Events

MedTech Compliance Bootcamp

September 10, 2024 | 8:00 AM – 6:30 PM
September 11, 2024 | 8:00 AM – 2:00 PM

Register now

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 | 8:00 AM – 6:30 PM
September 11, 2024 | 8:00 AM – 2:00 PM

Register now

  1. Overview
  2. Agenda
  3. Speakers
  4. Housing
  5. Pricing

MedTech Compliance Bootcamp

September 10, 2024 | 8:00 AM – 6:30 PM
September 11, 2024 | 8:00 AM – 2:00 PM

Register now

Registration is open for the MedTech Compliance Bootcamp hosted by AdvaMed and Porzio this September in Washington, D.C.! 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 secure your spot for this event!

This event will take place at the AdvaMed office located at 1301 Pennsylvania Ave NW Ste 400, Washington, D.C. 20004. Join our mailing list 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:

Porzio Logo

Agenda

The preliminary 2024 Compliance Bootcamp agenda is below. You can also download a copy of it here.

DAY ONE – Tuesday, September 10th
Start TimeTopic/Details
All Sessions Will Be Interactive Throughout
8:00 amBreakfast
8:30 amIntroduction
Faculty Bios
Program Overview
Attendees’ Goals for This Program/Polling
AdvaMed Intro
9:00 amThe Amorphous Power of Culture
Impact of Culture on Compliance
Pressure Points that Can Affect (and Change?) Culture
9:45 amThe 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 amBreak
11:00 amWhat Interests The Government These Days
Recent Government Enforcement Actions & Areas of Focus
Lessons Learned and Their Relevance to Your Business
New Developments
12:00 pmLunch
1:00 pmCompliance 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 pmBreak
3:15 pmInteractive Break Out Session
Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerations
Conducting a compliance risk assessment
5:15 pmReview of Day One/Plan for Day Two
5:30 pmAdjourn Day One
6:30 pmProgram Reception – The Henri
1301 Pennsylvania Avenue. N.W., Washington, DC
DAY TWO – Wednesday, September 11th
Start TimeTopic/Details
All Sessions Will Be Interactive Throughout
8:00 amBreakfast
8:30 amRecap of Day 1 and Interactive Q&A
9:00 amManaging 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”
10:00 amIndustry 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.
11:30 amAdvaMed 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 pmLunch Break
12:45 pmHot Topics
1:45 pmClosing 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

Speakers

Michelle Axelrod Headshot

Michelle D. Axelrod, J.D. Managing Principal of Porzio, Bromberg & Newman.

Michelle D. Axelrod is the Managing Principal of Porzio, Bromberg & Newman’s New England office. Michelle has over 25 years of experience addressing legal and compliance issues impacting companies in the life sciences industry; 15 years as in-house counsel. Michelle primarily counsels pharmaceutical, medical device, and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing, and reimbursement activities. Michelle reviews promotional
content and medical communications, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, and supports clients’ compliance initiatives, including the development of policies/SOPs, training, and monitoring and auditing programs. Michelle also negotiates, drafts and reviews commercial and government contracts, including discount and rebate agreements with health plans/PBMs, retail/specialty pharmacies, GPOs, wholesalers, and other healthcare entities. In addition, she handles distribution agreements and other fee-for-service consulting and service arrangements common in the life sciences industry.

Pat Fogarty Headshot

Pat Fogarty, Esq., Deputy General Counsel, Senior Vice President of Legal, AdvaMed

Pat Fogarty is the Deputy General Counsel & Senior VP of Legal at the Advanced Medical Technology Association (AdvaMed). AdvaMed advocates globally for the highest ethical standards and patient access to safe, effective and innovative medical technologies that save and improve lives. In addition to providing in-house legal counsel to the organization, Pat leads AdvaMed’s litigation reform legal policy work and related stakeholder outreach, which are emerging priorities for medtech innovators and patients who rely on FDA’s safety determinations. He also manages the association’s amicus curiae program, including filing multiple briefs on a myriad of issues in U.S. federal and state courts. Pat holds a B.A. from Virginia Tech and a J.D. from the Syracuse University College of Law. He is admitted to the District of Columbia Bar.

Marsha Goodman-Khan Headshot

Masha Goodman-Khan, Senior Director of Compliance and Legal Operations, Vericel

Masha Goodman-Khan is the Senior Director of Compliance and Legal Operations at Vericel Corporation.  She possesses over a decade of experience guiding biopharmaceutical and medical technology organizations in the area of healthcare and regulatory compliance, as well as healthcare law and policy.  Masha holds a Bachelor of Science in Biological Sciences from Georgia State University and a Master of Science in Jurisprudence (M.S.J) in Pharmaceutical and Medical Device Law & Compliance and Hospital and Health Policy from Seton Hall University School of Law.

Ida Nassar Headshot

Ida Nassar, Esq., Vice President, Assistant General Counsel, Ethics & ComplianceAdvaMed

Ms. Nassar manages AdvaMed’s ethics and compliance policy working groups on the AdvaMed Code, federal and state anti-kickback statutes, the Physician Self-Referral (Stark) Law, Sunshine Implementation, False Claims Act, and other health care laws and regulations applicable to medical device innovators and manufacturers. Ms. Nassar also handles AdvaMed’s global legal policy working groups, which seek to establish common global standards for anti­ corruption and business integrity and secure procurement, regulatory, and enforcement incentives that reward compliance. Prior to AdvaMed, Ms. Nassar was a Senior Attorney within the Drug Enforcement Administration’s Office of Chief Counsel where she handled enforcement actions under the Controlled Substances Act as well as defensive litigation matters for the department. She also served as Trial Attorney for the U.S. Department of Justice, managing commercial and torts litigation (including vaccine litigation). Ida also practiced for several years with the Hollingsworth law firm managing life sciences products liability litigation.

Jennifer Romanski Headshot

Jennifer Romanski, J.D., Principal, Porzio, Bromberg & Newman

Ms. Romanski, chair of the firm’s Life Sciences Legal, Regulatory, and Compliance Practice Group, has broad experience counseling pharmaceutical, biotech and medical device companies in regulatory and compliance matters, including preparation of corporate compliance programs, advertising and promotion activities, medical publication planning, interactions with healthcare practitioners, grants and continuing medical education programs, FDA enforcement activity, and sample accountability and PDMA requirements. She worked for many years in Porzio’s Key Client program where she served as part of the in-house legal team for various pharmaceutical companies several days a week. She has also served as acting compliance director at a large pharmaceutical company, where she was involved in over twenty compliance reviews and investigations.

Chris White Headshot

Christopher L. White, General Counsel, Chief Policy Officer, and Secretary, AdvaMed

Mr. White serves as the Association’s Chief Legal Officer and AdvaMed’s Chief Policy Officer, leading the Association’s work to develop and promote policy positions enhancing patient access to medical technology worldwide. Mr. White also leads the Association’s strategic planning activities and investor relations matters. In March 2020, Mr. White was appointed the organization’s COVID-19 Action Team Leader, leading all COVID-19-related initiatives and policy. Additionally, he guided the organization to fully remote functioning upon the onset of the pandemic.

He testified before state and federal legislative committees on priority legal policy issues; led the drafting team revising the AdvaMed Code; and led the multinational negotiating team to draft the Kuala Lumpur Principles, harmonizing industry Codes of Ethics in Asia. He is a frequent speaker on health law and policy issues, and posts health policy blogs on his Linkedln page.

Prior to AdvaMed, Mr. White was a partner with the global law firm Morgan Lewis; and he began his health law legal career with the firm Drinker Biddle. Mr. White is a graduate of Wake Forest University, where he studied electron microscopy and cell biology, and Catholic University Law School.

Hotel Information

Grand Hyatt Washington DC | 1000 H Street NW Washington, D.C. 20001

Deadline to book: Tuesday, August 20, 2024

We’re pleased to provide attendees with the lowest hotel rate in the city at the Grand Hyatt Washington located on 1000 H Street NW Washington, D.C. 20001. If you’ll need housing during the Bootcamp, please secure your reservation by Tuesday, August 20 so you can enjoy our premier rate. Our room block is open, so book your housing today!

Check to see if your company is an AdvaMed member here.

AdvaMed Member Companies: $1,825.00

AdvaMed Accel Member Companies: $925.00

Non-Members: $2,225.00

Government/Academic: $1,050

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