Hobson Lopes

Manager, Clinical Archive Management, Clinical Document Management Group, Global Clinical Operations
Regeneron

Check out the incredible speaker line-up to see who will be joining Hobson.

Pre-Conference Data Integrity Training Day

Monday, September 16th, 0019

Introduction:

Inspections can occur at anytime; therefore the preparation can be daunting. With acute consequences, it

is crucial that best practices are in place to ensure that your recorded data and documentation is compliant

when the inevitable inspection comes around.

This interactive, expert-led training course will give you the opportunity to put your current strategies to the

test, and bring you up to speed on the most pressing data integrity challenges, practices and expectations.

Key-Take Homes:

Explore the latest updates around data integrity guidelines and how this is reflected in recent industry
trends
Navigate the challenges of data integrity when applied to the collection of clinical trial data and
documentation
Mitigate the risk of losing the integrity of your data during the transfer of records between clinical trial
stakeholders, e.g. CRO and Sponsor, Investigator Site and Sponsor
Overcome the challenges of data integrity with respect to long-term retention of clinical trial data and
documents (archiving)
Safeguard your clinical trial from critical findings by designing an effective auditing strategy for data
integrity,

Agenda:

10:00 Welcome Coffee & Registration

10:30 Course Introduction & Welcome

10:45 Case Study Overviews

11:15 Networking Coffee

11.45 Discussion Based Group Work

12:45 Networking Lunch Break

13:45 Discussion Based Group Work Continued

15:30 Concluding Remarks

16:00 End of Workshop Day