10:30 AM – 12:00 PM
Concurrent Breakout Sessions: Policy and Legal Issues
How Technology is Driving Communication: Social Media Vehicles | Social Media Panel Slides
Although companies await guidance from FDA, they continue to use numerous social media vehicles to advertise and promote. This session will focus on the variety of vehicles that are available to companies (including well-known platforms like Facebook and newer models like Pinterest). Experts will suggest ways to comply with existing FDA enforcement policies, and provide advice on what practices seem beyond compliance.
Concurrent Breakout Sessions: Policy and Legal Issues
How Technology is Driving Communication: Social Media Vehicles | Social Media Panel Slides
Although companies await guidance from FDA, they continue to use numerous social media vehicles to advertise and promote. This session will focus on the variety of vehicles that are available to companies (including well-known platforms like Facebook and newer models like Pinterest). Experts will suggest ways to comply with existing FDA enforcement policies, and provide advice on what practices seem beyond compliance.
Zoe Dunn, Principal, Hale Advisors
Nicole D. Galli, Partner-in-Charge of Wilmington & Philadelphia Offices, Benesch Friedlander, Coplan & Aronoff LLP
Priya Mannan, Executive Director & Associate General Counsel, Novartis Institutes for BioMedical Research, Inc.
Nicole D. Galli, Partner-in-Charge of Wilmington & Philadelphia Offices, Benesch Friedlander, Coplan & Aronoff LLP
Priya Mannan, Executive Director & Associate General Counsel, Novartis Institutes for BioMedical Research, Inc.
Moderated by Bradley Merrill Thompson, Member of the Firm, Epstein Becker & Green, P.C.
Top Cases of 2012 and 2013: The Changing Legal Environment
A number of recent legal decisions deal with marketing
regulation issues and enforcement for drugs and medical devices. This panel of legal scholars will address the recent decisions and their implications.
A number of recent legal decisions deal with marketing
regulation issues and enforcement for drugs and medical devices. This panel of legal scholars will address the recent decisions and their implications.
Ralph Hall, Professor, University of Minnesota
Freddy Jimenez, Assistant General Counsel, Johnson & Johnson
Richard A. Samp, Chief Counsel, Washington Legal Foundation
Kai Peters, Partner, Gordon & Rees LLP
of MinnesotaFreddy Jimenez, Assistant General Counsel, Johnson & Johnson
Richard A. Samp, Chief Counsel, Washington Legal Foundation
Kai Peters, Partner, Gordon & Rees LLP
Moderated by Emalee G. Murphy, Of Counsel, Arnall Golden Gregory LLP
Changes in Promotion under the Sunshine Act
The Physician Payment Sunshine Act under the ACA adds new disclosure obligations that all drug and device companies must contend with. This session will examine how the various provisions of the Act will affect product promotion.
Thomas Sullivan, President, Rockpointe Corporation | Slides (Revised 9/16/13)
John F. Kamp, Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein LLP | Slides
Sarah K. diFrancesca, Associate, Cooley LLP | Slides
John F. Kamp, Executive Director, Coalition for Healthcare Communication; Of Counsel, Wiley Rein LLP | Slides
Sarah K. diFrancesca, Associate, Cooley LLP | Slides
Moderated by Iris Gibbs, Associate Director, Regulatory Affairs, Advertising and Promotions; Genzyme Corporation, a Sanofi Company
12:00 - 1:25 PM
Networking Luncheon
Networking Luncheon
1:30 - 3:00 PM
Shades of Gray I: Collateral Consequences of Risky Promotional Activities (Featuring Department of Justice)This session will explore the “fall-out” from negative promotional activities, including: activities by the Department of Justice; Securities & Exchange Commission exposure; and False Claims Act actions.
Shades of Gray I: Collateral Consequences of Risky Promotional Activities (Featuring Department of Justice)This session will explore the “fall-out” from negative promotional activities, including: activities by the Department of Justice; Securities & Exchange Commission exposure; and False Claims Act
actions.
Andrew S. Ittleman, Partner, Fuerst Ittleman David & Joseph, PL | Slides
Jeffrey Steger, Assistant Director; Consumer Protection Branch, Civil Division, Department of Justice | Slides
Jessica Tillipman, Assistant Dean for Field Placement and Professorial Lecturer in Law,The George Washington University Law School | Slides
Jeffrey Steger, Assistant Director; Consumer Protection Branch, Civil Division, Department of Justice | Slides
Jessica Tillipman, Assistant Dean for Field Placement and Professorial Lecturer in Law,The George Washington University Law School | Slides
Moderated by Heather Bates, Principal, Berkeley Research Group
3:00 - 3:30 PM
Refreshment and Networking Break
Refreshment and Networking Break
3:30 – 4:45 PM
Shades of Gray II: Best Practices for Compliance in Gray AreasA panel of experts will address issues with high prosecutorial activity, but little FDA guidance, including advisory boards, discussions with patient groups, medical science liaison activities, and speaker programs.
Shades of Gray II: Best Practices for Compliance in Gray AreasA panel of experts will address issues with high prosecutorial activity, but little FDA guidance, including advisory boards, discussions with patient groups, medical science liaison activities, and speaker programs.
Peter Currie, Senior Attorney, Novo Nordisk, Inc.
Kimberly K. Egan, Founder, Saltbox Consulting
Sandy Cohen Kalter, Vice President, Chief Regulatory Counsel, Medtronic, Inc.
Aaron S. Kesselheim, Assistant Professor of Medicine, Harvard Medical School
Kimberly K. Egan, Founder, Saltbox Consulting
Sandy Cohen Kalter, Vice President, Chief Regulatory Counsel, Medtronic, Inc.
Aaron S. Kesselheim, Assistant Professor of Medicine, Harvard Medical School
Moderated by William A. McConagha, Partner, Sidley Austin LLP
No comments:
Post a Comment