E-drug: Washington Post Series on Drug Development (cont)
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Tom Poe,
Perhaps you could clarify what you are saying about GMP standards.
Exactly what are they, who promulgates them, what authorities do you
propose should require them, and of whom should they be required?
What role would independent review play and who would play it?
Hello, Scott: I'll be more than happy to. I'm not sure if the following
outline is relevant or appropriate, but I can develop it quite easily
at any level wanted. Suggestions appreciated, e.g., limit topic
discussion to - - -
words, or don't bother with - - - , etc.
GMP STANDARDS FOR MANUFACTURERS OF DRUG PRODUCTS
1. General Intro
2. History (and explanation of why GMP standards are not followed for
multi-site clinical research at this time)
3. Present Development Process for Drug Approval
4. GMP Standards for Multi-Site Drug Development Requirements
4.a] History
4.b] Present Requirements
5. Rationale for GMP Standards Requirements for Multi-Site Studies
6. Who, What, Where, Why re: Implementation of Electronic Oversight
7. Discussion of cost considerations in implementing new "paradigm"
Let me know if any of this is of interest to the e-druggers.
Thanks, Tom
Thomas A. Poe, M.D., Director
The World Center For Clinical Research
2044 Plumas Street Reno, NV 89509-3708
Phone: 775-829-1799
admin@worldccr.org http://worldccr.org
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