European Poison Control – Managing the Complex Submission Update Requirements

Paul Brigandi Moderator
CGI
San Rafael, CA 
United States of America
 
Catherine Gallagher Presenter
ExxonMobil Biomedical Sciences, Inc.
Annandale, NJ 
United States of America
 
Paul Brigandi Co-Presenter
CGI
San Rafael, CA 
United States of America
 
Thu, 9/12: 8:30 AM  - 9:30 AM 
00183 
Standard Session 
Greater Columbus Convention Center 
Room: A 211, A 212 

Description

The data requirements for compliance with notifications to Poison Control Centers under Annex VIII to REACH are largely consistent with the various data requirements currently required by individual member states. While there are a few new data items to consider as part of the harmonized scheme covered by Annex VIII, the majority of data included in a dossier are those already used to generate Safety Data Sheets. However, the regulatory requirements for determining when a submission must be updated are detailed and create complex system requirements to track changes in key data elements.

The presenter will highlight the key data elements that need to be tracked and the benefits to automated change tracking events. An automated approach ensures the accuracy of identifying change events and improve the processes to manage compliance.

Learning Objectives

At the end of this session, attendees will be able to:
1. Identify the complexity related to tracking data changes that trigger mandatory submission updates
2. Gain an appreciation for the benefits of updating systems to automate the change tracking process
3. Identify strategies to manage compliance under the harmonized approach 

Learning/Experience Level

Experienced

Topic(s)

Emerging Chemical Regulatory Issues/Global Regulations