1. Real Example of an EU PV Inspection
a. Presenting a real EU PV inspection setting
b. Introducing a real standard question
c. Presenting a real critical PV finding
2. EU PV Inspection Procedure
a. Which EU authority will come to you?...
After triage, the case may enter the processing step. The purpose of case processing is to ensure a standard and structured way to capture the case information in the safety database.
In my last article in December 2016, I introduced about the pharmacovigilance system to be set up by pharmaceutical companies and one of the key elements being a quality system describing the procedures.
In my last article in October 2016, I used an example to discuss whether efficacy or safety comes first in the aspect of drug development. I would like to share Shyam Krishnan’s response, which well summarizes that pharmaceutical...
Further to my Introduction to Drug Safety Series posted in August 2016, I did not expect to a hot discussion over this not-so-popular topic. Indeed, there were only two comments posted - but I was surprised, and quite amazed to read these comments...
It started from three years ago. Peishan, the CEO of Taiwan Salt and Light Biotech Institute, invited me to give a workshop to share my experience in the pharmaceutical/clinical research industry abroad to the audience in Taiwan.