DAY TWOWednesday, 20 October 2021 - EST (Eastern Standard Time, GMT-5)

8:15am - 8:25am10 mins

Chair’s Opening Address

8:30am - 9:10am40 mins

CASE STUDY: Integrating and Automating Temperature Monitoring for Efficiency Gains

9:15am - 9:45am30 mins

CASE STUDY: Applying Fractional Prediction to Drive Clinical Supply Efficiency

9:50am - 10:20am30 mins

Best Practice and New Models for IRT User Acceptance Testing (UAT)

10:25am - 11:10am45 mins

PANEL DISCUSSION Vendor Selection and IRT System Implementation Best Practice

Sarosh Anjum - Senior Manager - Information & Systems Strategy, Astellas Pharma US
Carol Lee - Senior Director, Clinical Program Management, Ascentage Pharma
Patrick Nelligan - Associate Director, Interactive Response Technology (IRT), Bristol Myers Squibb
Elisa Holzbaur - IRT Manager – Clinical Systems and Analytical Reporting, Amgen

11:10am - 12:25pm75 mins

Live Virtual Networking Hub and Roundtable Session on Regulatory Expectations on IRT Data Ownership

12:30pm - 1:00pm30 mins

CASE STUDY: Innovation to Improve the IRT Site User Experience

1:05pm - 1:35pm30 mins

Take Confidence: Ensuring your IRT Remain Compliant in Global Trials

1:40pm - 2:10pm30 mins

CASE STUDY NEW FDA REQUIRMENTS: Moving from Software Validation to Computer Software Assurance