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RegisterMHRA inspection [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2009-05-30 15:22 (6239 d 06:02 ago) – Posting: # 3794
Views: 4,889
Dear Krish and Vinaya!
Not true according to a presentation by Luise Mawer of MHRA (Considerations in Bioequivalence Inspections, Paris, Sep 2008).
Terminology: 'Audit' is done by the sponsor or an external monitor, 'Inspection' by regulatory bodies.
❝ At least as far I know MHRA has not audited any CRO with respect to BA/BE studies.
Not true according to a presentation by Luise Mawer of MHRA (Considerations in Bioequivalence Inspections, Paris, Sep 2008).
Terminology: 'Audit' is done by the sponsor or an external monitor, 'Inspection' by regulatory bodies.
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Helmut Schütz
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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
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![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- MHRA audit krish3108 2009-05-30 08:32
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Ing. Helmut Schütz