16 - 19 September, 2019 | Pullman Brussels Centre Midi Hotel, Brussels, Belgium
Pre-Conference Data Integrity Training Day
10:00 am - 4:00 pm Data Integrity Expectations, Challenges and Best Practice for GCP Compliance
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
Hobson Lopes
Manager, Clinical Archive Management, Clinical Document Management Group, Global Clinical OperationsRegeneron
