Day Two: Wednesday, August 14, 2024 - EST/EDT (Eastern Daylight, GMT-4)
Day Two: Wednesday, August 14, 2024 - EST/EDT (Eastern Daylight, GMT-4)
- Dive into key oversight areas critical to a robust enterprise-wide monitoring program
- Dissect top risk areas and discuss how to enhance risk mitigation across your organization
- Patrick Wallace - Global Head, Risk Management & Monitoring, argenx
- Tara Kennedy - Senior Director, Ethics & Compliance North America, Apellis
- Katie Schottmiller - North America Compliance Monitoring Lead, GSK
Examine how optimized partnerships between transparency and compliance monitoring enhances accurate reporting and increased compliance with regulatory requirements
Discuss pragmatic strategies for overcoming common interdepartmental pain points and streamlining the collaboration and communication between roles
- Andrea Jenner - Transparency Reporting Manager, CSL Seqirus
- Patricia McKernan - Global Compliance Transparency, Stryker
- Jennifer Parsons - Director, U.S. Transparency and Compliance Operations, Biogen
- Dana Neill - Associate Director, State and Federal Transparency, Eisai
- Delve into strategies to develop a comprehensive approach to optimize HCP engagement throughout the product lifecycle
- Examine best practices in streamlining the HCP engagement process regarding operations, TOVs, and open payment submissions, and educating colleagues and end users
- Dawn DiPierro - Associate Director, Global Compliance Operations, Insmed
- Melissa Cox Swanson - Senior Manager, Compliance and Ethics, iRhythm Technologies, Inc.
- Dev Khanna - Senior Manager, HCP Commercial Contracts, Regeneron
- Delve into the complexities of navigating fostering HCP relationships with regulatory uncertainties, prioritizing compliance with limited resources, and fostering a compliance culture from the outset
- Explore factors that are crucial for startups' long-term success and require innovative strategies tailored to their unique circumstances
- Elena Shturman - Compliance Expert, Ceribell, Inc.
- Discuss the fundamentals of building a robust reporting infrastructure that prioritizes data integrity and quality, including how to evaluate and improve current data reporting processes throughout the reporting lifecycle
- Explore current common challenges in data integrity and remediation and strategies to streamline
- Vanessa Henkelman - Manager, Aggregate Spend, Alcon Vision
- Caitlin Oroho - Associate Manager, Global Compliance, PTC Therapeutics, Inc.
- Uncover how manufacturers are streamlining global data reporting using local and global infrastructure
- Explore challenges in working with global data and the importance of global partnerships in optimizing accurate reporting
- Discuss best practices in how to identify and navigate aggregate spend pitfalls, including examining common challenges manufacturers face, and how to prioritize critical areas of focus you may be missing
- Explore how to structure and analyze your aggregate spend program to optimize monitoring and ensure compliance with regulations and prepare for a CMS audit
- Ihab Ghaly - Managing Director, G&M Health
- Discuss how manufacturers are handling the new payment context field in their reports in terms of what responses were populated, and examine the results of those submissions and if this impacted the number of disputes
- Examine audit readiness to learn if any companies are conducting analyses on dispute data, what kinds are records are being kept, and if any companies have changed their dispute resolution process
- Kelly Tope, Esq., MBA, JD - Head of USBU Ethics & Compliance Monitoring and Reporting Operations, Takeda
- Explore strategies for delivering comprehensive training to commercial teams to ensure thorough understanding of reporting protocols and regulatory mandates
- Learn how to implement effective follow-up processes to reinforce learning and encourage commercial teams to execute accurate and timely reporting
- Patrick Thibodeau - Senior Compliance Manager, Kyowa Kirin, Inc.
- Shannon Mason - Associate Director, Compliance Operations, Apellis Pharmaceuticals
- Analyze critical areas of focus in enhancing comprehensive monitoring of AI
- Discuss the potential future application and forward-looking strategies of AI implementation in compliance and transparency operations
Spending is inevitable. For Life Sciences organizations, it's increasingly challenging to maintain control and comply with all expenses due to the strictly regulated nature of the industry and today’s complex, global economy. Fortunately, technological advancements and new processes are enabling organizations to adapt and do more with fewer resources. In this session, you’ll learn about the latest trends, topics, and technologies that will help optimize your programs in the current times. Join SAP Concur as they delve into specific topics like artificial intelligence, modern HCP spend controls, and updated guidance on 'taxable employee benefits', and their relevance to the industry.
- Steph Phenix - Senior Solutions Consultant for Life Sciences, SAP Concur
- Kris Atwood - Senior Solutions Consultant for Life Sciences, SAP Concur
- Discuss the current industry standards and guidelines in establishing fair market rates, and common challenges manufacturers face (including cross-border transactions, data availability, etc.)
- Explore key factors and nuances to consider, and effective frameworks manufacturers must maintain to navigate these challenges and maintain compliance and integrity
- Discuss the diverse relationships between manufacturers and various types of HCPs (different types of providers and key opinion leaders, government-funded HCPs, teaching hospitals, etc.) and challenges in standardizing the reporting process
- Employ best practices and practical strategies to optimize reporting amongst diverse stakeholders and equip your reporting systems to address these common challenges and nuances
- Terri Redline, MSL, CCEP - Manager, Corporate Compliance Transparency Reporting, B. Braun Medical Inc.
- Explore the crucial role that data governance plays in providing a robust infrastructure and streamlined processes to enable transparency reporting
- Discover firsthand the journey of establishing a comprehensive transparency program, including challenges faced and lessons learned
- Uncover strategic approaches to incorporating your vision into every facet of your transparency program to ensure sustainability and resiliency
- Sepideh Moghadam - Head, Integrity & Compliance Global Strategy, Indivior
- Rawan Fusisi - I&C Global Transparency Head, Indivior
- Explore common challenges manufacturers face in the disclosure of payments to HCPs involved in speaker programs
- Discuss key considerations to enhance accurate reporting of HCPs and ensure compliance with regulatory requirements
- Learn best practices in communicating expectations and processes to third-party organizations to ensure efficien
- Jessica Constant - Associate Director, Commercial Excellence, Business Controls, AstraZeneca
- Uncover the key elements of a robust data analytics strategy and how to assess its utility and value
- Delve into critical considerations in building a data analytics strategy from the ground up and adapting it as needed
- Thomas Sullivan - Editor, Policy & Medicine
- Discuss key challenges in enhancing compliance in cross-border HCP engagements to ensure adherence to regulatory requirements
- Explore top risk areas associated with cross-border engagements such as kickbacks, transparency and off-label promotions, and the nuanced differences faced by manufacturers based on product type
- Bryan Stefanski - Compliance Director, North America, Siemens Healthineers USA
- Explore how to transition between and leverage advanced tools such as Power BI to level up data reporting processes, identify pain points and improve inefficiencies
- Uncover strategies to enhance monitoring efforts by employing these tools
- Explore current trends in the transparency and reporting space and how to adapt your function to keep pace
- Discuss how to navigate this emerging landscape through data analytics and systems optimization to keep up with the everchanging reporting requirements