Medical Officer, OBE, CBER, FDA
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...
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Regulatory Affairs Promotional Review Fellow, Novo Nordisk
Project Manager CTSpedia, Vanderbilt University
Following a career in industry and academic clinical trials, Mary Banach currently leads two programs assisting in developing our understanding of risk in the clinical design process. The first program is a sub-group of the DIA Clinical Data Management group, called the DIA RBM Group...
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Innovation Lab, ERT
Karin Beckstrom is responsible for discovering common ground among technologists, scientists and clinical trial leaders, transforming ideas into solutions that enhance the patient and investigator experience during clinical trials. She has over 20 years’ experience driving software...
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President, Vivaquant, Inc.
Brian is President and CEO of VivaQuant, an innovative ECG Core lab services provider and medical device manufacturer. Prior to VivaQuant, he founded DSI, the largest and most trusted manufacturer of devices and software for monitoring and analysis of vital signs in preclinical assessment...
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Scientific Data Reporting Analyst, FDA
Section Chief, Division of Medicinal Products, TFDA
Lien-Cheng (Eric) Chang received his PhD degree from the Institute of Biopharmaceutical Sciences at Yang Ming University. Previously, he worked in Taichung Hospital and NTU Hospital in Clinical Pharmacy Services and also served in the former Bureau of Pharmaceutical Affairs for six...
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Co-Founder and Director, AWINSA Life Sciences
Mugdha Chopra is dentist by qualification and has over 14 years of experience in the field of dentistry, and Pharmacovigilance. She is Associate Vice President for US PV and clinical safety at APCER and oversees the delivery and operations from India which includes but not limited...
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Lead Developer, Analytics & Custom Solutions, BizInt Solutions, Inc.
"Matt Eberle is an information professional with over ten years spent in the pharmaceutical industry, where he held positions of Senior Information Scientist and Pharmaceutical Information Analyst. He has worked with groups across the organization, from early R&D to legal and clinical...
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Associate Director, Research & Development, Analgesic Solutions
Vice President, Global Head Patient Insights and Engagement, ICON plc
Kelly Franchetti has a diverse background comprised of nursing, patient advocacy and clinical research. This broad range of experiences gives her a unique view of patients’ and caregiver’s perspectives in the realm of disease management and treatment. As a critical care nurse...
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Senior Project Manager, Clinical Trials Transformation Initiative (CTTI), United States
As a senior project manager for the Clinical Trials Transformation Initiative (CTTI), Zachary Hallinan manages the development and implementation of CTTI projects in collaboration with team leaders and multi-stakeholder project teams. His portfolio includes Patient Group Engagement...
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Pharmacology/Toxicology Reviewer, FDA
Senior Director, Standards Development & Education, CDISC
Kit Howard has over 30 years’ experience in many areas of research and development, including developing data and process standards for exploratory through post-marketing human clinical research, pharmacogenomics and non-clinical research. She is CDISC's Senior Education Expert...
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Associate Director, Clinical Operations| WIN UK Chapter Co-Lead, Biogen
An innovation award winning operational strategy collaborator, blockchain advocate, eCOA and patient engagement thought leader with over 17 years in the NHS on commission by the DOH and in Industry (Hoffman La-Roche, Amgen, ALMAC, ICON and Biogen). An R&D transformation change champion...
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Director, Pharmacovigilance, Clinical Development, Nanocarrier Co., Ltd.
Drug Safety & Pharmacovigilance expert. EWG for ICH E2B, and Rapporter for ICH E2D. Lecturer of many educational seminars worldwide more than 20 years. Executive Consultant, and Auditors for Global Pharmacovigilance Compliance.
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Project Manager, Center For Drug Evaluation, Taiwan
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Clinical Programmer II / Senior Associate, Pfizer
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Senior Project Manager, China Medical University
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Senior Director and Practice Lead, Linguistic Validation, RWS Life Sciences
Founder, KEVA Health
Jyotsna Mehta is founder of KEVA health whose mission is to generate Knowledge that produces Evidence, builds Value of products and allows for Access and reimbursement. Her company creates both analytical and digital solutions that engage patients, improve health outcomes, and reduce...
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Clinical Research Associate II, Duke Clinical Research Institute
Tara Melton received an undergraduate degree and Masters of Science in Clinical Research. She is a Clinical Research Associate at Duke Clinical Research Institute in the Outcomes Research group. She currently oversees site management teams and data quality initiatives and has worked...
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Vice President, Site Engagement, Continuum Clinical
Continuum Clinical’s Vice President of Site Engagement Nariman Nasser has 15 years’ experience in clinical operations, patient recruitment and portfolio management in academic, pharma and consortia environments. She was formerly the global head of operational innovation and digital...
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Clinical Scientist, Rare Diseases - Scientific Affairs, PRA Health Sciences
Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining...
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Epidemiologist, Pharmaceuticals and Medical Devices Agency (PMDA)
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Analyst, Centers For Disease Control and Prevention (CDC)
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Director, Clinical Research Division, Armed Forces Research Institute of Medical Sciences
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Founder and CEO, HealthiVibe, LLC
Ms. Steel has more than 25 years in the life sciences industry, leading clinical development and post-marketing programs. She is an advisor to pharma sponsors in the design and implementation of patient-directed programs. She previously worked as Vice President of Patient & Physician...
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Co-Founder and CTO, Cliniops, Inc
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Vice President, Global Business Development, ICON plc
Postdoctoral Fellow, Global Regulatory Affairs, GlaxoSmithKline, University of North Carolina
Senior Clinical Scientific Advisor, ERT
Dr. Yamamoto holds a PhD in Experimental Psychology from Tufts University. She has experience in pre-clinical and clinical research in mood and anxiety disorders, substance use disorders, incentive salience, interactions of nutrition and behavior, and functional and pharmacological...
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