Agenda - 2026 Day 3 Agenda | Pharmaceutical Compliance Congress (PCC) 2026

Key Sessions

Brook Mishler

Transforming Compliance Data into a Strategic Asset - Macro Trends and Outlier Patterns

CaseIQ

James Stansel

PhRMA (Pharmaceutical Research and Manufacturers of America) Address

PhRMA

2026 Day 3 AgendaWednesday, 29 April 2026 - ET (Eastern Time, GMT-05:00)

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Registration

7:30am - 8:30am

Conference Registration and Continental Breakfast

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Topic Intensive A

Topic Intensive B

Topic Intensive C

8:30am - 9:25am

Pillars on Shifting Ground: Executing a Resilient Compliance Program

OIG Guidance: Summary of 7 Elements
Pillar 1: Establishing a Firm (Governance) Foundation
- Value of a Compliance Assessment/Gap Analysis
- Prioritization of Needs
- Size, culture, past experience with government agencies
- Algorithmic Auditability
- The Independent CCO
Pillar 2: Stabilizing the Human Element
- Training from top-bottom
- Behavioral Diagnostics
- Enforcement with Equity
Pillar 3: Real-Time Reinforcement—Auditing, Monitoring & Due Diligence
- Continuous Monitoring as a Safety Net
  - Built in processes
  - Creating a "speak up culture" so employees are comfortable reporting or raising compliance concerns/issues
- M&A-Stress Testing
Pillar 4: The 120-Day Race to Resolution
- Hotline Trust in a High-Stakes Era
- Strategic Disclosure

David Fisher - President, TDI Solutions
Sara Simon - Compliance Director, Legal Affairs and Compliance, IBSA USA
Catherine Kaucher - Health Care Compliance Director, Johnson & Johnson

9:25am - 10:20am

Commercial Risks in Patient Support Programs

How businesses co-ordinate patient support and the relationship between commercial teams and patients
Examining different roles engaging with patients including Nurse Educators, Patient Education Liaison, and Patient Advocacy groups
Practical compliance considerations for Patient Speaker programs and Patient Ambassador Program
Examining differing approaches on transfer of value in meals, speaker honorarium etc
Internal guidelines and spend for patients, and practical questions such as if alcohol is allowed etc?

Eliza Andonova - Partner, Global Regulatory, Hogan Lovells
Brian Sharkey - Head of NA, Compliance and Ethics, Teva Pharmaceuticals

8:30am - 9:25am

Navigating Data Privacy: What Compliance Professionals Need to Know

Privacy essentials for pharmaceutical companies
How do you set up privacy programs considering the varying privacy requirements and an ever-changing landscape?
As privacy considerations grow for your business, where does it sit and how do you operationalize it? Compliance vs. Legal department vs. independent privacy officer?

Erin Wagenberg - Director, Dovetail Consulting Group
Danielle Green - Senior Director, Legal & Compliance, Savara
Laurie Kathleen Durousseau - Vice President, Legal, Chief Compliance & Privacy Officer, GRAIL

9:25am - 10:20am

Embedding Compliance into Organizational Culture

Understanding the DOJ and FCPA focuses for compliance culture
How do you measure the culture of compliance?
How to cultivate a culture of Compliance
How do you become ‘the voice’ of Ethics and Integrity in your organization?
Ethical conduct with compliance – understanding group think, deviance etc

Carrie Amezcua - Shareholder, Buchanan
Elizabeth Weiss - Vice President, Chief Compliance and Privacy Officer, Invivyd
Maria Villanueva - Director, Ethics and Compliance, BioTissue

9:25am - 10:20am

Navigating Social Media

Fundamentals of a social media policy
What are your guardrails and parameters on influencers
Social media personalities and FMV
Commercial teams on social media: where is the line when posting, liking and reposting?
How do you monitor social media? 3^rd party? Monitoring via AI?
Global risks e.g. EU /ABHI

Kathleen Boozang - Professor of Law and Dean Emeritus, Seton Hall Law School
Derek Frueh - Head of NA Compliance & Canadian General Counsel, Leo Pharma
Amy Wilson - Vice President, Chief Compliance Officer, Esperion Therapeutics

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Networking

10:20am - 10:50am

Networking Break

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Main Stage

10:50am - 11:40am

Transforming Compliance Data into a Strategic Asset - Macro Trends and Outlier Patterns

How are you supporting the business with your compliance data?
Shifting the perception of compliance data from a regulatory obligation to a tool for driving business performance and protecting enterprise value.
Utilizing analytics to demonstrate how compliance initiatives contribute to operational success.
How to share compliance data effectively across teams, including sales and commercial, with clear purposes and transparency.
Can compliance data help identify macro trends and areas requiring attention: connecting compliance softness and performance.

Brook Mishler - Global Director Compliance Solutions - Life Sciences, CaseIQ
Marcus Green - Vice President, Risk Analytics and Monitoring, GSK
Piyush Sharma - Chief Ethics & Compliance Officer, Alnylam Pharmaceuticals
Daryl Kreml - Head of Ethics and Compliance, Takeda Oncology

11:40am - 12:20pm

Transparency Reporting: Centers for Medicare & Medicaid Services (CMS) Open Payments Program

Developments in audits: are we going to see more scrutiny in what companies are doing? What do we need to be doing differently going forward?
Data insight: how do regulators and investigators use the data? How can companies ensure they know what is in the data and what should they expect regulators to know about their data?
New enhancements and developments on the horizon

Amy Bedsaul - Open Payments Communications, Centers for Medicare & Medicaid Services (CMS)
Kathleen Ott - Compliance and Policy Lead for Open Payments, Centers for Medicare & Medicaid Services (CMS)
Veronika Peleshchuk Fradlin - Director of Division of Transparency Projects (DTP), Centers for Medicare and Medicaid Services (CMS)

12:20pm - 12:50pm

The Ripple Effects of a Shifting Payer Landscape on Compliance

Impact of recent legislative and administrative developments on drug pricing, reimbursement, and access
PBMs on shaky ground: examining the instability of Pharmacy Benefit Managers and its implications for the healthcare ecosystem
Rebates and Pharma Impact: understanding how rebate changes will primarily affect pharmaceutical companies and spill over into the medical device sector via GPOs
Implications of provider sector challenges: consequences of rising premiums and the growing physician exodus as the provider sector reaches a tipping point
Industry-wide implications: highlighting how the evolving payer and provider dynamics directly impact Life Sciences companies and their stakeholders

Meena Datta - Healthcare & Life Sciences Co-Chair, Executive Committee Member, Sidley Austin LLP

12:50pm - 1:20pm

PhRMA (Pharmaceutical Research and Manufacturers of America) Address

Impact of recent legislative and administrative developments on drug pricing, reimbursement, and access.

James Stansel - Executive Vice President, General Counsel and Corporate Secretary, PhRMA

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Close of Day

1:20pm - 2:20pm

Close of Conference