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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…
Sterile Process Validation, Microbiology, Steam Sterilization, Aseptic Filling, Rapid Micro Methods
Expert has over 25 years experience in various aseptic of sterile process validation. She has worked for Baxter, Fujisawa (now Astellas), Jordan Pharmaceuticals, Vectech Pharmaceutical Consultants and Excellent Pharma Consulting. This encompasses steam sterilization, aseptic filling, process validation, development of…
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…
HVAC and Refrigeration, Process Piping and Plumbing, Cleanroom Design, Hazard Occupancies, and Codes and Standards
Expert is principal and founder of a consulting LLC and is a consulting Mechanical Engineer specializing in the built environment; Expert provides: - Project Design and Management Consulting - Forensic Analysis and Litigation Consulting - Expert Testimony at Legal Proceedings…
Food Science, Beverages and Nutrition
Expert has over 23 years experience in food science especially beverages, having worked as a research scientist and project manager for leading FMCG companies such as GlaxoSmithKline (20 years) and Rank Hovis McDougall. He now works as a consultant 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…
Clinical Development, Safety Reviews, Pharmacovigilance, Pharmacoeconomics
• Employer for preparation for an FDA Advisory Committee regarding review of an NDA. • Design and implementation of Phase I-IV clinical studies • Employer to many large pharmaceutical companies • Employer to Biotechnology companies and CROs • Medical safety…
Cosmetic Dermatology products & services, including Neuromodulators/Dermal Fillers/Lasers/Peels
Expert began injecting Botox Cosmetic® when it was FDA-approved for strabismus, but not yet for wrinkles. Then a resident at the University of Miami Miller School of Medicine's Department of Dermatology & Cutaneous Surgery, she was among the first physicians…
Retail Pharmacy, Drug to Drug Interactions, Medication Management Therapy
Expert has had to deal with the retail aspects of PBMs from their infancy since he owned an independent pharmacy for thirty years before selling it to CVS. The PBMs have consolidated and the big players such as Medco, Caremark,…
Market Research, Global Healthcare Market Research
Experienced market researcher with over 35 years in the industry- last 25 years have focused in the healthcare space. Experienced in both qualitative and quantitative methodologies with concentration in brand-building. Primarily on vendor side working with pharmaceutical, biotech and medical…