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Marriott Wardman Park Hotel

Jan 27, 2020 7:00 AM - Jan 29, 2020 4:15 PM

2660 Woodley Road, NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference


Lesley  Wise, PhD, MSc

Lesley Wise, PhD, MSc

Managing Director, Wise Pharmacovigilance and Risk Management, Ltd, United Kingdom

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.

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, SVP & GM of Interactive Media for, 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

Strategy , Consultant, United Kingdom

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

Mariette  Boerstoel-Streefland, MD, MBA, MS

Mariette Boerstoel-Streefland, MD, MBA, MS

Senior Vice President, Worldwide Safety Officer , Bristol-Myers Squibb Company, United States

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

Gerald  Dal Pan, MD, MHS

Gerald Dal Pan, MD, MHS

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

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.

E. Stewart  Geary, MD

E. Stewart Geary, MD

MD, Global Safety Officer, Eisai Co., Ltd., Japan

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.

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

Chief Medical Officer, 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 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

Jill K. Logan, PharmD

Jill K. Logan, PharmD

Safety Evaluator, DPV I, 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, PhD, FISPE

Annette Stemhagen, DrPH, PhD, FISPE

Chief Science Officer, UBC, United States

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.

Jo  Wyeth, PharmD

Jo Wyeth, PharmD

Associate Director for Postmarket Assessments, OMEPRM, OSE, CDER, FDA, United States

Jo Wyeth is the Associate Director for Postmarket Assessments, serving as a senior-level scientist specializing in the application of risk management principles and leading efforts to implement and oversee medication error pharmacovigilance activities, research and quality assurance activities, and assessment of risk mitigation measures. She also performs complex safety analyses, advises Office and Division management, and provides leadership for planning, program development, policy and program analysis, and the implementation of safety initiatives that support OMEPRM.

Catherine  Baldridge, MSc

Catherine Baldridge, MSc

Head of Safety, Fusion Pharmaceuticals, United States

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

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, FRCP

Michael Richardson, MD, FFPM, FRCP

Senior Vice President, WorldWide Patient Safety , 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

Head of Vigilance Operations, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

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

Jeremy  Jokinen, PhD, MS

Jeremy Jokinen, PhD, MS

Vice President and Head, Safety Evidence and Sciences, Bristol-Myers Squibb Company, United States

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

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

Safety Data Scientist, ASAPprocess, United States

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

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

Vice President, Head of Safety Innovation and Analytics, GlaxoSmithKline, United Kingdom

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 has over 100 publications on AI RWE and signal detection and has participated in several international initiatives in the area. Andrew is Honorary Associate Professor of Epidemiology at LSHTM.. Andrew has and does contribute to several international initiatives and has been a member of the Transcelerate PV Steering Committee since 2020 and sponsor for several Transcelerate workstreams.

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.

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

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

President, CIOMS, Switzerland

Hervé is an Hepatologist, professor of clinical pharmacology and former head of the vigilance department of the Henri Mondor University Hospital, Assistance Publique-Hôpitaux de Paris (AP-HP), including the Pharmacovigilance unit, the Hemovigilance/ Biovigilance unit and the infection control team. He created and chaired the Pharmacovigilance Federation, and co-chaired the pharmaco–epidemiology unit of AP-HP. He has also served as a member of the European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC). Hervé is CIOMS President since 2016, and is also a former president of the International Society of Pharmacovigilance (ISoP). Herve was the CEO of the WHO/UMC from 2020 to 2022.

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 and Principal Engineer, Electrical and Data Sciences, Exponent, United States

Dr. Murray is a Group Vice President at Exponent, specializing in failure analysis of electrical and mechanical systems, and using advanced 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

Sophie Sommerer

Director General, Health Canada, Canada

Sophie Sommerer is the Director General of Health Canada’s Biologic and Radiopharmaceutical Drugs Directorate. She is responsible for regulating biologic drugs (including vaccines), radiopharmaceuticals, blood, cells, tissues and organs, and products for Assisted Human Reproduction. Prior to this, she held various positions in the Marketed Health Products Directorate, where she oversaw pharmacovigilance and risk management activities of medical, scientific and regulatory experts. Sophie spent the first 10 years of her public service career working on various health promotion policy initiatives at the Public Health Agency of Canada.

J Vijay  Venkatraman, MD, MBA

J Vijay Venkatraman, MD, MBA

Managing Director and CEO, Oviya MedSafe, India

Dr J Vijay is the Founder, MD & 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 have received the Fellowship of the Pharmaceutical Information & Pharmacovigilance Association (PIPA), UK. He has been the India Regional Editor of Global Forum, a DIA publication, since 2017. He served as Chair of the Pharmacovigilance Council of the Indian Society for Clinical Research (ISCR) since the Council’s inception in 2015 until 2019. He was the Chairman of the Indian Medical Association (IMA) Headquarters Standing Committee for Pharmacovigilance for 2021. He is a recipient of IMA’s Leadership Excellence Award.

Jacqueline A. Corrigan-Curay, JD, MD

Jacqueline A. Corrigan-Curay, JD, MD

Principal Deputy Center Director, Center for Drug Evaluation and Research (CDER), FDA, United States

Jacqueline Corrigan-Curay, JD, MD, serves as Principal Deputy Center Director in the Center for Drug Evaluation and Research, FDA. Dr. Corrigan-Curay provides executive leadership on strategic initiatives that advance CDER's mission to deliver safe, effective and high-quality medications including serving on executive governance committees and overseeing policy development on real world evidence, prescription drug promotion, clinical trial oversight and innovative trial design.

Kenneth  Lipetz, MD, PhD, MBA, MSc

Kenneth Lipetz, MD, PhD, MBA, MSc

Associate Director, PV Ops – PM, Moderna, United States

Kenneth J Lipetz, PhD, MBA, HCLD is currently the Associate Director, PV Ops – PM at Moderna, Inc. Prior to joining Moderna, he had been with Eli Lilly and Company for over 23 years, 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, 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

Consulting Physician, Austrian Association of Social Security Bodies, Austria

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 25 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, audits/non-compliance, qualitative data collection/analysis, and patient-reported outcomes. She has a BA in psychology and a Master of Public Health (MPH) from the University of North Carolina at Chapel Hill and a Doctor of Science (ScD) in Global Health Management and Policy from the Tulane University School of Public Health and Tropical Medicine. She is currently the team leader for the REMS Assessment team at FDA.

David  Martin, MD, MPH

David Martin, MD, MPH

Vice President, Global Head RWE, Moderna, United States

David Martin leads Global RWE for Moderna. Previously he completed 20 years of active duty service split between the United States Air Force and Public Health Service. At the FDA he led the Division of Epidemiology in the Center for Biologics. Subsequently, he established the Real World Evidence group in the Office of Medical Policy to drive the agency's scientific, guidance, and submission review responses to the RWE provisions of the 21st Century Cures Act. He initiated key RWE pathfinding efforts with external stakeholders including RCT Duplicate and the open-source FDA MyStudies mobile application. He holds an MD and MPH from Johns Hopkins and is board certified in occupational & environmental medicine as well as clinical informatics.

Rie  Matsui, RPh

Rie Matsui, RPh

Senior Director, Regional Labeling Head for APAC, International Labeling, Pfizer R&D Japan G.K., Japan

Rie Matsui is Senior Director, Regional Labeling Head for APAC, International Labeling Group, Global Regulatory Science, Pfizer Japan. She is also the Head, External Engagements for ILG. She is the founder of Asia Labeling Hub at Pfizer that has created various local label updates for more than 25 countries in Asia. She was a member of the Advisory Council of DIA Japan until 2020 and received the DIA Japan regional award in 2015. Her papers were published in scientific journals such as Therapeutic Innovation & Regulatory Science. She is the vice chair of the 2021 DIA Japan Annual Meeting Program Committee. She received DIA Global Inspire Award Connector in 2022. She is teaching at Keio University and Chiba University and is a pharmacist.

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

President, Covilance LLC, United States

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.

Krisztina L. Debreczeni, MD

Krisztina L. Debreczeni, MD

Head, Medical Safety Review and Expedited Safety Reporting, Bristol Myers Squibb Co., United States

Krisztina has been working at BMS for 15 years. In the past eight years, she has been leading a team of physicians responsible for the medical assessment of ICSRs as well as a team of scientists responsible for the preparation of expedited safety reports. Krisztina also oversees the Company's large ICSR processing outsourcing operation for medical review and expedited safety reporting. Krisztina has been serving as a subject matter expert on Reference Safety Information for several years, working closely with internal and external experts on this topic.

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  Avigan, MD

Mark Avigan, MD

Associate Director for Critical Path Initiatives, OPE, OSE, CDER, FDA, United States

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

Glenn  Carroll, MBA

Glenn Carroll, MBA

Principal, 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, Division of Clinical Safety and Surveillance, OSCE, OGD, CDER, FDA, United States

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.

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 International QPPV, Abbvie, 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 I-QPPV.

Allan  Fong, MS

Allan Fong, MS

Research Scientist and Data Scientist, Medstar Health 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  Seymour, MS

Haley 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. 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 Subject-Matter Expert on the REMS Compliance team.

Jamie  Wilkins, PharmD

Jamie Wilkins, PharmD

Head- Risk Management Center of Excellence, Pfizer Inc, United States

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. Jamie earned her Doctor of Pharmacy degree in 2008 from the University of Maryland School of Pharmacy, and in her free time, enjoys spending time with her children and watching softball.

Celeste  Karpow, PharmD, MPH

Celeste Karpow, PharmD, MPH

Acting Team Leader, DMEPA, OMEPRM, OSE, CDER, FDA, United States

Celeste Karpow is currently an acting team leader in the Division of Medication Error Prevention and Analysis (DMEPA). She also has postmarket experience working on DMEPA's Rapid Response Team which included monitoring medication errors for drug products used under emergency use authorizations during the COVID-19 pandemic. 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

Director, Risk Management Center of Excellence , Pfizer Inc , United States

Lubna is a Director in the Risk Management Center of Excellence at Pfizer, Inc., where she is responsible for the strategy and implementation of risk management plans globally. Dr. Merchant provides global leadership in delivering innovative and strategic risk management excellence, regulatory compliance, effectiveness evaluation, and operational excellence for Pfizer’s portfolio of drug products with risk management programs. Prior to joining Pfizer, Dr. Merchant was 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 was responsible for the Center’s programs in risk management and medication error prevention.

Kiernan  Trevett, MSc

Kiernan Trevett, MSc

Principal Quality Lead, PDQ Quality Assurance Process GVP, Genentech, A Member of the Roche Group, United States

Kiernan joined Roche as a Principal Quality Lead focussing on pharmacovigilance quality assurance strategies. Previously, she worked as a GPvP Inspector at the MHRA for 1O years, with her most recent role being Expert GPvP Inspector. She contributed to the development of the EU GVP, had a role in the training of GPvP Inspectors in other EU Member States and 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 (~125 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  Burns, MS

Melissa 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.

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