...the skills and knowledge required to perform a variety of roles across the agency. The proof is in the pudding The phrase proof is in the pudding is said to...
...turn as follows. Once you’ve read this, I’ll leave you to review the revised ICH GCP guideline yourself and you can let the MHRA and EWG know want you think...
...the MHRA at the time of onset of the SAR. Onset date As per CT-3 (55), the version of the RSI at the moment of occurrence of the SUSAR applies....
...themselves that the API is of an appropriate quality. Section 19 of Part II of the GMP Guide describes the expectations. The EMA has also published a Q&A concerning the...
...or, when appropriate, of a qualified dentist. The investigator has the medical responsibility for the trial subjects under their care. Ensuring that they have the information about the data used...
...amount of time to understand your processes and procedures. The inspectors aren’t there to try and catch you out – it’s your opportunity to demonstrate your compliance to them. Inspectors...
...this data belongs to the investigator and therefore should be available to, and under the control of the investigator (and not under the direct control of the sponsor). Where source...
...reporting is performed by your organisation (remember for the UK if you report through the eSUSAR system the MHRA will forward the report onto EVCTM on your behalf – see...
...normal clinical practice, the complexity of the protocol, and the specific operational aspects of the planned clinical trial or the clinical development project. The guidance covers areas where the regulation...
...retrospectively and dated with the “date the doctor looked at the results in the EHR”, whilst review of the results in the EHR required the reviewer to confirm this in...
