Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Eyes Changes To IRB Adverse Event Reporting; March Meeting Planned

This article was originally published in The Gray Sheet

Executive Summary

Device manufacturers and other stakeholders will have an opportunity next month to discuss ways that reporting adverse events to institutional review boards can be improved

You may also be interested in...



Adverse Event Reporting Deluge Diagnosed By IRB Reps At FDA Hearing

Clinical trial sponsors should assume oversight of safety data that currently burden institutional review boards, participants agreed at an FDA public hearing on adverse event (AE) reporting to IRBs

Adverse Event Reporting Deluge Diagnosed By IRB Reps At FDA Hearing

Clinical trial sponsors should assume oversight of safety data that currently burden institutional review boards, participants agreed at an FDA public hearing on adverse event (AE) reporting to IRBs

Risk-Based Approach To Clinical AE Reporting Needed – Medtronic’s Westrum

Clinical trial sponsors are limited in their ability to facilitate compliance with institutional review boards, even though investigators often lack thorough grounding in IRB policies, according to Medtronic Director of Clinical Affairs Barbara Westrum

Latest Headlines
See All
UsernamePublicRestriction

Register

MT021600

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