Agenda – 2018 Off-Label Regulatory Compliance Congress

  • Day One
  • Day Two

Day One

 MONDAY, MAY 21

9:00AM – 9:45AM

Understand What the FDA Considers to Be Misleading vs. Truthful
Glenn N. Byrd, MBA, RAC , Senior Director, Promotional Regulatory Affairs, ASTRAZENECA

9:45AM – 10:15AM

Considerations in the Promotion of Biologics in the Age of Biosimilars
Bruce A. Leicher, Senior Vice President and General Counsel, MOMENTA PHARMACEUTICALS, INC.

10:15AM – 11:00AM

Communications in Social and Digital Media: When in Doubt, Traditional Rules Apply
Sabrina Mays-Diagne, Senior Corporate Attorney, OTSUKA PHARMACEUTICALS

11:00AM – 11:30AM

Networking Break

11:30AM – 12:30PM

Developing Compliant Strategies in Disseminating Scientific Information to Healthcare Providers: Addressing Risk in a CIA-Focused Environment
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW

12:30PM – 1:30PM

LUNCHEON

1:30PM – 2:15PM

Determine How to Reduce Risks Involved in Off- Label Promotion
Richard Liner, Senior Compliance Counsel, BAYER

2:15PM – 3:00PM

Ensure Compliant Communications: During Scientific Exchange and Off-Label Data Dissemination
Jacqueline Armani, Medical Science Liaison, Surgical, ALCON

3:00PM – 3:30PM

Networking Break

3:30PM – 4:15PM

The Current Position of Off-Label Use in the U.S.
Leslie Gladstone Restaino, General Counsel, VALIDUS PHARMACEUTICALS

4:15PM – 5:00PM

Ensure Proactive Off-Label Education Across the Healthcare Ecosystem
Alma Azua-Cassady, Corporate Compliance Manager, The Mount Sinai Health System
Ilyssa Levins, President and Founder, Center for Communication Compliance


Day Two

 TUESDAY, MAY 22

9:30AM – 10:30AM

PANEL: Discuss Non-Promotional Mechanisms for Disseminating Information and the Approval Needed
Jennifer M. Williams, Ph.D., J.D., MBA, RN, MSM, Chief Global Compliance and Ethics Officer, VP of Government Affairs Assistant Professor, UNIVERSITY OF SOUTHERN INDIANA
Howard Dorfman, Distinguished Visiting Practitioner and Adjunct Professor, SETON HALL UNIVERSITY SCHOOL OF LAW
Jacqueline Armani, Medical Science Liaison, Surgical, ALCON
John Paul Benitez, Counsel, ELI LIILLY AND COMPANY

10:30AM – 11:15AM

Develop a Compliance Program That Includes Off-Label Communication
Jennifer M. Williams, Ph.D., J.D., MBA, RN, MSM, Chief Global Compliance and Ethics Officer, VP of Government Affairs Assistant Professor, UNIVERSITY OF SOUTHERN INDIANA

11:15AM – 11:45AM

Networking Break

11:45AM – 12:45PM

Address From the Department of Justice
Ethan Davis, Deputy Assistant Attorney General, DEPARTMENT OF JUSTICE

12:45PM – 1:45PM

LUNCHEON

1:45PM – 2:30PM

A Year in Review — Looking Back on How the Regulatory Landscape Changed in the Past Year
Richard Lem, Assistant Director, Regulatory Affairs — Advertising and Promotion, BAYER HEALTHCARE

2:30PM – 3:15PM

Determine How to Reduce Risks Involved in Off-Label Promotion
Sergio Alegre, Vice President, Global Compliance, OSMOTICA PHARMACEUTICALS