September 29-30, 2026
Philadelphia, PA
Ensuring Compliance of your Promotional Review Operations in the Current Regulatory Environment
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7:45 AM
Networking
Registration and Networking Breakfast
8:45 AM
Opening
Co-Chairs Opening Remarks
Georgia Gayle
Director, Head of US Commercial Promotional Review & Marketing Operations · AstraZeneca
9:00 AM
Session
FDA Enforcement Trends: Warning Letters Not Slowing Down
Understand the Latest Enforcement Actions and How They Should Shape Promotional Review Strategy
- Analyze recent warning letters to identify recurring compliance gaps and high-risk promotional claims
- Translate enforcement trends into practical PRC guardrails and review checkpoints
- Apply proactive strategies to mitigate risk before materials reach regulatory scrutiny
Priya Karkhanis
Director, Regulatory Affairs Advertising and Promotion · Kyowa Kirin
Anthony Haddad
Associate Director, Promotion Compliance · Otsuka
9:45 AM
Session
Letters from the FDA: The Perfect Learning Opportunity
Invest Time into Internal Stakeholder Education, Explain and Show What the Warning Letters are Focusing On
- Deconstruct FDA warning and untitled letters to uncover root causes and preventable missteps
- Translate enforcement feedback into actionable improvements for PRC processes and decision-making
- Leverage real examples to strengthen internal training and elevate compliance standards across teams
Melissa Sadowski
Director, US Advertising and Promotion · EMD Serono
Dawn Castillo Harper
Supervising Counsel, Brand Strategy · Servier Pharmaceuticals
10:30 AM
Break
Networking Break
11:00 AM
Sponsor
Sponsor Session
11:45 AM
Session
Internal Risk Tolerance Assessment Due to Current Enforcement Activity
How Organizations Define, Communicate, and Operationalize Risk within PRC
- Assess how recent enforcement trends are reshaping organizational risk thresholds and decision frameworks
- Align cross-functional stakeholders on a consistent, clearly defined risk tolerance model within PRC
- Implement governance approaches to operationalize risk decisions and ensure consistent application across reviews
Heather McFalls
Director, Promotion Compliance · Otsuka
12:30 PM
Break
Lunch Break
1:30 PM
Session
Modernizing the PRC Process: Improving Speed, Clarity and Accountability
Address Review Timelines, Clearer Feedback, and Reviewer Role Definition
- Identify process bottlenecks to reduce review cycle times without compromising compliance
- Establish standards for clear, actionable, and consistent reviewer feedback
- Define roles, responsibilities, and governance to increase accountability across PRC stakeholders
Ana Rasack
Associate Director, Promotional Material Review Chair · Menarini Stemline
Leah Wood
Director, Regulatory Affairs · Vericel
2:15 PM
Panel
Perspective Panel: Learn from Everyone's Take on PRC/MLR
Hear from Marketing, Medical, Regulatory, Compliance and Legal Peers their Ideas and Experience with PRC/MLR
- Explore how each team experiences PRC/MLR and where friction impacts speed, creativity, and execution
- Identify opportunities to align individual objectives with overall expectations better
- Share practical approaches to improve collaboration, communication, and mutual understanding across teams
3:00 PM
Break
Networking Break
3:30 PM
Session
Scaling Promotional Pieces with Modular Content Strategies
Leveraging Modular Content to Accelerate Compliant Content Reuse
- Design modular content frameworks to enable faster creation and reuse of approved assets
- Align PRC review processes to support modular claims, components, and lifecycle management
- Maximize efficiency by reducing redundant reviews while maintaining compliance and consistency
4:15 PM
Interactive
Interactive Potluck Session 4.0
Ask our Expert Panel Members Questions Regarding any Aspect of MLR-PRC. We Will Collect Questions Throughout the Day and Then Have them Answered
- Feel free to ask any PRC/MLR-related question to our panel composed of regulatory experts from different companies
- Engage in this fun, quick-fire session that allows for extra content and great insights
- Interest in sharing challenges or recent setbacks to hear other perspectives? This session is ideal for you
Georgina Lee
Executive Director, Global Regulatory Labeling, Advertising and Promotion · Disc Medicine
Melissa Sadowski
Director, US Advertising and Promotion · EMD Serono
Larry Herring
Senior Director, Regulatory Affairs, Advertising & Promotion · Merz Aesthetics
5:00 PM
Closing
Day One Concludes
7:45 AM
Networking
Networking Breakfast
8:35 AM
Opening
Co-Chairs Recap of Day One and Welcome to Day 2
Georgia Gayle
Director, Head of US Commercial Promotional Review & Marketing Operations · AstraZeneca
8:45 AM
Interactive
Interactive Session: AI Tools and Prompting for PRC/MLR
Practical Approaches to Prompting AI Tools for Compliant, Useful Outputs
- Apply effective prompting techniques to generate compliant, review-ready content and insights
- Evaluate use cases where AI can enhance PRC workflows without introducing regulatory risk
- Establish guardrails and validation steps to ensure accuracy, consistency, and compliance of AI outputs
9:45 AM
Session
The Fine Line Between Scientific Exchange and Promotional Messaging
Managing the Unapproved Use Communications, Clarify, Identify and Differentiate
- Distinguish between scientific exchange and promotion to reduce risk in communications involving unapproved uses
- Apply regulatory frameworks to ensure appropriate handling of unsolicited requests and off-label discussions
- Implement internal guidelines to maintain consistency, control, and compliance across cross-functional teams
Georgina Lee
Executive Director, Global Regulatory Labeling, Advertising and Promotion · Disc Medicine
William Pezzolo
Senior Counsel, Commercial Law · uniQure
10:15 AM
Break
Networking Break
10:45 AM
Sponsor
Sponsor Session
11:30 AM
Session
Oh DAM! Optimization for Promotional Team
Improve Asset Governance, Accessibility, and Collaboration
- Optimize DAM systems to improve asset discoverability, version control, and compliance tracking
- Establish governance models to ensure consistent tagging, approval status, and lifecycle management
- Enable seamless collaboration across teams to accelerate content access and reduce duplication of effort
12:15 PM
Break
Networking Lunch
1:15 PM
Session
Direct-to-Consumer Promotion in the Social Media Era
Navigate Digital Channels While Maintaining Regulatory Compliance
- Navigate platform-specific risks to ensure compliant DTC engagement across social media channels
- Apply best practices for fair balance, risk disclosure, and real-time content moderation
- Develop governance models to manage user-generated content, comments, and adverse event reporting
Melissa Sadowski
Director, US Advertising and Promotion · EMD Serono
Ann Lee
Associate Director, Regulatory Affairs US Advertising and Promotion · Allergan Aesthetics
2:00 PM
Session
Metrics That Matter: Measuring PRC Effectiveness and Impact
Define and Track Performance Metrics that Improve Promotional Review Outcomes
- Identify KPIs that go beyond timelines to measure quality, consistency, and strategic impact of PRC decisions
- Build dashboards and reporting frameworks to track performance and drive continuous process improvement
- Leverage data insights to optimize workflows, resource allocation, and cross-functional alignment
Cara Gagliano
Senior Manager, PRC Operations · Former Radius Health
Leah Donohue
Manager, Promotional Review Operations · Supernus Pharmaceuticals
Rajvir Amin
Associate Director, Hematologic Malignancies, Medical Communications · Johnson & Johnson
2:45 PM
Closing
Day 2 Concludes
TWO COMMERCE SQUARE
2001 Market Street, Philadelphia, PA 19103
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