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DAY ONE MONDAY, MAY 22, 2017

7:30

Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Victoria Browning
Chief Compliance Officer
Karl Storz

8:45

KEYNOTE PANEL Chief Compliance Officer Panel

MODERATOR:

Eileen Erdos
Principal
EY

PANELISTS:

Diane Biagianti
Vice President, Chief Responsibility Officer
Edwards Lifesciences

Bill Hrubes
Vice President and Chief Compliance Officer
ACell Inc.

Jessica R. Puathasnanon
Ethics and Compliance Officer, Medtronic Diabetes Group
Medtronic

9:45

ENFORCEMENT TRENDS PANEL U.S. Attorney’s Office

PANELISTS:

Gregg Shapiro
Assistant United States Attorney, District of Massachusetts
U.S. Department of Justice

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

10:30

Networking and Refreshment Break

11:00

Update on International Cooperation and Enforcement Efforts

Darryl Wegner
Unit Chief, International Corruption Unit
FBI HQ — Criminal Investigative Division

11:45

The Enforcement Outlook Post-Yates Under the New Administration and
Risk Mitigation Strategies for Criminal Liability

MODERATOR:

Bill Hrubes
Vice President and Chief Compliance Officer
ACell Inc.

PANELISTS:

Jessica R. Puathasnanon
Ethics and Compliance Officer, Medtronic Diabetes Group
Medtronic

Victoria Browning
Chief Compliance Officer
Karl Storz

12:30

Networking Luncheon

1:30

Privacy and Security —
Managing Cyber Security Threats, Global Risk and Enterprise-Wide Programs

MODERATOR:

Rishi Ballakhan
Senior Manager
EY

PANELISTS:

Christian Krautkramer
Global Compliance Manager
GE Healthcare

David Chan, CISA, CISSP
Senior Manager, Cybersecurity
EY

2:30

Evaluate Recent Trends in Global Anti-Bribery/Anti-Corruption Legislations

Emily E. Gerdts
Senior Consultant
Polaris

Brendan Washburn
Manager
Polaris

3:15

Networking and Refreshment Break

3:45

It’s Legit — Needs Assessments For Engaging HCPs

Gina M. Cavalier
Partner, FDA and Life Sciences Practice Group
King & Spalding

4:30

Trade Compliance Update

Angelica Tsakiridis
Manager, Tax Practice
EY

5:15

Aggregate Spend — 20 Things to Know About Transparency

Brian Sharkey
Principal
Porzio Life Sciences

John Oroho
Principal
Porzio Life Sciences

6:00

Close of Day One

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

DAY TWO TUESDAY, MAY 23, 2017

8:00

Continental Breakfast

8:45

Chairperson’s Review of Day One

Victoria Browning
Chief Compliance Officer
Karl Storz

9:00

CHOOSE BETWEEN 2 CONCURRENT SESSIONS (A & B)

A. INVITATION-ONLY CHIEF COMPLIANCE OFFICER SUMMIT*

This invite-only Chief Compliance Officer segment of the program offers a unique opportunity for experienced device compliance executives to meet in a closed-door setting to share findings with peers.

FACILITATORS:

Victoria Browning
Chief Compliance Officer
Karl Storz

Avi Spira
Vice President, Chief Compliance Officer
Cantel Medical Corp.

*Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a medical device company at the time of the conference. Final eligibility approval is at the discretion of CBI. For more details on how you can participate as a delegate for this portion of the MDCC program, please contact John Kuchinski at [email protected].

There will be a 30-minute refreshment break at 10:30am

B. TWO INCLUSIVE, HANDS-ON, INTERACTIVE WORKSHOPS All MDCC delegates are invited to participate in our Interactive Workshops.

9:00

WORKSHOP 1 Compliance Metrics and Data Reporting

Learn how compliance officers can efficiently harness the advantages of big-data platform to develop a data analytics programs and cut thru the “noise” to create meaningful compliance reports.

Sapan Singh
Director, Compliance,
Indirect Channels and Data Analytics Programs
Stryker

Mohammad Ovais
Founder & CEO
qordata

10:30

Networking and Refreshment Break

11:00

WORKSHOP 2 Third-Party Distributor Monitoring Programs and Measuring Success

Share best practices on third-party distributor compliance monitoring programs. Discuss common challenges on how to manage the risk related to use of third-party distributors in emerging markets and how to prioritize and strike a balance between risk mitigation and resource limitation. Illustrate how to engage distributors to buy into the compliance requirements.

Sapan Singh
Director, Compliance,
Indirect Channels and Data Analytics Programs
Stryker

Emily C. Huebener
Manager, Assurance Services,
Fraud Investigation & Dispute Services
Ernst & Young, LLP

12:30

CCO Networking Luncheon and Delegate Networking Luncheon

1:30

FDA Cybersecurity Update

Seth D. Carmody, PhD
Cybersecurity Program Manager Center, Devices and
Radiological Health, Office of the Center Director Emergency
Preparedness/Operations & Medical Countermeasures
FDA

2:15

Antitrust Compliance Efforts

Chris Branch
Deputy General Counsel
ACell, Inc.

3:00

Ethics Training Strategies and Tools —
Effectively Serving Employees While Managing Compliance Risks

Avi Spira
Vice President, Chief Compliance Officer
Cantel Medical Corp.

Christian Krautkramer
Global Compliance Manager
GE Healthcare

3:45

Close of Conference

Want more agenda details? Download the brochure.

DAY ONE MONDAY, MAY 22, 2017

7:30

Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Victoria Browning
Chief Compliance Officer
Karl Storz

8:45

KEYNOTE PANEL Chief Compliance Officer Panel

MODERATOR:

Eileen Erdos
Principal
EY

PANELISTS:

Diane Biagianti
Vice President, Chief Responsibility Officer
Edwards Lifesciences

Bill Hrubes
Vice President and Chief Compliance Officer
ACell Inc.

Jessica R. Puathasnanon
Ethics and Compliance Officer, Medtronic Diabetes Group
Medtronic

9:45

ENFORCEMENT TRENDS PANEL U.S. Attorney’s Office

PANELISTS:

Gregg Shapiro
Assistant United States Attorney, District of Massachusetts
U.S. Department of Justice

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

10:30

Networking and Refreshment Break

11:00

Update on International Cooperation and Enforcement Efforts

Darryl Wegner
Unit Chief, International Corruption Unit
FBI HQ — Criminal Investigative Division

11:45

The Enforcement Outlook Post-Yates Under the New Administration and
Risk Mitigation Strategies for Criminal Liability

MODERATOR:

Bill Hrubes
Vice President and Chief Compliance Officer
ACell Inc.

PANELISTS:

Jessica R. Puathasnanon
Ethics and Compliance Officer, Medtronic Diabetes Group
Medtronic

Victoria Browning
Chief Compliance Officer
Karl Storz

12:30

Networking Luncheon

1:30

Privacy and Security —
Managing Cyber Security Threats, Global Risk and Enterprise-Wide Programs

MODERATOR:

Rishi Ballakhan
Senior Manager
EY

PANELISTS:

Christian Krautkramer
Global Compliance Manager
GE Healthcare

David Chan, CISA, CISSP
Senior Manager, Cybersecurity
EY

2:30

Evaluate Recent Trends in Global Anti-Bribery/Anti-Corruption Legislations

Emily E. Gerdts
Senior Consultant
Polaris

Brendan Washburn
Manager
Polaris

3:15

Networking and Refreshment Break

3:45

It’s Legit — Needs Assessments For Engaging HCPs

Gina M. Cavalier
Partner, FDA and Life Sciences Practice Group
King & Spalding

4:30

Trade Compliance Update

Angelica Tsakiridis
Manager, Tax Practice
EY

5:15

Aggregate Spend — 20 Things to Know About Transparency

Brian Sharkey
Principal
Porzio Life Sciences

John Oroho
Principal
Porzio Life Sciences

6:00

Close of Day One

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

DAY TWO TUESDAY, MAY 23, 2017

8:00

Continental Breakfast

8:45

Chairperson’s Review of Day One

Victoria Browning
Chief Compliance Officer
Karl Storz

9:00

CHOOSE BETWEEN 2 CONCURRENT SESSIONS (A & B)

A. INVITATION-ONLY CHIEF COMPLIANCE OFFICER SUMMIT*

This invite-only Chief Compliance Officer segment of the program offers a unique opportunity for experienced device compliance executives to meet in a closed-door setting to share findings with peers.

FACILITATORS:

Victoria Browning
Chief Compliance Officer
Karl Storz

Avi Spira
Vice President, Chief Compliance Officer
Cantel Medical Corp.

*Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a medical device company at the time of the conference. Final eligibility approval is at the discretion of CBI. For more details on how you can participate as a delegate for this portion of the MDCC program, please contact John Kuchinski at [email protected].

There will be a 30-minute refreshment break at 10:30am

B. TWO INCLUSIVE, HANDS-ON, INTERACTIVE WORKSHOPS All MDCC delegates are invited to participate in our Interactive Workshops.

9:00

WORKSHOP 1 Compliance Metrics and Data Reporting

Learn how compliance officers can efficiently harness the advantages of big-data platform to develop a data analytics programs and cut thru the “noise” to create meaningful compliance reports.

Sapan Singh
Director, Compliance,
Indirect Channels and Data Analytics Programs
Stryker

Mohammad Ovais
Founder & CEO
qordata

10:30

Networking and Refreshment Break

11:00

WORKSHOP 2 Third-Party Distributor Monitoring Programs and Measuring Success

Share best practices on third-party distributor compliance monitoring programs. Discuss common challenges on how to manage the risk related to use of third-party distributors in emerging markets and how to prioritize and strike a balance between risk mitigation and resource limitation. Illustrate how to engage distributors to buy into the compliance requirements.

Sapan Singh
Director, Compliance,
Indirect Channels and Data Analytics Programs
Stryker

Emily C. Huebener
Manager, Assurance Services,
Fraud Investigation & Dispute Services
Ernst & Young, LLP

12:30

CCO Networking Luncheon and Delegate Networking Luncheon

1:30

FDA Cybersecurity Update

Seth D. Carmody, PhD
Cybersecurity Program Manager Center, Devices and
Radiological Health, Office of the Center Director Emergency
Preparedness/Operations & Medical Countermeasures
FDA

2:15

Antitrust Compliance Efforts

Chris Branch
Deputy General Counsel
ACell, Inc.

3:00

Ethics Training Strategies and Tools —
Effectively Serving Employees While Managing Compliance Risks

Avi Spira
Vice President, Chief Compliance Officer
Cantel Medical Corp.

Christian Krautkramer
Global Compliance Manager
GE Healthcare

3:45

Close of Conference