Day Two - EST/EDT (Eastern Daylight, GMT-4)
Day Two - EST/EDT (Eastern Daylight, GMT-4)
- Shane White - Product Owner, HCP Engagement, Porzio Life Sciences
During this opening session, level set with an overview of critical trends related to HCP interactions and engagement, review the overall risk environment and regulatory frameworks. Uncover and utilize key learnings throughout the track sessions.
- Shane White - Product Owner, HCP Engagement, Porzio Life Sciences
- Tracy Redondo - Chief Compliance Officer, Integra LifeSciences
- Share best practices for data collection and reporting
- Discuss the roadblocks overcome by your organization and concerns for data submissions
- Caitlin Oroho - Associate Manager, Global Compliance, PTC Therapeutics, Inc.
- Christine Fernandes - Head of Global Payment Transparency, AstraZeneca Pharmaceuticals
- Gus Papandrikos - Executive Director, Daiichi Sankyo
- Review recent CIAs to uncover emerging risk areas needing oversight
- Benchmark and share effective strategies to overcome and remediate risk
- Create an innovative, cost-sensitive, and collaborative in-person/virtual/hybrid approach for traditional monitoring activities (field ride, speaker program, advisory board etc.)
- Utilize data analytics to your advantage as part of an innovative auditing approach for transactions involving HCPs
- Understand the importance of establishing a strong relationship and open communication to ensure strong compliance support with the initiative to be unique and forward-thinking in HCP engagement strategies
- Discuss how teams work cross-functionally and determine which departments/roles own certain processes
- Debbie Macolino - Assistant Director, Compliance, Ionis Pharmaceuticals, Inc.
Key questions and areas covered include:
- Why is FMV important?
- How to Select?
- Why?
- Who fits where? Exceptional vs U.S. vs. Regional
- Who reviews the options? Who (what department) is in the process?
- Criteria for leveling
- CV review vs. a high school resume
- External data sources
- Virtual vs. live events
- Handling HCP disputes “I’m worth way more than that!”
- Bill Friedrich, MBA - Associate Director, Compliance, Hikma Pharmaceuticals
- Discuss assumptions documents, policy and SOP building
- Assess training and documentation (who is managing and building this)
- Nicole Colapietro - Manager, HCP Engagement & Transparency Reporting, Arthrex
- Dannielle Cartwright - Manager, Global Transparency & Data Privacy, Corporate Ethics & Compliance, Henry Schein, Inc
- Vicki Bouchat - Director, Global Payment Transparency, AstraZeneca Pharmaceuticals
- Create standardized processes for data collection, validation, and verification
- Integrate data and utilize automation
- Utilize third parties (internal and external) for data review
- Kelly Tope, Esq., MBA, JD, USBU - Ethics & Compliance Lead, Monitoring, Transparency and Samples, Takeda
Now more than ever, life sciences organizations need to be prepared for the increasing industry demands of today’s highly regulated, global economy. In this session:
- Hear about what tools you can use to make it easy for both employees and your organization to stay compliant with the ever-changing global transparency regulations
- Apply solutions that can help life sciences organizations simplify HCP spend tracking
- Wendy Sward - Principal Value Engineer, SAP Concur
- Amanda Owen - Senior Solutions Consultant, SAP Concur
- Highlight new technologies and next generation approaches to identifying and consolidating key risk areas
- Assess current controls and consider forward-thinking capabilities to prevent risk
- Enhance and refine assessments to prioritize risks and resources
- Rethink the approach to HCP engagement
- Translate the idea of omnichannel engagement into practical and actionable insights
- Benchmark with peers on PhRMA code guidelines and OIG guidance
- Assess practical approaches for managing compliance risk
- Share best practices for achieving compliant speaker programs
- Streamline processes to improve efficiency by analyzing transparency data
- Using data Insights to identify areas of improvement
- Hear examples of transparency data insights for Sunshine reporting
- Benefit from case studies demonstrating how transparency data insights can be applied
- Identifying high-risk HCPs or organizations
- Paul Steele - Director, Transparency Reporting,, Sumitomo Pharma America Holdings, Inc.
- Rajiv Shah - Director, Global Compliance Spend Transparency, Monitoring, & Analytics,, EQRx
- Kseniia Kipot - Senior Compliance Manager, E&C,, Otsuka
- Entering the global transparency arena is daunting - hear considerations for how to be prepared and know what your obligations are and when they are triggered
- Is your team separated by multiple time zones and source systems? Learn about the best practices for ensuring your data is properly collected and sent to the correct stakeholders
- Elan Schefflein - Senior Compliance Advisor,, MedPro Systems, LLC
- James Dawson - Vice President, Compliance Solutions,, qordata
- Connect data points to create a holistic view of monitoring activities and risk areas with the help of machine learning
- Utilize technological efficiencies to draw conclusions and synthesize insights
- Kshitij Aggarwal - Manager, Compliance Operations & Transparency Reporting, Alexion Pharmaceuticals
Participate in a live benchmarking survey of new and emerging issues around HCP engagement and transparency, including topics such as rep licensing and related transparency obligations (e.g., Oregon sales rep licensing and disclosure), HCP meal limits, HCP compensation caps, speaker program planning and execution, virtual interactions, Open Payments audit preparation, among other issues. Attendees will be asked to participate in a live benchmarking survey and related discussion of the issues.
- Brian Bohnenkamp - Partner, FDA and Life Sciences Practice,, King & Spalding LLP
Connect with fellow compliance and transparency experts to share experiences and benchmark common challenges. With a specific survey conducted prior to the meeting, attendees will level-set their experiences, share top-of-mind pain points and areas of interest. Facilitators will prepare key topics of discussion and carefully review survey insights 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 company. Informa Connect reserves the right to qualify participants for this Summit. To reserve your seat, email Caitlin.Murgia@informa.com
- Kelly Tope, Esq., MBA, JD, USBU - Ethics & Compliance Lead, Monitoring, Transparency and Samples, Takeda
- Patrick Wallace - Associate Director, Compliance, Global Transparency, Argenx