Communicating During the Pre-Approval Stages

Day & Time:
February 28, 12:30PM - 1:45PM

Type:
Session

Title:
Communicating During the Pre-Approval Stages

Chair(s):
Michael Misocky, JD,RPh
President
Misocky Consulting Group LLC, United States

Description:
This session will examine what can be done, and what poses risks, during the investigational/pre-approval stage of a new product. What precautions are needed in reaching out to patient groups and insurers/formulary committees? Are there any truly safe harbors?

Presentation(s) & Speaker(s):
Medical Perspective
Katie Lyons, PharmD,MS
Director
Medical Content Consulting Services, United States

Regulatory Perspective
Mary Sullivan
Boehringer Ingelheim Pharmaceuticals, Inc., United States

Legal Perspective
Kellie B. Combs, JD
Counsel
Ropes & Gray, United States

© 2014