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Ear Surgeon, Inventor, Treatment of Dizziness and Hearing Loss
Expert is a double board-certified ear surgeon and trained expert witness with over 40 years of experience treating and operating on ear, balance, and hearing conditions. He has expertise in all common otolaryngologic disorders with special interest in tinnitus, cholesteatoma,…
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…
Medicated Aerosol and Inhalers
Expert has been in the field of Medicated aerosol (MDI, DPI and nebulizers) since 2004. His PhD was in this field and most of his 77 published paper and 48 conferences presentations are in this field. Expert has a respiratory…
BioStatistics, Pharmaceutical Devices, Biotechnology, and FDA and EMA Submissions
Expert holds a Ph.D in Statistics and has 25 years' applicable industry experience. He currently serves as a biostatistical expert witness in high-stakes pharmaceutical and medical device litigations. He has expertise in pre- and non-clinical, Phases I-IV in biostatistics, data…
Pulmonary Hypertension Drugs, Nitric Oxide and Nitric Oxide Delivery Systems
Seasoned Executive with a unique combination of scientific and business expertise in the pharmaceutical industry. Over 18 years of drug development experience (i.v, subcutaneous, inhaled and oral products), 15+ years in Pulmonary Hypertension, including 10 years in years at a…
Good Clinical Practice (GCP), clinical trials, regulatory authority inspections, audits, QM
Expert is a former GCP inspector with the German Federal Institute for Drugs and Medical Devices [BfArM]. She has led and conducted GCP inspections on behalf of EMA and national authorities all over the world. Expert has experience in assessing…
Consumer Goods, Exporting, International Outsourcing, and Big Box Retail
Expert offers consulting, marketing, sales, outsourcing, financial and business expansion services to investment firms, legal concerns, banks, venture capitalists, hedge funds, manufacturers, retailers, importers and exporters for international and domestic markets, new product development, introductions and placement. Previously, he was…
Large Animal pharmacology/pharmacokinetics, Sterile products,GMP,Product Development, Safety and ID
Expert has training is antimicrobial monitoring and reporting to Blue Cross/Blue Shield of hospital infectious diseases. She is an occupational safety officer for laboratory animal programs and a pharmacy safety instructor. She has completed GMP training to include auditing in…
Cardiac Electrophysiology, Cardiology Drugs, Pacemakers, Defibrillators, Cardiac Medical Devices
Expert. Expert is a board certified cardiac electrophysiologist (cardiologist with expertise in the diagnosis and treatment of all cardiac rhythm disorders) with over 20 years experience as a clinical investigator, IRB Chair, and high volume implanter of cardiac rhythm devices.…
Clinical Epidemiology, Public Health Medicine, Drug Safety, Clinical Trials
Expert is Director of Pharmacoepidemiology in a Public Health Consultancy providing advice and expertise to the public, regulators and medical professionals on the evaluation and safety monitoring of drugs in the European Community. He has: conducted state-of-the-art pharmacoepidemiological studies including…