PPT-Drug Safety and PV Revision

PGCPM Revision Module July 2019 With thanks to Tina Strutt 1 Syllabus Drug Safety PV and Pharmacoepidemiology The role of the pharmaceutical professional in drug safety and pharmacovigilance Assessment and classification of Adverse Events Adverse Drug Reactions Serious Adverse Events and Suspected Unexpected Serious Adverse Reactions SUSARs evidence for association and causality. Using OHSAS 18001 the internationally recognized and adopted British Standard for Occupational Health and Safety as the blueprint the standard will also be aligned with ISO 9001 Quality Management and ISO 14001 Environmental Management There are c MOP - AL 204 A Revision 1.0 1 Revision History Revision Description Author 1.0 Initial Release Clark 0.2 Updates as per issue #333 Clark 0.1 Initial Draft Clark 2 Contents Revision History ......... MOP - AL 082B Revision 1.0 1 Revision History Revision Description Author 1.0 Initial Release Clark 0.2 Updates as per issue #333 Clark 0.1 Initial Draft Clark 2 Contents Revision History .......... Entity Employee Drug Testing Policies. Michael J. Roper, Esquire . Bell & Roper, P.A. . 2707 E. Jefferson Street . Orlando, Florida 32803 . (407) 897-5150 . MRoper@bellroperlaw.com. , Health, and Safety (EHS) TC Chapter Liaison Report. April 2017. v1. . Meeting Information. Last Meeting:. April 6, 2017. NA . Standards . Spring Meetings. SEMI HQ, Milpitas, California . Next Meeting:. Conference. Sacramento, CA. March 2016. Small Transit System Challenges. Compliance and Best Practices. Presented . by:. Linda De Herrera. Precision Compliance, Inc.. Today’s . Objectives. Challenges facing small agencies.. Reasonable Suspicion Training. Presented by:. Bev Krieger & Linda De Herrera. Precision Compliance, Inc.. ADOT/. AzTA. Spring Conference 2013. Provide information about physical, behavioral, speech and performance indicators of substance abuse. Center for Veterinary Medicine. Regulating Animal Drugs . Protect the Public Health by ensuring . safe and effective animal drugs reach the market. unsafe and ineffective animal drugs do not reach the market. Philip J. Schneider MS, FASHP, FASPEN, FFIP. Professor and Associate Dean. University of Arizona College of Pharmacy. Phoenix Biomedical Campus. Yes!. The business community. The political arena. Payers. Joseph D. Tessitore, Esquire . Bell & Roper, P.A. . 2707 E. Jefferson Street . Orlando, Florida 32803 . (407) 897-5150 . jtessitore@bellroperlaw.com. Bellroperlaw.com . 10/24/14. Leonard Sacks. Office of Medical Policy. CDER, FDA. 2. Mission of regulatory agencies. Protection of people. Most countries in the world have regulatory institutions. Various levels of complexity. 3. Zahraa. Abdul Ghani. Background. In . an attempt to improve patient safety due . to different . nomenclature of medicines, . European law . use . the Recommended International . Non-proprietary Name (. Drug Regulation means the control of Drug by regulatory authority to ensure safety efficacy quality of drug. . This is achieved by following and practicing the good practices in pharmaceutical. 1. Science. Integration . . FDA. 10. The . Food . and . Drug . Administration . (FDA) . touches . the . lives . of . virtually . every . American, . every . day. . It’s . FDA’s . job . to. . see . that . medicines . and .