MHRA's Summary Of PV Systems (SPS) Document
Source: Sentrx
By Bart Cobert
As everyone who deals with the EU and the UK in drug safety knows, the EMA issued a new set of Good PV Guidelines to replace (largely) Volume 9A. These are more than “guidelines” in the US sense where guidelines represent FDAs current thoughts on the matters addressed but are not binding. In the EU, these guidelines are binding.
For the past several years the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has been using a document called the Summary of Pharmacovigilance Systems (SPS or SPVS).
access the Article!
Log In
Get unlimited access to:
Trend and Thought Leadership Articles
Case Studies & White Papers
Extensive Product Database
Members-Only Premium Content
Welcome Back! Please Log In to Continue.
X
Enter your credentials below to log in. Not yet a member of Clinical Leader? Subscribe today.
Subscribe to Clinical Leader
X
Subscribe to Clinical Leader
This website uses cookies to ensure you get the best experience on our website. Learn more