dose of digital fda pharma social media hearing testimony - adverse event reporting
Post on 05-Dec-2014
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Are pharma companies supposed to be private investigators?
Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital
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.
Is this a reportable adverse event?
1. An Identifiable Patient
Is this “identifiable”?
1. An Identifiable Patient
1. An Identifiable Patient
2. An Identifiable Reporter
2. An Identifiable Reporter
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.
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
In the “Old Days”...
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
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A New Reality
HealthGuy
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
New Guidance Needed?
2. an identifiable reporter
New Guidance Needed?
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
Jonathan RichmanDirector of Strategic Planning, Bridge WorldwideAuthor, Dose of Digital
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