Day Three: Thursday, August 15, 2024 - EST/EDT (Eastern Daylight, GMT-4)
- John Oroho, JD - Senior Advisor, Global Life Sciences – RLDatix Life Sciences; Of Counsel - Porzio, Bromberg & Newman, PC., RLDatix Life Sciences
- Jennifer Mac Neil - Senior Director, Compliance Operations, Eisai Inc.
Experience an in-depth, multi-stakeholder examination dedicated to exploring the Open Payments audit process. The goal of this session is to provide manufacturers with critical insights and practical experience to navigate an Open Payments audit from the perspectives of integral stakeholders. During the session, attendees will develop a deeper understanding of an audit by breaking down the process and identifying key risk areas to prioritize.
- Walk through a mock Open Payments audit process and scenario to gain a deeper understanding of what to expect
- Understand the potential after effects of an Open Payments audit on your organization and compliance/transparency function
- Brian Bohnenkamp - Partner, FDA & Life Sciences, King & Spalding
- Jonathan Wilkenfeld - President, Potomac River Partners
- James Accumanno - Vice President, Legal & Chief Compliance Officer, Karyopharm Therapeutics
- Uncover critical foundational steps in creating an Open Payments audit readiness plan and incorporating integral team members
- Explore from the manufacturer perspective key strategies to create, assess, and strengthen audit readiness to prepare for potential Open Payments audits
- Matt Zebley - Senior Manager, Compliance & Transparency, Incyte Corporation
Highlight critical insights and updates based on the updated OIG guidance
Navigate emerging high-risk areas garnering enhanced oversight within the organization
Share strategies to prioritize proactive risk mitigation to fortify compliance programs and stay on the pulse of evolving compliance needs
Explore innovative strategies for collaborating with business partners
Discuss the use of data analytics and artificial intelligence in assessing operational risks and advancing the business
- John Oroho, JD - Senior Advisor, Global Life Sciences – RLDatix Life Sciences; Of Counsel - Porzio, Bromberg & Newman, PC., RLDatix Life Sciences
- Karen Lowney - Head of the Office of Ethics & Compliance (OEC), Sun Pharmaceutical Industries, Inc.
- Jennifer McGee - Senior Vice President & Global Chief Compliance Officer, Otsuka Pharmaceutical Development & Commercialization, Inc.
Engage in live, in-person polling with transparency and compliance monitoring industry peers to benchmark on key challenges and current priorities.
- Valerie Burkholder - Experienced Manager, Baker Tilly
Connect with fellow compliance and transparency experts to share experiences and benchmark common challenges. Attendees will level-set their experiences, share top-of-mind pain points and areas of interest. Facilitators will prepare key topics of discussion to tailor the dialogue. Take part in this critical, interactive knowledge exchange in an open, collaborative format.
*This summit is an exclusive, senior-level benchmarking discussion. Attendees should have a minimum of 5 years’ experience in compliance and transparency, and be currently employed at a bio/pharmaceutical or medical device manufacturer. Informa Connect reserves the right to qualify participants for this Summit. To reserve your seat, please email aiko.laski@informa.com.
- Kelly Tope, Esq., MBA, JD - Head of USBU Ethics & Compliance Monitoring and Reporting Operations, Takeda
- Nicole Colapietro - Manager, HCP Engagement & Transparency Reporting, Arthrex