Join us

2nd Annual Gardner Law GC Summit

Snowbird, Utah on Friday, April 3rd, 8:00 AM – 1:30 PM

The GC Summit meeting is a premiere educational and networking event for in-house attorneys from medical device & pharmaceutical companies who focus on health care compliance & FDA law.

Why attend?

  • Learn. Earn CLE credits while learning about the latest legal and regulatory updates (applied for 6 CLE credits).
  • Network with your peers.
  • Have fun! Enjoy the mountains and resort amenities.

Schedule

  • Thursday, April 2: Arrive
    Complimentary reception:
    6:30 PM – 8:00 PM

  • Friday, April 3:
    CLE session:
    8:00 AM – 1:30 PM
    Breakfast and lunch provided. 

Location/Lodging

  • The meeting is at the Cliff Lodge, Snowbird, Utah
  • Group lodging discount available.
  • Snowbird is 1 hour from Salt Lake City International Airport.

Fees

  • Complimentary event


8:00 AM – 8:30 AM
Breakfast

8:30 AM – 9:15 AM
What company attorneys need to know about FDA regulation. Review critical FDA CDRH guidance documents issued in 2019
Amy Fowler, Counsel, Gardner Law
Amanda Johnston, Senior Attorney, Gardner Law

9:15 AM – 10:00 AM
Tips and tricks for attorneys that work with Regulatory, Medical and Marketing staff to review product claims. Learn how to use the FDA CFL guidance & K97 Blue Book Memo. Off-label update.
Heather Potter, Associate Attorney, Gardner Law

Break

10:15 AM – 11:00 AM
How to prepare for diligence and design and implement a compliance program that will protect the company and WOW strategics. How to perform due diligence (for buyers).
Mark Gardner, Managing Attorney, Gardner Law

11:00 AM – 11:45 AM
Enforcement update—review of recent cases involving the AKS, FCA, FDCA, HIPAA, Sunshine. Tips on what a company attorney can do to help mitigate the risk of an enforcement action.
Amanda Johnston, Senior Attorney, Gardner Law

Lunch

12:15 PM – 1:00 PM
Fiduciary duties of directors in risk management and compliance oversight.
Michael Pisetsky, General Counsel & Chief Compliance Officer, SI-BONE, Inc.

1:00 PM – 1:30 PM
Group presentation and discussion regarding contemporary legal regulatory and health care compliance topics.

Please Register by Friday, March 13th. Space is limited.

Contact Tracy at terickson@gardner.law with questions.

Join us at

Snowbird, Utah.

Register Now