dose of digital fda pharma social media hearing testimony - adverse event reporting
DESCRIPTION
This is my testimony that I will present to the FDA at the upcoming hearings on the use of social communications in pharma. This specifically will address their question regarding adverse event monitoring and reportingTRANSCRIPT
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Are pharma companies supposed to be private investigators?
Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital
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Required for reporting:
1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the
event4. an adverse event or fatal outcome
Only 1 in 500 posts have all this info.
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Is this a reportable adverse event?
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1. An Identifiable Patient
Is this “identifiable”?
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1. An Identifiable Patient
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1. An Identifiable Patient
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2. An Identifiable Reporter
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2. An Identifiable Reporter
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3. a specific drug involved in the event
I can't remember the name it was something with a R. I got the shakes so bad that I had to take beta blockers to stop them.
I can't remember the name it was something with a R. I got the shakes so bad that I had to take beta blockers to stop them.
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4. An adverse or fatal outcome
I ‘m beginning to wonder if the Parkinson-like movement of my left hand is related to taking Lipitor
I ‘m beginning to wonder if the Parkinson-like movement of my left hand is related to taking Lipitor
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In the “Old Days”...
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A New Reality1
1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the event4. an adverse event or fatal outcome
23
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A New Reality
HealthGuy
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New Guidance Needed?
1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the
event4. an adverse event or fatal outcome
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New Guidance Needed?
2. an identifiable reporter
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New Guidance Needed?
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New Guidance Needed?
1. an identifiable patient2. an identifiable reporter3. a specific drug or biologic involved in the
event4. an adverse event or fatal outcome
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Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital