Agenda – 6th Promotional Review Committee Compliance & Best Practices

  • Workshop Day
  • Day One
  • Day Two

Workshop Day

 MONDAY, SEPTEMBER 24

1:30PM – 2:00PM

Registration

2:00PM – 5:00PM

WORKSHOP: Learn OPDP Expectations During a Sample Regulatory Review Scenario

OPDP reviewers and outside counsel provide crucial feedback on your commercial pieces. By sitting in and learning from the thought processes of people familiar with OPDP’s review of your promotional materials, you can better understand how they take claims apart and how regulatory analysis may come down against you if you don’t have the right evidence. This interactive workshop enables you to internalize and work with OPDP expectations during a real-time “mock” review meeting.

  • Clarify where your expectations of labeling and promotional information differ from those of OPDP reviewers
  • Zero in on areas where terminology use may cause confusion from a regulatory perspective
  • Gain understanding of truthful, balanced, and accurately communicated information
  • Anticipate the level of investment in both time and resources required for successful review
Nneka Onwudiwe, PRO/PE Regulatory Review Officer, OPDP, FDA
Keren Tenenbaum, Assistant General Counsel, PFIZER
Cristina Masseria, Methods and Capabilities Lead, PFIZER


Day One

 TUESDAY, SEPTEMBER 25

 COMPLIANCE WITH NEW REGULATIONS AND MEDIA FORMATS

9:00AM – 9:45AM

Formulate a Social Media Comment-Moderating Policy When Clear Guidance Signals Are Lacking
Stephanie Jameison, Director, Global Regulatory Affairs, Promotion Compliance, OTSUKA
Heather Ramirez, Senior Corporate Counsel, NOVO NORDISK
Sabrina Mays-Diagne, Senior Corporate Attorney, OPDC Legal Affairs, OTSUKA

9:45AM – 10:30AM

Prepare Your PRCs to Cope With Black Box Warnings
Linda Pollitz, Senior Director, Regulatory Affairs, Advertising and Promotion, ALKERMES
Tiffany Mura, former Director, Consumer and Digital Marketing, ALKERMES

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Resolve Unanswered Questions About Using Off- Label Information
Cecilia Bakker, Assistant General Counsel, PFIZER

11:45AM – 12:30PM

Refine Your Promotional Review Compliance for Reprints and Textbooks
Alan Bergstrom, Commercial Regulatory Affairs, PTC THERAPEUTICS

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Formalize the Use of References in Promotional Pieces
Jill Charbonneau, Director, Regulatory Affairs, HARMONY BIOSCIENCES

2:15PM – 3:00PM

Anticipate and Prevent Miscommunication With Marketing Agencies
Joyce Pearl, Senior Manager, Marketing Services, MALLINCKRODT

3:00PM – 3:30PM

Networking Break

3:30PM – 5:00PM

Gather Perspectives and Experience When Reviewing Promotional Websites
Janet Gottlieb, Executive Director, Medical Communications, ALLERGAN
Jimmie Overton, Associate Vice President, Global Medical Scientific Information and Medical Science Library, ALLERGAN


Day Two

 WEDNESDAY, SEPTEMBER 26

 IMPROVING PRC COOPERATION AND EFFECTIVENESS

9:00AM – 9:45AM

Prioritize Promotional Review Agility to Increase Time for Strategy and Patient Value
Jan Jeffords-Schenck, Assistant Director, Review Services, UCB
Ariail Roberts, Senior Manager, Review Services, UCB
Ilyssa Levins, President, CENTER FOR COMMUNICATION COMPLIANCE

9:45AM – 10:30AM

Evaluate the Editor Model for PRCs
Terri Silver, Senior Copy Editor, Immunology, UCB

10:30AM – 11:00AM

Networking Break

11:00AM – 11:45AM

Find a Way Forward for “Borderline” Cases in FDAMA 114 Compliance
Denise Sanchez, Executive Director, Regulatory Affairs Advertising and Promotion, ALLERGAN

11:45AM – 12:30PM

Stay Within Proper Channels and Avoid “Offline” Reviews
Jacob Nyman, Director, Office of Promotion and Advertising Review, MERCK

12:30PM – 1:30PM

Luncheon

1:30PM – 2:15PM

Incorporate Execution Risk Into Marketing Material Review
Dan Spicehandler, U.S. Compliance Officer, SANOFI PASTEUR