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