- the latest anti-fraud and FDA cases;
- what it takes to design and maintain an effective compliance program and perform investigations; and
- how to respond to a government investigation.
Date: Thursday, October 14th, 8am-12pm CT
Location: Online six-session webinar. Join for all or part of the program.
* This is a complimentary event.
Session one: Recent FDA, AKS, and FCA Cases
In this session, Mark Gardner of Gardner Law and Dulce Foster of Fredrikson & Byron present on:
- the latest Anti-Kickback Statute, the False Claims Act and the Physician Payments Sunshine Act cases;
- recent FDA cases; and
- the Office of Inspector General (OIG) Special Fraud Alert: Speaker Programs
- Dulce Foster, Shareholder with Fredrikson & Byron, is a practiced white collar defense attorney.
- Mark Gardner is the Directing Attorney at Gardner Law and a skilled FDA and anti-fraud regulatory attorney.
Session two: Impact of Recent Cases and OIG Guidance
Led by two experienced in-house attorneys from the pharmaceutical and medical device spaces, this session covers: how the recent FDA and anti-fraud cases and the OIG Special Fraud Alert on Speaker Programs have impacted industry business practices.
- Brent Eilefson, Vice President, Legal Affairs, Chief Compliance Officer and Corporate Secretary at Upsher-Smith Laboratories, is an experienced compliance attorney and former litigator.
- Sarah Karlgaard, General Counsel of Canon Medical Systems Corporation, HIT Division, leads the legal, compliance and regulatory functions at Canon using her extensive experience as a health care lawyer.
9:30-9:45 AM – Break
Session three: Deploying a Compliance Program & Performing Investigations
In this session, Amanda Johnston of Gardner Law explains step-by-step how to: (1) practically design and deploy a compliance program that meets the seven OIG CPG requirements; and (2) perform investigations. She shares experiences and outlines must-haves and nice-to-haves when crafting a compliance program.
- Amanda Johnston, Managing Attorney of Gardner Law, is a practiced FDA and anti-fraud regulatory attorney. She is a former Compliance Officer with Coloplast and a former Medtronic regulatory affairs professional.
Session four: Managing Compliance
In this session, Sandra Sedo of CSI presents on managing a compliance program, including monitoring and auditing, along with anecdotes and best practices. This session is valuable for those responsible for health care compliance who are relatively new to such responsibilities, as well as seasoned professionals.
- Sandra Sedo is the Chief Compliance Officer with Cardiovascular Systems, Inc. (CSI), where she is responsible for managing the ethics and compliance program, including implementation of a Corporate Integrity Agreement. She is a former partner at Dorsey & Whitney and former in-house attorney and Deputy Compliance Officer at Medtronic.
10:45-11 AM – Break
Session five: Responding to a Government Investigation
Dulce Foster of Fredrikson & Byron covers how to react to a government investigation, including FDA and anti-fraud matters. She discusses tactical best practices to deploy while under fire and what to think about when establishing a defense strategy.
- Dulce Foster, Shareholder with Fredrikson & Byron, is a tried-and-true litigator who has litigated numerous healthcare fraud cases and successfully defended Howard Root in a landmark criminal FDA case.
Session six: FDA Enforcement
During this session, Amanda Johnston of Gardner Law interviews Anne Miller of Medtronic regarding best practices for responding to FDA enforcement actions, how to engage with the Agency, FDA trends, and predictions.
- Amanda Johnston is Managing Attorney of Gardner Law.
- Anne Miller is Principal Legal Counsel at Medtronic and former Associate Chief Counsel at the FDA.
Mary Heath, Associate Attorney, Fredrikson, will introduce speakers and programing throughout the morning and make sure that your questions receive attention.
Attendees include general counsel, corporate counsel, compliance officers, regulatory lawyers, executives, and allied non-lawyer professionals in regulatory- and quality- affairs that work in the medical technology, pharmaceutical, biotechnology, and diagnostics industries.
CLE credits – Applied for in Minnesota
Please contact Tracy Erickson at email@example.com with questions.