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Featured Topics
· Enforcement by the three centers within FDA that regulate drugs, biological products and veterinary drugs
· Direct-to-consumer advertising
· State regulations
· Oversight of off-label issues by the Office of Inspector General and Department of Justice
· Latest innovations in the use of the internet for product communication
Learning Objectives:
At the conclusion of this conference, participants should be able to:
· Identify the trends reflected in the latest enforcement actions and policies by the FDA
· Summarize best practices by other companies in implementing regulatory policies
· Describe how companies can best navigate the regulatory review process at FDA
· Outline the policies and actions being taken by others, such as OIG, DOJ and trade and professional associations
Target Audience:
Professionals who are new to pharmaceutical advertising and promotion as well as those who have been involved in this area for some time, including professionals from:
· Marketing
· Legal/Regulatory affairs
· Public relations/Advertising
· Marketing communications
· Compliance and management in pharmaceutical, veterinary medicine, biologics and medical device companies and organizations
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