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Pharmacovigilance and Risk Management Strategies Conference


Speakers

  • Lesley  Wise, PhD, MSc

    Lesley Wise, PhD, MSc

    • Managing Director
    • Wise PV&RM Ltd, United Kingdom

    Lesley Wise has nearly 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 liaised regularly with regulators, including meetings with PRAC, CHMP and FDA.

  • Hui-Lee  Wong, PhD, MS

    Hui-Lee Wong, PhD, MS

    • Epidemiologist, Sentinel Central Team, OBE, CBER
    • FDA, United States

  • Representative Invited

    Representative Invited

    • DIA, United States
  • Bill  Allman

    Bill Allman

    • Chief Digital Officer
    • DIA, United States

    Bill Allman is Chief Digital Officer (CDO), developing and implementing DIA’s digital strategy to create digital products/services that enhance DIA’s global impact. Previously the CDO of Smithsonian Enterprises, Mr. Allman has been cited as one of the "100 most innovative CDOs globally”. He was also VP of Digital Media for Bonnier Corp, Chief Content/Creative Officer for HealthCentral.com, SVP & GM of Interactive Media for Discovery.com, and founding GM for US News & World Report. Mr. Allman began his career as a journalist, helping create Science 80, an award-winning publication of the AAAS. He has written three books on evolution, brain science, and the science of sports, and has a BA in English and a BS in Biology from Brown University.

  • Stella  Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

    Stella Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP

    • Vice President, Global Head of Early Access and Risk Management
    • IQVIA, United Kingdom

    Dr Stella Blackburn. MB BS, MA, MSc, FRCP(Ed), FISPE, FFPM, DLSHTP, Dip Pharm Med.VP, Global Head of Early Access & Risk Management, Real World Insights at IQVIA. Stella studied medicine at Cambridge and Guys and worked in hospital medicine before joining the pharmaceutical industry. She has worked in pharmacovigilance and pharmacoepidemiology for 30+ years: in industry (11+ years) as a regulator (nearly 17 years) and CRO (5+ years).She has an MSc in Epidemiology from the London School of Hygiene and Tropical Medicine. In 1997 she joined the European Medicines Agency (EMA). Stella developed EU policy on risk management and helped implement the 2010 PhV legislation. She now advises companies on early access and navigating the EU system.

  • Mariette  Boerstoel-Streefland, MD, MBA, MS

    Mariette Boerstoel-Streefland, MD, MBA, MS

    • Senior Vice President Global Drug Safety
    • Alexion Pharmaceuticals, Inc., United States

    Mariette Boerstoel-Streefland, MD, MBA, MS(epi) is SVP, Head of Global Safety at Alexion Pharmaceuticals, Inc, a world leader in rare diseases. Prior to her current role, Mariette was SVP, Head of Global Drug Safety at Shire, having been appointed to lead the safety organization after the Baxalta acquisition in 2016. She joined Baxalta two years prior to establish their safety department with the split off from Baxter. Mariette joined the pharmaceutical industry from clinical practice and had a progressive career, holding various leadership positions in drug safety and medical affairs at Organon (now Merck), Mayne Pharma (now Hospira), Forest Labs (now Allergan) for 30 years.

  • Gerald J. Dal Pan, MD, MHS

    Gerald J. Dal Pan, MD, MHS

    • Director, Office of Surveillance and Epidemiology, CDER
    • FDA, United States

    Gerald J. Dal Pan, MD, MHS, is Director of the Office of Surveillance & Epidemiology in FDA’s Center for Drug Evaluation and Research, where he oversees adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. A member of the WHO Advisory Committee on the Safety of Medicinal Products, he served on the Council of International Organization of Medical Sciences and the International Council on Harmonisation. He received his MD from Columbia University College of Physicians and Surgeons and his Master of Health Science in Clinical Epidemiology from the Johns Hopkins University School of Hygiene and Public Health. Before joining FDA, he was a faculty member in Neurology at Johns Hopkins.

  • E. Stewart  Geary, MD

    E. Stewart Geary, MD

    • Senior VP, Global Safety Officer, Director, Corporate Medical Affairs HQ
    • Eisai Co., Ltd., Japan

    E. Stewart Geary, MD, is Global Safety Officer and Senior Vice President at Eisai Co., Ltd. He is a Councilor of the Japanese Association of Pharmaceutical Medicine and serves on the Editorial Advisory Boards for Applied Clinical Trials and 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

  • William  Gregory, PhD

    William Gregory, PhD

    • Senior Director, Safety and Risk Management
    • Pfizer Inc, United States

    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.

  • Stephen  Knowles, MD, MRCP

    Stephen Knowles, MD, MRCP

    • Vice President, Drug Safety and Pharmacovigilance
    • Halozyme Therapeutics, United States

    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. 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 case management and safety surveillance

  • Jill K. Logan, PharmD

    Jill K. Logan, PharmD

    • Safety Evaluator, DPV I
    • Office of Surveillance and Epidemiology (OSE), CDER, FDA, United States

    Jill K Logan is a Safety Evaluator in the FDA-CDER Division of Pharmacovigilance. She received her Doctor of Pharmacy degree from the University of Connecticut, completed a Pharmacy Practice Residency at Inova Fairfax Hospital in Falls Church, Virginia, and a Critical Care Residency at Boston Medical Center in Boston, Massachusetts. Prior to her work at the FDA, she practiced as an Emergency Medicine Pharmacy Practice Specialist at Johns Hopkins Bayview Medical Center and the University of Maryland System.

  • Barbara  Morollo, RN

    Barbara Morollo, RN

    • Head, Pharmacovigilance
    • Corbus Pharmaceuticals, United States

    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.

  • Annette  Stemhagen, DrPH, FISPE

    Annette Stemhagen, DrPH, FISPE

    • SVP & Chief Scientific Officer
    • UBC, United States

    Dr. Annette Stemhagen is an epidemiologist with more than 30 years of public health research experience, including 20 years in safety surveillance of pharmaceutical, biotechnology, and vaccine products. She is the SVP of Safety, Epidemiology, Registries and Risk Management and the Chief Scientific Officer within UBC, where she provides strategic consultative services to biopharmaceutical clients. Dr. Stemhagen has specific expertise in safety surveillance and design, implementation, and analysis of epidemiologic studies, Risk Evaluation and Mitigation Strategies (REMS) registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval.

  • Jo  Wyeth, PharmD

    Jo Wyeth, PharmD

    • Postmarket Safety Program Lead, DMEPA, OMEPRM, OSE, CDER
    • FDA, United States

    Jo Wyeth is the Postmarket Surveillance Program Lead in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for coordinating projects related to reporting, analyzing, identifying, communicating, and training related to medication error safety issues. She is also the team leader for the DMEPA Rapid Response Team, and represents DMEPA on several internal and external workgroups.

  • Catherine  Baldridge, MSc

    Catherine Baldridge, MSc

    • Founder/Owner, Principal Consultant
    • Essential Pharmacovigilance, LLC, United States

    Catherine Baldridge has more than 16 years of experience in safety and pharmacovigilance, and currently serves as an executive consultant to the industry providing leadership and support in Pharmacovigilance Operations, development, training, regulatory, and inspection readiness. She has a Masters of Science in Clinical Investigation and Patient Oriented Research from the University of Virginia, and currently serves as Adjunct Faculty at Temple University School of Pharmacy, teaching several courses in Safety and Pharmacovigilance. Catherine was the Chair of the DIA Clinical Safety & PV Community and is a member of the Community Leadership Counsel as the CSP representative.

  • Ingrid N. Chapman, PharmD

    Ingrid N. Chapman, PharmD

    • Senior Risk Management Analyst, DRM, OMEPRM, OSE, CDER
    • FDA, United States

    Ingrid Chapman is a Senior Risk Management Analyst in the Division of Risk Management (DRM), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She provides risk management expertise and reviews proposed risk evaluation and mitigation strategies (REMS), REMS modifications, and REMS assessments for all products with approved REMS for conformance with current FDA standards. In addition, she reviews FDA applications to determine if a REMS is necessary to ensure the benefits of the product outweigh the risks. Prior to working for the FDA, Ingrid worked as a residency-trained Pediatric Clinical Pharmacy Specialist at Children’s National.

  • Michael  Richardson, MD, FFPM

    Michael Richardson, MD, FFPM

    • International GPV&E and EU QPPV, Qualified Person for Pharmacovigilance
    • Bristol-Myers Squibb, United Kingdom

    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.

  • Sarah  Vaughan

    Sarah Vaughan

    • Pharmacovigilance Information Unit Systems Manager
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Sarah has worked in pharmacovigilance at the MHRA for the past 15 years, with 6 years as the Pharmacovigilance Information Unit Manager. The unit has responsibility for handling Adverse Drug Reaction (ADR) data, signal management processes and the detection & evaluation of safety signals for established medicines. Alongside this Sarah has been an MHRA representative on the MedDRA Points to Consider Group, and has worked on implementation of the 2012 EU Pharmacovigilance legislation. Her current role is as a Systems Manager in the Vigilance, Intelligence and Research Group working specifically on pharmacovigilance IT projects.

  • Jeremy  Jokinen, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Head of Business Capabilities and Innovation Worldwide Patient Safety
    • Bristol-Myers Squibb Company, United States

    Jeremy is the Senior Director, Decision Sciences, within the Safety Sciences organization of AbbVie Inc. In this role, he leads a team of data scientists, analysts, and data managers developing novel analytical approaches and methodologies to improve patient safety. Jeremy is also active within numerous TransCelerate PV initiatives and is a deputy topic lead for ICH E19. Jeremy has over 20 years of experience as a statistician in early phase to post-market pharmaceutical, biological, and medical device research. He holds MS and PhD degrees in quantitative psychology from Ohio University.

  • Ashleigh  Lowery, PharmD, RPh

    Ashleigh Lowery, PharmD, RPh

    • Medication Error Safety Advisor, DMEPA, OMEPRM, OSE, CDER
    • FDA, United States

    Ashleigh is currently an acting team leader in the Division of Medication Error Prevention and Analysis (DMEPA). She has also has worked on postmarket and policy projects on DMEPA's Rapid Response Team. She is a graduate of the University of Maryland School of Pharmacy and completed her PGY-1 Pharmacy Practice and PGY-2 Critical Care residencies at the University of Maryland Medical Center (UMMC) and the R Adams Cowley Shock Trauma Center. Prior to coming to FDA, she worked as a clinical pharmacy specialist and clinical assistant professor in the Cardiac Surgery ICU at UMMC.

  • Greg  Ball, PhD

    Greg Ball, PhD

    • Senior Principal Biostatistician
    • Merck & Co., Inc, United States

    After graduating from Northwestern University with a bachelor’s in economics, Greg served in the Navy for 4 years and taught high school math and physics for 5 years, before going back to school to get a master’s in applied statistics from Purdue University. Eventually, while working as a statistician, he earned his PhD in Biostatistics from the University of Texas. Greg’s current research on blinded safety monitoring procedures emerged from his early work at academic medical centers and CROs, developed into his college dissertation and continues to be developed in collaboration with statistical and clinical scientists from several pharmaceutical companies.

  • Rhiannon  Leutner, PharmD, MBA, MPH

    Rhiannon Leutner, PharmD, MBA, MPH

    • Medication Error Safety Advisor,CDER, OSE, OMEPRM, DMEPA
    • FDA, United States

    Rhiannon Leutner is a Medication Safety Advisor in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). She is responsible for the collection, detection, assessment, monitoring, and prevention of medication errors with pediatric drug products. Her duties include analysis of reported medication errors and continuous surveillance of adverse drug events and drug usage in pediatric populations.

  • Andrew  Bate, PhD, MA

    Andrew Bate, PhD, MA

    • Head of Safety Innovation and Analytics
    • GlaxoSmithKline, United Kingdom

    Andrew is Head of Safety Innovation & Analytics at GSK and a member of the Global Safety Medical Governance 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 has over 100 publications on RWE and signal detection and has participated in several international initiatives in the area. Andrew is Honorary Associate Professor of Epidemiology at LSHTM, and Adjunct Associate Professor in Clinical Pharmacology at New York University.

  • Peter F. Bross, MD

    Peter F. Bross, MD

    • Medical Review Officer OTAT, CBER
    • FDA, United States

    Peter Bross is a clinical oncology team leader in the FDA Center for Biological Evaluation and Research (CBER), Office of Tissue and Advanced Therapies (OTAT) and previously worked as a clinical reviewer in the Division of Oncology Drug Products in the Center for Drug Evaluation and Research (CDER). Dr. Bross has expertise in the design and analysis of clinical oncology trials of cellular, tissue and gene therapies, especially cancer vaccines, combination therapies, and companion diagnostics.

  • Herve  Le Louet, DrMed, DrSc, MD, PhD, MS

    Herve Le Louet, DrMed, DrSc, MD, PhD, MS

    • President, Head of PV Coordination
    • CIOMS and APHP, France

    Herve Le Louet is Professor of Clinical Pharmacology. He is currently head of Pharmacovigilance department of Paris University Hospitals (AP-HP). He is an hepatologist by training and has a PhD in Pharmacogenetic from the Paris University. He is the President of CIOMS and immediate Past President of the International Society of Pharmacovigilance (ISoP). He was a co-opted member by the European Commission of PRAC at the EMA. He is member of the board of ENCEPP. He was the advisor of the Minister of Health and Social Security.He worked on Pharmacovigilance and Public Health.

  • Christina  Michalek, RPh

    Christina Michalek, RPh

    • Medication Safety Specialist
    • Institute for Safe Medication Practices , United States

    Christina Michalek, BS, RPh, FASHP is a Medication Safety Specialist and Administrative Coordinator for the Medication Safety Officers Society at the Institute for Safe Medication Practices. She also serves as an analytic contractor to the ECRI Institute Patient Safety Organization. Christina received her pharmacy degree from the Philadelphia College of Pharmacy and Science and completed a PGY1 residency at Suburban General Hospital. She is a fellow of the American Society of Health-System Pharmacists (ASHP).

  • Steven  Murray, PhD

    Steven Murray, PhD

    • Group Vice President
    • Exponent, United States

    Dr. Murray is a Group Vice President at Exponent, specializing in failure analysis of electrical and mechanical systems, and using advacned data tools to inform failrue analysis and understanding of risk. Engineering systems investigated include appliances, computers and consumer electronics, medical electronics, and large electrical generators and motors. These investigations have involved understanding and analysis of complex electrical and electronic systems, fracture and fractography, risk assessment, environmental effects, electrical and magnetic modeling, and materials defects. Dr. Murray was a Consulting Assistant Professor at Stanford University where he taught the course Techniques of Failure Analysis from 2006 - 2015

  • Sophie  Sommerer, MS

    Sophie Sommerer, MS

    • Director
    • Health Canada, Canada

    Sophie Sommerer is the Director of the Marketed Biologicals, Biotechnology and Natural Health Products Bureau at Health Canada where she is responsible for overseeing pharmacovigilance and risk management activities of a team of medical and scientific evaluators. Previously, she held positions as director of the Marketed Health Products Safety and Effectiveness Information Bureau and as acting director and associate director of the Bureau of Cardiology, Allergy and Neurological Sciences, following over 10 years working primarily in health promotion policy at the Public Health Agency of Canada. Sophie has a Bachelor of Science (Honours) in Biology from Queen’s University and a Master of Science in Biology from Carleton University.

  • J Vijay  Venkatraman, MD, MBA

    J Vijay Venkatraman, MD, MBA

    • Managing Director and CEO
    • Oviya MedSafe, India

    Dr J Vijay Venkatraman is the Founder, Managing Director & CEO of Oviya MedSafe, a global Pharmacovigilance consulting & Drug Safety services providing company based in India and the United Kingdom. He is the first Indian to receive the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (UK). Dr Vijay has served as Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research since the Council’s inception in 2015 until 2019. He is the India Regional Editor of Global Forum, a DIA publication, since 2017. From 2018, he is Chairman of the Pharmacovigilance Standing Committee of the Indian Medical Association (IMA) Tamil Nadu State Branch. He is a recipient of IMA’s Leadership Excellence Award.

  • Jacqueline A. Corrigan-Curay, JD, MD

    Jacqueline A. Corrigan-Curay, JD, MD

    • Director, Office of Medical Policy, CDER
    • FDA, United States

    Jacqueline Corrigan-Curay, J.D., M.D., serves as Director of the Office of Medical Policy (OMP) in the Center for Drug Evaluation and Research, FDA. OMP is comprised of the Office of Prescription Drug Promotion (OPDP) and the Office of Medical Policy Initiatives (OMPI). Dr. Corrigan-Curay leads the development, coordination, and implementation of medical policy programs and strategic initiatives, including policy development on real world evidence, drug labeling, prescription drug promotion, clinical trial oversight and innovative trial design. She works collaboratively with other CDER program areas, FDA centers, and stakeholders on enhancing policies to improve drug development and regulatory review processes.

  • Kenneth  Lipetz, MD

    Kenneth Lipetz, MD

    • GPS Medical Business Advisor
    • Eli Lilly and Company, United States

    Kenneth J Lipetz, PhD, MBA, HCLD is currently the Global Patient Safety (GPS) Medical Business Advisor/Process Owner for GPS Medical and Benefit Risk Management, Eli Lilly and Company, Indianapolis, Indiana. In the 20 years he has been with Eli Lilly and Company, Ken has had a number of key strategic, technical and administrative roles in Clinical PM, Clinical Data Management, Data Privacy, Drug Safety, Pharmacovigilance and Drug Development. Ken is also a Certified Lean/Six Sigma Black Belt working on multiple process improvement projects.

  • Steven A. Anderson, PhD

    Steven A. Anderson, PhD

    • Director, Office of Biostatistics and Epidemiology, CBER
    • FDA, United States

    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.

  • Andrea  Best, DO, MPH

    Andrea Best, DO, MPH

    • Executive Medical Director
    • AbbVie, Inc., United States

    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.

  • Hans-Georg  Eichler, MD, MSc

    Hans-Georg Eichler, MD, MSc

    • Senior Medical Officer
    • European Medicines Agency, Netherlands

    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.

  • Shelly  Harris, DrSc, MPH

    Shelly Harris, DrSc, MPH

    • REMS Assessment Team Leader, OSE, CDER
    • FDA, United States

    Dr. Shelly Harris has over 20 years of experience in program evaluation, health policy, qualitative research, health communication, health outcomes, and health disparities. She has expertise in the evaluation of assessments and methodologies for risk evaluation and mitigation strategies (REMS), research design/implementation, project management, qualitative data collection/analysis, and patient-reported outcomes. She has a Master of Public Health (MPH) from the University of North Carolina at Chapel Hill and a Doctor of Science (ScD) from the Tulane University School of Public Health and Tropical Medicine. She joined FDA in 2013 as a reviewer and is currently the team leader for the REMS Assessment team in the Division of Risk Management.

  • David  Martin, MD, MPH

    David Martin, MD, MPH

    • Associate Director for Real World Evidence Analytics, OMP, CDER
    • FDA, United States

    David Martin is the Associate Director for Real World Evidence Analytics, Office of Medical Policy, FDA Center for Drug Evaluation and Research. He oversees demonstration projects intended to support the agency’s evaluation of real world evidence, reviews real world evidence submissions, and contributes to medical policy development mandated by the 21st Century Cures Act. He led the development of the open source FDA MyStudies mobile app. Other key focus areas include FDA-Catalyst and PCORI pragmatic trials as well as replication of clinical trial results with non-interventional study designs. He completed his M.D. and M.P.H. at the Johns Hopkins University and is board certified in Occupational Medicine and Clinical Informatics.

  • Rie  Matsui, RPh

    Rie Matsui, RPh

    • Senior Director, Regional Labeling Head for APAC
    • Pfizer R&D, Japan

    Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group(ILG), Global Regulatory Affairs, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer. The Asia Labeling Hub has created various local label updates for more than 25 countries in Asia ever since its launch and she works with 15 affiliates in Asia. She has been a member of the Advisory Council of DIA Japan. She won the DIA Japan regional award in 2015. She has been actively involved in a number of conferences in Japan, China, Singapore and the U.S., both as a session chair and speaker. Her paper has been recently published in “Therapeutic Innovation & Regulatory Science”.

  • Reema  Mehta, PharmD, MPH

    Reema Mehta, PharmD, MPH

    • Senior Director, Head of Risk Management and Safety Surveillance Research
    • Pfizer Inc, United States

    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.

  • Paula  Rausch, PhD, RN

    Paula Rausch, PhD, RN

    • Director, Division of Health Communications, Office of Communications, CDER
    • FDA, United States

    Paula Rausch, PhD, RN, is Associate Director of Research and Risk Communications in FDA’s Center for Drug Evaluation and Research Office of Communications, where she oversees development of the Drug Safety Communications, CDER’s primary tool for communicating new safety information to the public. She also directs the office’s social science research program, conducting formative and evaluative communication studies.

  • Arie  Regev, MD

    Arie Regev, MD

    • Chair, Liver and GI Safety Committee
    • Eli Lilly and Company , United States

    Dr. Regev heads the safety advisory hub and chairs the liver and GI safety advisory committee at Eli Lilly. He serves as co-chair of the CIOMS drug induced liver injury (DILI) working group and co-chair of the immunotherapy working group of the IQ DILI initiative. He is an associate professor of medicine at the division of gastroenterology and hepatology of Indiana University School of Medicine. Prior to joining Eli Lilly Dr. Regev was an associate professor of medicine and director of the hepatology fellowship program of the University of Miami School of Medicine.

  • James  Buchanan, PharmD

    James Buchanan, PharmD

    • Drug Safety Consultant
    • Covilance LLC, United States

    Dr. James Buchanan is presently an independent drug safety consultant. After leaving Gilead Sciences, Dr. Buchanan started the drug safety department at Tularik Inc where he acted as Chief Safety Officer until the company was acquired 5 years later by Amgen. Following the merger with Amgen, he moved to Nuvelo to establish a drug safety department and act as Chief Safety Officer where he also had responsibility for clinical operations, biostatistics and data management. Dr. Buchanan next served with BioSoteria for 5 years as the head of the medical and safety consulting group, which was subsequently acquired by Dohmen Life Science Services. Dr. Buchanan is currently president of Covilance, LLC, a drug safety consulting service.

  • Krisztina L. Debreczeni, MD

    Krisztina L. Debreczeni, MD

    • Group Medical Director, Medical Safety Review, Global Pharmacovigilance
    • Bristol-Myers Squibb Co., United States

    Krisztina has started her career in Drug Safety over 14 years ago at a small family-owned CRO in Princeton. After working for 2 years at the CRO, Krisztina joined BMS as a Medical Safety Review Physician responsible for providing medical assessment of individual case safety reports from any source. Over the years, she has taken on increasing responsibilities, including various project works as well as leading the medical review-related quality monitoring efforts for their off-shore single case processing operations. Krisztina has been in her current role for 5 years overseeing medical review physicians and scientists responsible for expedited safety reports.

  • Otto  Townsend, PharmD

    Otto Townsend, PharmD

    • Medication Error Safety Reviewer Team Lead, OSE, CDER
    • FDA, United States

    Otto Townsend is a Team Leader in the Division of Medication Error Prevention and Analysis (DMEPA), Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA). Otto oversees the DMEPA team responsible for the pre- and post-market safety review of Anti-infective, Anesthetic, Addiction, Pain, Transplant, and Ophthalmology products. Otto has over 20 years of experience as a clinical pharmacist and pharmacy manager in both ambulatory and inpatient care settings. He received his Doctor of Pharmacy degree from the University of Michigan.

  • Mark I. Avigan, MD

    Mark I. Avigan, MD

    • Associate Director, Office of Pharmacovigilance and Epidemiology, OPE, CDER
    • FDA, United States

    Mark Avigan, MD, CM, is Associate Director for Critical Path Initiatives in the Office of Pharmacovigilance and Epidemiology at the FDA. As a clinical hepatologist with expertise both in drug safety science and cellular regulation, he served as a division director in drug safety at FDA and more recently as an expert consultant for the evaluation of risk surrounding drug-induced liver injury during the life-cycle of drugs and biological agents. Earlier, Dr. Avigan served as a staff fellow at the NIH and then became a faculty member at the Georgetown University Medical Center where he attended patients on the GI/Liver Service. At Georgetown he was also the principal investigator and leader of a NIH-funded lab in cellular regulation.

  • Glenn  Carroll, MBA

    Glenn Carroll, MBA

    • Principal, Strategy | Life Sciences
    • Deloitte, United States

    Glenn Carroll is a principal in our life science strategy practice with over 15 years pharmaceutical and biotech experience. Glenn leads Deloitte's US Safety and Medical practices. He has a strong track record in delivering strategic and operational excellence, specifically in the last 3 years, Glenn has led several global transformation medical and pharmacovigilance engagements delivering significant operational improvement. Glenn holds a BE in biochemical engineering from University College Dublin and an MBA from Imperial College London.

  • Howard  Chazin, MD, MBA

    Howard Chazin, MD, MBA

    • Director, Clinical Safety Surveillance Staff, Office of Generic Drugs, CDER
    • FDA, United States

    Dr. Chazin joined FDA in 2002 and has held several mid-level and senior leadership positions related to clinical safety of new drugs, generic drugs and biologic drug products. He is the Director of the Clinical Safety Surveillance Staff in the Center for Drug Evaluation and Research's Office of Generic Drugs. He leads a multidisciplinary team tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug products. As Director, he also provides oversight on assessment of critical aspects related to challenging, controversial and sensitive generic drug safety issues.

  • Donella  Fitzgerald, PharmD

    Donella Fitzgerald, PharmD

    • Risk Management Analyst, Team Leader
    • FDA, United States

    Dr. Donella Fitzgerald is a Risk Management Analyst Team Leader in the Division of Risk Management at the Food and Drug Administration. There her focus is on leading analysts to provide critical reviews and recommendations related to risk evaluation and mitigation strategies (REMS) for both pre- and post-marketed drug and biologic products. Before joining the Agency, she served as a community pharmacist for several years, specializing in Medication Therapy Management. Dr. Fitzgerald received her Pharm.D. in 2007 from the University of Maryland School of Pharmacy.

  • Elena  Prokofyeva, MD, PhD, MPH

    Elena Prokofyeva, MD, PhD, MPH

    • Head of Drug Safety Unit, Department of Research & Development, DG PRE
    • Federal Agency for Medicines and Health Products (FAMHP), Belgium

    Dr. Elena Prokofyeva is head of drug safety unit at the Department of Research & Development, DG PRE, the FAMHP, Brussels, Belgium. She represents Belgium within the CTFG safety subgroup. She initiated and led an update of the Q&A-RSI document within the CTFG. Dr. Prokofyeva holds a research doctorate from the University of Tuebingen, Germany, a Ph.D. and an M.D. from the Northern State Medical University, Arkhangelsk, Russia, and a Master of Public Health from the University of Umeå, Sweden. Harmonization of safety assessment across members of states in Europe, preparation for the implementation of a safety related part of clinical trial regulation, and safeguarding the safety of trial participants are main objectives of her work.

  • Paul  Sheehan, MS

    Paul Sheehan, MS

    • Vice President, Global Risk Management
    • Celgene Corporation, United States

    Paul Sheehan, MSJ, BSc (Hons), CPHIMS joined Bristol-Myers Squibb in 2019 after their acquisition of Celgene Corporation who he joined in 2005. Paul is currently the Vice President of Global Risk Management, where he leads GRM activities that include strategy, submissions, operations, and assessments. Paul has more than 20 years’ experience working in the pharmaceutical risk management industry, participated in FDA REMS advisory panels, and co-authored 16 scientific posters and manuscripts about pharmaceutical risk management. Paul holds a Master of Science in Jurisprudence from Seton Hall University School of Law, a BSc (Hons) Information Systems Management from Bournemouth University, England, and is a Certified Professional in Health

  • Stella  Xu

    Stella Xu

    • Senior Manager, Drug Safety and Pharmacovigilance
    • dMed, China

    Stella Xu works as lead of safety operation & reporting function in dMed (a full service CRO), and takes the responsibility for providing professional pharmacovigilance service both in clinical trial and post-marketing drug safety. Before joining dMed, she had more than 6 years experience in pharmaceutical industry, worked in Pfizer (China) Research & Development Center drug safety unit. Experienced with pharmacovigilance activity including product acquisition, divestiture, migration in safety database, familiar with regulations in China, US and EU. She attended ICH E2B (R3) specification and implementation meeting organized by National Medical Products Administration (NMPA), and gave a speech on ICH E2B in Korea ICH training day.

  • Briana  Rider, PharmD

    Briana Rider, PharmD

    • Medication Error Safety Reviewer Team Lead, DMEPA, OMEPRM, OSE, CDER
    • FDA, United States

    Briana Rider is a pharmacist officer in the U.S. Public Health Service stationed at the FDA where she serves as a Team Leader in the Division of Medication Error Prevention and Analysis (DMEPA). In her role, she is responsible for promoting and protecting the health of the American public by increasing the safe use of drug products through reduction of use errors related to the naming, labeling, product design, and packaging of drug products. Prior to joining DMEPA as a Safety Evaluator in 2016, Briana completed two postdoctoral fellowships. She completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use.

  • Vicki  Edwards, RPh

    Vicki Edwards, RPh

    • Vice President, Pharmacovigilance Excellence and QPPV
    • AbbVie, Inc., United Kingdom

    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 QPPV. In this g

  • Allan  Fong, MS

    Allan Fong, MS

    • Research Scientist and Data Scientist
    • MedStar Institute for Innovation National Center for Human Factors in Healthcare, United States

    Allan Fong focuses on developing, integrating, and applying advanced technologies and techniques to study and improve healthcare systems. Allan has a background in engineering, computer science, and human factors, and is particularly interested in natural language processing, predictive analytics, information visualization, and sensor integration to understand clinical workflow and promote patient safety and health literacy. Allan received a master’s degree in aeronautical and astronautical engineering from Massachusetts Institute of Technology, a master’s degree in computer science from University of Maryland College Park, and a bachelor’s degree in mechanical engineering from Columbia University.

  • Haley H Seymour, MS

    Haley H Seymour, MS

    • Consumer Safety Officer, OSI, OC, CDER
    • FDA, United States

    Haley Seymour earned her Bachelor of Science degree from Howard University in Clinical Laboratory Science and her Master of Science in Bioscience Regulatory Affairs from Johns Hopkins University. She joined the Food and Drug Administration (FDA) in 2009 as a Regulatory Project Manager for the Office of New Drugs, Division of Endocrinology and Metabolic Products. Currently she is a Consumer Safety Officer for the Risk Evaluation and Mitigation Strategies (REMS) Compliance Team in the Division of Enforcement and Postmarketing Safety (DEPS). She has represented DEPS and the FDA in several outreach programs, communicating with a number of internal and external stakeholders, and lectured on topics related to REMS Compliance. She serves as a

  • Jamie  Wilkins, PharmD

    Jamie Wilkins, PharmD

    • Director, Risk Management Product Lead
    • Pfizer, United States

    Jamie Wilkins, Pharm.D. is the Deputy Director for the Division of Risk Management (DRISK) in the Office of Surveillance and Epidemiology (OSE) in the Center for Drug Evaluation (CDER) at the U.S. Food and Drug Administration (FDA). DRISK provides risk management expertise on development and implementation of Risk Evaluation and Mitigation Strategies (REMS). Jamie joined the FDA in 2011, and has prior roles in the District of Columbia Medicaid Program and in community and inpatient pharmacy. She earned her Pharm.D. from the University of Maryland School of Pharmacy in 2008 and received the FDA Francis O. Kelsey drug safety award in 2015. In her free time, she enjoys spending time with her children and watching softball.

  • Celeste  Karpow, PharmD, MPH

    Celeste Karpow, PharmD, MPH

    • Medication Error Safety Advisor, DMEPA, OMEPRM, OSE, CDER
    • FDA, United States

    Celeste Karpow joined the Division of Medication Error Prevention and Analysis (DMEPA) as a Safety Evaluator in in 2017. In her current role, she works on postmarket and policy projects as a member of DMEPA's Rapid Response Team. Prior to joining DMEPA, Celeste completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use. She earned her Doctor of Pharmacy and Master of Public Health degrees from the University of Connecticut and completed her PGY-1 Pharmacy Practice residency at Henry Ford Hospital.

  • Lubna  Merchant, PharmD, MS

    Lubna Merchant, PharmD, MS

    • Deputy Office Director, OMEPRM, OSE, CDER
    • FDA, United States

    Dr. Merchant currently serves as the acting Director of the Division of Medication Error Prevention and Analysis. She is also the Deputy Director of the Office of Medication Error Prevention and Risk Management in FDA’s Center for Drug Evaluation and Research’s (CDER) where she is responsible for the Center’s programs in risk management and medication error prevention. She provides expertise on development and implementation of programs and initiatives to support the Center’s policies related to Risk Evaluation and Mitigation Strategies (REMS). She serves as expert/scientific advisor on medication errors associated with drug and biological products within the Center and outside agencies.

  • Kiernan  Trevett, MSc

    Kiernan Trevett, MSc

    • Expert Pharmacovigilance Inspector
    • Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

    Kiernan Trevett has worked as a GPvP Inspector at the Medicines and Healthcare products Regulatory Agency since April 2012 and is currently working in the role of Expert GPvP Inspector. She has contributed to the development of the EU Good Pharmacovigilance Practices (GVP), has had a role in the training of GPvP Inspectors in other EU Member States and has contributed significantly to the MHRA’s preparedness work in relation to the UK’s withdrawal from the EU. Before joining the MHRA, Kiernan worked as a certified Quality Assurance auditor for a central laboratory that provided services for Phase I-III pharmaceutical clinical trials. Kiernan has a Master of Biomedical Sciences degree from the University of Southampton.

  • Stephanie  DeGraw, PharmD

    Stephanie DeGraw, PharmD

    • Medication Error Safety Reviewer, DMEPA, OMEPRM, OSE, CDER
    • FDA, United States

    Stephanie DeGraw is a medication safety evaluator in the Division of Medication Error Prevention and Analysis (DMEPA). She is responsible for the evaluation of proprietary names, labels and labeling, medication error reports, and human factors-related submissions for combination products. Prior to joining DMEPA, Stephanie worked as a medication safety analyst for Med-ERRS, a subsidiary of the Institute for Safe Medication Practices (ISMP), and as a community pharmacist. Stephanie received her Doctor of Pharmacy degree with specialized drug safety education and training from Temple University School of Pharmacy.

  • Claudia  Manzo, PharmD

    Claudia Manzo, PharmD

    • Director, Office of Medication Error Prevention and Risk Management, OSE, CDER
    • FDA, United States

    Claudia Manzo, PharmD is the Director of the Office of Medication Error Prevention and Risk Management, Office of Surveillance and Epidemiology (OSE), FDA. She has over 20 years of drug safety experience and in her current role she directs review staffs (~100 FTEs) that advise and review Risk Evaluation and Mitigation Strategies (REMS), REMS Assessments, REMS Modifications, Proprietary Names, Human Factors Studies, and Medication Errors for drugs and biologic products regulated by CDER.

  • Millie B. Shah, PharmD

    Millie B. Shah, PharmD

    • Human Factors Team Leader, DMEPA, OSE, CDER
    • FDA, United States

    Millie Shah joined the Division of Medication Error Prevention and Analysis (DMEPA) as a Safety Evaluator in in 2014. In her current role as Human Factors Team Leader, Millie is responsible for evaluation of human factors-related submissions for combination products. Prior to joining DMEPA, Millie completed the FDA/ISMP Safe Medication Management Fellowship, where she gained valuable experience focused on medication error prevention and safe medication use. Millie received her Doctor of Pharmacy degree from Drake University in Des Moines, IA. She completed her PGY-1 Pharmacy Practice Residency at Edward Hines, Jr. VA Hospital.

  • Sonja  Brajovic, MD

    Sonja Brajovic, MD

    • Medical Officer, OSE, CDER
    • FDA, United States

    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.

  • Melissa B Burns, MS

    Melissa B Burns, MS

    • Senior Program Manager, Office of Combination Products, OCPP, OC
    • FDA, United States

    CAPT Melissa Burns is a Senior Program Manager in FDA’s Office of Combination Products (OCP). In this role, she is responsible for coordinating activities related to combination product review and regulation including development and review of guidance documents, regulations, and procedures and policies. Prior to joining OCP, Melissa worked for several years in FDA CDRH. Melissa worked for several years in the private sector including positions with a medical device manufacturer, a hospital, a healthcare architecture firm, and a consulting firm. Melissa received a Bachelor of Science degree in Mechanical Engineering from Virginia Tech and a Master of Science degree in Biomedical Engineering from The University of Connecticut.