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Pharmacovigilance Training

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정훈 신

on 24 April 2015

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Transcript of Pharmacovigilance Training

Pharmacovigilance Training
2013.11.05
Dong-A ST PV part
Clinical Development Department
What is Pharmacovigilance?
Pharmakon
(Greek)
Drug
Phenyl Propanolamine (PPA)
Thalidomide
Vioxx (Rofecoxib)
Vigilare
(Latin)
to keep awake or alert,
to keep watch
Pharmacovigilance
Approval/Marketing
Phase I
Healthy volunteers
Pharmacodynamics and Pharmacokinetics
Screening for Safety
Phase II
Establishing Efficacy of the Drug
Phase III
Confirmation of
Efficacy and Safety
How is a New Drug Developed?
SAFETY INFORMATION
Pharmacovigilance?
Science and activities relating to the detection, assessment, understanding and prevention of adverse effects or any other medicine-related problem
Sibutramine

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