There are two workshops running on 28th September, from 13:00-17:00, please use the form below to indicate which you would like to attend.

WORKSHOP 1: Best Practices for the Effective Management of Electronic Records

Presented by: Dora Endreffy & Russell Joyce

This interactive workshop will look at the challenges and opportunities presented by digitisation and provide practical guidance to those responsible for the management of electronic records and data within their organisation, including the management of:

• records in regulated business systems (such as eTMF and SharePoint sites);
• record lifecycles, including workflow and permissions;
• digital archives

The session will cover a wide range of aspects related specifically to electronic records including:

• regulatory and legal requirements;
• file formats and storage media;
• electronic mail;
• electronic signatures; and
• an introduction to digital preservation.

WORKSHOP 2: Exploring Archiving Considerations & Challenges to Effectively Navigate Shifting Regulations

Presented by: Jamie Toth & Hobson Lopes

While eTMF systems advance, the maintenance of data integrity and management of long-term records become more complex. With rapidly changing regulations, now is the time to join industry experts, Jamie Toth, Beigene and Hobson Lopes, Regeneron, and dive into an in-depth exploration of what record management and regulatory frameworks are required for long-term archiving to ensure a healthy and compliant eTMF:

• Understanding records management principles to ensure a healthy eTMF
• Outlining regulatory framework for GxP archives to best navigate requirements
• Illuminating key required roles for archiving and document management
• Exploring the GxP archive to understand what it involves
• Navigating the use of third parties