Reducing Legal Risks in the Sale and Marketing of Medical Devices: Understanding the Role of Medical Affairs

InterContinental Chicago Magnificent MileChicago, IL

Ryan Benz, Associate, copresents "Understanding the Role of Medical Affairs: Implementing Safeguards to Ensure That Interactions Do Not Run Afoul of the Company's Culture of Compliance" at ACI's Reducing Legal Risks in the Sale and Marketing of Medical Devices, which runs from April 9 to 11.

Topics include:

  • Identifying gaps and developing the knowledge to address the need
  • Reducing the risk of noncompliance
  • Developing capabilities to support the company's operations in the countries in which it is operating
  • Enlisting Medical Affairs as an ally and partner with Compliance
  • Managing interactions between commercial personnel and MSLs
  • Keeping documented evidence of MSL training
  • Crafting a response to solicited and unsolicited requests for information regarding grant funding
  • Clarifying the range of permissible field-based dissemination of information by MSLs
  • How pharmacovigilance and adverse events reporting under FDAAA should be factored into your compliance program
  • How medical affairs has become a hot bed of compliance enforcement actions
  • Exploring the proper relationship between sales and marketing and medical affairs
  • Developing guidelines for post-marketing studies
  • Establishing advisory board protocols

For more information, visit ACI.