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

Redacting Personal Data/CCI In EU Clinical Trial Inspection Reports On The Agenda

Executive Summary

Work is expected to start this year on developing guidance for the EU member states on how to redact clinical trial Inspection reports to protect personal data and commercially confidential information under the new Clinical Trials Regulation.

You may also be interested in...



Commission Consults On New Risk-Proportionate Approaches Under EU Clinical Trials Regulation

The European Commission is inviting stakeholder feedback on recommendations to help implement several key aspects of the new EU Clinical Trials Regulation, including how to apply a risk proportionate approach for the design and conduct of trials, and how to present a summary of clinical trial results to laypersons1.

The ICER Process: Allergan Engagement Improves Cost Effectiveness Rating For Ubrelvy

ICER president Steve Pearson is ‘cautiously optimistic’ that net pricing for acute migraine treatments will align with benefits once discounts are factored in.

US FDA’s 2020 Approvals: A Deep Pipeline, And More Of The Expected

Almost 50 novel agents are already under review at FDA for potential 2020 approval. Candidates are notably diverse, with concentrations in established strongholds (oncology, neuroscience), popular programs (breakthrough), and powerhouse sponsors (keep an eye on Bristol-Myers Squibb right out of the gate).

Topics

UsernamePublicRestriction

Register

PS120099

Ask The Analyst

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 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