From Drug Discovery to Patient (The Role and Value of Industry)
Rena Coll, Pharm.D.
Nova Southeastern University -- November 15, 2017
Learning Obiectives
Describe the FDA submission and approval process
Describe the clinical and economic impact of pharmaceuticals
Discuss the role of the pharmacist in medication management
List career opportunities for pharmacists in the pharmaceutical industry
Pfizer founded in 1849,large bippharmatputical cnmpany w/ about a?K employees
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Increases in U.S.Life Expectancy
Food and Drug Administration - Center for Drug Evaluation and Research (CDER) Evaluation and Approval of New Medications (RX and OTC) Drug advisory committees approval process
FpA:regulates the pharmaceunical imdustry-eficacy satety
Monitors the use of Marketed Medications (RX and OTC) bom ntw+exishng drugJ Appropriate Labeling Unexpected health risks
Monitors Manufacturers for Quality
Food and Drug Administration - Center for Drug Evaluation and Research (CDER) Monitors the MedWatch program Enables HCP and consumers to report ADRs AERS (Adverse Event Reporting System)
FDA Administration Amendments Act of 2007 (FDAAA)- 9/07
Risk Evaluation and Mitigation Strategies (REMS) eYrya parient educanon handout,lxtya lab monitorina -- Medication guide, Communication Plan, Elements of Safe Use, - Implementation system Monitors advertising of prescription medications (not OTCs) DTC Advertising counte
Where do New Medications Come From?
from me privatt StloY (may hQve Col(aboraKM w/ NIH)
tal Biopharmaceutical Company R8D, PhRMA Member R&D, andNIH Operating Budget:1995200
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