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Pharmacovigilance and Risk Management Strategies Conference


  • 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 (3+ 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, writing the EU guidelines on this topic and was part of the core team implementing the 2010 PhV legislation.

  • Mariette  Boerstoel-Streefland, MD

    Mariette Boerstoel-Streefland, MD

    • Senior Vice President, Head Global Drug Safety
    • Shire, United States

    Accomplished Global Drug Safety Executive with extensive expertise (25yrs) in all areas of drug safety and risk management in the pharmaceutical industry. Was VP Drug Safety at Organon, VP Global Drug Safety and Med Affairs at Mayne Pharma, and Chief Safety Officer, VP Drug Safety and Med Info & Communication at Forest. Energetic, goal-oriented and creative personality passionate about making a difference building organizations and driving change. Strong leadership and people management skills.

  • Gerald J. Dal Pan

    Gerald J. Dal Pan

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

    Dr. Dal Pan is the Director of the Office of Surveillance and Epidemiology in FDA’s CDER, where he is responsible for the Center’s programs in adverse event surveillance and analysis, pharmacoepidemiology, risk management, and medication error prevention. He is involved in both the premarket and postmarket regulation of drugs and therapeutic biologics. He is a member of the WHO Advisory Committee on the Safety of Medicinal Products, and has served on working groups of the CIOMS and ICH.

  • Mick  Foy

    Mick Foy

    • Head of Pharmacovigilance Strategy, Vigilance Intelligence and Research Group
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Mick has been with the MHRA’s Vigilance Intelligence and Research Group for 11 years. Amongst his responsibilities is the operation of the UK’s Yellow Card Scheme and the signal detection system. He is responsible for two major projects to improve drug safety. Firstly a Gates Foundation funded project to build PV capacity in low and middle income countries and the IMI funded WEB-RADR project to deliver mobile Apps for reporting ADRs and to utilise social media for drug safety purposes.

  • E. Stewart  Geary, MD

    E. Stewart Geary, MD

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

    Stewart Geary has worked at Eisai since 1996 in PV, clinical safety and regulatory science. He was a member of the CIOMS VII, VIII and IX Working Groups, and currently serves on the Executive Committee of JAPhMed and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical Medicine. He is also the content editor for Safety and Pharmacovigilance for the DIA Global Forum.

  • William  Gregory, PhD

    William Gregory, PhD

    • 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.

  • Lisa Melanie Harinstein, PharmD

    Lisa Melanie Harinstein, PharmD

    • Team Leader, Division of Pharmacovigilance I, OSE, CDER
    • FDA, United States

    Lisa Harinstein is a Safety Evaluator in the FDA-CDER Division of Pharmacovigilance. She received her Doctor of Pharmacy degree from the University of Michigan and completed a Pharmacy Practice and Critical Care Residency at the University of Pittsburgh Medical Center. She worked as a Surgical ICU Clinical Specialist at Cleveland Clinic prior to working at the FDA.

  • 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

  • Barbara  Morollo

    Barbara Morollo

    • Head, Pharmacovigilance Operations
    • Moderna Therapeutics, United States

    Barbara Morollo has over 20 years experience in biopharmaceutical, device, and vaccine Pharmacovigilance and Risk Management. Over the past several years she has focused on the challenges presented by advances therapies. She is currently Head, Pharmacovigilance Operations at Moderna Therapeutics, whose platform mRNA technology encompasses therapeutic and preventative vaccines, and immuno-oncology. Prior to joining Moderna, she lead the Pharmacovigilance and Risk Management function at bluebird bio, a gene therapy and immuno-oncology company.

  • Simone  Pinheiro, PhD

    Simone Pinheiro, PhD

    • Lead Epidemiologist
    • FDA, United States

  • Michael  Richardson, MD, FFPM

    Michael Richardson, MD, FFPM

    • International GPV&E and EU QPPV
    • Bristol-Myers Squibb, United Kingdom

    Currently International Head of BMS’s Pharmacovigilance Function and EU QPPV based in the UK. He is medically qualified graduating from Stellenbosch University and specialised in Obstetrics and Gynaecology. He practiced in Cambridge prior to joining the Pharmaceutical industry in Clinical Research and then Medical affairs. He has worked in major MNCs across the globe and heading up Research and Development in Asia. He is also a long serving member of the EFPIA PV committee, served on ICH E2C(R2) EWG and Q&A IWG. Additionally Heads BMS Global Risk Management function.

  • Annette  Stemhagen, DrPH, FISPE

    Annette Stemhagen, DrPH, FISPE

    • Senior Vice President, Safety, Epidemiology, Registries & Risk Management
    • United BioSource Corporation, United States

    Dr. Stemhagen has more than 30 years of research experience, 20 yrs in safety surveillance. She has expertise in design, conduct, and analysis of peri-approval registries, LSS, actual use studies, including >35 regulatory-mandated safety studies. She has developed REMS for more than 80 products.

  • Lesley  Wise, PhD, MSc

    Lesley Wise, PhD, MSc

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

    Lesley Wise has more than 15 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.

  • Bruce A. Donzanti, PhD

    Bruce A. Donzanti, PhD

    • Senior Group Director, Global Pharmacovigilance Innovation Policy
    • Genentech, A Member of the Roche Group, United States

    Bruce has a PhD in pharmacology with 20+ years experience in the pharma/bio industry, mostly in drug safety but he has also worked in other areas such as pre-clinical research. During the past 5 years, Bruce was Head, Drug Safety at Genentech before transitioning into a new role in that focuses on proactive ways to enhance drug safety as well as addressing current challenges. Bruce is also the current Chair of the Pharmacovigilance/Benefit Risk Working Group at BIO.

  • Hans-Georg  Eichler, MD, MSc

    Hans-Georg Eichler, MD, MSc

    • Senior Medical Officer
    • European Medicines Agency, European Union, United Kingdom

    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.

  • David Takura Chonzi

    David Takura Chonzi

    • Vice President of Patient Safety and Risk Management
    • Kite, A Gilead Company, United States

    David T Chonzi is a Vice President (Head) of Patient Safety and Risk Management for Kite, a Gilead Company. Previously was the Safety Lead for Tecentriq (Immuno-Oncology) at Genentech. Internal Medicine Physician and holds an MD from the University of Zimbabwe and MSc Epidemiology from the University of London. David has extensive experience in BLA , MAA submissions, REMS/RMPs in Immuno-Oncology and Cellular therapy

  • Sean  Khozin, MD, MPH

    Sean Khozin, MD, MPH

    • Associate Director (Acting), Oncology Center of Excellence
    • FDA, United States

    Dr. Khozin is a thoracic oncologist, acting associate director at FDA’s Oncology Center of Excellence, and founding director of Information Exchange and Data Transformation (INFORMED), a data science incubator focused on innovations that enhance FDA’s mission of promotion and protection of the public health. The research portfolio of INFORMED includes investigations into real world data for clinical evidence generation, biosensors and the internet of things, machine learning and artificial intelligence, and blockchain for secure exchange of health data at scale. Previously, Dr. Khozin was in private practice in NYC and an entrepreneur specializing in building health information technology systems.

  • Christine  McSherry, BSN, RN

    Christine McSherry, BSN, RN

    • Executive Director
    • Jett Foundation, United States

    Christine McSherry is the executive director of Jett Foundation, a non-profit dedicated to Duchenne muscular dystrophy, and the co-founder of Casimir Trials, a CRO that designs patient, caregiver, and observer reported outcomes that support regulatory approval and reimbursement. Christine began working in rare disease in 2001 when her son, Jett, was diagnosed with Duchenne muscular dystrophy, and has become an advocate for including the patient voice in every stage of drug development.

  • Sandra  Mitchell, PhD

    Sandra Mitchell, PhD

    • Research Scientist & Program Director, Outcomes Research Branch
    • Division of Cancer Control and Population Sciences National Cancer Institute, United States

    Dr. Sandra A. Mitchell is a Research Scientist and Program Director in the Outcomes Research Branch in the Healthcare Delivery Research Program. Her work focuses on the measurement of symptoms and impairments in physical functioning, and the testing of interventions to improve these outcomes, especially in vulnerable populations, including older adults and patients with multimorbidity. Dr. Mitchell serves as the NCI Scientific Director for the development and testing of the National Cancer Institute’s Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE). PRO-CTCAE is a new measurement system designed to integrate patient-reporting of symptomatic adverse events into cancer clinical trials.

  • Eric D. Perakslis

    Eric D. Perakslis

    • Senior Vice President, Informatics at Takeda Pharmaceuticals
    • Takeda Pharmaceuticals, United States

    Eric is currently Chief Science Officer at Datavant, an innovative new company with the mission to organize the worlds healthcare data. Eric is also Visiting Scientist in the Department of Biomedical Informatics at Harvard Medical School and a frequent volunteer advisor to Médecins Sans Frontières and other international aid and relief NGOs. Most recently Eric was Senior Vice President and Head of the Takeda R&D Data Science Institute where he built an integrated institute of more than 165 multi-disciplinary data scientists serving all aspects of biopharmaceutical R&D and digital health.

  • Mark  Perrott, PhD

    Mark Perrott, PhD

    • Head of Development Consulting
    • Pope Woodhead, United Kingdom

    Mark is Head of Development Consulting at PopeWoodhead where he leads a team of Benefit-Risk and Risk Minimisation professionals. He joined PW in November 2016 and his >20 year pharma career has included industry (Wellcome, GW, GSK and AZ) and consultancy roles (WCI and Foresight). He is now focusing on the opportunities presented by new benefit-risk management approaches to improve development decision-making and enhance the interactions of industry and customers to maximise B-R balance.

  • Amanda Marie Roache, MS

    Amanda Marie Roache, MS

    • Operations Research Analyst, OSP, CDER
    • FDA, United States

    Amanda Roache is FDA's ICH Coordinator and has served as an Operations Research Analyst in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration since 2012. Ms. Roache works in CDER's International Program and facilitates scientific exchanges with international organizations and representatives of foreign government. Ms. Roache received her B.S. in Chemistry from Saginaw Valley State University and M.P.P. from The George Washington University.

  • Shinobu  Uzu, MSc

    Shinobu Uzu, MSc

    • Associate Executive Director
    • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

    Mr. Shinobu Uzu is Associate Executive Director, PMDA since April 2018. As Chief Safety Officer, PMDA, he was responsible for post-market surveillance and GMP/QMS audit of pharmaceuticals, medical devices regulated by Pharmaceuticals and Medical Devices Law until March 2018. Mr. Uzu took Master degree of Pharmacy from graduate school of the University of Tokyo. He has over twenty years’ experience in Ministry of Health, Labour and Welfare and dealt with pharmaceutical and food safety affairs including international pharmaceutical affairs and food standard issues.

  • Gary K. Zammit, PhD, MS

    Gary K. Zammit, PhD, MS

    • President and CEO
    • Clinilabs Drug Development Corporation, United States

    Gary Zammit, PhD, is the President & CEO of Clinilabs, a full-service CRO that provides clinical drug development to industry, focusing on CNS therapeutics. He also is an Associate Clinical Professor of Psychiatry, Icahn School of Medicine at Mount Sinai (New York, NY), where he provides physician education in the field of sleep medicine.Dr. Zammit earned a Ph.D. degree in clinical psychology from the University of Toledo (Toledo, OH), where he won both the Turin Service Award and the Leckie Scholar Award. He completed an internship and clinical research fellowship in the Department of Psychiatry at the New York Hospital - Cornell University Medical College (White Plains, NY), where he won the Alumni Award for Excellence.

  • Jaspal (JP)  Ahluwalia, MD, MPH

    Jaspal (JP) Ahluwalia, MD, MPH

    • Medical Officer, OBE, CBER
    • FDA, United States

    Jaspal (JP) Ahluwalia is a physician working on post marketing safety within FDA CBER. He also reviews pharmacovigilance plans for new BLAs. His professional career began with an eight-year stint in the US Army where he served as a medical officer at the Defense Department’s premier biological research facility at Ft. Detrick, Maryland. Dr. Ahluwalia received his undergraduate and medical degrees from The Ohio State University and his Masters in Public Health from Johns Hopkins University. He is currently an officer in the US Public Health Service and has attained the rank of Commander (O-5).

  • 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.

  • Robert M Baker

    Robert M Baker

    • Vice President, Global Patient Safety
    • Eli Lilly and Company, United States

    Robert Baker is a VP of Eli Lilly and Company and leads several groups within its Medicines Development Unit: Global Patient Safety, Clinical Development Design Hub, and Clinical Pharmacology Medical/Design Group. Robert has been at Lilly for 18 years in various roles across Drug Discovery, Drug Safety, and Medical Affairs. Prior to joining Lilly he was an Academic Psychiatrist studying schizophrenia and substance abuse. Robert completed medical school at Northwestern University and psychiatry training at the University of Pittsburgh.

  • Melissa  Hunt, MSc

    Melissa Hunt, MSc

    • Scientific Manager
    • Health Canada, Canada

    Melissa Hunt joined Health Canada in 2005. She holds a Bachelor of Science in Life Sciences from Queen’s University and a Master of Science in Pharmacology from the University of Toronto. Prior to working at Health Canada, Melissa worked for several years within the pharmaceutical industry in pharmacovigilance. Melissa has worked as both a Scientific Evaluator and, in her current position, a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau (MPMDB) of the Marketed Health Products Directorate (MHPD) at Health Canada; where she has been responsible for the evaluation and management of a number of drug safety issues.

  • Jeremy  Jokinen, PhD, MS

    Jeremy Jokinen, PhD, MS

    • Senior Director, Decision Sciences
    • AbbVie, Inc., 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, statisticians, and data managers developing novel approaches and methodologies to improve patient safety. 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.

  • Tamy  Kim, PharmD

    Tamy Kim, PharmD

    • Associate Director for Regulatory Affairs, OHOP and OCE (Acting), CDER
    • FDA, United States

    Tamy Kim is the Associate Director for Regulatory Affairs (ADRA) in the Office of Oncology and Hematology Products (OHOP) and Acting ADRA in the Oncology Center of Excellence (OCE) at the FDA. In OHOP, her responsibilities include developing policies related to review processes, including for breakthrough therapies, expedited reviews and safety. In the OCE, Dr. Kim is responsible for developing policies and procedures affecting the review of products under the OCE across CDER, CBER and CDRH.

  • Sara  Loud, MBA, MS

    Sara Loud, MBA, MS

    • Chief Operating Officer
    • Accelerated Cure Project, United States

    As COO of Accelerated Cure Project, Sara Loud ensures delivery of research resources to scientists studying multiple sclerosis. Passionate about the integration of people into “people-powered” research, Sara combines a love of technology, business expertise, and social enterprise into her work, most recently focusing on the development of iConquerMS, a people-powered research network. Sara holds a BS/MS in electrical engineering from Northeastern University and a MBA from Babson College.

  • Jacques   P. Tremblay, PhD

    Jacques P. Tremblay, PhD

    • Deputy Editor, Molecular Therapy and Cell Transplantation;Professor, Department
    • Laval University, Canada

    Dr. Jacques P. Tremblay received a PhD in Neuroscience from the University of California at San Diego in 1974. Since that time, he has been at Laval University as a postdoctoral researcher, Professor and Director of the Department of Anatomy. He is currently Full Professor in the Department of Molecular Medicine. He has published over 250 scientific articles on hereditary diseases. He has worked specifically on myoblast transplantation as a treatment for Duchenne muscular dystrophy. For the last 3 years he also worked on gene correction with the CRISPR/Cas9 technology for Duchenne muscular dystrophy, Friedreich's Ataxia and Alzheimer’s disease.

  • Ellis  Unger, MD

    Ellis Unger, MD

    • Director, Office of Drug Evaluation I, OND, CDER
    • FDA, United States

    Ellis F. Unger is the Director, Office of Drug Evaluation-I, Office of New Drugs, Center for Drug Evaluation and Research, FDA. His Office oversees the regulation of drugs for cardiovascular, renal, neurological, and psychiatric disorders. Dr. Unger is a board-certified internist and cardiologist. Prior to coming to CDER in 2003, previous positions included director of a translational angiogenesis program at NHLBI, NIH; and Medical Officer, Team Leader, and Deputy Division Director in CBER.

  • John Barlow Weiner, JD

    John Barlow Weiner, JD

    • Associate Director, Policy and Product Classification Officer, OCP, OC
    • FDA, United States

    John Barlow Weiner is the Associate Director for Policy in the Office of Combination Products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA's Office of Chief Counsel and in private practice. He received a BA from Princeton University and a JD with honors from the Columbia University School of Law.

  • Jeffrey  Anderson, MD, PhD

    Jeffrey Anderson, MD, PhD

    • HCC Program Lead Oncology Clinical Development
    • Bristol-Myers Squibb, United States

    Jeffrey Anderson, MD-PhD, leads the global clinical development for Immuno-Oncology agents in gastrointestinal tumors at Bristol-Myers Squibb.He is also a core member of the BMS Medical Surveillance Team, which is responsible for the pharmacovigilance and safety signal detection in ongoing clinical trials.Jeffrey has been involved in early and late-stage clinical development in Virology and Immuno-Oncology with the goal of helping patients prevail over serious diseases.Jeffrey received his MD-PhD from West Virginia University. He completed Internal Medicine residency training at University of Michigan and Infectious Diseases fellowship training at UNC Chapel Hill.

  • Shaun  Comfort, MD, MBA

    Shaun Comfort, MD, MBA

    • Associate Director and Senior Safety Science Leader IIDO
    • Genentech, A Member of the Roche Group, United States

    Dr. Comfort is Associate Director for Risk Management and Sr. Safety Science Leader for Roche-GNE Late Stage Ophthalmology/Hematology Products. He is a Board Certified Neurologist with 13 years combined industry experience including roles as former Medical Reviewer at the US FDA and VP of Clinical Research at Anesiva. Most recently, he has been involved in evaluating Artificial Intelligence solutions in Pharmacovigilance.

  • Adrian  Dana, MD

    Adrian Dana, MD

    • Vice President, Global Patient Safety and Risk Management at Alnylam
    • Alnylam Pharmaceuticals Cambridge, United States

    Dr Adrian Dana is the VP of Global Patient Safety and Risk Management at Alnylam, a leader in the development of RNAi therapeutics. In this role, she is building an innovative safety organization to support the development of this new therapeutic class. Her past positions include VP, Safety Science Oncology at Genentech/Roche, and 10 years at Merck in Clinical Safety and Risk Management. Her experience includes multiple therapeutic areas encompassing vaccines, infectious diseases and oncology. During her time in industry she has contributed to the filings and ultimate approval for more than 9 new vaccines and drugs.

  • Suranjan  De, MBA, MS

    Suranjan De, MBA, MS

    • Deputy Director, Regulatory Science, OSE, CDER
    • FDA, United States

    Suranjan De has over twenty years of demonstrated achievements, across FDA, NIH & Pharma, impacting superior program performance through alignment of policies, regulation and innovative healthcare informatics solutions with strategic business objectives. Currently, in OSE Mr. De provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products.

  • Vicki  Edwards, RPh

    Vicki Edwards, RPh

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

    Vicki Edwards qualified as a pharmacist and spent time in hospital pharmacy and community pharmacy before going GlaxoWellcome in 1995 to begin her career in pharmacovigilance .She moved to AstraZeneca in 2000 as head of Safety & Medical Information at the UK affiliate and moved to Abbott as QPPV in 2005. When Abbott split into Abbott and AbbVie in 2013 Vicki became AbbVie QPPV and Head of Affiliate Vigilance Excellence. Today Vicki is Vice President, Pharmacovigilance Excellence and QPPV.

  • Simon  Johns

    Simon Johns

    • Product Specialist
    • IQVIA, United Kingdom

    Simon Johns is Product Specialist at IQVIA, formerly Quintiles IMS, responsible for Lifecycle Safety and Marketed Product Maintenance. He has 20 years senior product specialist and commercial experience, including 11 years in drug development covering preclinical, clinical, market authorization and post-marketing phases. Simon was recently invited by the British Government to attend the first ever Trade Mission for the Pharmaceutical Sector from the UK to Russia, where he presented on Pharmacovigilance to Russian pharmaceutical developers and members of the British Government including the British Ambassador to Russia, discussing strategies to drive increased drug safety alignment with Western European approaches.

  • Sadiqa Hafeez Mian, MD, MPH

    Sadiqa Hafeez Mian, MD, MPH

    • Executive Medical Director, Head Safety Management
    • Amgen Inc., United States

    Sadiqa Mian MD MPH currently works as an Executive Medical Director, heading Safety Management Team in Global Patient Safety Department at Amgen. Her current areas of responsibilities include Signal and Benefit Risk Management, Medical Review and Aggregate Reports. She has been at Amgen for 4 and half years. Prior to Amgen, her industry experience includes working at Geznyme, Sanofi and Boston Scientific.

  • John  Peters, MD

    John Peters, MD

    • Deputy Director, Office of Generic Drugs, CDER
    • FDA, United States

    John R. Peters, MD graduated from the George Washington University School of Medicine. He is a Family Physician certified in Forensic Medicine with a Certification in Public Health from Georgetown University. He practiced Family and Emergency medicine in MN, later joining the US Army FP residency teaching staff at DeWitt Army Hospital Ft Belvoir and Uniformed Services University of Health Science. In 1992 he moved to the FP residency program of Georgetown University. He has been Director of Managed Care and Associate Director of an MCO. In 2006 he joined the FDA 2009 where he is currently the Deputy Director of the Office of Generic Drugs.

  • Peter  Verdru, MD

    Peter Verdru, MD

    • Vice President, Head of Patient Safety
    • UCB Biopharma S.P.R.L., Belgium

    Peter Verdru, MD was trained as neurologist and joined UCB in 1997. He is heading the global Patient Safety team since 2015. Prior to his current role, Peter was heading the Therapeutic Area CNS in Medical Affairs and Clinical Development.

  • Elenee  Argentinis, JD

    Elenee Argentinis, JD

    • Offering Management Leader
    • IBM Watson Health, United States

    Elenee is an attorney with 15 years experience in biopharmaceutical commercial leadership roles spanning COPD, Type II Diabetes and Atrial Fibrillation. Elenee leads Watson for Patient Safety (WPS), a solution that applies cognitive computing and the Watson Platform for Heath to pharmacovigilance to add speed, consistency and insight to adverse event processing. She is also guiding the development of signal detection and advanced causality solution using several big data sets including EHR and administrative claims data.Elenee is also the Watson Health Life Sciences Academic Collaborations Lead where she has forged novel partnerships to pilot and evaluate Watson Life Sciences Solutions.

  • Khaudeja  Bano, MD, MS

    Khaudeja Bano, MD, MS

    • Senior Medical Director, Medical Affairs, Diagnostics
    • Abbott Laboratories, United States

    Dr. Bano is a Senior Medical Director at Abbott. She is a Physician, with a Masters in Clinical Research (UCSD), Pharmaceutical engineering Certification, a Database Administrator and a certified Project Management Professional. She is an Abbott President’s award winner, avid Toastmaster and a certified coach. Khaudeja has more than 25 years professional experience, including patient care. She has held several global safety positions at Guidant, Abbott (multiple divisions like Vascular, Diagnostics, and Established Pharma), and AbbVie Inc. She currently serves as the working group chair of the Combination Product Coalition's Post-marketing Safety Reporting team.

  • Michelle  Bulliard, BSN

    Michelle Bulliard, BSN

    • Vice President, Global Head Real-World Evidence Strategy Unit
    • IQVIA, Switzerland

    Ms. Bulliard has over 20 years’ experience in conducting real-world & late-phase studies, patient registries, safety studies, and other specialized real-world programs for orphan drugs, disease and medical device studies including studies measuring effectiveness of risk minimization measures. With an extensive global portfolio, specialising in post-authorisation safety studies, she has conducted many large and successful programs for a wide range of life science and healthcare organizations. Michelle is responsible for real-world evidence program strategy translating evolving methodological observational research standards into effective delivery strategies.

  • 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 is currently the Director of the Clinical Safety Surveillance Staff (CSSS) in the Office of Generic Drugs. He leads a multidisciplinary team tasked with identifying and assessing emerging complex safety issues related to potentially inferior generic drug product quality, adverse events and other safety concerns. He helps to facilitate post marketing safety process improvements and provides oversight on critical aspects of challenging, controversial and sensitive generic drug safety issues.

  • Tatyana  Prokhorova

    Tatyana Prokhorova

    • Cluster Safety Lead
    • Pfizer LLC, Russia EAEU/Ukraine QPPV, Russian Federation

    Graduated from Russian Medical University, specialized in medicinal biophysics. Have a PhD scientific work on human brain with a morphometric studies of brain cortex (speech-motor areas), with 8-year experience in light microscopy in National Brain Research Institute (Moscow, Russia). Have a 15-year experience in pharmaceutical industry, working in clinical studies (Novartis), Drug Safety and Medical Quality Oversight (Pfizer). Now as a Drug Safety Unit Head, EAEU/Ukraine QPPV (Pfizer), with oversight on countries under the Eurasian region (Armenia, Belarus, Kazakhstan, Kyrgyzstan, Russia) and CIS countries not included in the EAEU (Azerbaijan, Georgia, Mongolia, Uzbekistan, Turkmenistan, Tajikistan).

  • Valerie E. Simmons, MD, FFPM

    Valerie E. Simmons, MD, FFPM

    • EU QPPV, Global Patient Safety
    • Eli Lilly and Company Ltd, United Kingdom

    Dr. Simmons is currently the EU QPPV for Eli Lilly & Company Ltd. She is a registered physician from the University of London and, since joining the pharmaceutical industry in 1987, she has focussed her career drug safety through senior management positions in Glaxo Eli Lilly. Val is also an active member of various expert working groups , including the EFPIA Pharmacovigilance Committee, ICH E2D, E2F, E2C (R2), CIOMS VII and IX and speaks extensively on pharmacovigilance and risk management

  • Robert  Ball, MD, MPH

    Robert Ball, MD, MPH

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

    Robert Ball MD, MPH, ScM is Deputy Director, Office of Surveillance and Epidemiology (OSE), Center for Drug Evaluation and Research (CDER), FDA. Dr. Ball shares in the responsibilities for leading OSE staff evaluating drug risks and promoting the safe use of drugs by the American people, including managing the Sentinel System. Dr. Ball’s research interests lie at the interface of clinical medicine, epidemiology, and computational science. His recent research has concentrated on the application of computational and informatics approaches, including natural language processing and machine learning, to improve the evaluation of medical product safety in electronic health data systems.

  •   Panel Discussion

    Panel Discussion

    • All Session Speakers, United States