New QP requirements 'in sync with real world', but EU drug industry concerns persist

This article was originally published in SRA

17 Dec 2013
News

Vibha Sharma @ScripRegVibha vibha.sharma@informa.com

Executive Summary

Pharmaceutical companies have largely welcomed the European Commission's revised draft guideline on qualified person (QP) requirements as the update aims to bring the document in line with the current globalized nature of the drug industry¹^,2. They are, however, worried about the practical implementation of some of the provisions in the proposed guideline, saying these could lead to unnecessary challenges "while feasible alternatives are at hand".

Already Registered? Sign in to continue reading.

New to Pink Sheet? Start a free trial today!

Table
View full table

ASK THE ANALYST
Email

Print
Bookmark
Share

Tags:

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

PS117654

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel

PS117654

All set! This article has been sent to my@email.address.

All fields are required. For multiple recipients, separate email addresses with a semicolon.

Please Note: Only individuals with an active subscription will be able to access the full article. All other readers will be directed to the abstract and would need to subscribe.

New QP requirements 'in sync with real world', but EU drug industry concerns persist

News

Executive Summary

You must sign in to use this functionality

Authentication.SignIn.HeadSignInHeader

Register

Ask The Analyst

Email Article

Sign In To Set a Search Alert