The new legislation has been in place for almost 3 years now and there has been a lot of experience and discussion regarding some of the practicalities of implementation. If you are responsible for enacting its requirements, this can be quite daunting as you fight your way through all the legislation, guidelines and documents.
As a consultant working with a number of companies, I have been able to see a number of approaches to do this. What follows is hopefully a pragmatic view of how best to approach this, which may also be of use when re assessing the PV system as a whole.
Seema’s article appeared in Pharma Times and you can read the full article here:
Good Pharmacovigilance Practice.