Medical Affairs and Scientific Communications Forum

In 2013, the Center for Drug Evaluation and Research (CDER) created three long-term objectives for human drugs:

• Promoting public health by helping to ensure the availability of safe and effective drugs
• Protecting public health by promoting the safe use of marketed drugs
• Protecting public health by helping to ensure the quality and integrity of marketed drug products

How successful was CDER in 2016 in meeting these ambitious objectives? Were there new guidances released by the FDA in 2016 - how do these guidances affect personnel in the medical communications, medical science liaisons, and medical writing roles? What effect has the US Presidential election had on the FDA in the short term since November? How do recent discussions regarding off-label discussions impact medical and scientific affairs? These topics and others have been at the forefront of the industry dialogue over the last year and beyond.
In this session, Lucy Rose will lead a discussion in which you will gain perspectives on these and additional, pertinent, hot topics from the FDA. The session lays the foundation for the remainder of the conference by discussing at large topics, which directly affect the daily roles of individuals in the medical communications, medical science liaison, and medical writing roles.