Wednesday, August 13th, 2025 - Day 2 - EST/EDT (Eastern Daylight, GMT-4)
- Deep dive into the complete lifecycle of HCP engagements, identifying key challenges and risk areas at each stage
- Discuss the critical role of needs identification and strategic planning in aligning engagement strategies with compliance requirements, including effective stakeholder communication
- Explore strategies for addressing system gaps, enhancing documentation, improving processes, and tracking recurring issues to mitigate potential risks
- Terri Redline - Manager, Corporate Compliance Transparency Reporting, B. Braun Medical Inc.
- Maria Villanueva - Head of Compliance, BioTissue
- Navigate the complexities of global HCP engagement by defining cross-border engagements and understanding the critical differences between global and local needs assessments
- Discuss the benefits of integrated management of nominations, contracting, closeout, audit trails, and invoicing, and the importance of flexibility of systems and the need for localization
- Maximize efficiency and compliance by exploring the opportunities and challenges of integrating HCP engagement and transparency systems, including implementing a unified platform for in-country and cross-border activity approvals and the benefits of source data integrations
- Erin Vales - Principal Consultant, Cresen Solutions
- Jacob Wolf - Associate Director of Delivery, Cresen Solutions
- Dawn DiPierro - Director, Global Compliance Operations, Insmed
- Explore how to transition from basic monitoring data and investigations to prescriptive and predictive analytics for proactive compliance
- Focus on real-world applications of AI and data analytics in compliance monitoring, with case studies from companies successfully implementing these strategies
- Discuss the advantages and potential pitfalls of using AI in monitoring, including successful implementation examples and instances of unnecessary complexity
- Jim Dawson - Vice President, Compliance Solutions, qordata
- Roberta Rima - Vice President, Global Compliance Audit, Monitoring, Analytics, Zimmer Biomet
- Eren Efe - Associate Director, Risk & Compliance Analytics and Monitoring, Becton Dickinson
- Discuss how to develop and implement comprehensive training strategies for all field-based colleagues (sales, medical affairs, and other commercial roles) to ensure accurate HCP interaction reporting and compliance with internal policies and external regulations
- Explore strategies to simplify complex reporting requirements and compliance messages, providing clear guidance and practical examples to enable all end-users engaging with HCPs to understand and effectively execute accurate reporting practices
- Establish ongoing training and reinforcement programs for field teams, leveraging technology and real-world scenarios, to maintain consistent adherence to reporting and compliance standards
- Shelley L. Hays-Fisher, RN, BSN - Director, Ethics and Compliance, Alnylam Pharmaceuticals
- Learn to effectively capture and categorize diverse spending related to clinical trials, including investigator payments, research grants, and associated expenses
- Discover optimal strategies for data collection and validation to minimize errors and ensure precise reporting of clinical trial expenditures
- Beth Baker - Senior Manager, Financial Transparency, Biogen
- Explore practical techniques to maximize data accuracy and integrity, critical for achieving reliable spend reporting
- Learn proven strategies for identifying and resolving data inconsistencies, including robust data audits, optimized systems, and streamlined processes, to guarantee complete and accurate aggregate spend submissions
- Focus on the hands-on application of data quality controls and validation techniques to enhance the integrity of reported data
- Patrick Thibodeau - Senior Compliance Manager, Kyowa Kirin, Inc.
- Caitlin Oroho - Associate Manager, Global Compliance, PTC Therapeutics, Inc.
- Kseniia Kipot - Associate Director, Transparency & Aggregate Spend, Otsuka Pharmaceutical
- Stacy Parr-Paskali - Lead, Transparency Operations, Takeda
- Explore methodologies for ensuring consistent and transparent FMV rates across international operations
- Learn how accurate FMV assessments support regulatory adherence and how to reduce potential compliance issues within HCP engagements
- Discover best practices and tools for streamlined FMV management, including effective engagement with HCPs and regulatory bodies
- Review real-world examples of successful FMV rate refresh implementations and any lessons learned
- Matt Zebley - Senior Manager, Compliance & Transparency, Incyte Corporation
- Discuss key compliance challenges with cross-border HCP engagements to ensure adherence to regulatory requirements
- Explore top risk areas associated with working with international HCPs such as kickbacks, transparency and off-label promotions, and the nuanced differences faced by manufacturers based on product type
- Bryan Stefanski - Senior Compliance Director, North America, Siemens Healthineers USA
- Ashley McQuaide - Global Compliance Business Practices Officer, Teleflex
- Focus on strategies for effective compliance in Life Sciences organizations & learn methods to streamline regulatory reporting
- Uncover common issues and practical approaches & empower your organization with tools and knowledge for better compliance processes
- Kris Atwood - Senior Solutions Consultant for Life Sciences, SAP Concur
- Steph Phenix - Senior Solutions Consultant for Life Sciences, SAP Concur
- 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.
- Navigate varying international regulations to adapt reporting programs and develop a unified global data framework for consistent compliance
- Address global compliance risks, prepare for audits (including emerging requirements), and optimize global program structure, including HCP engagement and transparency systems
- Gain insights into the complexities of speaker programs and other cross-border interactions with HCPs
- A walkthrough of the aggregate spend reporting process, from legislative preparation to report submission to dissecting common challenges facing manufacturers
- Learn how to identify and mitigate hidden risks preceding and throughout the reporting process, such as fragmented data sources, inconsistent HCP/HCO identifiers and shifting state and federal regulations
- Uncover reliable strategies to streamline your reporting processes, enhance overall reporting accuracy and reduce compliance risks
- Amir Ayad - Vice President, Compliance and Transparency Reporting, G&M Health
- Alexander MacDonald, JD - Compliance Research Associate, Team Lead, G&M Health
- Examine the spectrum of HCP engagement models, including advisory boards, consulting arrangements, and medical/commercial speaker engagements outside of formal speaker programs, pinpointing each’s unique compliance considerations
- Establish best practices for monitoring and documenting diverse engagements, with a focus on fair market value determination, conflict of interest management, and precise transparency reporting
- Formulate strategies to ensure consistent compliance across all HCP interactions, adapting to evolving regulations and industry best practices while fostering ethical and transparent relationships
- Chrissy Bradshaw - Senior Director, Brand and Compliance Counsel, Rocket Pharma
- Micah Ackerman - Associate Director, Compliance, Eisai Inc.
- Scrutinize the latest regulatory guidelines for speaker program compliance and synthesize lessons learned from the Biohaven lawsuit and other pertinent cases
- Discuss essential controls companies utilize to evaluate speaker program risk in light of recent legal developments, and explore best practices for proactive documentation, particularly when engaging third-party vendors, to ensure audit readiness
- Stephanie Macholtz - Vice President, Healthcare Compliance, Organogenesis
- Unpack the unique challenges and critical considerations of global monitoring interactions between US-based and ex-US entities
- Master how to effectively align and implement compliance initiatives across diverse jurisdictions, ensuring consistent monitoring and adherence to varying regulatory requirements
- Denis Jacob - Ethics & Compliance Business Partner, Henry Schein
Join this interactive breakout session to gain targeted insights and practical solutions to elevate your monitoring program. This session is tailored to address specific monitoring challenges by company size: Small/Mid-Sized Companies and Large Companies.
For Small/Mid-Sized Pharma:
- Explore effective monitoring strategies within resource constraints, including first-line monitoring and vendor utilization
- Discover methods to enhance messaging, communication and training to secure organizational and leadership buy-in
- Learn how to design and scale a right-sized monitoring program, benchmarking against peers' successful approaches
For Large Pharma:
- Benchmark on the tools and strategies large companies employ to monitor travel and entertainment (T&E) expenses
- Discuss strategies to optimize a risk-based monitoring approach to efficiently manage high volumes of data
- Jennifer Parsons - Director, U.S. Transparency and Compliance Operations, Biogen
- Emily Cunningham - Associate Director, Compliance, Ultragenyx Pharmaceutical Inc.
- Gain a deep understanding of the aggregate spend data pipeline, from initial capture to final reporting, and identify critical bottlenecks in the flow
- Learn how to connect disparate systems and departments, fostering collaboration and ensuring seamless data flow across the entire reporting lifecycle
- Discover proven methods for pinpointing and resolving data flow issues, leveraging upstream insights to optimize your reporting processes and prevent costly errors
- Jason DiPietro - Senior Manager, Compliance Data Analytics and Transparency Reporting, Lundbeck US
- Inge Tham - Senior Manager, HCP Transparency Reporting, Edwards Lifesciences
- Robert Gooltz - Manager, Aggregate Spend, Global HCP Transparency Program, Center of Excellence, Fresenius Medical Care
Join interactive roundtables designed to address the most pressing challenges faced by transparency and aggregate spend professionals. Rotate through focused discussions on key topics, collaboratively sharing best practices and developing actionable solutions. This dynamic session will provide targeted strategies to optimize your reporting processes through knowledge exchange.
- Terri Redline - Manager, Corporate Compliance Transparency Reporting, B. Braun Medical Inc.
- Stacy Parr-Paskali - Lead, Transparency Operations, Takeda
- Chrissy Bradshaw - Senior Director, Brand and Compliance Counsel, Rocket Pharma
Participate in role-specific roundtables designed to tackle scenarios based on real-world examples in transparency reporting, monitoring, and HCP engagement. Facilitated discussions will guide you through practical exercises, enabling you to apply key learnings from the conference and leverage peer expertise to develop effective solutions. This highly interactive session provides a unique opportunity to refine your problem-solving skills and simulate real-life challenges.
Role Types:
- HCP Engagement
- Compliance Monitoring
- Transparency/Aggregate Spend Reporting
- Roberta Rima - Vice President, Global Compliance Audit, Monitoring, Analytics, Zimmer Biomet
- Micah Ackerman - Associate Director, Compliance, Eisai Inc.
Designed for senior-level compliance and transparency experts, this session offers a unique opportunity to engage with peers and benchmark common challenges through shared practical experiences. Participants will collaboratively identify key pain points and areas of interest, shaping a tailored discussion led by expert facilitators. This interactive knowledge exchange fosters open collaboration and provides valuable insights for seasoned professionals.
*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.
- Dawn DiPierro - Director, Global Compliance Operations, Insmed
- Peter Christopulos - Senior Director, Global Transparency Reporting, Johnson & Johnson