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
Stacy Harker, Director, Medical Promotional Review, Allergan


Day One

 SEPTEMBER 24, 2019

9:00AM – 9:15AM

Introduction From Conference Chairperson
Gary Wieczorek, Director, Regulatory Affairs, ABBVIE

9:15AM – 10:00AM

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, CELGENE

10:00AM – 10:45AM

Optimizing Your Digital Commercial Content Process
Maura Wiswall, Manager, Product Management, Content Management Solutions, 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

PANEL: Can Agility and Risk Management Co-Exist?
Ilyssa Levins, President, Center for Communication Compliance
Stacy Joseph-Reese, Director, Regulatory Promotion and Labeling, TEVA
Preeti Pinto, Former Executive Director and Head of Promotional Regulatory Affairs, Astra Zeneca

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, Senior Brand Strategist, BIZPROX

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

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

5:15PM – 5:15PM

End of Day One


Day Two

 SEPTEMBER 25, 2019

9:15AM – 10:00AM

PANEL: Create Better Partnership Between Medical, Regulatory, and Commercial Operations Moderator:
Moderator:
Rebecca Burnett, Executive Director and Head of Strategic Services, FRAMEWORK SOLUTIONS
Penalists:
Richard Lem, Associate Director, Regulatory Affairs Affairs, Advertising and Promotion, BAYER HEALTHCARE
Nicole Lare, Associate Director, CELGENE
Dan Zavodnick, General Counsel, KEDRION BIOPHARMA
Denice Simon, Assistant General Counsel, TAKEDA

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

Countdown to June 2021: Preparing for eCTD Advertising and Promotions Submissions
Bill Robinson, Director, Commercial Content Strategy, VEEVA

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 Manager, Compliance, Pacira Pharmaceuticals

12:45PM – 1:45PM

Luncheon

1:45PM – 2:45PM

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

2:45PM – 3:30PM

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