Agenda – 7th Promotional Review Committee Compliance & Best Practices

  • WORKSHOP DAY
  • Day One
  • Day Two

WORKSHOP DAY

 SEPTEMBER 23, 2019

9:00AM – 12:00PM

MORNING WORKSHOP: A Walk in Their Shoes: A Look at PRC Meetings From the Marketing Agency’s Perspective
Howard Dorfman, Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW; Founder, H.L. DORFMAN CONSULTING

12:00PM – 1:30PM

Morning Workshop Concludes

1:30PM – 2:00PM

Registration

2:00PM – 5:00PM

AFTERNOON WORKSHOP: CASE STUDY: Training and Development for Ad/Promo Professionals
Janet Gottleib, Exectuive Director, Medical Promotional Review, ALLERGAN


Day One

 SEPTEMBER 24, 2019

9:15AM – 10:00AM

PANEL: Take Control of Medical, Legal and Regulatory to Establish PRC Meetings
Jill Charbonneau, Director Regulatory Affairs, HARMONY BIOSCIENCES
Denice Simon, Assistant General Counsel, TAKEDA PHARMACEUTICALS

10:00AM – 10:45AM

Are You Optimally Orchestrating Your Digital Commercial Content From Creation to Expiry?
Ted Zobel, Lead Solutions Engineer, IQVIA
Victoria Marsh, Director of Content Offerings Management, IQVIA

10:45AM – 11:15AM

Networking Break

12:00PM – 12:45PM

Address and Implement Best Practices for Promotional Use
Linda Pissott Reig, Co-Chair, BIONJ LEGAL, COMPLIANCE, & REGULATORY GROUP; Adjunct Professor, Management and Global Business, RUTGERS BUSINESS SCHOOL

 


12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Can Agility and Risk Management Co-Exist?
Ilyssa Levins, President, Center for Communication Compliance

2:30PM – 3:15PM

The Rise of New Technologies and Best Practices for Applying FDA Promotional Guidelines
Linda Pollitz, Senior Director, Regulatory Affairs, Advertising and Promotion, ALKERMES
Tiffany Mura, Director, Consumer and Digital Marketing, ALKERMES

3:15PM – 3:45PM

Networking Break

3:45PM – 4:30PM

Models of Success for High-Level Leadership Styles With Cross-Functional Collaboration
Gary Wiezorek, Director, RegulatoryAffairs, AbbVie

4:30PM – 5:15PM

The Sound of Silence: Build a Way Forward When Lacking FDA Enforcement Cases
Alexander Zachos, Associate Director, U.S. Regulatory Advertising and Promotion, TAKEDA

5:15PM – 5:15PM

End of Day One


Day Two

 SEPTEMBER 25, 2019

9:15AM – 10:00AM

PANEL: Diversify the Use of Social Media and Advertising Promotion
Kate Ho, Manager and Regulatory Affairs Advertising Promotions, TESARO BIOSCIENCES
Anita Kachappilly, Manager, Regulatory Affairs — Advertising, Labeling, and Promotion, BIOGEN

10:00AM – 10:45AM

Learnings From FDA Ad\Promo Enforcement Actions and Trends
Kimberly Belsky, Executive Director, Regulatory Policy and Intelligence, Regulatory Affairs, Mallinckrodt Pharmaceuticals

10:45AM – 11:15AM

Networking Break

11:15AM – 12:00PM

Panel: Create Better Partnership Between Medical, Regulatory, and Commercial Operations
Richard Lem, Associate Director, Regulatory Affairs Affairs, Advertising and Promotion, BAYER HEALTHCARE
Nicole Lare, Associate Director, CELGENE
Dan Zavodnick, Head of U.S Legal Department, KEDRION BIOPHARMA

12:00PM – 12:45PM

Company Perspectives on Implementing the “Consistent With Label and Payer Guidances”
Anthony Molloy, Esq, Vice President, Legal and Compliance, General Counsel, Deputy Compliance Officer, PACIRA PHARMACEUTICALS
Alex Celius, Senior Compliance Associate, Pacira Pharmaceuticals

12:45PM – 1:45PM

Luncheon

1:45PM – 2:30PM

Interactive Session: Learn OPDP Expectations During a Sample Regulatory Review Scenario and New Regulations
Nneka Onwudiwe, Pharm.D., Ph.D., MBA, Founder and Chief Executive Officer, Pharmaceutical Economics Consultants of America (PECA) LLC
Keren Tenenbaum, VP and Assistant General Counsel, Head of Legal, Salix, Bausch Health
Cristina Masseria, Methods and Capabilities Lead, PFIZER

2:30PM – 3:15PM

Eliminate Error Sources in E-Detailing
Doreen Morgan, VP of U.S Regulatory Affairs and Quality Assurance, LEO PHARMACEUTICALS

3:15PM – 3:45PM

CASE STUDY: Dive Into the PRC Process and New Technology
Kathy Tavakoli, Regulatory Affairs Advertising and Promotion, LUPIN PHARMACEUTICALS