Guideline on the content, management and archiving of …
management, exchange or remote access and retention of documentation amongst CROs. Specific requirements may be put in place when CRO interaction is required. The sponsor should provide CROs access to sponsor essential documents of the TMF that are required by the CRO to execute their delegated duties and functions.
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Q12 Step 2b Technical and regulatory …
www.ema.europa.euICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management EMA/CHMP/ICH/804273/2017 Page 3/36
Guideline on good pharmacovigilance practices …
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Guideline on good pharmacovigilance practices …
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