2018 Off-Label Regulatory Compliance Congress – 2018 Off-Label Regulatory Compliance Congress

As the demand for information outside of approved labeling continues to rise, the FDA has been called by the industry to provide guidance that governs off-label communications. The regulatory landscape that monitors this space is often blamed for limiting the amount of information received by patients and restricting their ability to make well-informed decisions.

Given the public health issues at stake and the public interest involved, it is imperative that this event details the importance of the timely communication of truthful scientific information that currently challenges pharmaceutical, biotech, and medical device professionals. The 2018 Off-Label Regulatory Compliance Congress also explores the ever-changing regulatory landscape and explains how professionals can work with officials to ensure that promotional practices remain compliant and expedite the transmission of relevant scientific information to advance public health.

Top Five Reasons to Attend

  1. Better understand the ever-changing FDA landscape and revised guidelines
  2. Participate in discussions and examine case studies to identify how industry leaders develop compliant promotional practices
  3. Discuss ways to sync the availability of scientific and real-world data with the speed of regulatory action
  4. Analyze the limitations and risks of off-label promotion
  5. Discuss challenges posed by the changing regulations of safety data and the implications of new guidelines

Who Should Attend

This conference is designed for representatives at healthcare insurance, biopharmaceutical, medical device, and formulary organizations with the following responsibilities:

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

This conference is also of interest to:

  • Regulatory Affairs Service Providers/Consultants
  • Compliance Service Providers
  • Promotional Review Vendors
  • Off-Label Service Providers
  • Law Firms
  • Marketing/Advertising Agencies
Startdate: 2018-05-21
End Date 2018-05-22

Description: Attend the 2018 Off-Label Regulatory Compliance Congress to discover emerging technologies and innovative methods to improve audit and inspection outcomes, through risk assessment and quality assurance
Performer: ExL Events
Address : 2018 Off-Label Regulatory Compliance Congress