FDA Compliant Marketing/Promotions for Medical Device Companies - Best Selling Package Webinar

ComplianceOnline has created these courses individually through world renowned experts and combined them together to create a comprehensive training resource for companies to train their employees. You can store it as a library material and train all your employees in these compliance issues to get them ready to face any kind of compliance challenge and overcome it through expert advice and best practices.

All Modules:

Module 1: Fraud & Abuse in healthcare sales and marketing – Update on the Law and Tips on Compliance
Module 2: Lawful Pre-FDA Approval & Pre-FDA Clearance Communication
Module 3: Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices
Module 4: Using Social Media in a FDA Compliant Manner

Module 1 : Fraud & Abuse in healthcare sales and marketing – Update on the Law and Tips on Compliance

Learning Objectives:

• About fraud and abuse laws which govern healthcare sales and marketing, e.g. Anti-Kickback Statute, False Claims Act, FDA’s Off-Label Marketing laws, Sunshine Provision, et al.
• How to help keep their sales reps, marketing professionals, and other employees that have contact with healthcare providers in compliance with these laws.
• About companies that have gotten into trouble by promoting their products improperly.
• About resources that help to determine whether behavior is compliant or not, e.g. Federal Safe Harbors [and how to qualify for them], Advisory Opinions, etc.
• Learn the right questions to ask in order to determine if a marketing or sales activity violates the law or not.
• Learn about the consequences to violating the laws.

Areas Covered:

• Introduction/Agenda/Goals.
• Players Involved (FDA, OIG, DOJ, etc).
• Anti-Kickback Statute
  • Remuneration – What is it?
  • How Detect Problems
  • FDA import detention prevention
  • Safe Harbors
  • Anti-Kickback Analysis
  • Examples
• False Claims Act
  • Examples
• Off-Label Marketing
  • Examples
• Qui Tam Suits
  • Examples
• Update on Sunshine Provision and State Laws.
• Questions & Answers.

Module 2 : Appropriate and Lawful Off-Label Dissemination

Areas Covered:

• Sales Activity.
• Marketing Literature.
• Coming Soon Ads.
• Trade Shows and Medical Conventions.
• Unsolicited Requests.
• Company Public Relations.
• Sponsorship of Broadcast Programs.
• Sponsorship of CME Programs.
• Sponsorship of Investigator Initiated Trials.
• Market Research.
• Publication Planning.
• Consultancies.
• Company Websites.

Module 3 : Off-Label Promotion of Medical Devices: Maximizing Your Performance Claims within FDA's Framework of Acceptable Practices

Areas Covered:

• What are the critical issues that arise in advertising and promotion of medical devices.
• What constitutes valid scientific evidence to support advertising and promotional claims.
• What are the rules and regulations for off-label use of medical devices.
• What types of promotional claims go too far and run the risk of generating a Warning Letter from FDA.
• What data are necessary to compare your product to a competitor’s product.
• Examples of successful and problematic advertising and promotional strategies.
• The current FDA environment for post-market compliance of medical devices.
• Examples of punitive enforcement actions.
• Why FDA may now be holding medical device manufacturers to a higher standard than previously, especially regarding misleading claims and off-label use.

Module 4 : Using Social Media in a FDA Compliant Manner

Learning Objectives:

• How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media.
• The ways companies are currently using social media
• FDA advertising and promotion issues related to social media.
• A structure for analysis of responsibility for promotion in social media.
• Recent FDA enforcement situations involving social media.
• Industry proposals on how to govern social media in the future.

Areas Covered:

• How Direct-to-consumer-advertising (“DTCA”) guidance impacts the use of social media.
• The ways companies are currently using social media.
• FDA advertising and promotion issues related to social media.
• A structure for analysis of responsibility for promotion in social media.
• Recent FDA enforcement situations involving social media.
• Industry proposals on how to govern social media in the future.

Who Will Benefit?

The following individuals or disciplines will benefit from these training courses:

• Marketing Management
• Clinical Management
• Attorneys (In-house or Outside Counsel)
• Senior executives of pharmaceutical and device firms
• Regulatory Affairs - Vice Presidents, Directors and Managers
• Sales Vice presidents, Directors and Managers
• Compliance Management
• Sales Management
• QA managers
• Quality system auditors

Instructor Profiles:

(Modules 1,2 & 4)  

Mark DuVal, J.D., is President of DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice includes providing strategic regulatory advice, developing compliance programs, designing and implementing sophisticated marketing programs, counseling on reimbursement matters, conducting sales training and interfacing extensively on behalf of companies with the FDA with relation to product approvals and clearances, clinical trial negotiations, approvals, policy arguments, appeals, etc. Prior to founding the firm, Mark was general counsel for 3M Pharmaceuticals and Drug Delivery Systems working both domestically and internationally. He was on assignment for 3M Health Care Systems, Ltd. In Europe based out of the United Kingdom. He then worked at Medtronic in Corporate Compliance for FDA, Anti-kickback, False Claims Act, HIPAA & HITECH, and other advice related to the FDA-regulated industry.

Mark earned his Juris Doctor from the William Mitchell College of Law where he served as executive editor on the law review, and his Bachelor of Arts in Public Administration from St. Cloud State University. Mark has served on various boards including the Minnesota BioBusiness Alliance, Minnesota Biosciences Council, The Food and Drug Law Institute and has been a former Chairman of the Minnesota State Food, Drug, and Medical Device Section of the Minnesota State Bar Association. He is also on the Board of Advisors of the Masters in Regulatory Affairs Services program at St. Cloud State University. Mark is a frequent national speaker and writer on issues relating to product approvals/clearances; combination products, product advertising and promotion, Anti-kickback and False Claims Act (reimbursement) matters.

(Modules 1,2 & 4)

Mark Gardner, M.B.A., J.D., is an Associate Attorney at DuVal & Associates, P.A., a law firm dedicated to counseling companies in the medical device, pharmaceutical, biotech, food, and nutritional supplement industries. His practice focuses on compliance (federal and state anti-fraud and abuse laws, anti-kickback analysis, HIPAA & HITECH, and development of training and compliance programs) and promotion (appropriate and lawful off-label dissemination procedures, sales contracts, labeling and advertising review, continuing medical education programs (CME), product launch campaigns, pre-approval communications programs, direct-to-consumer (DTC) advertising, and domestic and international web strategy). Prior to joining the firm, Mark worked in the medical device industry for 10 years as a marketer in product management and previously in sales roles. While working at ev3, Celleration, and Medtox Mark focused on commercializing and developing products used for surgical, wound healing, and diagnostic applications.

Mark earned his Juris Doctor from Hamline University School of Law, his Master of Business Administration from the University of St. Thomas, and his Bachelor of Science, Finance and Economics from the University of Wisconsin-La Crosse. Mark is currently serving as Co-Chair for LifeScience Alley's Regulatory Special Interest Group.

(Module 3) 

Stuart Portnoy, MD is Senior Consultant, Medical Devices, Biologics Consulting Group, Inc., where he advises medical device manufacturers regarding regulatory strategy, clinical trial design issues, and technical considerations to gain FDA market-approval for their products. He previously worked as a consultant at PharmaNet for 5 years and before that, at FDA for 8 years including positions as Branch Chief of Interventional Cardiology Devices and Acting Deputy Director of the Division of Cardiovascular Devices in the Center for Devices and Radiological Health. While at FDA, Dr. Portnoy performed the clinical review of a wide range of cardiac devices and was an agency leader in developing the now well-established multicenter review practices for evaluating drug-eluting stents and other combination products. Dr. Portnoy is a graduate of George Washington University School of Medicine and also has an MS in Bioengineering from the University of Pennsylvania.

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