Events

MedTech Compliance 101 Bootcamp

September 14, 2022: 8:00 AM – 5:30 PM
September 15, 2022: 8:00 AM – 12:45 PM

Register now

Join us at our AdvaMed office in Washington, D.C. for two days of in-depth and interactive training where you’ll learn everything you need to be the next compliance leader within your organization.

MedTech Compliance 101 Bootcamp

September 14, 2022: 8:00 AM – 5:30 PM
September 15, 2022: 8:00 AM – 12:45 PM

Register now

  1. Overview
  2. Agenda
  3. Panel
  4. Location & Schedule
  5. Pricing

MedTech Compliance 101 Bootcamp

September 14, 2022: 8:00 AM – 5:30 PM
September 15, 2022: 8:00 AM – 12:45 PM

Register now

Save the Date!

AdvaMed and Porzio Life Sciences have designed these Bootcamp courses for those who have recently taken on compliance responsibilities, are currently revamping an existing program or simply require a refresher. These programs will provide you with a comprehensive understanding of the current compliance framework; practical, hands-on approaches for addressing challenges and hurdles; and methods to effectively manage compliance within a medical device company. Whether you have minimal compliance knowledge, or you simply need a quick review, this two day program offers individuals from start-ups to multi-billion dollar companies an intense review of the fundamentals of compliance. You’ll apply the soft skills learned in this program paired with the technical skills and knowledge you already have to be an effective and successful compliance leader and rising executive within the medtech industry.

What to expect?

  • How to build and maintain an effective compliance program, as well as implement best practices
  • Group breakouts and interactive discussions of hypothetical case studies
  • An in-depth look at major risk areas, compliance challenges and mitigating those risks
  • Opportunity to learn from real world medical device compliance leaders
  • And so much more!

Housing

We’ve partnered with the JW Marriot located on 1331 Pennsylvania Ave NW Washington, DC 20004 to provide attendees with first-class housing near the AdvaMed office. Please use the cluster code YG9 at www.marriott.com/wasjw and enter it into the corporate/promo area to receive a discounted rate.

Agenda

Take a look at the agenda for the Compliance 101 Bootcamp, or download it here.

             DAY ONE – Wednesday, September 14th

Program SectionStart TimeDurationTopic/Details All Sessions Will Be Interactive Throughout
  8:00 am30 min.Breakfast
One8:30 am30 min.Introduction (AdvaMed & Porzio) Faculty BiosProgram OverviewAttendees’ Goals for This Program/PollingAdvaMed Intro – Chris White  
Two 9:00 am45 min.The Amorphous Power of Culture (Porzio) Impact of Culture on CompliancePressure Points that Can Affect (and Change?) Culture  
Three 9:45 am45 min.The Foundation of Your Compliance Program (Porzio) Converting the Required Elements of an Effective Compliance Program into a StructureThe Tools and an Environment to Manage RiskMotivating Senior Management and Educating the Board  
 10:30 am15 min.Break
Four10:45 am60 min.What Interests The Government These Days (Porzio) Recent Government Enforcement Actions & Areas of FocusLessons Learned and Their Relevance to Your BusinessNew Developments:  Privacy, FDA Initiatives, and COVID-19, Telehealth SFA, Medical Education  
Five11:45 am60 min.Identifying & Mitigating Your Major Compliance Risk Areas (Porzio) Critical Areas to Assess and Address Including: Interactions with HCPs and Other Health Care Entities; Managing Third-Party Distributors; Data Privacy; Other Compliance ChallengesPractical Methods to Address Risk  
 12:45 pm45 min.Lunch
Five (Continued)  1:30 pm60 min.Identifying & Mitigating Your Major Compliance Risk Areas (Porzio) Critical Areas to Assess and Address Including: Interactions with HCPs and Other Health Care Entities; Managing Third-Party Distributors; Data Privacy; Other Compliance ChallengesPractical Methods to Address Risk  
Six2:30 pm60 min.The 2022 AdvaMed Code (AdvaMed) – Pat Fogarty speaker & panel, Terry Chang & Ethan Gumpert Goals of the CodeRecent Updates to the 2022 Code (e.g. alcohol at Speaker Programs)AdvaMed Code Tools & Resources (VBH, Benchmarking, HealthStream Training Course, Certification)Attendees’ Questions
Seven3:30 pm60 min.Interactive Break Out Session (Porzio) Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerationsConducting a compliance risk assessment  
 4:30 pm15 min.Break
Seven (continued)4:45 pm60 min.Interactive Break Out Session (Porzio) Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerationsConducting a compliance risk assessment  
Eight 5:45 pm15 min.Review of Day One/Plan for Day Two  
  6:00 pm15 min.Adjourn Day One
  6:15 pm120 min.Program Reception – AdvaMed Rooftop

             DAY TWO – Thursday, September 15th

Program SectionStart TimeDurationTopic/Details All Sessions Will Be Interactive Throughout
  8:00 am30 min.Breakfast
Nine 8:30 am60 min.Managing Promotional, Medical, Corporate & Investor Communications (including Social Media): What You Can/Should/Shouldn’t Say to Whom (Porzio) Regulatory Requirements for PromotionRecent Developments:  FDA and FTC EnforcementKey Considerations for Scientific Exchange, Disease Awareness and Corporate CommunicationsSocial Media and Considerations with Use of “Influencers”  
Ten9:30 am90 minIndustry Panel – Healthcare Compliance and All Its Glory in the Medical Device Business (AdvaMed & Porzio) This session will involve current in-house Compliance Officers and the AdvaMed Senior Executive Vice President and General Counsel and Chief Policy Officer who will discuss the multifaceted considerations associated with managing and mitigating health care compliance risks in today’s medical device industry.  
 11:00 am45 minOUS- Focused Panel on Foreign Corrupt Practices Act, Global Compliance, Distributor Compliance, AdvaMed Tools & Resources  (AdvaMed)
 11:45 am15 min.Break
Eleven12:00 am30 min.Spend Transparency Developments: Inside and Outside of the U.S. (Porzio) The Last Federal Reporting Period – A Top Line ReviewRecent US State Activities OUS Developments  
Twelve12:30 pm30 minsClosing Discussion, Q&A and Wrap-up (Chris White, AdvaMed and Porzio) Any Remaining (Burning) QuestionsSo What Are You Going to Do When You Get Back to Work?
 1:00 pmAdjourn Day Two

Panelists

Stay tuned for more information on our panelists!

Schedule

A schedule for the Compliance Bootcamp is included below. The training and reception will take place in our AdvaMed offices located at 1301 Pennsylvania Avenue NW Suite #400, Washington, D.C. 20004 with the following reception being held on the rooftop.

  • Wednesday, September 14, 2022
    • Training: 8:00 AM – 5:30 PM
    • Reception: 5:30 PM – 7:30 PM
  • Thursday, September 15, 2022
    • Training: 8:00 AM – 12:45 PM

Pricing

  • AdvaMed Member Registration ($1,595)
  • AdvaMed Accel Member Registration ($695)
  • Non-Member Registration ($2,095)
  • Government Registration ($695)

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