her medical degree in the former Yugoslavia.

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.

Dr. Gao is a safety risk lead with Safety Surveillance & Risk Management department at Pfizer. She is responsible for developing safety strategy, overseeing pharmacovigilance activities and risk management in a multidisciplinary team to support Pfizer portfolio in global market. She is based in Shanghai China. Dr. Gao received her medical degree from Fudan University. She joined Pfizer in 2009 as External Research Manager, mainly responsible for managing the scientific collaboration and business development activities between Pfizer and a broad network of academic institutes, biotech and CROs in Asia. Prior to Pfizer, she worked in McKinsey & Company as a business consultant focusing on healthcare industry.

Dr. Hirsch is the Executive Director of the MIT Center for Biomedical Innovation (CBI) where she leads NEWDIGS, a “think and do tank” that is re-engineering pharmaceutical innovation to deliver more clinical value to patients faster, in ways that work for all stakeholders. NEWDIGS’ flagship project on “Adaptive Biomedical Innovation” (ABI) helped inspire the successful EU-wide Adaptive Pathways pilot program led by the European Medicines Agency (2014-2016).

Dr. Jonathan P. Jarow is currently the senior medical advisor to the Center Director and chair of the medical policy council in CDER at FDA. Jonathan previously served as the director of CDER’s Office of Medical Policy and as deputy director of the Office of Hematology and Oncology Products. Prior to joining the FDA he was Professor of Urology, Pathology, Radiology, and Molecular Biology & Biochemistry at Johns Hopkins University.

Dr. Malin is a Medical Director in Pharmacovigilance and Patient Safety and Head of Medical Device Safety at AbbVie. He has a MD from the Medical College of Ohio. Prior to his time at AbbVie, he worked for FDA CDRH in the Office of Compliance, where he had oversight of all medical device recalls, and Director of CDRH’s emergency operations and medical countermeasures programs. While at CDRH, Murray was instrumental in developing guidance and regulations for medical device software.

18 years of pharmaceutical drug safety experience. Currently oversees global PV expedited reporting business processes. She supported multiple projects including the FDA IND rule changes, database updates, creation of an investigator line listing report, & EU GVP process updates. Previously she worked in PV surveillance, case management, quality, & call center AE reporting. Before pharma, she worked as a hospital clinical pharmacist consulting on drug dosing & safe cost-effective medication use.

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. Sajjan Daniel is currently Vice President, Global Head of Drug Safety Surveillance at Shire. Most recently served as the VP of Drug Safety Surveillance at Baxalta and worked previously in leadership roles at Pfizer, Novartis and Johnson & Johnson. A Drug Safety physician with over 15 years in the pharmaceutical industry with extensive experience in Drug Safety, Strategic PV & Risk Planning, Clinical Research, Risk Management and Drug Safety Crisis Management.

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.

Professor Sarah Garner is a pharmacist specialising in the interface between Health Technology Assessment (HTA) and regulation. Sarah is the Associate Director for Scientific Policy and Research at NICE and an honorary professor at UCL and Manchester University. She leads Work Packages of the GetReal and ADAPT SMART projects funded by the EU Innovative Medicines Initiative.

Dr. Hampp is a senior epidemiologist in the Office of Surveillance and Epidemiology in FDA’s Center for Drug Evaluation and Research. He serves as the CDER liaison to the Board of Directors of the International Society for Pharmacoepidemiology. He has lectured internally and externally about epidemiologic methods, protocol writing, and FDA’s pharmacoepidemiology guidance. Dr. Hampp is also an Affiliate Clinical Assistant Professor at the University of Florida, College of Pharmacy. He received his pharmacy degree from Saarland University in Saarbrücken, Germany, and a PhD in pharmacoepidemiology from the University of Florida.

Dr. Harrison is the Chief Medical Officer of the MedDRA Maintenance and Support Services Organization (MSSO) where she is responsible for overall medical strategy. She has over 25 years’ experience in clinical research and pharmacovigilance, and is a member of the ICH M1 “Points to Consider” Working Group and the CIOMS Implementation Working Group on Standardised MedDRA Queries (SMQs).

Prior to joining CTTI, Ms. Okun led a consultancy firm that specialized in projects related to patient and public involvement in research, care, policy, and socially accountable ethics. From 2013 to 2019, she served as vice president of the online patient research network PatientsLikeMe (PLM) where she was responsible for the company’s patient advocacy initiatives, contributed to health policy discussions at the national and global level, and was PLM’s liaison with government and regulatory agencies, including the U.S. Food and Drug Administration (FDA), Center for Medicare and Medicaid Services (CMS), and the European Medicines Agency (EMA).

Juergen Schmider MD, PhD, is a psychiatrist and clinical pharmacologist with 8 years of academic and practice experience and 18 years of industry professional experience. His pharmaceutical career includes employment of increasing responsibilities with Pfizer, Johnson and Johnson, Cephalon, Sanofi, Hospira and most recently return to Pfizer as the VP for Safety Evaluation and Reporting. He is recognized as an innovative pharmacovigilance and risk management leader with 16years of global pharmacovigilance and device-vigilance experience from first-in-human to end of drug-life-cycle.

Abla A Creasey, PhD is an Associate Director, Therapeutics, California Institute for Regenerative Medicine, Oakland California. She has been with the Institute for almost a year. She leads Ophthalmic and Neurodegenerative diseases’ stem cell focused therapies. Dr. Creasey has broad experience in science, technology, and pharmaceutical development. She was at Johnson & Johnson (J&J) for twelve years. During that time she was a Senior Scientific Director in Pharmaceutical Development & Manufacturing Sciences at Janssen for three years. She also led drug delivery systems and patient centered design strategy and its application to drug/device combination products.

Leann is the Vice President, Global Pharmacovigilance Operations at PAREXEL, International. She is responsible for leading the Global Pharmacovigilance team for clinical trials and post-market safety programs. Prior to joining PAREXEL, Leann has worked for over 25 years in the pharmaceutical industry leading global safety operations and safety compliance departments. She has led cross-functional global reengineering processes including implementation of new tools and systems at three pharmaceutical companies including Pfizer, Hoffmann-La Roche, and Schering-Plough. Leann received her Doctor of Pharmacy from St. John’s University and Bachelor of Science in Pharmacy from University of Wisconsin.

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK Regulatory Authority, then the international pharmaceutical industry and as the Director of the Drug Safety Research Unit (DSRU) in Southampton. The DSRU is a service provider and associate department of the University of Portsmouth. At the DSRU Saad leads a research team with an active programme for monitoring and studying the safety of medicines in populations. He has led many important drug safety studies and has worked and advised on many drug safety issues including product withdrawals, major restrictions and important safety hazards.

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

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.

François is a patient and works at the European Organisation for Rare Diseases as Director of Treatment Information and Access since 2003. He's been involved in EUnetHTA since the first Joint Action back in 2010, and supervises Eurordis policy and advocacy on HTA. François also represents Eurordis at the European Medicines Agency.

As Amgen develops its biosimilars, Dr. Thomas Felix works to advance science and policy for a successful, patient-focused implementation. Dr. Felix partners with drug safety experts to characterize the ability to track and trace multisource therapeutic outcomes in various treatment settings and regions. He is committed to advancing pharmacovigilance systems to quickly and accurately identify adverse events and facilitate manufacturer accountability.

Dr. Jill Buckley serves as Adjunct Assistant Professor in the School of Health Professions at Rutgers University as well as Adjunct Faculty in the Department of Health Technologies at Durham Technical Community College teaching drug safety and pharmacovigilance courses. Jill has worked over 30 years in pharmaceutical industry. For nearly 20 years, Jill has held leadership roles in drug safety and pharmacovigilance at several pharma companies, a CRO, and a consulting firm. Jill gained experience in clinical research and regulatory affairs developing protocols, clinical trial monitoring, regulatory application preparation and FDA interactions. Jill earned Doctor of Pharmacy degree from the University of Michigan.