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Day Three - EST/EDT (Eastern Daylight, GMT-4)
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Day Three - EST/EDT (Eastern Daylight, GMT-4)
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Free / Premium
8:00am - 8:30am
Networking Continental Breakfast
8:30am - 8:45amFree
Co-Chairs’ Review of Day One and Two
- Shane White - Product Owner, HCP Engagement, Porzio Life Sciences
- Tracy Redondo - Chief Compliance Officer, Integra LifeSciences
8:45am - 9:30amFree
State Transparency Showcase and Tracker – Journey Through New and Unique Requirements Across the Nation
9:30am - 10:15amFree
Drug Pricing Legislation and Price Transparency Reporting
- Discuss the current drug pricing transparency environment impacting the industry
- Examine key state drug pricing reporting law requirements
- Address best practices for monitoring the evolving drug pricing landscape
10:15am - 10:45am
Networking and Refreshment Break
10:45am - 11:30amFree
Stakeholder Spotlight Session—HCP Fireside Chat
- Discover best practices for collaboration
- Establish mutually beneficial relationships with HCPs
- Understand, from first-hand experience, what works well and what can be improved upon to maximize value
- Thomas Sullivan - Editor, Policy & Medicine
11:30am - 12:15pmFree
CCO Luminary Panel— The Top 10 Items on Their Radar and Why They Should be on Yours
12:15pm - 1:15pm
Networking Luncheon
1:15pm - 2:00pmFree
Best Practices for Preparing for a CMS Audit
- Review the audit process and what industry could/should expect
- Share insight into the recent pilot audits
- Create an audit playbook to ensure compliance
- Gus Papandrikos - Executive Director, Daiichi Sankyo
2:00pm - 3:00pmFree
Spotlight on R&D Transparency
Key topics include:
- Global research overview and importance (including CMS requirements for transparency related to research)
- Global studies and sites contracted to and run by multiple CROs
- Third-party vendor for CRO transparency submissions
- Leveraging Clinical Reference Data (CRD) for consistent reporting (MDM)
- CRO Reviews – check for completeness and accuracy of transparency data submitted
- Research sub-certification – prior to CMS submission
- Research database dashboards
- CMS dashboard for research sub-certification
- Financial transparency dashboard for the CRO Reviews
- Research delays
- MMSEA adverse event process and reporting requirements
- Beth Baker - Senior Manager, Financial Transparency, Global Clinical Operations, Biogen
3:00pm - 3:05pm
Close of Conference
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