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Session 3: Drug Safety – A Balance of Safety and Risk
Session Chair(s)
Nancy D. Smith, PhD
Adjunct Professor
Temple University, FDA Alumni, United States
What do we mean when we say a drug is safe? What do we mean when we say the benefit of a drug outweighs the risk? How can safety and benefit be maximized at the same time?
- History of Drug Safety
- International Conference on Harmonisation (ICH)
- Theory of Managing Risks
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