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Medical Device Regulatory Affairs: CE (Canada) and FDA
Expert has 25 years' experience in FDA, TGA, CE, and Health Canada product approvals for medical devices and combination devices. He has experience writing CER, CE applications, FDA applications, TGA and Health Canada applications. He has performed PMS, PMCF, recall,…
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…
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…
Radiology, Nuclear Medicine, Nuclear Pharmacy, Molecular Imaging, Patient Safety, Compounding
Director of Radiopharmacy and Associate Professor of Radiology and Medical Physics at a University Medical Center. He is also an adjunct faculty member at several colleges of pharmacy. Expert has expertise in research, development, and clinical use of radiopharmaceuticals for…
Pharmaceutical Development
Expert has over 28 years experience as a pharmaceutical executive managing various aspects of drug product development, including outsourced pharmaceutical manufacturing and broad aspects of the CDMO industry. Previously, Expert was the President of Pharmaceutical Development Services and the Chief…
Formulation Development
Expert has over 20 years of versatile, industrial experience in areas of the pharmaceutical preformulation, formulation and process development and technology transfer of all oral dosage forms and parenterals dosage forms with leading companies as TTK, Parke-Davis, Strides, Banner Pharma…
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…
Statistics (Pharmaceuticals (CMC): Design of Experiments, Process Validation, Stability)
After receiving a Expert in statistics, expert has worked in the pharmaceutical industry for over 30 years as a non-clinical statistician applying statistical methodologies, performing data analysis, and interpreting results with scientists in research and development. He collaborated with scientists…
Pharmaceuticals & Healthcare in Brazil: Entry Strategy, Market Evaluation & BD
Expert has ran 6 pharma & healthcare businesses as General Manager/CEO/President in his 40 years in Brazil ranging from subsidiaries of US, German, UK & Latin American labs to local start ups. Businesses covered Rx & hospital products, OTCs &…