2017 Off-Label Regulatory Compliance Congress – 2017 Off-Label Regulatory Compliance Congress

Thank you very much for your interest in the Off-Label Regulatory Compliance Congress!

We’d like to thank our fantastic partners, faculty, sponsors, media partners and attendees for being a part of our 2017 event. We are already at work on 2018’s conference, so keep watching this space for updates.

For information on speaking opportunities, please contact Tyler Lobo at tlobo@exlevents.com or 917-242-3899.

2017 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 2017 Off-Label Regulatory Compliance Congress also explores the ever-changing regulatory landscape and explain 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.

Featured Speakers

Top Five Reasons to Attend

  1. Hear firsthand accounts from the “FDA’s Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products” public hearing

  2. Explore how the 21st Century Cures Act will transform the way that information is disseminated across the industry

  3. Establish a clear definition of scientific communication exchange without fear of persecution

  4. Discover ways to coordinate the availability of science and real-world data with the speed of the regulatory landscape

  5. Participate in panel discussions and examine case studies to identify how industry leaders develop compliant promotional practices

Who Should Attend

This conference is designed for representatives from pharmaceutical, medical device and biotechnology companies with responsibilities in the following areas:

  • 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