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Physiology, Neuroscience, Epilepsy, Neurophysiology, Seizure, EEG, Neurology, Evoked Potentials, EEG
Expert is the director of Clinical Neurophysiology and the Comprehensive Epilepsy Center at a major regional hospital. He has clinical expertise in epilepsy, electroencephalography, clinical neurophysiology, and general neurology. Expert has extensive experience in basic science, translational, and clinical research.…
Pharmaceutical Marketing and Litigation, Major Pharmaceutical Trends, International Business
Expert has been a Vice President, Marketing for two major pharmaceutical companies, most recently Pfizer, overseeing sales of $600 million. He has twenty years of experience in pharmaceutical marketing Expert was a Managing Director for the Nordic region in Europe…
Pediatrics, Adolescent, & Young Adult & Administrative Medicine, Medical-Legal Issues, Public Health
Strong background since establishing the first student internship program in bioehtics at the Kennedy Bioethics Institute in 1972 - mentor Andre Helligers, then director of the CEnter. Published in medical ethics journals. Hospital ethics committee experience. Licensed to practice law…
Clinical Pharmacology, Toxicology, Drug Development, Product Liability, Regulatory Affairs, Pharmaceutical Patents
Expert worked in pharmacological research concerning opiate analgesics. The objective of the research was to find an anti-diarrheal drug with minimal analgesic and addiction potential. In particular, he led the research team that discovered and developed nufenoxole, an antidiarrheal drug.…
Pharmaceutical Development, CMC, Project Management, Intellectual Property
Expert has developed modified release products throughout his career. Most recently he led the development of proprietary oral modified release systems at Phoqus Pharmaceuticals. These included zero-order, increasing-rate, pulsatile, delayed-release, chronotherapeutic and fast-release formulations. Prior to that he was responsible…
Pharmaceutical Engineering Maintenance, Calibration, Training, Safety System Implementation & Audits
As he has been the Head of Facility & Chief Engineer & Administration of world class standards,he was overall in charge of Facility Management of Medicorp’s as well as Unit I & VI. Of Aurobindo’s world class manufacturing facilities complying…
FDA Regulations, GMP/GLP/GCP Compliance; IND, NDA, BLA, PMA and Product Regulation; Toxicology
Experienced in all aspects of validation and compliance including, GMP/GLP/GCP and part 11. Expert worked for over five years as a reviewer of investigational new drug applications, marketing applications, developing guidance and government policy and supporting approval process. In addition,…
Toxicology, Environmental Health and Safety, OSHA Regulatory, Mold, Healthcare and Laboratory Safety
Expert's experience is very broad in the areas of chemicals effects on humans and environmental systems. He has performed academic research on the effects of hazardous chemicals on the lungs, as well as carcinogenic effects of chemicals and air pollutants,…
FDA Compliance, Project Management, New Product Development, Validation, Cultural Transformation
Expert has audited many cGMP operations. A good audit starts with a good plan. Before starting an on-site audit, he reviews past audits. He notes indications of possible problem areas and items, if any, that were identified for corrective action…
Clinical Trial, Biomarker, Clinical Development, Drug Safety, Medical Affairs, Commercialization
As a prescribing physician and a physician in drug development for many years, Expert has expertise in drug mechanism of action and clinical data, and clinical use. Expert is an expert in drug clinical development from planning to protocol design,…