Agenda – 5th Promotional Review Committee Compliance & Best Practices

  • Workshop Day
  • Main Conference Day One
  • Main Conference Day Two

Workshop Day

 Monday, October 16

9:00AM – 12:00PM

WORKSHOP: FDAMA 114 — Promotional Review and Compliance Strategies
Amy Van Sant, Director, Regulatory Advertising and Promotion, JANSSEN
Kimberly Belsky, Sr. Director, Regulatory Policy and Intelligence, Regulatory Affairs, MALLINCKRODT
Freddy Jimenez, Vice President, Law and Compliance, CELLDEX THERAPEUTICS
Jessica Cirillo, Director, HEOR – Acute Care Lead, MALLINCKRODT


Main Conference Day One

 Monday, October 16

1:00PM – 1:10PM

Introduction From Conference Chairperson
Gary Wieczorek, Director, Regulatory Affairs, U.S. Ad/Promo, ABBVIE

 ADAPT TO NEW REGULATORY GUIDELINES AND NEW PRODUCTS

1:10PM – 1:50PM

Transition Ad/Promo Submissions to the eCTD Gateway
Josephine Secnik, Director, Ad/Promo Regulatory Affairs, ELI LILLY

1:50PM – 2:30PM

Increase Efficiency and Productivity of the Promotional Review Process
David Jacobs, Assistant General Counsel, Commercial Brands, DAIICHI SANKYO

2:30PM – 3:10PM

Chart a Path for Off-Label Communications in Light of Recent 1st Amendment Court Decisions
Anthony Molloy, Vice President, Legal and Compliance, PACIRA PHARMACEUTICALS

3:10PM – 3:40PM

Networking Break

3:40PM – 4:20PM

Resolve the Future of Compliant Scientific Exchange
Howard Dorfman, Senior Corporate Counsel, EDGE THERAPEUTICS

5:00PM – 6:00PM

Prep PRCs for Urgent Responses to Launches and Label Changes
Jill Charbonneau, Director, Regulatory Affairs, AdProm, Product Launch and Labeling, former MARATHON PHARMACEUTICALS
Leslie North, Principal, TLBF Consulting
Nicole Lare, Associate Director, Regulatory Affairs Advertising and Promotion, MALLINCKRODT
Rebecca Burnett, Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS


Main Conference Day Two

 Tuesday, October 17

8:45AM – 9:00AM

Chairperson’s Recap of Day One
Gary Wieczorek, Director, Regulatory Affairs, U.S. Ad/Promo, ABBVIE

 FINE-TUNE YOUR SOCIAL MEDIA PROMOTIONAL STRATEGIES

9:00AM – 9:40AM

Reorient Promotional Review Around the Assumptions of a New, Networked Generation
Cynthia Akue, Promotional Planner, ALLERGAN

9:40AM – 10:20AM

Devise a Spectrum of Approaches for Social Media
Sergio Alegre, Vice President, Global Compliance, Osmotica Pharmaceutical

 SET A CULTURE OF EXCELLENCE IN PRC TRAINING

10:20AM – 10:50AM

Networking Break

10:50AM – 11:30AM

Presentation by VEEVA
Terri Howard, Senior Manager, Medical Device Commercial Content, VEEVA

11:30AM – 12:10PM

Update Procedures After Changing Ownership of the PRC Process
Keri F. Shugrue, Marketing Operations Manager, SUNOVION

12:10PM – 1:10PM

Luncheon

1:10PM – 1:50PM

Set Appropriate Frameworks for Communications and Conversations With Payers
Doreen V. Morgan, Vice President, U.S. Regulatory Affairs, LEO Pharma Inc.

1:50PM – 2:30PM

Set Best Practice for the Re-Submission and Re-Review of Information From Past Campaigns
Nellie Mamuya, Quality and Compliance Manager, KEDRION BIOPHARMA