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Pharmacovigilance and Risk Management Strategies Conference


Speakers

  • 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, MBA, MS

    Mariette Boerstoel-Streefland, MD, MBA, MS

    • Senior Vice President, Global Drug Safety
    • Alexion, United States

    Mariette Boerstoel-Streefland, MD, MSc, serves as Senior Vice President, Pharmacovigilance & Drug Safety, for Alexion Pharmaceuticals, Inc. An accomplished drug safety executive, she previously served as Senior Vice President and Head, Global Drug Safety, for Shire, and as Vice President and Head, Global Drug Safety, for Baxalta. Dr. Boerstoel-Streefland earned her Medical Degree and Masters Degree in Epidemiology from the University of Utrecht.

  • Gerald J. Dal Pan

    Gerald J. Dal Pan

    • Director, Office of Surveillance and Epidemiology
    • 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.

  • Mick  Foy

    Mick Foy

    • Group Manager, Vigilance Intelligence and Research Group
    • Medicines and Healthcare products Regulatory Agency (MHRA), United Kingdom

    Mick Foy is Head of Pharmacovigilance Strategy at the MHRA. Among is responsibilities is the running of the UK ADR reporting system and signal detection activities. Mick is also leads the MHRA's work with WHO and the Bill and Melinda Gates Foundation on capacity building in low and middle income countries. Mick is the current Chair of the MedDRA Management Committee and is a board member of the Uppsala Monitoring Centre.

  • E. Stewart  Geary, MD

    E. Stewart Geary, MD

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

    E. Stewart Geary, MD, is Chief Medical Officer and a Senior Vice President at Eisai Co., Ltd. He is a member of the Executive Committee of the Japanese Association of Pharmaceutical Medicine and the Editorial Advisory Boards for Applied Clinical Trials and Pharmaceutical Medicine. A member of the CIOMS Working Group on Drug-Induced Liver Injury, he also served on the CIOMS VII Working Group on the Development Safety Update Report, CIOMS VIII Working Group on Signal Detection, CIOMS Working Group on Standardized MedDRA Queries, and the CIOMS IX Working Group on Medicinal Product Risk Management. Dr. Geary is a DIA Fellow and a Fellow of the Academy of Physicians in Clinical Research. He earned his MD from Stanford Medical School.

  • William  Gregory, PhD

    William Gregory, PhD

    • Senior Director, Worldwide Medical and Safety
    • 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

    • Safety Evaluator, Division of Pharmacovigilance-I, Office of Surveillance , 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

    • 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

    • Pharmacovigilance and Risk Management Consultant
    • 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

    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.

  • Annette  Stemhagen, DrPH, FISPE

    Annette Stemhagen, DrPH, FISPE

    • Senior Vice President, Safety, Epidemiology, Registries, and Risk Management
    • 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 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, registries, large streamlined safety studies, and actual use and observational studies for products in Phase IIIb and post approval.

  • 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  Donzanti, PhD

    Bruce Donzanti, PhD

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

    Bruce has a PhD in pharmacology/neuroscience with almost 30 years of experience in the pharma/biotech industry. Prior to industry, he performed research on mechanisms of neuronal degeneration and neurotoxicology and lectured in neuropharmacology to graduate and medical students while in academia. He continued his research in industry before moving over to clinical development and eventually Medical Affairs. Bruce has held various positions in industry, including Head of Drug Safety at Genentech and now Senior Group Director of Pharmacovigilance Innovation Policy in Global Regulatory Affairs. In this role, Bruce focuses on current challenges in pharmacovigilance, such as predictive drug safety and quality of safety data sources.

  • Hans-Georg  Eichler, MD, MSc

    Hans-Georg Eichler, MD, MSc

    • Senior Medical Officer
    • European Medicines Agency (EMA), 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  Chonzi

    David Chonzi

    • Managing Director
    • PVSS, United States

  • 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
    • Huron Life Sciences, 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, OCD, 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

    Jaspal (JP) Ahluwalia

    • 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

    • Director
    • 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. At Health Canada she has worked as a Scientific Evaluator and a Manager in the Marketed Pharmaceuticals and Medical Devices Bureau within MHPD, as well as on the core team Health Products and Food Branch "Regulatory Review of Drugs and Devices" initiative. Most recently she has taken a position as the Director of the Bureau of Metabolism, Oncology and Reproductive Sciences within the Therapeutic Products Directorate.

  • 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 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.

  • 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 for Policy, Office of Combination Products, OSMP
    • 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

    • Principal Medical Director
    • Genentech, A Member of the Roche Group, United States

    Dr. Comfort is Principal Medical Director for Roche in the Inflammatory, Infectious Disease, and Ophthalmology Safety Science group and leads innovation work supporting Pharmacovigilance. He is a Board Certified Neurologist with 16 years combined industry/regulatory experience including roles as former Medical Reviewer at the US FDA, VP of Clinical Research at Anesiva, and CMO for Adaptix Clinical Solutions. Most recently, he has been involved in evaluating and developing AI solutions for Pharmacovigilance resulting in two 2018 papers with his team in Drug Safety. He has a broad range of interests including operations research, monte-carlo applications in real options/project valuation, statistics and computational physics.

  • 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

    Suranjan De

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

    Mr. De is the Deputy Director of CDER’s Office of Surveillance and Epidemiology, Regulatory Science Staff at FDA. He provides expert advice and technical direction on regulatory science for developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all FDA-regulated products. He has over twenty years of experience with the FDA, the NIH & in the pharmaceutical industry. His current work includes compounding reporting guidance, data management of FAERS system, Safety Reporting Portal for mandatory post-marketing electronic submissions and the FAERS Public Dashboard.

  • 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

  • Simon  Johns

    Simon Johns

    • Director Medical Information
    • 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  Mian, MD, MPH

    Sadiqa 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, DrMed, MD, MS

    Khaudeja Bano, DrMed, MD, MS

    • Head, Medical / Clinical / Scientific Affairs, Molecular 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

    Howard Chazin, MD

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

    Dr. Chazin joined FDA in 2002 and is the Director of the Clinical Safety Surveillance Staff 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 facilitates postmarketing safety process improvements and provides oversight on critical aspects of challenging, controversial and sensitive generic 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, MSc

    Robert Ball, MD, MPH, MSc

    • 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