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DAY TWO - EST/EDT (Eastern Daylight, GMT-4)
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DAY TWO - EST/EDT (Eastern Daylight, GMT-4)
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8:20am - 8:30am10 mins
Practical Data Challenges
Chairperson’s Opening Remarks
8:30am - 9:30am60 mins
Practical Data Challenges
SPONSOR BENCHMARKING SESSION: Practical Data Challenges
- Kyle Rader - Principal IXRS Analyst, Vertex Pharmaceuticals, USA
- Haneen Mazahreh-Boivert - Senior Director, Global Clinical Supply, Optinose
- Jeff Discenza - Associate Director, Randomization & Trial Supply Management, Janssen
- David Morin - Director of Research, Holston Medical Group, USA
9:30am - 10:05am35 mins
Practical Data Challenges
KEYNOTE CASE STUDY: Meeting Regulatory Requirements for IRT
10:05am - 10:35am30 mins
Networking Break
10:35am - 11:10am35 mins
Efficiencies, KPIs, UAT, Governance and Validation
CASE STUDY: Leveraging IRT Data to Drive Clinical Supply Efficiency
- Senior Representative, Suvoda
11:10am - 11:45am35 mins
Efficiencies, KPIs, UAT, Governance and Validation
CASE STUDY: Creating Efficiencies in Day-to-Day IRT Activities
- Senior Representative, Atreo.io
11:45am - 1:15pm90 mins
Networking Lunch
1:15pm - 1:30pm15 mins
CASE STUDY: How to Get the Best from UAT
- Alex Ayres - UAT Consultant, Poxy Clinical
1:30pm - 2:05pm35 mins
CASE STUDY: Best Practice and New Models for IRT User Acceptance Testing (UAT)
- Rob Delaney - Associate Director, Clinical Supply Systems, Regeneron
2:05pm - 2:40pm35 mins
CASE STUDY: Creating IRT Standards and KPIs
- Maria Napoliello Humagain - Senior Manager, IRT Systems, Beigene, China
2:40pm - 3:10pm30 mins
Networking Break
3:10pm - 3:45pm35 mins
CASE STUDY: Vendor Governance and KPIs
3:45pm - 4:45pm60 mins
SPONSOR BENCHMARKING SESSION: How are sponsors organizing their Standards, UAT, and Governance?
- Maria Napoliello Humagain - Senior Manager, IRT Systems, Beigene, China
- Jeff Discenza - Associate Director, Randomization & Trial Supply Management, Janssen
- Rob Delaney - Associate Director, Clinical Supply Systems, Regeneron
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