Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

WHO Tackles Submission Of Insufficient Or False Data By Pharma

This article was originally published in SRA

Executive Summary

The World Health Organization has developed what it claims is the first comprehensive guidance document on data integrity that should help regulatory authorities and inspectors identify instances of pharmaceutical companies submitting insufficient or false data1.

You may also be interested in...



WHO To Clean Up Data Integrity Failings

The World Health Organization has proposed changes to its 2016 guideline on data integrity requirements to provide streamlined information to sponsors and to take account of experience gained to date. 

49 PIC/S Inspectorates Test-Drive Data Integrity Guidance

Pharmaceutical Inspection Cooperation Scheme member inspectorates are trying out the most comprehensive manufacturing data integrity guidance yet developed. Issued amid a flurry of guidance from various authorities, it could play a key role in harmonizing regulatory approaches.

EMA Clarifies Compliance With ALCOA Principles Is Key To Meeting Data Integrity Expectations

The EMA's guidance on data integrity expectations focuses on good manufacturing practice requirements and offers advice on minimizing risks at all stages of the data lifecycle in pharmaceutical quality systems.

Related Content

UsernamePublicRestriction

Register

LL1126230

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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 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