EVENTS

“ Medical Device Promotional Compliance” Speaker, University of St. Thomas, St. Paul, Minnesota (August 24, 2016).

“Executive Liability For Alleged Marketing Misconduct With Today’s DOJ” Panelist, Medical Alley, Minneapolis, Minnesota (April 7, 2016).

“What Management and Marketers Should Know About the Amarin Off-Label Case and What it Means for Marketing” Speaker and Moderator, LifeScience Alley, Minneapolis, Minnesota (October 27, 2015).

“What does a “corporate audit” or “review” look like?” Moderator, LifeScience Alley, Minneapolis, Minnesota (May 12, 2015).

“Beyond The Traditional Talk: Implementing Impactful & Compliant Peer-to-Peer Programs in 2015.” Speaker, CBI, webinar (April 7, 2015).

“Regulatory 101 — Advertising and Promotional Practices: Regulatory Process and Considerations.” Speaker, LifeScience Alley, St. Paul, Minnesota, (March 3, 2015).

“Is Your App an FDA-regulated medical device?” Speaker, DuVal EDU webinar, (February 17, 2015).

“Medical Applications — What is the Impact of FDA’s New MMA Guidance for the Life Science Industry?” Speaker, Minnesota State Bar Association, CLE, Minneapolis, Minnesota (December 5, 2014).

“Physician Payment Sunshine Act: How To Avoid Sunburn!” Speaker, DuVal EDU seminar, San Francisco, California (November 7, 2014).

“Marketing Your Medical Device in the New FDA OIG Enforcement Environment.” Speaker, DuVal EDU webinar (October 7, 2014).

“Physician Payment Sunshine Act: How To Avoid Sunburn This Summer!—Seminar” Speaker, LifeScience Alley, Minneapolis, Minnesota (June 20, 2014).

“Physician Payment Sunshine Act: How To Avoid Sunburn This Summer!—Webinar” Speaker, DuVal EDU webinar (June 17, 2014).

“Physician Payment Sunshine Act: How To Avoid Sunburn This Summer!—CLE” Speaker, Minnesota State Bar Association, CLE, Minneapolis, Minnesota (June 11, 2014).

“Marketing Your Medical Device in the New FDA/OIG Enforcement Environment” Speaker, DuVal EDU, webinar (June 10, 2014).

“Mobile Medical Applications – What Is the Impact of FDA’s New MMA Guidance for the Life Science Industry?” Minnesota CLE, 2014 Health Law Institute, Minneapolis, Minnesota (June 6, 2014).

“Sunshine Survival Kit” Speaker, CBI, Webinar (May 15, 2014).

“Regulatory Affairs 101 — Advertising and Promotional Practices.” Organizer/Speaker, LifeScience Alley, St. Paul, Minnesota, (March 26, 2014).

“The Physician Payment Sunshine Act: Are You Ready to Report & React?” Speaker, DuVal EDU, Seminar, Irvine, California (March 20, 2014).

“The Sunshine Act–Are You Prepared? The March 31 Reporting Deadline is Approaching Quickly!” Speaker, DuVal EDU, Seminar, Chicago, Illinois (February 5, 2014).

“Brief Overview of the U.S. Healthcare System and the Regulatory Environment for MedTech Companies.” Speaker, LifeScience Alley Pre-Conference Day, Minneapolis, Minnesota (November 19, 2013).

“The U.S. Healthcare System & the FDA Approval Process.” Speaker, Innovation Norway, webinar, (October 15, 2013).

“The U.S. Healthcare System & the FDA Approval Process.” Speaker, FastTrac TechVenture, Minneapolis, Minnesota, (October 3, 2013).

“FDA and Social Media – How to Promote your Products Using Web 2.0 in Compliance with FDA and FTC Laws.” Speaker, MetricStream / Compliance Online, Webinar (June 24, 2013).

“The Sunshine Act – Have you seen the light? What you need to know to get prepared for August 1, 2013. The clock is ticking. Get prepared now, before it’s too late!” Speaker, MetricStream / Compliance Online, Seminar, Chicago, Illinois (June 21, 2013).

“Is Your Advertising Working? Media Planning and Buying: How to Forecast, Plan and Implement an FDA- and FTC-Compliant Media Outreach Campaign for Maximum Response and ROI.” Speaker, LifeScience Alley, Minneapolis, Minnesota, (June 19, 2013).

“U.S. Market Access Workshop.” Speaker, SwedenBIO, Stockholm, Sweden (June 14, 2013).

“U.S. Market Access Workshop.” Speaker, Biopeople/University of Copenhagen, Copenhagen, Denmark (June 12-13, 2013).

“Hot Marketing Topics – Including the Questions Clients Are Asking About Social Media Marketing, the Caronia Off-Label Case, the Extent to Which New Sunshine Training of Sales Reps Is Needed, and More.” Faculty/Planner/Speaker, Minnesota CLE, 2012 Health Law Institute, Minneapolis, Minnesota (June 6, 2013).

“Device Law Updates.” Speaker, Minnesota State Bar Association, Minneapolis, Minnesota, (June 5, 2013).

“The Sunshine Act Final Rule.” Speaker, MetricStream / Compliance Online, webinar (May 16, 2013).

“Regulatory Affairs 101 — Advertising and Promotional Review.” Organizer/Speaker, LifeScience Alley, St. Paul, Minnesota, (May 8, 2013).

“Promoting and Advertising Dietary Supplements In Compliance with FDA and FTC Regulations—Two Day Seminar.” Speaker, MetricStream / Compliance Online, Seminar, Miami, Florida (May 2-3, 2013).

“The U.S. Healthcare System & the FDA Approval Process.” Speaker, FastTrac TechVenture-Mayo Clinic, Rochester, Minnesota, (March 20, 2013).

“Ins and Outs of the Sunshine Act: Compliance Guidelines for Manufacturers.” Speaker, Progressive Healthcare Conferences, webinar (Thursday, March 13, 2013).

“The Sunshine Act Final Rule.” Speaker, LifeScience Alley, Minneapolis, Minnesota (Thursday, March 13, 2013).

“Social Media in 2013: Diving in (or Staying Afloat) Without Sinking.” Speaker, LifeScience Alley, Minneapolis, Minnesota (Thursday, March 7, 2013).

“Promoting and Advertising Dietary Supplements In Compliance with FDA and FTC Regulations—Two Day Seminar.” Speaker, MetricStream / Compliance Online, Seminar, Salt Lake City, Utah (December 6-7, 2012).

“Food, Drug & Device Facility Inspections: Lessons from FDA, the Minnesota Department of Agriculture, and Industry.” Speaker, Minnesota State Bar Association, Minneapolis, Minnesota, (November 9, 2012).

“U.S. Market Access Workshop, Copenhagen, Denmark.” Speaker, Biopeople/University of Copenhagen, Copenhagen, Denmark (October 11-12, 2012).

“Breakfast with the New FDA District Office Director and Staff.” Organizer/Moderator, LifeScience Alley, Minneapolis, Minnesota (September 12, 2012).

“Beyond the Border Initiative.” Roundtable discussion, Consulate General of Canada, Minneapolis, Minnesota (June 28, 2012).

“Promoting and Advertising Dietary Supplements In Compliance with FDA and FTC Regulations.” Speaker, MetricStream / Compliance Online, webinar (June 13, 2012).

“FDA’s 510(k) Program: Past, Present and Future.” Faculty/Planning Committee/Moderator, Minnesota CLE, 2012 Health Law Institute, Minneapolis, Minnesota (June 8, 2012).

“Physician Payment Sunshine Act and State Sunshine Law Compliance. Are you Prepared for the New Federal Requirements?” Speaker, MetricStream / Compliance Online, webinar (April 27, 2012).

“Physician Payment Sunshine Act and State Sunshine Laws.” Speaker, LifeScience Alley, Minneapolis, Minnesota (April 25, 2012).

“Career Pathways.” Panelist, Hamline University School of Law, St. Paul, Minnesota (April 19, 2012).

“Medical Device Guidance Workshop–Network of Experts & Center Science Council.” Organizer/Moderator/Speaker, Minnesota State Bar Association & LifeScience Alley, Minneapolis, Minnesota, (March 29, 2012).

“Regulatory Affairs 101 — Enforcement.” Organizer/Moderator/Speaker, LifeScience Alley, St. Louis Park, Minnesota, (March 14, 2012).

“Obtaining and Marketing Your 510(k) with Today’s FDA, a 510(k) Workshop.” Instructor, LifeScience Alley, St. Louis Park, Minnesota, (March 2, 2012).

“An Update on Fraud Prosecution and Trends involving Drugs and Medical Devices from the US Attorney’s Office.” Moderator, LifeScience Alley, Minneapolis, Minnesota, United States (February 22, 2012).

“Clear as Mud: Obtaining and Marketing Your 510(k) With Today’s FDA.” Instructor, MetricStream / Compliance Online, Salt Lake City, Utah (January 27, 2012).

“Off Label Promotion: Lessons Learned from Recent Enforcement Activity.” Speaker, Thompson Publishing Group, webinar (December 7, 2011).

“The Shifting Global Regulatory Environment.” Faculty, (Moderator/Speaker), LifeScience Alley, Minneapolis, Minnesota (December 7, 2011).

“Clear as Mud: Obtaining and Marketing Your 510(k) With Today’s FDA.” Instructor, MetricStream / Compliance Online, Boston, Massachusetts (October 21, 2011).

“Advertising and Promoting FDA Regulated Products-Is Your House In Order?” Speaker, MetricStream / Compliance Online, webinar (October 19, 2011).

“Sales & Marketing Compliance: Setting the Tone from the Top Early On.” Speaker, Austin Technology Council, Austin, Texas (July 19, 2011).

“Advertising and Promoting FDA Regulated Products-An Update on Prosecution and Trends.” Moderator, LifeScience Alley, New Brighton, Minnesota (June 22, 2011).

“Obtaining and Marketing Your 510(k) with Today’s FDA, a 510(k) Workshop.” Instructor, LifeScience Alley, St. Louis Park, Minnesota, (June 16, 2011).

“Recent Changes in FDA, DOJ and OIG Enforcement Initiatives and Prosecutions Related to the Medical Device and Pharma Industries.” Faculty (speaker and moderator), Minnesota State Bar Association, Minneapolis, Minnesota (June 9, 2011).

“E-Health/Mobile Health Technology: Evolving Regulations and Current Challenges with Wireless Connectivity.” Moderator, LifeScience Alley, New Brighton, Minnesota (April 27, 2011).

“Hamline Business Law Association – General Member Meeting.” Speaker, Hamline University School of Law, St. Paul, Minnesota (April 12, 2011).

“Patent Protection for Medical Devices:  Law and Strategy.” Faculty (speaker), Minnesota State Bar Association, Minneapolis, Minnesota (April 6, 2011).

“Regulatory Affairs 101.” Organizer/Moderator/Speaker, LifeScience Alley, St. Louis Park, Minnesota, (March 11, 2011).

“Clear as Mud: Obtaining and Marketing Your 510(k) With Today’s FDA.” Instructor, MetricStream / Compliance Online, San Francisco, California (January 21, 2011).

“Clear as Mud: Obtaining and Marketing Your 510(k) With Today’s FDA.” Instructor, MetricStream / Compliance Online, Irvine, California (January 20, 2011).

“Compliance: Don’t Be Too Late Getting Your House in Order.” Moderator, Minnesota State Bar Association & LifeScience Alley, St. Louis Park, Minnesota (January 13, 2011).

“Using Social Media & Direct-to-Consumer Marketing in a Regulated Environment.” Faculty, (Moderator/Speaker), LifeScience Alley, Minneapolis, Minnesota (December 8, 2010).

“Commercializing New Technology.” Moderator/Speaker, LifeScience Alley, New Brighton, Minnesota (October 27, 2010).

“Using Social Media in a FDA Compliant Manner.” Speaker, MetricStream / Compliance Online, webinar (October 20, 2010).

“Social Media and FDA Regulations.” Speaker, Medmarc, webinar (August 25, 2010).

“Social Media and FDA Regulations: Where Practical and Legal Meet.” Speaker, University of Minnesota, Healthcare Communication Series – FDA and Social Media, Minneapolis, Minnesota (June 24, 2010)

“FDA and Innovation–Turn Out the Lights?” Faculty (speaker), Spine Technology and Educational Group Organization–Innovative Techniques in Spine Surgery, Cabo San Lucas, Mexico (June 18, 2010).

“Fraud & Abuse in healthcare sales and marketing – Update on the Law and Tips on Compliance.” Speaker, MetricStream / Compliance Online, webinar (May 26, 2010).

“Fraud & Abuse, Enforcement & Compliance – Rules of the Road for Sales & Marketing.” Speaker/Moderator, LifeScience Alley, New Brighton, Minnesota (April 29, 2010).

“Regulatory Affairs 101.” Organizer/Moderator/Speaker, LifeScience Alley, St. Louis Park, Minnesota, (March 11, 2010).

“Appropriate and Lawful Off-Label Dissemination.” Speaker, MetricStream / Compliance Online, webinar (February 23, 2010).

“Lawful Pre-FDA Approval & Pre-FDA Clearance Communication.” Speaker, MetricStream / Compliance Online, webinar (February 3, 2010).

“Food & Drug Law, Practicing FDA Law.” Speaker, Hamline University School of Law, St. Paul, Minnesota (November 18, 2009).

ABOUT THE FIRM
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Gardner Law specializes in laws and regulations that govern the development and commercialization of pharmaceuticals and medical technologies. The firm provides practical and responsive counsel to company leaders navigating the regulatory minefield which they face today.

Proud Member of Medical Alley Association

CONTACT
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    Stillwater, MN - 55082
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