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Expert ID: 732491 Washington, USA

Expert in Pharmaceutical Manufacturing, Combination Products, Medical Devices, and Good Clinical Practices

Expert is a retired Public Health Service (PHS) Officer with 16 years of FDA experience in Pharmaceuticals, Medical Devices, Biologics, and Bioresearch Monitoring. She has held the positions of Investigator, Pre-Approval Manager, Supervisory Investigator, and Foreign Inspection Cadre Member. She…

Expert ID: 731813 Belgium

Expert in 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…

Expert ID: 730446 Pennsylvania, USA

Expert in Bioethics, Medical Ethics, Ethnography Research, Qualitative Research, Good Clinical Practice, Medic

Expert is a professional bioethicist and works seamlessly among clinicians, entrepreneurs, venders, and business owners addressing critical healthcare issues such as ethics, risk, policy, content, technology, and quality care. She provides leadership to complete multiple projects in a timely manner…

Expert ID: 733995 Canada

Expert in 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,…

Expert ID: 732909 United Kingdom

Expert in Healthcare Practice, Senior Healthcare Management, and Health IT

Expert has over 25 years' experience as a medical practitioner, 18 of which have taken place at the consultant level. He has significant experience studying and working with other professions, healthcare environments and countries. He has developed a keen understanding…

Expert ID: 730734 Florida, USA

Expert in Transdermal Development Including INDs, ANDAs, NDAs, MAAs, CMC, Preclinical, Clinical, Bioequivalence

I have been involved in transdermal product development for 15 years and have spearheaded the development of quality control, quality assurance, regulatory affairs and clinical research departments. Among my activities are: 1. Designing preclinical, clinical and bioequivalence studies. 2. Filing…

Expert ID: 730696 Italy

Expert in Clinical Development, Regulatory Development

Following more than 25 years in the pharmaceutical industry (Big Pharma, Contract Research Organizations, Small Pharma), Expert has accumulated experience from several hundred clinical studies, primarily in Phase I/Phase II ("First-in-Human", "proof-of-concept") across most therapeutic areas (Metabolic, Infectious, Oncology, Urology,…

Expert ID: 729771 California, USA

Expert in Clinical Trials, Drug Development, Medical Monitoring, AIDS, FDA Regulation, Safety Assessment

Expert is a public health professional who has extensive international and domestic experience. She has worked for pharmaceutical/biotech companies, hospitals, public health institutions, non-profit organizations, in the areas of clinical trials design and management, community-based research, educational programs’ development and…

Expert ID: 727493 Australia

Expert in Pharmaceuticals, Biotechnology, Clinical Pharmacology, Pharmacokinetics, Clinical Trials

Expert is an expert in drug discovery and development years of experience in clinical pharmacology, pharmacokinetics and clinical trials of pharmaceuticals. Trained in medicinal chemistry, Expert undertook clinical pharmacology research in a University Hospital for 12 years before joining the…

Expert ID: 727345 Nevada, USA

Expert in Survey Data, Complex weighted data, Clinical Statistics, General Linear Models, Power Analysis, Reliability Analysis, Survival Analysis

Expert's teaching courses include Chronic Disease Epidemiology, Survey Sampling, Applied Linear Models for Public Health, Environmental Health, Epidemiology, and Biostatistics. Her research interests include children’s health with a focus on pediatric asthma (prevalence, clinical management, environmental triggers and academic outcomes…

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