MedTech Compliance Bootcamp
September 10, 2024 | 8:00 AM – 6:30 PM
September 11, 2024 | 8:00 AM – 2:00 PM
![Man giving a presentation at a podium in front of an audience](https://www.advamed.org/wp-content/uploads/2024/01/Compliance-Bootcamp-Web-graphic-v2-1024x459.jpg)
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
MedTech Compliance Bootcamp
September 10, 2024 | 8:00 AM – 6:30 PM
September 11, 2024 | 8:00 AM – 2:00 PM
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](https://www.advamed.org/wp-content/uploads/2023/04/MicrosoftTeams-image-20-1024x341.png)
Agenda
The preliminary 2024 Compliance Bootcamp agenda is below. You can also download a copy of it here.
DAY ONE – Tuesday, September 10th
Start Time | Topic/Details All Sessions Will Be Interactive Throughout |
---|---|
8:00 am | Breakfast |
8:30 am | Introduction Faculty Bios Program Overview Attendees’ Goals for This Program/Polling AdvaMed Intro |
9:00 am | The Amorphous Power of Culture Impact of Culture on Compliance Pressure Points that Can Affect (and Change?) Culture |
9:45 am | 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 am | Break |
11:00 am | 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 pm | Lunch |
1:00 pm | 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 pm | Break |
3:15 pm | Interactive Break Out Session Present hypothetical scenarios and consider application of the AdvaMed Code and other compliance considerations Conducting a compliance risk assessment |
5:15 pm | Review of Day One/Plan for Day Two |
5:30 pm | Adjourn Day One |
6:30 pm | Program Reception – The Henri 1301 Pennsylvania Avenue. N.W., Washington, DC |
DAY TWO – Wednesday, September 11th
Start Time | Topic/Details All Sessions Will Be Interactive Throughout |
---|---|
8:00 am | Breakfast |
8:30 am | Recap of Day 1 and Interactive Q&A |
9:00 am | 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” |
10:00 am | 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. |
11:30 am | 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 pm | Lunch Break |
12:45 pm | Hot Topics |
1:45 pm | 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 pm | Adjourn Day Two |
Speakers
![Michelle Axelrod Headshot](https://www.advamed.org/wp-content/uploads/2024/01/Michelle-Headshot.jpg?_t=1716933733)
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](https://www.advamed.org/wp-content/uploads/2023/07/Pat-Headshot.jpg?_t=1716934451)
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](https://www.advamed.org/wp-content/uploads/2023/08/Masha-Goodman-Kahn-Headshot.png)
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](https://www.advamed.org/wp-content/uploads/2023/07/Ida-Headshot.jpg?_t=1716934591)
Ida Nassar, Esq., Vice President, Assistant General Counsel, Ethics & Compliance, AdvaMed
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](https://www.advamed.org/wp-content/uploads/2024/01/romanskijenniferweb_image_8512.jpg?_t=1716934946)
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.
![Daniel Spicehandler Headshot](https://www.advamed.org/wp-content/uploads/2023/09/Daniel-Spicehandler.jpg)
Daniel Spicehandler, VP, Compliance- Commercial Divisions, Stryker Corporation
Dan Spicehandler is currently the vice president for Compliance Commercial Divisions at Stryker, a leading international medical device and technology company. He is responsible for leading a team of compliance officers who support the commercial divisions at Stryker through a proactive, principles and risk-based program.
His career has involved multiple operational and leadership positions across the medtech, biotech, and pharmaceutical industries. Prior to Stryker, he served as the U.S. compliance officer for Sanofi Pasteur; led the monitoring, auditing, policy, and risk team at Novo Nordisk Inc.; and served as the director of compliance for Meda Pharmaceuticals (acquired by Mylan). His career has involved both compliance and legal positions, and he has also served as in-house counsel at both Novo Nordisk and Meda. Dan’s experience at both large multinational organizations under monitorships for Corporate Integrity Agreements and REMS programs and smaller U.S.-based companies have helped him to understand the importance of developing compliance programs designed to fit the needs of the business and adapt to the changing expectations of regulators.
Prior experience also includes work as a consultant in developing compliance programs with Polaris Management Partners (now IQVIA) and as a lawyer with the firm of Reed Smith LLP. He is a graduate of Fordham University School of Law, where he serves as an alumnus on its Advisory Board for Compliance Programs, and Union College in Schenectady, New York.
![Chris White Headshot](https://www.advamed.org/wp-content/uploads/2021/04/C.-White-1-819x1024.jpg?_t=1716935004)
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
AdvaMed Accel Member Companies: $925
Non-Members: $2,225
Government/Academic: $1,050