Tuesday, May 14th
9:00 – 9:15
Welcome
9:15 – 10:00
Product Overview, Vision, and Roadmap
CTO Max Kanevsky and product leaders present on the end-to-end platform, covering study build through TFLs and submission, including integration with Certara Cloud.
10:00 – 10:30
Regulatory Update
FDA and PMDA experts Michael Beers and Seiko Yamazaki present on implications of the latest changes from Health Authorities, including best practices for optimizing study data for global multi-agency submissions, with tips for emerging agencies NMPA, EMA, MFDS.
10:30 – 10:45
Break
10:45 – 11:00
Metadata Repository Exploration
Product leaders Erin Erginer and Darren Bill provide their first-hand experience of how integrated form design and study build truncates timelines toward SDTM via options for full automation for metadata-driven SAS programming.
11:15 – 12:00
Customer Spotlight - Using ryze for study automation, from start to finish
12:00 – 12:30
Feedback session breakouts
Pick your booth. Visit our live support desk for troubleshooting bugs and/or our product design usability testing to improve the user experience of our next release.
12:30 – 1:00
Networking Lunch
Enjoy a meal while engaging with industry peers and representatives from Certara.
1:00 – 1:45
Integrations: P21E, Formedix ryze, Certara Cloud
Head of Certara Cloud, Phillip Johnston, presents how Certara’s increasingly unified platform simplifies user and asset management, and allows cross-study and cross-product insights to emerge.
1:45 – 2:15
Expert Discussion Panel
Try to stump our product SME and engineering experts with your most challenging edge cases, standardization ambiguities, techniques for process change.
2:15 – 3:00
Customer Spotlight - An Approach to SDTM and ADaM Programming
3:00 – 3:15
Break
3:15 – 4:00
Stack Rank Your Pain Points
Add to our pre-event survey of client requests, discuss in small groups with our experts which problems’ solutions would have the highest ROI for your organization and the industry.
4:00 – 4:45
From Forms to SDTM: Acceleration Approaches
4:45 – 5:00