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Omni Shoreham Hotel

Jan 28, 2019 7:00 AM - Jan 30, 2019 3:00 PM

2500 Calvert Street NW, , Washington, DC 20008 , USA

Pharmacovigilance and Risk Management Strategies Conference

NEW! The 2019 meeting will be a full three days, allowing maximum learning opportunities!


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.

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.

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

Cheryl  Campbell, MS

Cheryl Campbell, MS

Associate Director of Executive Operations/Outreach and Communications, OSE,CDER, FDA, United States

Cheryl L. Campbell, M.S., joined the Food and Drug Administration in 2001. She started at FDA’s Center for Biologic Evaluation and Research (CBER) as a Consumer Safety Officer. She was responsible for the regulatory review of FDA applications for in vitro diagnostics. In 2007 she joined the Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). Currently she is the Associate Director of Outreach and Communications in OSE where she manages and coordinates regulatory policy and communications projects. She has a B.A. degree from Temple University, and a M.S. in Regulatory Science from the University of Maryland's School of Pharmacy.

Mick  Foy

Mick Foy

Director of Delivery, Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom

Mick Foy has been with the MHRA for more than 35 years, he is a member of the MHRA’s Executive Committee and has recently been appointed Director of Delivery . Amongst his responsibilities is to drive initiatives to introduce new and improved services to stakeholders. Mick is SRO for the SafetyConnect and RegulatoryConnect programmes. He also leads MHRA efforts to build PV capabilities in other countries particularly low and middle income countries as part of a global initiative with the Bill and Melinda Gates Foundation.

E. Stewart  Geary, MD

E. Stewart Geary, MD

Senior Vice President, 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.

Lisa Melanie Harinstein, PharmD

Lisa Melanie Harinstein, PharmD

Team Leader, Division of Pharmacovigilance, FDA, FDA, United States

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

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

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.

Robert  Pratt

Robert Pratt

Risk Management Analyst, FDA, United States

CAPT Robert Pratt, USPHS, received his undergraduate degree from Penn State University and his Pharm.D. from the University of Florida. His career includes 9 years as a clinical pharmacist with the Indian Health Service on reservations in Arizona and New Mexico and 19 years of experience with the FDA. He has held various regulatory review positions in the Agency with the Office of Orphan Products Development, the Division of Pharmacovigilance in CDER, and the Division of Risk Management. His current responsibilities are focused on the review and development of REMS.

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.

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.

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.

Robert  Reynolds, DrSc, MSc, FISPE

Robert Reynolds, DrSc, MSc, FISPE

Vice President, Epidemiology, Worldwide Regulatory and Safety, Pfizer Inc, United States

Dr. Reynolds is Vice President, Epidemiology in Worldwide Safety at Pfizer. He heads a group of epidemiologists and statistical analysts responsible for developing epidemiologic programs to support drug development and safety assessment. He is also an Adjunct Associate Professor of Epidemiology at Tulane School of Public Health and Tropical Medicine where he teaches pharmacoepidemiology. He is a Fellow and former Board member of the International Society for Pharmacoepidemiology. He holds a BA in Biology from Bard College and a MSc in Epidemiology and ScD in Population and International Health from the Harvard School of Public Health.

Martin  Cheatle, PhD

Martin Cheatle, PhD

Associate Professor of Psychology in Psychiatry, Perelman School of Medicine, University of Pennsylvania, United States

Dr. Cheatle is an Associate Professor of Psychology in Psychiatry, Perelman School of Medicine, University of Pennsylvania. Dr. Cheatle specializes in the evaluation and treatment of chronic pain disorders from a biopsychosocial perspective and has been involved in extensive research including a currently funded NIH/NIDA grant assessing phenotypic and genotypic markers of prescription opioid abuse. His main focus of research is pain management and substance use disorders in vulnerable populations (HIV/AIDS, psychiatric patients) and pain and suicidal ideation and behavior.

Karin  Coyne, PhD, MPH

Karin Coyne, PhD, MPH

Vice President, Research, Evidera, United States

Dr. Coyne is Vice President, Patient-centered Research at Evidera, a health outcomes research organization. She has over 25 years’ experience in clinical and health outcomes research specializing in clinical outcome assessment development and validation. Karin has extensive experience in qualitative and quantitative methodologies and expertise in regulatory strategy regarding the inclusion of COA as primary or secondary endpoints in clinical trials.

Nicole  Kelly

Nicole Kelly

, American Chronic Pain Association, United States

Nicole Kelly is a communications strategic planning consultant and writer who is retired after 18 years as a Principal and Communications Practice Leader for Buck Consultants and William M. Mercer, Pittsburgh.

Sudip  Parikh, PhD

Sudip Parikh, PhD

Senior Vice President and Managing Director, DIA Americas, DIA, United States

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

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.

Khaudeja  Bano, DrMed, MD, MS

Khaudeja Bano, DrMed, MD, MS

Vice President, Combination Product Quality, Amgen, United States

Dr. Bano is the Vice President of Combination product Quality at Amgen. 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.

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.

Quynh Nhu  Nguyen, MS

Quynh Nhu Nguyen, MS

Associate Director for Human Factors, DMEPA, CDER, FDA, United States

CDR QuynhNhu Nguyen is an engineer officer and has been with FDA for more than 13 years. She began her work at FDA evaluating human factors (HF) and use safety of medical products with the MedSun project in Office of Surveillance and Biometrics, then with the Human Factors Premarket Evaluation Team in Office of Device Evaluation within the Center for Devices and Radiological Health, and now with the Division of Medication Error Prevention and Analysis (DMEPA).She currently serves as the Associate Director for Human Factors for DMPEA and her current responsibilities include developing policy and best practices for HF reviews to ensure clarity and consistency within the Division.

Cathy W Critchlow, PhD, MSc

Cathy W Critchlow, PhD, MSc

Vice President, R&D Data Strategy, Amgen, Inc, United States

Dr. Critchlow leads R&D Data Strategy, focusing on synergizing cross-functional capabilities in multi-omics, clinical trial and real world data (RWD) to increase the probability of success in bringing innovative medicines to patients. She previously led Amgen’s Center for Observational Research, providing strategic leadership in use of RWD to inform decision-making by multiple internal and external stakeholders. Prior to joining Amgen in 2004, Dr. Critchlow was on the Epidemiology faculty at the University of Washington. Dr. Critchlow earned her bachelor’s degree from Stanford University, and her MS in Biostatistics and PhD in Epidemiology from the University of Washington.

Oswaldo L Bracco, MD

Oswaldo L Bracco, MD

Associate Vice President Oncology Early Phase and External Collaborations , Merck & Co, United States

MD, MSc Associated Vice President Oncology Early Phase Clinical Safety and Risk Management Merck

Madhavi  Gidh-Jain, PhD

Madhavi Gidh-Jain, PhD

Global Medical Writing and Document Management Head, Sanofi, United States

Madhavi Gidh-Jain is the Global Head of Medical Writing and Document Management for all therapeutic areas and regions at Sanofi. Madhavi has more than 20 years of experience in designing, writing, and reviewing medical and regulatory documents for pharmaceuticals, biologics, devices, and combination healthcare products. Her work at various pharmaceutical and biotech companies includes digital innovation, process management, and preparation of marketing applications for Health Authorities.

Danijela  Stojanovic, PharmD

Danijela Stojanovic, PharmD

International Policy Analyst, FDA, United States

Danijela Stojanovic is an epidemiologist on the Sentinel Core Team in FDA’s Office of Surveillance and Epidemiology. Her background is multidisciplinary, including prospective cohorts, administrative claims data, pharmacoepi methods, pharmacovigilance, and clinical pharmacy. She has been at FDA since 2014 and worked in the Divisions of Pharmacovigilance and Epidemiology. Dr. Stojanovic has a BS in Chemistry and a PharmD from the University of Texas and a PhD in pharmacoepidemiology from the University of Florida.

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.

Deborah  Ashby, PhD, MSc

Deborah Ashby, PhD, MSc

Professor of Medical Statistics and Clinical Trials, Imperial College London, United Kingdom

Professor Deborah Ashby is Director of the School of Public Health and holds the Chair in Medical Statistics and Clinical Trials at Imperial College London. Her research interests are in clinical trials, risk-benefit decision making for medicines, and the utility of Bayesian approaches in these areas. She was founding Co-Director of Imperial Clinical Trials Unit. Professor Ashby is President of the Royal Statistical Society for 2019 and 2020 and is Chair of the Population Research Committee for Cancer Research UK. She was awarded the OBE for services to medicine in 2009, was appointed an NIHR Senior Investigator in 2010, and elected to the Academy of Medical Sciences in 2012.

Larry  Bauer, MA, RN

Larry Bauer, MA, RN

Senior Regulatory Drug Expert, Hyman, Phelps & McNamara, P.C., United States

Larry Bauer is an independent rare disease drug development consultant. Prior to that, he was an FDA Regulatory Scientist in the Center for Drug Evaluation and Research, Office of New Drugs Immediate Office (CDER, OND IO) in the Rare Diseases Program. He was one of the original members of the Rare Diseases Program where he worked from 2010-2018. In that role, he provided regulatory expertise internally and externally regarding FDA laws, regulations, guidances and policies and supports the overall work of the Rare Diseases Program. Prior to coming to the FDA, he worked for 17 years at the National Institutes of Health Clinical Center.

Michael  Forstner, PhD, MPH, MSc

Michael Forstner, PhD, MPH, MSc

Head of Global Safety Science, SOBI, Switzerland

Michael's main focus areas are the planning, development, implementation and evaluation of benefit-risk management solutions, as well as the optimization of processes around benefit-risk management. He is engaged in developing and applying (benefit-) risk analysis and signal management methodologies in order to make RM planning more formally reproducible. Furthermore, he supports the development, implementation and evaluation of effectiveness of additional risk minimization and PV measures in the context of RMPs, as well as post-authorization studies to optimize the benefit-risk profiles of medicines.

Katherine A. High, MD

Katherine A. High, MD

Co-Founder and Former President, Sparks Therapeutics; Visiting Professor, Rockefeller University, United States

Dr. Katherine High is the former President at Spark Therapeutics, a biotech company that she co-founded in 2013. Under Dr. High’s leadership, Spark received FDA approval of the first AAV gene therapy product in the US, a treatment for a rare form of congenital blindness. Dr. High was formerly a Professor at the Perelman School of Medicine at the University of Pennsylvania, an Investigator of the Howard Hughes Medical Institute, and the Founding Director of the Center for Cellular and Molecular Therapeutics at the Children's Hospital of Philadelphia.

Raj  Long, MEd, MSc

Raj Long, MEd, MSc

Deputy Director, Safety and Pharmacovigilance, Bill and Melinda Gates Foundation, United Kingdom

Raj is currently a Senior Regulatory Officer at the Bill & Melinda Gates Foundation (BMGF) responsible for Malaria and Neglected Diseases medicines portfolio. In 2014 Raj was invited by the UK Secretary of State to be a member to the World Dementia Council (WDC) she is also appointed by the UK Government as Director, Integrated Development to lead innovative approaches in the regulatory development of clinically relevant therapies for dementia.

Adamma  Mba-Jonas

Adamma Mba-Jonas

Chief Medical Officer, CBER, FDA, United States

David  Paar

David Paar

Associate Medical Director, Medical Safety Assessment, Bristol-Myers Squibb, United States

David Paar M.D. is board certified in Internal Medicine and Infectious Diseases. He has pharmacovigilance experience in infectious diseases, immuno-oncology and immunosciences. He is currently employed at Bristol-Myer Squibb.

Sebastian  Schneeweiss, DrSc, MD

Sebastian Schneeweiss, DrSc, MD

Professor, Medicine and Epidemiology; Chief of the Div of Pharmacoepidemiology, Harvard Medical School and Brigham and Women's Hospital, United States

Dr. Schneeweiss's research focuses on assessing the effectiveness and safety of biopharmaceuticals in clinical practice. He has developed analytic methods to improve the accuracy of estimating causal treatment effects of new drugs using complex digital healthcare databases. His work is published in >500 articles and is used for regulatory and coverage decision making around the globe. He is funded by NIH, PCORI, IMI, and FDA where he is also a voting consultant. He is Principal Investigator of the FDA Sentinel Innovation Center and co-leads the RCT-DUPLICATE initiative to understand when and how real-world evidence studies can reach causal conclusions.

Dionne  Usher

Dionne Usher

Associate Director, Office of the EU QPPV, Merck Sharp & Dohme Limited, United Kingdom

Dionne works in the Office of the EU QPPV for MSD in the UK as the PSMF Owner. Interested in “all things PSMF” and other primary areas of support are EudraVigilance access management, PV Audits and Inspections and ad hoc EU QPPV Office projects and activities.

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.

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.

Karen  Feibus, DrMed, MD

Karen Feibus, DrMed, MD

Lead Medical Officer, Drug-Device Combination Team, Division of Therapeutic Perf, FDA, United States

I practiced obstetrics and gynecology for 9 years before joining FDA as a medical officer (MO). I worked in the Office of Nonprescription Products for 3 years and then served as Lead MO of OND's Maternal Health Team for 5 years. I joined the Veterans Administration as the Office of Women's Health Services' Deputy Director of Reproductive Health. I returned to FDA in October 2014 as a clinical reviewer in the Office of Generic Drugs and joined the Clinical Safety Surveillance Staff in 2017.

William  Haddock

William Haddock

Dr, Ovid Rx, United States

Bill is a biotech safety professional with more than 13 years’ experience in the industry with expertise in pediatrics, public health, epidemiology, and benefit-risk management. He is head of Safety at Ovid Therapeutics, a small biotech focused on therapeutics for neurologic conditions. Previously, he was at Biogen as Global Safety Lead for Tysabri. Prior to this he was a Global Safety Officer at Amgen for 10 years in roles of increasing responsibility leading teams across multiple therapeutic areas including nephrology (Aranesp, Epogen Velcalcetide), heart failure (Aranesp, Omecamtiv), and oncology products (Denosumab, Neulasta, Neupogen).

Jennifer B Hannan, MS

Jennifer B Hannan, MS

Director, Pharmacovigilance Business Liaison, Merck & Co., Inc., United States

Jen leads the development and implementation of pharmacovigilance (PV) standards covering cross-functional activities such as social media, patient support programs, observational studies and other organized data collection schemes at Merck & Co., Inc. Working with colleagues from the business units, she helps incorporate PV requirements into the business process, therefore ensuring consistency and compliance with PV regulations. Prior to Jen’s 20+ years of PV experience, she worked as a microbiologist at Merck’s vaccine manufacturing division. Outside of work, she likes to do anything outdoors: run, ski, yardwork or explore new destinations with family and friends. To contact Jen, please email

Donna  Kolp

Donna Kolp

Social Media Director and Board Member , The Atypical HUS Foundation, United States

Donna Kolp, CPht, Social Media Director and Board Member of The Atypical HUS Foundation. Originally from Orange County, California, and moved to Texas in 2007, Donna is first and foremost, Mom to Jonathan, her only son, who was diagnosed in 1993 with Atypical Hemolytic Uremic Syndrome, an Ultra rare disease. A caregiver, and a Rare Disease advocate, she has made it her life's purpose to advocate, be a voice and share his story in hopes to inspire those facing life challenges. On a professional note, she is a Certified Pharmacy Technician, still focusing her passion in healthcare and caring for others.

Han  Ma

Han Ma

Asia Pacific Site Head, Roche, China

Han Ma is currently the Asia Pacific (APAC) Site Head of the Safety Risk Management Group of Roche China Pharma Development based in Shanghai. Prior to her current tenure with Roche China, she was a senior safety science medical director in the oncology therapy area with Genentech, a member of the Roche group. She received her medical training in the field of radiation oncology in China and her Ph.D. in molecular pathology in the US.

Rosa  Piccirillo, MD

Rosa Piccirillo, MD

VP and Global Head, Medical Safety, Core Safety Services, IQVIA, United States

Dr. Piccirillo is a Sr. Director Medical Safety at IQVIA. Dr. Piccirillo has experience in clinical trial development and implementation, with special focus on safety reviews, post-marketing surveillance, signal detection, risk management, reference safety information review-updates, aggregate review-analysis and post-marketing regulatory concerns.

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.

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.

Bethany  Lovegrove

Bethany Lovegrove

, United States

"Bethany Lovegrove of Greer, South Carolina, was diagnosed with Crohn’s disease in 1986 and ultra-rare atypical hemolytic uremic syndrome (aHUS) in 2013, for which she receives infliximab and eculizumab infusions. She developed a passion for helping others after becoming caregiver to another adult aHUS patient. She is an advocate for the aHUS community, speaking to patients and caregivers around the country, and administrates a social media group for patients. In her free time, Bethany enjoys helping her 14-year-old son as he builds a small media empire. "

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.

Sanjeev  Miglani, MD

Sanjeev Miglani, MD

Founder and Director, AWINSA Life Sciences, United States

Naomi  Morris, MS

Naomi Morris, MS

Head of QPPV Compliance Office, Pfizer Srl., Italy

Pharmacologist and toxicologist with over 20 years experience in the industry. She started work in the laboratories as a senior scientist and then moved into the field of Pharmacovigilance. She has lived and worked in three countries and was very involved with the implementation of electronic reporting to EMA back in 2005 and has progressed in several management roles to her current role of Head of Compliance in the Global QPPV Office at Pfizer, based in Italy. She is a member of the International Pharmacovigilance Working Group and the sub group SiGiR within EFPIA.

James  Osterhout

James Osterhout

Scientist, FDA, United States

James Osterhout, PhD has worked at the FDA as a pharmacologist since 2003. The entirety of his Agency experience has been with the Office of Generic Drugs in both the Division of Bioequivalence, the Division of Clinical Review and the Immediate Office. Prior to joining the FDA, Dr. Osterhout completed a post-doctoral fellowship at the National Institute of Allergy and Infectious Diseases, National Institutes of Health, in Bethesda, MD where he researched G-protein signaling in mast cells.His industry experience includes positions in the fields of pharmacokinetics and drug metabolism at Proctor & Gamble Pharmaceuticals, Astra Zeneca Pharmaceuticals, and Fisons Pharmaceuticals.

Jan  Petracek, MD, MSc

Jan Petracek, MD, MSc

CEO, Ivigee, Czech Republic

Jan is a passionate and visionary leader in the field of pharmacovigilance, with over 20 years of experience in the industry. He is the CEO of iVigee, a company that provides innovative and sustainable solutions for drug safety and risk management. He is also a Fellow of the International Society of Pharmacovigilance (FISoP), a Global Fellow in Medicines Development (GFMD), and a Qualified Person for Pharmacovigilance (QPPV). Jan has a proven track record of establishing, growing, and selling successful organizations, both for-profit and non-profit, in the pharmacovigilance sector. He has received multiple awards and recognitions, including the DIA Excellence in Service Award in 2018 and HM Queen's Award for International Trade in 2019.

Valerie E. Simmons, MD, FFPM

Valerie E. Simmons, MD, FFPM

Senior Medical Fellow, Global Patient Safety, Eli Lilly and Company Ltd, United Kingdom

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

David  Chonzi

David Chonzi

Vice President, Head of PV and Epidemiology, Allogene Therapeutics, United States

Irene  Cosmatos, MS

Irene Cosmatos, MS

Senior Director, Epidemiology & Real-World Evidence, UBC, United States

Ms. Cosmatos is an experienced epidemiologist who leads UBC’s team of real-world data epidemiologists. She and her team support UBC’s work which involves the use of diverse, observational healthcare databases, registries, or patient medical charts to answer sponsors' research questions. She brings more than 25 years of experience in analyses of large, retrospective patient databases across all therapeutic areas, US and non-US, in support of epidemiologic and health outcomes research.

Andrew  Robertson, JD, PhD

Andrew Robertson, JD, PhD

Vice President, Head of Global Regulatory Policy and Innovation, Takeda, United States

Andrew Robertson is the Global Head of Strategy and Transformation for Sanofi-R&D Digital & Data Sciences. Andrew has more than 14 years of collective experience working in life sciences, policy and law, and has authored multiple peer-reviewed articles on topics pertaining to health product development, in vitro diagnostics, health technology law and innovation incentives.

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