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Uncertainty is the Hot Word in Town, Let's Discuss Regulatory Trends and the Recent Changes in OPDP and How it Affects PRC/MLR

We know agencies can be a mystery, and sometimes a frustration. In this interactive panel, three agency insiders who specialize in medical/regulatory intelligence invite your toughest questions and share candid answers on how creative and compliance teams can work together more smoothly, more transparently, and yes—even with a few laughs. You’ll leave with practical insights on how small shifts in workflows, submission strategy, and feedback loops can make a big difference for everyone.

Explore the Nuances of Product Launches and the Optimal Ways to Bring Your PRC Teams Onboard While Fostering Collaboration with Marketing Teams 

Social Media shifts overnight.  Are Your MRL Processes Ready to Keep Pace? Transform  Compliance from a Bottleneck into a Growth Driver. 

Support Claims Made About the Benefits, Outcomes, and Value of Having RWE Data in Promotional Pieces

• Leverage real-world data to substantiate promotional claims, reinforcing trust and confidence among healthcare providers, payers, and patients
• Use RWE to showcase meaningful outcomes, such as improved adherence, patient satisfaction, or cost-effectiveness, that go beyond clinical trial results
• Navigate regulatory expectations by appropriately integrating RWE into promotional materials, ensuring claims are accurate, balanced, and well-supported

Colleen Davenport

Vice President, Regulatory Affairs

RADIUS 

Discuss the Daily Activity of Review Teams and Share Best Practices on How to Keep your PRC/MRL Streamlined

Ask our Expert Panel Members Questions Regarding any Aspect of MLR-PRC. We Will Collect Questions Throughout the Day and Then Have them Answered

Identify the Situations that Call for Additional Peers to Get Involved, How to Exhaust and When to Educate by Escalating

• Use escalation moments as opportunities to clarify guidance, build consensus, and strengthen future decision-making
• Explore strategies to resolve challenges constructively by exhausting internal alignment before moving upward
• Learn to recognize red flags and determine when an issue truly warrants cross-functional or leadership involvement 
  

Manage Your Agency Partners Effectively, Discuss Best Practices on Working with them and Selecting the Right Agency for the Right Projects

• Discover best practices to get new agency partners up to speed quickly and integrated seamlessly with your team
• Gain tips for managing agency relationships effectively while maintaining compliance and quality control
• Learn criteria and strategies to choose agencies that align with your brand, compliance needs, and project goals
  

Ashley Long

Manager, Medical Affairs

SK LIFE SCIENCES

Explore Concrete Applications on How AI is Being Successfully Used to Expedite and Support PRC/MLR Operations

• Explore real-world examples of how AI technologies are accelerating review workflows and boosting efficiency
• Learn how AI supports PRC/MLR teams by identifying compliance risks and streamlining content analysis
• Understand the potential of AI to transform promotional review while maintaining rigorous regulatory standards

Ferry Tamtoro

CEO

REVISTO

Learn How Companies are Reacting to the Unprecedented Crackdown by the FDA on DTC TV Ads and Beyond

Develop a Structured PRC Prioritization Strategy in a Complex Brand Environment. Examine how to Align the Needs of the Business, Clear the Runway to Streamline Reviews, and Ensure the Most Critical Materials are Cleared for a Smooth Takeoff

Milalie Francisco

Senior Brand Marketing Operations Specialist

MALLINCKRODT PHARMACEUTICALS

Engage on the Importance of the Coordinator Role and the Future Career Paths Coordinators Can Explore