Join the Gardner Law team and colleagues for this CLE event to discuss 2022 medtech and pharma legal and regulatory trends. Discussion topics include:

  • Ad Promo Enforcement
  • Clinical Research Contracting
  • FDA Regulatory Submissions
  • Privacy and Sunshine Updates
  • FDA Inspections
  • Complaint Handling/MDR
  • Anti-fraud Update

Date: Thursday, May 19th, 8:30am registration & breakfast, program from 9am-3pm CT, reception 3pm - 5pm CT

Location: The Loft at Studio J, 214 Main St. S, downtown Stillwater MN. Register for in person option by May 11th.  An online option is also available.

* Individual sessions can be viewed in the links included in the agenda below.

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Presenters

Jesse Atkins, JD

Jesse Atkins, JD, RAC

Senior Attorney

Gardner Law 

Nate-400px-300x300

Nathan Downing, JD

Associate Attorney

Gardner Law

Mark Gardner

Mark Gardner, JD, MBA

Directing Attorney

Gardner Law

Amanda_400x400- Headshot

Amanda Johnston, JD, RAC

Managing Attorney

Gardner Law

 

TPhilips

Tim Philips

Consultant

Gardner Law 

Paul-400px-300x300

Paul Rothermel, JD, CIPM

Associate Attorney

Gardner Law

Brynn_400x400-300x300

Brynn Stanley, JD

Associate Attorney

Gardner Law

Theodore Thompson

Theodore Thompson, JD, RAC

Associate Attorney

Gardner Law

Frank Piskolich

Frank Piskolich, JD

Division General Counsel

ZOLL Medical Corporation

Sarah Karlgaard, JD

Sarah Karlgaard, JD

General Counsel

Canon Medical Systems Corporation - HIT Division

Mike Pisetsky

Mike Pisetsky, JD, MBA

Sr. VP Operations and Administration & Chief Legal Officer

SI-Bone

Agenda

8:30-9:00 AM  Continental Breakfast

 

9:00-9:45 AM 

Session one: Ad Promo Enforcement Update  - VIEW SESSION ONE

  • Enforcement update (Warning Letters, FDA guidance, case law)
  • Tips and tricks and best practices
  • Navigating the dynamics of copy review teams

Speakers:

  • Jesse Atkins, Senior Attorney, specializes in FDA regulatory matters, product approvals/clearances, post-market change control, advertising and promotional activities, and fraud and abuse issues.
  • Nate Downing, Associate Attorney, focuses on counseling medical technology and pharmaceutical companies on FDA regulatory/submissions work and copy review.

 

9:45-10:15 AM

Session two: Clinical Research Contracting - VIEW SESSION TWO

  • Clinical trial agreement review 101
  • Recent OIG Advisory Opinion on study subject cost-sharing
  • Compensation dos and don'ts

Speaker:

  • Mark Gardner,  Directing Attorney, has worked in FDA-regulated industry since 1999. He advises companies on a wide variety of topics including health care compliance, advertising and promotion review, FDA -regulatory, -quality, and -clinical matters, privacy, transparency reporting, and enforcement.

 

10:15-10:30 AM – Break

 

10:30-11:00 AM

Session three: FDA Regulatory Submissions: Tips & Tricks - VIEW SESSION THREE

  • Communicating with FDA
  • Submission strategy
  • Putting together an effective submission

Speaker:

  • Amanda Johnston, Managing Attorney, specializes in counseling medical technology and pharmaceutical companies on FDA law, regulatory submissions and strategy, healthcare compliance programs, and fraud and abuse laws. Amanda has worked on 100+ FDA submissions, including PMAs, 510(k)s, HDEs, IDEs, NDAs, Pre-Submissions (Q-Subs), Breakthrough Designations, De Novos, RFDs, EUAs, change control supplements, and annual reports for drugs and devices.

 

11:00-11:45 AM

Session four: How to Survive an FDA Inspection  - VIEW SESSION FOUR

  • Hear from an expert with over 30 years at the FDA
  • Preparing for an inspection
  • Strategy and tactics

Speaker:

  • Tim Philips, Consultant, is a quality assurance and regulatory affairs professional with over 30 years of experience in commodities regulated by the U.S. Food & Drug Administration (FDA).

 

11:45-12:30 PM – Lunch Buffet

 

12:30-1:15 PM

Session five: Privacy & Cybersecurity (FDA)- VIEW SESSION FIVE

  • 2022 privacy update (US and O-US)
  • New state laws (NY, CA, UT, CO, VA)
  • FDA cybersecurity guidance

Speakers:

  • Paul Rothermel, Associate Attorney, focuses on privacy and cybersecurity, including HIPAA, GDPR, and other state and international laws as well as health care compliance matters.
  • Brynn Stanley,  Associate Attorney, specializes in counseling medical technology and pharmaceutical companies on FDA law and regulations. She possesses deep expertise in quality system compliance and remediation.

 

1:15-1:45 PM

Session six: Complaint Handling/MDR  - VIEW SESSION SIX

  • Assessing whether or not a complaint is an MDR
  • How to improve complaint handling compliance
  • FDA enforcement update

Speaker:

  • Theodore Thompson, Associate Attorney, focuses on quality and regulatory affairs. He has experience in regulatory submissions to FDA, EU Notified Bodies and Health Canada. He has a lot of experience counseling companies on the MDR requirements of 21 C.F.R Part 803, and recently served as an expert witness on this topic in a federal trial.

 

1:45-2:15 PM

Session seven: Anti-fraud and Sunshine Update - VIEW SESSION SEVEN

  • Mallory case and other recent case law involving fraud
  • Fraud investigation best practices
  • Sunshine: Federal, state, and local update

Speakers:

  • Mark Gardner,  Directing Attorney, has worked in FDA-regulated industry since 1999. He advises companies on a wide variety of topics including health care compliance, advertising and promotion review, FDA -regulatory, -quality, and -clinical matters, privacy, transparency reporting, and enforcement.
  • Amanda JohnstonManaging Attorney, specializes in counseling medical technology and pharmaceutical companies on FDA law, regulatory submissions and strategy, healthcare compliance programs, and fraud and abuse laws. Amanda has worked on 100+ FDA submissions, including PMAs, 510(k)s, HDEs, IDEs, NDAs, Pre-Submissions (Q-Subs), Breakthrough Designations, De Novos, RFDs, EUAs, change control supplements, and annual reports for drugs and devices.

 

2:15-3:00 PM

Panel Discussion - Q&A with general counsel from industry on various regulatory topics.  - VIEW PANEL DISCUSSION

Panel Members:

  • Frank Piskolich, Division General Counsel at ZOLL Medical Corporation, is responsible for legal issues associated with developing, studying, promoting, and selling FDA-approved implantable medical devices containing proprietary technology and covered by government and private health insurance.
  • 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.
  • Mike Pisetsky, Sr. VP Operations & Administration and Chief Legal Officer, oversees worldwide legal and compliance functions and advises the Board of Directors on legal and corporate governance matters.
  • Jesse Atkins, Senior Attorney, will moderate the panel discussion.

 

Lisa Damhof, Associate Attorney, Gardner Law, will introduce speakers and programing throughout the morning and make sure that your questions receive attention.

 

3:00-5:00 PM Reception

 


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 terickson@gardner.law with questions.

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