Medical Affairs and Scientific Communications 2016 Annual Forum

Cross-functional forum spotlights topics related to medical communication, medical science liaison, medical call center, and medical writing professionals.

戻る Agenda

Session 1: FDA Update and Potpourri

Session Chair(s)

J. Lynn Bass, PHARMD, RPH

Medical Affairs Lead

Mesoblast, United States

Will the new FDA Commissioner usher in a new era for the FDA? How will new guidances, released by the FDA, affect personnel in the medical communications, medical science liaisons, and medical writing roles? What effect does the Presidential election have on the FDA in the future? How do recent rulings regarding off-label discussions impact medical and scientific affairs? How are PRC/MLR Review and social media engagement affected by these rulings? These topics and others have been at the forefront of the industry dialogue over the last year and beyond. In this session, you will gain perspectives on these and additional hot topics from the FDA. The session lays the foundation for the remainder of the forum by presenting an overview of the current regulations, enforcement actions, recent developments, and insights from the FDA and Department of Justice, which directly affect individuals in the medical communications, medical science liaisons, and medical writing roles.

Learning Objective : At the conclusion of this session, participants should be able to:
Identify the trends reflected in the latest enforcement actions and policies issued by the FDA
Discuss how new FDA guidances will affect the roles of medical communications, medical science liaisons, and medical writing staff

Speaker(s)

Speaker

Darshan Kulkarni, JD, PHARMD, MS

Kulkarni Law Firm, PC, United States

Principal Attorney