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. Speakers
  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

Click here to access a list of hotels near the AdvaMed office for you to stay in for the duration of The MedTech Compliance 101 Bootcamp.

Agenda

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

AdvaMed/Porzio 2022

MedTech Compliance 101 – THE BOOT CAMP

             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 Bios, Program Overview
Attendees’ Goals for This Program/Polling
AdvaMed Intro – Chris White  
Two 9:00 am45 min.The Amorphous Power of Culture (Porzio)
Impact of Culture on Compliance, Pressure 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 Focus, Lessons Learned and Their Relevance to Your Business, New 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 Challenges, Practical 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 Challenges, Practical Methods to Address Risk  
Six2:30 pm60 min.The 2022 AdvaMed Code (AdvaMed) (AdvaMed) – Pat Fogarty speaker & panel, Terry Chang  
Goals of the Code, Recent 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 considerations
Conducting 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 considerations
Conducting 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 – The Henri – 1301 Pennsylvania Avenue. N.W., Washington, DC

MedTech Compliance 101 – THE BOOT CAMP

             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 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”  
Ten9:30 am90 minIndustry Panel – Healthcare Compliance and All Its Glory in the Medical Device Business
Moderator: Michelle Axelrod, Senior Vice President, Porzio Life Sciences
Speakers: Chris White, Chief Operating Officer, General Counsel, AdvaMed;
Daniel Spicehandler, Vice President, Compliance – Commercial Divisions, Stryker;
Marc Began, Executive Vice President, General Counsel and Secretary, ABIOMED;
Kathryn Stager, Compliance Officer and Vice President of Regulatory Affairs and Quality Systems, SPR Therapeutics  
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.  
Eleven11:00 am45 minOUS- Focused Panel on Foreign Corrupt Practices Act, Global Compliance, Distributor Compliance, AdvaMed Tools & Resources  (AdvaMed)
 11:45 am10 min.Break
Twelve11:55 am50 min.Spend Transparency Developments: Inside and Outside of the U.S. (Porzio)
The Last Federal Reporting Period – A Top Line Review
Recent US State Activities OUS Developments  
Thirteen12:45 pm15 minsClosing Discussion, Q&A and Wrap-up (AdvaMed and Porzio)
Any Remaining (Burning) Questions
So What Are You Going to Do When You Get Back to Work?
 1:00 pmAdjourn Day Two

Speakers

Michelle Axelrod, Managing Principal, Porzio

Michelle D. Axelrod is the managing principal of Porzio, Bromberg & Newman’s New England office and Senior Vice President, Porzio Life Sciences.  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.  

As principal of Porzio, Michelle primarily counsels medical device, pharmaceutical and biotech clients on legal and compliance issues related to product commercialization and related sales, marketing and reimbursement activities. Michelle reviews marketing and related content, advises on fraud and abuse matters and related issues, provides direction regarding field and account management, counsels on privacy matters and supports clients’ compliance initiatives, including conducting compliance assessments/audits, and developing and implementing compliance programs, policies/SOPs, training, and monitoring and auditing programs.  Michelle also negotiates, drafts and reviews various types of agreements and common in the life sciences industry. 

As Senior Vice President of Porzio Life Sciences, Michelle offers additional services to provide clients with innovative and practical solutions to satisfy compliance program objectives and improve compliance initiatives as they relate to healthcare professional and other third party engagements, spend transparency/Sunshine Act compliance, state distribution licensing and sampling. Drawing from her in-house experience, Michelle offers valuable insights to clients on corporate dynamics and provides innovative ideas to support business goals while effectively protecting companies and mitigating organizational risk.  She understands the importance of collaboration between business units, and the Legal and Compliance teams. 

Michelle received her J.D. from Brooklyn Law School and her B.A. degree, cum laude, from the University of Rochester. She is admitted to practice in Massachusetts and New York.

Marc A. Began, Executive Vice President, General Counsel and Secretary, ABIOMED

Mr. Marc Began joined ABIOMED in June 2018 and serves as vice president, general counsel, and secretary responsible for leading the company’s legal and compliance functions worldwide. Mr. Began has worked as a lawyer for more than 20 years, supporting various sectors of the life sciences industry, including pharmaceuticals, medical devices, and biotechnology. He joined ABIOMED from Boehringer Ingelheim where he was vice president of intellectual property responsible for medical device, pharmaceutical, and biologic intellectual property issues.

Before joining Boehringer Ingelheim, Mr. Began held various positions of increasing responsibility at Novo Nordisk during a 15-year period. As assistant general counsel, he oversaw complex litigation matters. He also supported strategic transactions and business development. Prior to that, as assistant chief IP counsel, he managed global patent portfolios and enforcement strategy. Before joining Novo Nordisk, Mr. Began was an associate at the law firms of Sullivan & Cromwell and White & Case in New York where he handled a broad range of legal matters, including litigation, intellectual property, corporate transactions, regulatory and compliance.

Mr. Began earned a Juris Doctor degree from Albany Law School at Union University and holds a Bachelor of Science degree in mechanical engineering from Rensselaer Polytechnic Institute. He is also a licensed professional engineer and previously practiced engineering with the New York State Department of Environmental Conservation.

Terry Chang, Vice President, Assistant General Counsel, and Director of Legal and Medical Affairs of AdvaMed

Dr. Chang provides legal and medical expertise on legislation, regulations, and policy matters. He serves as the legal-medical liaison to the Association’s technical and policy workgroups and committees and works collaboratively to advocate on a global basis for the highest ethical standards, timely patient access to safe and effective medical technologies, and economic policies that reward value creation. 

Dr. Chang holds a Bachelor of Science with Distinction in Economics from the University of Michigan in Ann Arbor and a Medical Doctorate from the Wayne State University School of Medicine in Detroit, MI. Before receiving his Juris Doctorate from the George Washington University Law School, he received postgraduate training in general surgery through the Mount Sinai School of Medicine (Cabrini) Program in Manhattan. Dr. Chang is a Board Certified Medical Affairs Specialist licensed to practice medicine and surgery in Washington, D.C., and is admitted to the New York State and District of Columbia Bars.

Pat Fogarty, Deputy General Counsel and Senior Vice President, General Counsel Office, 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. Immediately prior to joining AdvaMed in March of 2019, Mr. Fogarty served as Assistant General Counsel and Compliance Officer at the Biotechnology Innovation Organization (BIO).  Pat spent nearly a decade at BIO in a series of roles with increasing legal responsibilities.

Mr. Fogarty 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.

Jennifer A. Romanski, Principal, Porzio

Jennifer A. Romanski is a principal of Porzio, Bromberg & Newman and a co-chair of the firm’s Life Sciences Compliance and Regulatory Counseling Department.

Ms. Romanski is also a Vice President of Regulatory and Compliance Services and Chief Privacy Officer of Porzio Life Sciences, LLC, a wholly owned subsidiary of the law firm. In collaboration with the other Directors of Regulatory and Compliance Services, Ms. Romanski is responsible for ensuring that all Porzio Life Sciences products are relevant to the needs of the industry and working with other company personnel to create new products.

Ms. Romanski 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.

She has drafted contracts with co-promotion partners, direct mail companies, medical publication facilitators, and market research organizations. She has provided counsel on implementation of compliance measures for research and development companies, with emphasis on pre-market requirements, clinical trial registration and disclosure, and patient recruitment. In addition, she regularly counsels clients on compliance with state marketing disclosure reporting laws and the new requirements under the Patient Protection and Affordable Care Act, including compliance with healthcare practitioner transparency requirements.

Dan Spicehandler, Vice President, Compliance Commercial Division, 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

Kathryn Stager, Compliance Officer and Vice President of Regulatory Affairs and Quality Systems, SPR Therapeutics

Kathryn Stager is the Compliance Officer and Vice President of Regulatory Affairs and Quality Systems at SPR Therapeutics, where she has worked for over 10 years contributing to the growth of the company from less than 5 employees to over 175.  During this time, she contributed to the securement of over $30M in grant funding from Federal agencies, obtained numerous regulatory approvals for clinical studies and medical devices, established a compliance program, and managed the company’s ISO 13485-certfied quality system. 

Kathryn has a B.S. in Physics from Miami University and an M.S. in Bioengineering from the University of Pittsburgh. 

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

Mr. White serves as the Association’s Chief Legal Officer and manages AdvaMed’s Legal Committee to develop and promote legal policy positions enhancing patient access to medical technology. Mr. White also leads the Association’s global working groups on legal policy and compliance, including over 1500 in-house medtech lawyers. 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 has guest lectured at Northwestern, UPenn, Wharton, GWU School of Medicine and Health Sciences and is an Advisory Board Member to the GWU School of Medicine and Health Sciences. He serves as a frequent speaker and author on industry legal and compliance issues.

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.

Mr. White is a graduate of Wake Forest University where he studied cell biology, and Catholic University Law School. He is an avid sailor, cyclist and beekeeper.

Schedule

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

  • 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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