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DAY ONE Wednesday, June 12, 2019

8:00

Conference Registration and Networking Breakfast

9:00

Choose Between Two Concurrent Summits (1-2)

1. CCO Summit
(Invitation Only*)

This Summit is designed to encourage an open dialogue and high-quality information exchange which C-suite leaders can use to develop into an actionable plan. Collaborate with colleagues to gain valuable insights through discussions on the most critical legal and regulatory issues in the MedTech, device and diagnostic industry.

Michelle Scharfenberg
Vice President and Chief Compliance Officer
Cantel Medical

Ilana Shulman
Chief Compliance Officer
Hillrom

Jackie Huber
Chief Compliance Officer
Medacta USA

*Invited participants hold the title of a compliance leadership position within a medical devices, diagnostics or medical technology company at the time of the event. Final eligibility approval is at the discretion of CBI.

 
2. Ensuring Compliant Interactions with HCPs

As the healthcare industry continues to face significant regulatory oversight, it is critical for manufacturers to ensure strategies are in place to enhance effectiveness and compliance. This in-depth workshop focuses on streamlining the communication, engagement and management between medical device manufacturers and HCPs. Benefit from open discussions and practical takeaways to manage compliance risk, streamline communication and enhance digital engagement.

Alexis Wermuth
Ethics and Compliance Officer
Fresenius Medical Care North America

Stephanie Trunk
Partner
Arent Fox

There will be a 30 Minute Networking and Refreshment Break at 10:30

12:00

Networking Luncheon

1:00

Chairman’s Welcome and Opening Remarks

Rodrigo Grion
Executive Director, Americas Compliance
GE Healthcare

1:15

OPENING ADDRESS AdvaMed Code of Ethics Update

Matthew Wetzel
Senior Counsel, Akin Gump Strauss Hauer & Feld LLP;
former Vice President and Deputy General Counsel, AdvaMed

Avi Spira
Chief Compliance, Risk and Privacy Officer
FUJIFILM Holdings America Corporation

2:00

Emerging Risks in Off-Label Marketing and Promotions

John Kelly
Member
Bass, Berry & Sims

2:45

PANEL DISCUSSION Transparency Regulations and Achieving Compliance on a Global and
National Scale

Moderator:

Ned Mumtaz
Partner and U.S. Practice Leader
qordata

Panelists:

Michelle Scharfenberg
Vice President and Chief Compliance Officer
Cantel Medical

Joanne Thompson
Senior Manager, Compliance Operations
Hillrom

Jackie Huber
Chief Compliance Officer
Medacta USA

Kelly Tope
Global Director Compliance
Zimmer Biomet

3:30

Networking and Refreshment Break

4:00

POLICY AND REGULATORY UPDATE Pressing Legislative and Policy Issues Facing the Medical Device and
MedTech Industry

Angela Brown
Director, Regulatory Affairs
ICON, plc

4:45

Navigate the Grey Zone of Corporate Conduct, Business Ethics and Compliance

Michaela Ahlberg
Chief Ethics and Compliance Officer
Getinge

Meena Datta
Partner
Sidley Austin

5:30

Close of Day One

Join Us Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday, June 13, 2019

8:00

Networking Breakfast

8:30

Chairman’s Welcome and Review of Day One

Rodrigo Grion
Executive Director, Americas Compliance
GE Healthcare

8:15

PANEL DISCUSSION Enforcement Update — Trends and Top Priorities for 2019 and Beyond

Moderator:

Seth Lundy
Partner
King & Spalding

Panelists:

David Walk
Assistant U.S. Attorney
District of New Jersey, U.S. Department of Justice

Patrick Otlewski
Partner, King & Spalding;
former Assistant U.S. Attorney,
U.S. Attorney’s Office for the Northern District of Illinois

Heather McShain
Supervisor, Health Care Fraud Unit and
Criminal Division Health Care Fraud Coordinator
U.S. Attorney’s Office for the Northern District of Illinois

9:45

Managing Compliance of Third-Parties

Tyler Brady
Forensics and Integrity Services Senior Manager
EY

10:30

Networking and Refreshment Break

11:00

Practical Approaches to Ensure Data Privacy and Mitigate Cybersecurity Risks

Stephanie Lewko, CFE
Director
Navigant

Brian Segobiano, CIPP/E
Director
Navigant

11:45

Develop and Maintain Dynamic Auditing and Monitoring Compliance Programs

Emily Huebener
Forensics and Integrity Services Senior Manager
EY

Corey Dunbar
Forensics and Integrity Services Senior Manager
EY

12:30

Networking Luncheon

1:30

Ensure Alignment Across Internal Audit and Compliance to Enhance Value

Khalil Thomas
Senior Director, Internal Audit
Siemens

2:15

Role of Compliance Teams and Mitigating Risk During M&A

Patrick Rao, Esq.
Compliance Director
CONMED Corporation

3:00

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE Wednesday, June 12, 2019

8:00

Conference Registration and Networking Breakfast

9:00

Choose Between Two Concurrent Summits (1-2)

1. CCO Summit
(Invitation Only*)

This Summit is designed to encourage an open dialogue and high-quality information exchange which C-suite leaders can use to develop into an actionable plan. Collaborate with colleagues to gain valuable insights through discussions on the most critical legal and regulatory issues in the MedTech, device and diagnostic industry.

Michelle Scharfenberg
Vice President and Chief Compliance Officer
Cantel Medical

Ilana Shulman
Chief Compliance Officer
Hillrom

Jackie Huber
Chief Compliance Officer
Medacta USA

*Invited participants hold the title of a compliance leadership position within a medical devices, diagnostics or medical technology company at the time of the event. Final eligibility approval is at the discretion of CBI.

 
2. Ensuring Compliant Interactions with HCPs

As the healthcare industry continues to face significant regulatory oversight, it is critical for manufacturers to ensure strategies are in place to enhance effectiveness and compliance. This in-depth workshop focuses on streamlining the communication, engagement and management between medical device manufacturers and HCPs. Benefit from open discussions and practical takeaways to manage compliance risk, streamline communication and enhance digital engagement.

Alexis Wermuth
Ethics and Compliance Officer
Fresenius Medical Care North America

Stephanie Trunk
Partner
Arent Fox

There will be a 30 Minute Networking and Refreshment Break at 10:30

12:00

Networking Luncheon

1:00

Chairman’s Welcome and Opening Remarks

Rodrigo Grion
Executive Director, Americas Compliance
GE Healthcare

1:15

OPENING ADDRESS AdvaMed Code of Ethics Update

Matthew Wetzel
Senior Counsel, Akin Gump Strauss Hauer & Feld LLP;
former Vice President and Deputy General Counsel, AdvaMed

Avi Spira
Chief Compliance, Risk and Privacy Officer
FUJIFILM Holdings America Corporation

2:00

Emerging Risks in Off-Label Marketing and Promotions

John Kelly
Member
Bass, Berry & Sims

2:45

PANEL DISCUSSION Transparency Regulations and Achieving Compliance on a Global and
National Scale

Moderator:

Ned Mumtaz
Partner and U.S. Practice Leader
qordata

Panelists:

Michelle Scharfenberg
Vice President and Chief Compliance Officer
Cantel Medical

Joanne Thompson
Senior Manager, Compliance Operations
Hillrom

Jackie Huber
Chief Compliance Officer
Medacta USA

Kelly Tope
Global Director Compliance
Zimmer Biomet

3:30

Networking and Refreshment Break

4:00

POLICY AND REGULATORY UPDATE Pressing Legislative and Policy Issues Facing the Medical Device and
MedTech Industry

Angela Brown
Director, Regulatory Affairs
ICON, plc

4:45

Navigate the Grey Zone of Corporate Conduct, Business Ethics and Compliance

Michaela Ahlberg
Chief Ethics and Compliance Officer
Getinge

Meena Datta
Partner
Sidley Austin

5:30

Close of Day One

Join Us Networking, Wine and Cheese Reception immediately following the final session on day one

DAY TWO Thursday, June 13, 2019

8:00

Networking Breakfast

8:30

Chairman’s Welcome and Review of Day One

Rodrigo Grion
Executive Director, Americas Compliance
GE Healthcare

8:15

PANEL DISCUSSION Enforcement Update — Trends and Top Priorities for 2019 and Beyond

Moderator:

Seth Lundy
Partner
King & Spalding

Panelists:

David Walk
Assistant U.S. Attorney
District of New Jersey, U.S. Department of Justice

Patrick Otlewski
Partner, King & Spalding;
former Assistant U.S. Attorney,
U.S. Attorney’s Office for the Northern District of Illinois

Heather McShain
Supervisor, Health Care Fraud Unit and
Criminal Division Health Care Fraud Coordinator
U.S. Attorney’s Office for the Northern District of Illinois

9:45

Managing Compliance of Third-Parties

Tyler Brady
Forensics and Integrity Services Senior Manager
EY

10:30

Networking and Refreshment Break

11:00

Practical Approaches to Ensure Data Privacy and Mitigate Cybersecurity Risks

Stephanie Lewko, CFE
Director
Navigant

Brian Segobiano, CIPP/E
Director
Navigant

11:45

Develop and Maintain Dynamic Auditing and Monitoring Compliance Programs

Emily Huebener
Forensics and Integrity Services Senior Manager
EY

Corey Dunbar
Forensics and Integrity Services Senior Manager
EY

12:30

Networking Luncheon

1:30

Ensure Alignment Across Internal Audit and Compliance to Enhance Value

Khalil Thomas
Senior Director, Internal Audit
Siemens

2:15

Role of Compliance Teams and Mitigating Risk During M&A

Patrick Rao, Esq.
Compliance Director
CONMED Corporation

3:00

Close of Conference