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Thursday, August 14th, 2025 - Day 3 - EST/EDT (Eastern Daylight, GMT-4)
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Thursday, August 14th, 2025 - Day 3 - EST/EDT (Eastern Daylight, GMT-4)
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Free / Premium
Showing 1 of 1 Streams
Networking Break
8:15am - 8:45am
Networking Breakfast
Showing 1 of 1 Streams
General Session
Free 8:45am - 9:00am
Chair's Day Three Remarks
- Dawn DiPierro - Director, Global Compliance Operations, Insmed
9:00am - 10:00am
Exploring Open Payments Enforcement – Practical Strategies and Evolving Trends
- Analyze the current Open Payments enforcement landscape, including recent audits and settlements, to examine real-world consequences and understand potential penalties
- Discuss the evolving regulatory approach, including the complexities of speaker program reporting and the implications of recent settlements
- Develop practical strategies for risk mitigation, drawing on insights from recent cases and anticipating future enforcement trends
- Brian Bohnenkamp - Partner, FDA & Life Sciences, King & Spalding
Showing 1 of 1 Streams
Networking Break
10:00am - 10:30am
Networking & Refreshment Break
Showing 1 of 1 Streams
General Session
Free 10:30am - 11:30am
Manufacturer Fireside Chat – Lessons Learned from Undergoing a CMS Audit
- Gain firsthand knowledge from manufacturers who have navigated CMS audits, covering preparation strategies, the audit process itself, and post-audit takeaways
- Understand the specific audit areas of focus and glean key lessons on assumptions and process details directly from those who have experienced it
- Learn practical steps to prepare your organization for potential audits and identify critical risk areas to avoid outlier status
- Brian Bohnenkamp - Partner, FDA & Life Sciences, King & Spalding
- Jonathan Wozniak - Head of Global Transparency Reporting, Daiichi Sankyo, Inc.
11:30am - 12:30pm
CCO Spotlight Fireside Chat
- Explore strategies for navigating the growing complexity of state, national, and global regulatory environments
- Discuss how to leverage data from reporting and HCP engagements for enhanced monitoring, and analyze the opportunities and risks of AI and machine learning on compliance
- Delve into updated considerations for auditing and monitoring practices to effectively mitigate risk in today's landscape
- Jenny McVey, PhD - Former Lead Compliance Risk Management, Novo Nordisk; Adjunct Professor, Fordham Law School; Former NA Compliance Officer, (Formerly) bioMerieux, Inc.
- Timothy Roberts - Global Chief Compliance Officer, Legend Biotech
- Jonathan Turner - Vice President, Chief Ethics & Compliance Officer, Avanos Medical
12:30pm - 12:35pm
Chair’s Closing Remarks and Close of Conference
- Dawn DiPierro - Director, Global Compliance Operations, Insmed
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