5th Promotional Review Committee Compliance & Best Practices — Midwest -

5th Promotional Review Committee Compliance & Best Practices — Midwest
May 17 - 18, 2018
Chicago, IL

The ONLY industry event devoted specifically to uniting cross-team expertise, maximizing quality oversight during review, and improving regulatory compliance in all multimedia promotional messaging

Agenda – 5th Promotional Review Committee Compliance & Best Practices — Midwest



Workshop

 THURSDAY, MAY 17, 2018

9:00AM – 12:00PM

WORKSHOP: FDAMA 114 — Promotional Review and Compliance Strategies


Erica Chertow, Director, Regulatory Affairs, U.S. Prescription Drug Promotion, ABBVIE
Jessica Cirillo, Director, HEOR — Acute Care Lead, MALLINKCRODT
Richard Kim, Associate Director, Medical Review, ABBVIE


Day One

 THURSDAY, MAY 17, 2018

12:00PM – 1:00PM

Registration


1:00PM – 1:15PM

Chairperson’s Opening Remarks


John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

 TECHNIQUES FOR NEW REGULATIONS AND PRODUCT AREAS

1:15PM – 2:00PM

PANEL: Conduct Both Gradual and Immediate Label Updates


Sue Duvall, Head, North America Advertising and Promotion, Regulatory Affairs, MYLAN
Michael Saad, Senior Manager, Marketing Operations, ABBVIE
Christi Bruce, Senior Manager, MLR Operations and Platforms, SANOFI

2:00PM – 2:45PM

Analyze the Promotional Compliance Risks and Successes of Patient Support Programs


John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

2:45PM – 3:30PM

PANEL: The Sound of Silence: Build a Way Forward When Lacking FDA Enforcement Cases


Leeann Bonaventura, Associate Director, Promotional Regulatory Affairs, ASTRAZENECA
Alexander Zachos, Lead (Associate Director), U.S. Regulatory Advertising and Promotion, SHIRE
Kevin Hollister, Senior Director, Regulatory Affairs, TESARO

3:30PM – 4:00PM

Networking Break


4:00PM – 4:45PM

PANEL: Evaluate the Use of Data “Consistent With Labels”


Lynn Bowen, Director, Commercial Regulatory Oversight, VERTEX PHARMACEUTICALS
Jennifer Banovic, Executive Medical Communications Liaison, TAKEDA
James Vigil, Director, U.S. Regulatory Affairs, Advertising and Promotion, ABBVIE

4:45PM – 5:30PM

Telemedicine, VR, and More: Anticipate the Greatest Challenges Facing PRCs in the Next Decade


Ilze Antons, Senior Director, Regulatory Affairs, LUNDBECK


Day Two

 FRIDAY, MAY 18, 2018

8:00AM – 8:45AM

Continental Breakfast


8:45AM – 9:00AM

Chaiperson’s Recap of Day One


John Marcus, Director, Regulatory Affairs, Labeling, Advertising and Promotion, HORIZON PHARMACEUTICALS

 TOOLS FOR TEAMWORK, EFFICIENCY, AND SPEED

9:00AM – 9:45AM

PANEL: Develop QC Processes for Promotional Review


Mimi Giordano, Senior Copy Editor, UCB
Rebecca Burnett, Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS
Marge Garcia, Associate Director, Program Review Operations, GENENTECH

9:45AM – 10:30AM

Learn the “Soft Skills” of Negotiation to Avoid Conflict Within Committees


Elke Carter, Regulatory Manager, ZAVATION MEDICAL PRODUCTS

10:30AM – 11:00AM

Networking Break


11:00AM – 11:45AM

Learn to Analyze and Anticipate Patterns in Review Comments


Leeann Bonaventura, Associate Director, Promotional Regulatory Affairs, ASTRAZENECA

11:45AM – 12:30PM

Ensure Compliant Presentation and Successful Evaluation of Convention Materials


Zafar Toor, Senior Director, Commercial Regulatory Affairs, LEXICON PHARMACEUTICALS

12:30PM – 1:30PM

Luncheon


1:30PM – 2:15PM

PANEL: Find the Optimal Time Frame for Your Review Process


Megan Francis-Sedlak, Senior Manager, Medical Affairs, HORIZON PHARMACEUTICALS

2:15PM – 3:00PM

Highlight the Role of PRC Coordinators to Streamline Processes


Christi Bruce, Senior Manager, MLR Operations and Platforms, SANOFI


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