2018 Off-Label Regulatory Compliance Congress

Topics

• How the 21st Century Cures Act will transform the way that information is disseminated across the industry
• Firsthand accounts from the FDAs Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products public hearing
• Ways to coordinate the availability of science and real-world data with the speed of the regulatory landscape
• A clear definition of scientific communication exchange without fear of persecution
• Case studies to identify how industry leaders develop compliant promotional practices

Who should Attend

Attendees from pharmaceutical, medical device and biotechnology companies with responsibilities in

• Legal Affairs/Compliance
• Regulatory Affairs
• Marketing/Advertising and Promotion
• Medical Affairs/MSL
• Clinical/Promotional Review
• Sales
• Medical Information
• Brand Management
• Medical Communication
• Medical Education
• Commercial/Scientific Legal Affairs
• Product Training
• Quality Assurance

Others:

• Compliance Service Providers
• Regulatory Affairs Service Providers/Consultants
• Off-Label Service Providers
• Promotional Review Vendors
• Marketing/Advertising Agencies
• Law Firms