Events

MedTech Compliance Bootcamp

September 10, 2024 – September 11, 2024

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Join us at the AdvaMed office in Washington, D.C. for two days of in-depth and interactive compliance training, where you’ll gain the necessary skills to be a compliance leader within your organization.

MedTech Compliance Bootcamp

September 10, 2024 – September 11, 2024

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  1. Overview
  2. Agenda

MedTech Compliance Bootcamp

September 10, 2024 – September 11, 2024

Join the mailing list

Join AdvaMed and Porzio for the MedTech Compliance Bootcamp this September in Washington, DC. This event is perfect for those who have recently taken on compliance responsibilities, are currently revamping an existing program, or just want a quick refresher. The carefully curated program will provide you with a comprehensive understanding of the current compliance framework; practical, hands-on approaches for addressing challenges and hurdles; and methods for effectively managing compliance within a medical technology company. Ensure your team is up to speed on compliance issues and mark your calendar for this event! Complete the mailing list below to be the first to receive updates on the 2024 program.

Learning Objectives

  • How to build and maintain an effective compliance program, as well as implement best practices.
  • Group breakout sessions and interactive discussions of relevant hypothetical case studies.
  • An in-depth look at major risk areas and compliance challenges and the ways to mitigate those risks.
  • A holistic breakdown of the fundamentals of compliance.

This event is in partnership with:

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Agenda

A draft of the 2024 Compliance Bootcamp agenda is below. You can also download a copy of it here.

DAY ONE – Tuesday, September 10th
Program SectionStart TimeDurationTopic/Details
All Sessions Will Be Interactive Throughout
 8:00 am30 min.Breakfast
One8:30 am30 min.Introduction
Faculty Bios
Program Overview
Attendees’ Goals for This Program/Polling
AdvaMed Intro
Two9:00 am45 min.The Amorphous Power of Culture
Impact of Culture on Compliance
Pressure Points that Can Affect (and Change?) Culture
Three9:45 am  60 min.The Foundation of Your Compliance Program
Relevant Laws, Rules and Guidance
Converting the Required Elements of an Effective Compliance Program into a Structure
The Tools and Environment to Manage Risk
Motivating Senior Management and Educating the Board
 10:45 am15 min.Break
Four11:00 am60 min.What Interests The Government These Days
Recent Government Enforcement Actions & Areas of Focus
Lessons Learned and Their Relevance to Your Business
New Developments
 12:00 pm60 min.Lunch
Five1:00 pm120 min.Compliance Deep Dive: Identifying and Mitigating Ongoing and Emerging Risk Areas Inside and Outside the United States Identifying High Risk Areas
Addressing and Mitigating Risks Locally and Globally   Considerations related to Interactions with HCPs and Other Health Care Entities;
Managing Third-Party Distributors;
Data Privacy; Other Compliance Challenges
 3:00 pm15 min.Break
Six3:15 pm120 min.Interactive Break Out Session
Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerations
Conducting a compliance risk assessment
Seven5:15 pm15 min.Review of Day One/Plan for Day Two
 5:30 pm15 min.Adjourn Day One
 6:30 pm120 min.Program Reception – The Henri
1301 Pennsylvania Avenue. N.W., Washington, DC
DAY TWO – Wednesday, September 11th
Program SectionStart TimeDurationTopic/Details
All Sessions Will Be Interactive Throughout
 8:00 am30 min.Breakfast
Nine8:30 am30 min.Recap of Day 1 and Interactive Q&A
Ten9:00 am60 min.Managing Promotional, Medical, Corporate & Investor Communications (including Social Media): What You Can/Should/Shouldn’t Say to Whom
Regulatory Requirements for Promotion
Recent Developments:
FDA and FTC Enforcement
Key Considerations for Scientific Exchange
Disease Awareness and Corporate Communications
Social Media and Considerations with Use of “Influencers”
Eleven10:00 am90 min.Industry Panel – Healthcare Compliance and All Its Glory in the Medical Device Business
This session will involve current in-house Compliance Officers and AdvaMed compliance leaders who will discuss the multifaceted considerations associated with managing and mitigating health care compliance risks in today’s medical device industry.
Twelve11:30 am45 min.AdvaMed Session (TBD)
Patrick Fogarty, Deputy General Counsel and Senior Vice President, Legal, AdvaMed
Ida Nassar, Vice President, Assistant General Counsel, Compliance & Ethics, Legal, AdvaMed
 12:15 pm45 min.Lunch Break
Thirteen12:45 pm60 min.Hot Topics
Fourteen1:45 pm15 min.Closing Discussion, Q&A and Wrap-up
Any Remaining (Burning) Questions
So What Are You Going to Do When You Get Back to Work?
 2:00 pmAdjourn Day Two

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