Day Three: Thursday, August 15, 2024 - EST/EDT (Eastern Daylight, GMT-4)
Day Three: Thursday, August 15, 2024 - EST/EDT (Eastern Daylight, GMT-4)
- Shane White - Director, HCP Engagements & Compliance, RLDatix
- Jennifer Mac Neil - Senior Director, Compliance Operations, Eisai Inc.
Participate in this facilitator-led interactive working group dedicated to exploring the CMS audit process. The goal of this session is to provide manufacturers with critical insights and practical experience to navigate a CMS audit. During the session, attendees will develop a deeper understanding of an audit by breaking down the process and identifying key risk areas to prioritize.
- Insights into the audit selection process and what manufacturers need to know to prepare
- Walk through the CMS audit process to gain a deeper understanding of what to expect
- Understand the after effects of the CMS audit on your organization and compliance/transparency function
- Brian Bohnenkamp - Partner, FDA & Life Sciences, King & Spalding
- Jonathan Wilkenfeld - President, Potomac River Partners
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
- 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.
Join forces with your peers to tackle complex transparency and compliance monitoring scenarios based on real-world industry challenges. Attendees will submit scenario suggestions prior to the conference and the top scenarios will be chosen to solve during this facilitator-led interactive session. Attendees will leave this session armed with new strategies, best practices and key takeaways through this unique, collaborative problem-solving session.
- Elena Shturman - Compliance Expert, Ceribell, Inc.
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