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Pharmacovigilance
Pharmacovigilance professional with 18 years’ experience developing and reengineering PV departments in small to medium sized pharmaceutical/biotechnology companies. Operational expertise includes the evaluation, development and implementation of PV processes and infrastructure, vendor management, SOP development and revision, CAPA management, compliance…
Pharmacokinetics/Pharmacodynamics
Expert has over 37 years of experience in the pharmaceutical industry, including work as an independent consultant. As a consultant he offered preclinical and clinical pharmacokinetic, pharmacodynamic, and pharmacometric support services, with emphasis on providing strategic planning services throughout a…
Medical Devices and Plastics
Expert has been recognized frequently by upper management for his contributions to groundbreaking product development and launch of medical devices. He has over 24 years of engineering consulting experience in the design and manufacturing of medical devices and FDA investigation…
Public Health, Epidemiology, Infectious Diseases, Vaccines, Internal Medicine, Environmental Health
The overarching vision of Expert's research program is the reduction of disease burden associated with bacterial and viral infections among infants, children and adults. His research program focuses on the study of infections using innovative, multi-disciplinary tools that enable more…
Hepatology Nonalcoholic Fatty Liver Disease (NAFLD), Nonalcoholic Steatohepatitis (NASH) Liver Disease, Pharmacovigilance, Drug Development- Drug-Induced Liver Injury Hepatotoxicity
Expert has been a hepatologist since 1988. She was in a solo practice devoted to treating and evaluating patients with liver disease until 2009 at which time she became Director of Hepatology. During that time she served as a consultant…
Pet and Vet Industry; Specializing In Pharmaceutical, Food, Treat and Nutraceutical Formulation
Forward-looking, entrepreneurial CEO and Managing Director with stellar, 20+ year record of achievement. Sets core business strategies that deliver major professional and customer demand in competitive markets. Spurs organizational growth and excellence by proactively developing staff; nurturing and fostering strengths…
Medicinal Chemistry and Pharmaceuticals
Expert's services have been retained in a high-profile ANDA case against Pfizer. Expert was deposed and participated in pretrial preparation. He has recently provided expert witness consulting services in a case for a nutraceutical company, where he was deposed and…
Clinical Research, Clinical Trials, Drug Development, Drug Safety, Patient Consenting Process
Experienced clinical research professional with a demonstrated global leadership in the pharmaceutical and medical device industry. Global organization and oversight of clinical research, QA and regulatory strategies. Leadership in new business development (medical device and medical software development quality management,…
Healthcare Strategy, Technology & Innovation
Expert has 20+ years of experience in the healthcare industry. He is currently a Principal at a healthcare consultancy focused on health care strategy, technology, and innovation. He offers advising services like topic-specific research, environmental/market assessments, strategic planning, operations/workflows design…
Pharmaceutical Development
Expert is a former FDA Review Chemist, with > 39 years of career experience in pharmaceutical R&D, Quality Operations and Regulatory Affairs. For 25+ years as a consultant in his own pharmaceutical development advisory firm, Expert has furnished clients with…