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Agenda

Benchmark Winning Frameworks for Successful Compliance Programs — Global Transparency • Open Payments • HCP Relationships • Data Analytics • Risk Monitoring

August 20-22, 2018
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

Day One — Monday, August 20, 2018

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS

12:30

Workshop Registration

1:30

Workshop Commences

A Medical Device Transparency Reporting

Workshop Objective:

This workshop provides a detailed overview of the critical issues in transparency reporting for consideration by medical device, supplies and dental manufacturers as well as distributors.

Workshop Outline:

I. Understand Open Payments Reporting Guidelines and How They Impact Manufacturers

II. State and Global Transparency Requirements (plus MedTech Europe Code of Ethical Business Practices)

III. Loaner Devices

Workshop Leaders:

Kelly J. Tope, Esq., MBA
Director, Global Compliance: Transparency, Systems and Data,
Zimmer Biomet

Rawan Fusisi
Transparency and Analytics Manager
Stryker

B Guidelines for Global Transparency Reporting

Workshop Objective:

This workshop provides the latest information on emerging regulations and guidelines as well as updates on existing codes. Special emphasis is provided on areas considered most challenging and those that hold promise for harmonization of systems and processes.

Workshop Outline:

I. Understand the Latest Changes in Transparency Guidelines Around the World

II. Operationalize a Successful Global Transparency Compliance Program

III. Gain Buy-In and Alignment Enterprise-Wide on a Strategy for Global Transparency

Workshop Leaders:

Lauren Miretsky
Global Spend Transparency Program Lead
Vertex Pharmaceuticals Incorporated

Brian Sharkey
Vice President
Porzio Life Sciences

Kiran Vuppala
Director, Global Compliance Operations
Alexion Pharmaceuticals, Inc.

Rhonda Sobral O’Toole, Esq.
Director, Compliance Reporting and Systems
Ferring Pharmaceuticals, Inc.

 

There will be a 30-minute networking break at 3:00pm

5:00

Close of Workshops and Day One

Please Join Us for a Networking Wine and Cheese Reception at the Conclusion of the Workshops

Day Two — Tuesday, August 21, 2018

7:00

Main Conference Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Benjamin Yao
Director, Transparency Ethics & Compliance, America
Astellas US LLC

8:15

CMS KEYNOTE CMS Keynote Address on Open Payments

Robin Usi
Director, Division of Data & Informatics,
Center for Program Integrity, Data Sharing & Partnership Group
Centers for Medicare and Medicaid Services (CMS)

9:00

Address Gift Bans and Analyze State-by-State Transparency and Aggregate Spend Regulations

John Patrick Oroho
Executive Vice President and Chief Strategy Officer
Porzio Life Sciences, LLC

9:45

Examine the Impact of State Pricing Transparency and Disclosure Legislation on Legal and Compliance Practices

Amie Phillips Pablo
Associate Director, Compliance Operations
Novo Nordisk

10:15

Networking and Refreshment Break

10:45

ENFORCEMENT PANEL Recent Settlements and Ongoing Investigations Impacting Compliance Programs

MODERATOR:

Benjamin Yao
Director, Transparency Ethics & Compliance, Americas
Astellas US LLC

PANELISTS:

William Weinreb
Assistant U.S. Attorney
U.S. Attorneys Office for the District of Massachusetts

David Walk
Assistant U.S. Attorney
U.S. Attorneys Office for the District of New Jersey

Corey R. Amundson
First Assistant U.S. Attorney
U.S. Attorneys Office for the Middle District of Louisiana

11:30

Champion Effective and Compliant HCP Interactions

Katie Jacyna
Product Manager – Engagement Manager
MediSpend

12:15

Networking Luncheon

1:15

Live Polling Benchmarking Discussion

Melissa Blaco
Director Compliance Reporting
Regeneron Pharmaceuticals, Inc.

Jennifer Parsons
Associate Director, US Transparency Operations, US Customer Excellence & Operations
Biogen

2:00

Emerging Trends in Transparency Disclosure Around the World

Marc Adler, Esq.
Senior Principal, Compliance and Ethics
IQVIA

2:45

“Stepping-Up” Your Data Analytics Program

MODERATOR:

Darryl Williams
Senior Director Analytics in Project Management
MediSpend

PANELISTS:

Lauren M. Hickson
Associate Director, Compliance Monitoring and Analytics
Allergan

Paul Steele
Director, Transparency Reporting
Sunovion Pharmaceuticals, Inc.

Ishita Arora
Compliance Manager
Horizon Pharma

Alexis Wong
Executive Director, Compliance
Allergan

3:30

Networking and Refreshment Break

4:00

Choose to Attend One of Four Concurrent Working Groups

Peer-to-peer working groups provide the opportunity to share experiences and problem solve with colleagues.

A Geo Meet-Up Dedicated to Transparency Best Practices

FACILITATOR:

Paul Steele
Director Transparency Reporting
Sunovion Pharmaceuticals, Inc.

B Key Factors on Distributors and Transparency Reporting

FACILITATOR:

Samantha Brabant
Senior Manager, Compliance
Medline Industries, Inc.

C Data Migration Strategies — How Everything Changes When Implementing a New IT System

FACILITATOR:

Margaret Rossini
Associate Director — Compliance Government Reporting, Integrity & Compliance Department
Sandoz Inc.

D Data Migration Strategies — How Everything Changes When Implementing a New IT System

FACILITATOR:

Jon Wozniak
Manager — Compliance, Transparency and Reporting
Daiichi Sankyo, Inc.

5:15

Close of Day Two

Please join us for a wine & cheese reception following the last session

Day Three — Wednesday, August 22, 2018

7:30

Continental Breakfast

8:15

À LA CARTE —
CHOOSE TO ATTEND FIVE OF TEN CONCURRENT SESSIONS

The À La Carte is designed to provide an opportunity for each participant to customize the learning experience. You may choose to attend 5 of 9 concurrent sessions. Sessions are a variety of formats, including working groups as well as extended session.

À LA CARTE 1 CHAIR

Charles Bell
Director of Compliance
Kedrion Biopharma Inc.

8:15

1
Ensure Compliance for Speaker Programs

Eric Jen
Associate Director, Compliance
Heron Therapeutics, Inc.

 

À LA CARTE 2 CHAIR

Kelly J. Tope, Esq.,MBA
Director, Global Compliance: Transparency, Systems, and Data
Zimmer Biomet

8:15

6
Gain Best Practices for Creating a Valuable Assumptions Document

Donna L. Felker
Assistant General Counsel
Olympus Corporation of the Americas

9:00

2
Risk Prioritization — Using Data Analytics to Identify the Right ToV Oversights to Resolve, Mitigate and Accept In Open Payments

Mohammad Ovais
Founder & CEO
qordata

Elizabeth Bodine
Compliance Analyst
Merz North America

 

9:00

7
Examine Trends Over Four Full Years of Open Payments Data

Thomas Sullivan
Editor
Policy and Medicine;
Publisher
Life Science Compliance Update

9:45

Networking & Refreshment Break

 

9:45

Networking & Refreshment Break

10:15

3
Implementing New Markets in Global Programs

Antoinette Brock
Head, Global HCP Transparency
Reporting and Operations
Bristol-Myers Squibb

 

10:15

8
Understand the Risks Associated with HCP Interactions and Ensure Compliance

Mareike Hinck
Senior Finance Manager,
Compliance & Process Development
Carl Zeiss Meditec Inc.

11:00

4
Risk Assessment and Compliance Monitoring

Ishita Arora
Compliance Manager
Horizon Pharma

11:45

5
Capture Complete and Accurate Spend

Jennifer Parsons
Associate Director, US Transparency Operations, US Customer Excellence & Operations
Biogen

 

11:00

9
Optimizing your Data to Make Better Business Decisions

Ronan Daly
Global Transparency Lead,
Compliance Operations
Shire

Neeraj Gupta
Managing Partner
Cresen Solutions

11:45

10
Herding Cats — Working with Business Partners and Third-Parties

Rhonda Sobral O’Toole, Esq.
Director, Compliance Reporting and Systems
Ferring Pharmaceuticals, Inc.

12:30

Close of À La Carte / Networking Luncheon

1:30

Transparency of Financial Relationships Between Patient-Advocacy Organizations and the Life Sciences Industry

Matthew McCoy, Ph.D.
Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine
University of Pennsylvania

2:15

The Essentials of Change Management

Amie Phillips Pablo
Associate Director, Compliance Operations
Novo Nordisk

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

Day One — Monday, August 20, 2018

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS

12:30

Workshop Registration

1:30

Workshop Commences

A Medical Device Transparency Reporting

Workshop Objective:

This workshop provides a detailed overview of the critical issues in transparency reporting for consideration by medical device, supplies and dental manufacturers as well as distributors.

Workshop Outline:

I. Understand Open Payments Reporting Guidelines and How They Impact Manufacturers

II. State and Global Transparency Requirements (plus MedTech Europe Code of Ethical Business Practices)

III. Loaner Devices

Workshop Leaders:

Kelly J. Tope, Esq., MBA
Director, Global Compliance: Transparency, Systems and Data,
Zimmer Biomet

Rawan Fusisi
Transparency and Analytics Manager
Stryker

B Guidelines for Global Transparency Reporting

Workshop Objective:

This workshop provides the latest information on emerging regulations and guidelines as well as updates on existing codes. Special emphasis is provided on areas considered most challenging and those that hold promise for harmonization of systems and processes.

Workshop Outline:

I. Understand the Latest Changes in Transparency Guidelines Around the World

II. Operationalize a Successful Global Transparency Compliance Program

III. Gain Buy-In and Alignment Enterprise-Wide on a Strategy for Global Transparency

Workshop Leaders:

Lauren Miretsky
Global Spend Transparency Program Lead
Vertex Pharmaceuticals Incorporated

Brian Sharkey
Vice President
Porzio Life Sciences

Kiran Vuppala
Director, Global Compliance Operations
Alexion Pharmaceuticals, Inc.

Rhonda Sobral O’Toole, Esq.
Director, Compliance Reporting and Systems
Ferring Pharmaceuticals, Inc.

 

There will be a 30-minute networking break at 3:00pm

5:00

Close of Workshops and Day One

Please Join Us for a Networking Wine and Cheese Reception at the Conclusion of the Workshops

Day Two — Tuesday, August 21, 2018

7:00

Main Conference Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Benjamin Yao
Director, Transparency Ethics & Compliance, America
Astellas US LLC

8:15

CMS KEYNOTE CMS Keynote Address on Open Payments

Robin Usi
Director, Division of Data & Informatics,
Center for Program Integrity, Data Sharing & Partnership Group
Centers for Medicare and Medicaid Services (CMS)

9:00

Address Gift Bans and Analyze State-by-State Transparency and Aggregate Spend Regulations

John Patrick Oroho
Executive Vice President and Chief Strategy Officer
Porzio Life Sciences, LLC

9:45

Examine the Impact of State Pricing Transparency and Disclosure Legislation on Legal and Compliance Practices

Amie Phillips Pablo
Associate Director, Compliance Operations
Novo Nordisk

10:15

Networking and Refreshment Break

10:45

ENFORCEMENT PANEL Recent Settlements and Ongoing Investigations Impacting Compliance Programs

MODERATOR:

Benjamin Yao
Director, Transparency Ethics & Compliance, Americas
Astellas US LLC

PANELISTS:

William Weinreb
Assistant U.S. Attorney
U.S. Attorneys Office for the District of Massachusetts

David Walk
Assistant U.S. Attorney
U.S. Attorneys Office for the District of New Jersey

Corey R. Amundson
First Assistant U.S. Attorney
U.S. Attorneys Office for the Middle District of Louisiana

11:30

Champion Effective and Compliant HCP Interactions

Katie Jacyna
Product Manager – Engagement Manager
MediSpend

12:15

Networking Luncheon

1:15

Live Polling Benchmarking Discussion

Melissa Blaco
Director Compliance Reporting
Regeneron Pharmaceuticals, Inc.

Jennifer Parsons
Associate Director, US Transparency Operations, US Customer Excellence & Operations
Biogen

2:00

Emerging Trends in Transparency Disclosure Around the World

Marc Adler, Esq.
Senior Principal, Compliance and Ethics
IQVIA

2:45

“Stepping-Up” Your Data Analytics Program

MODERATOR:

Darryl Williams
Senior Director Analytics in Project Management
MediSpend

PANELISTS:

Lauren M. Hickson
Associate Director, Compliance Monitoring and Analytics
Allergan

Paul Steele
Director, Transparency Reporting
Sunovion Pharmaceuticals, Inc.

Ishita Arora
Compliance Manager
Horizon Pharma

Alexis Wong
Executive Director, Compliance
Allergan

3:30

Networking and Refreshment Break

4:00

Choose to Attend One of Four Concurrent Working Groups

Peer-to-peer working groups provide the opportunity to share experiences and problem solve with colleagues.

A Geo Meet-Up Dedicated to Transparency Best Practices

FACILITATOR:

Paul Steele
Director Transparency Reporting
Sunovion Pharmaceuticals, Inc.

B Key Factors on Distributors and Transparency Reporting

FACILITATOR:

Samantha Brabant
Senior Manager, Compliance
Medline Industries, Inc.

C Data Migration Strategies — How Everything Changes When Implementing a New IT System

FACILITATOR:

Margaret Rossini
Associate Director — Compliance Government Reporting, Integrity & Compliance Department
Sandoz Inc.

D Data Migration Strategies — How Everything Changes When Implementing a New IT System

FACILITATOR:

Jon Wozniak
Manager — Compliance, Transparency and Reporting
Daiichi Sankyo, Inc.

5:15

Close of Day Two

Please join us for a wine & cheese reception following the last session

Day Three — Wednesday, August 22, 2018

7:30

Continental Breakfast

8:15

À LA CARTE —
CHOOSE TO ATTEND FIVE OF TEN CONCURRENT SESSIONS

The À La Carte is designed to provide an opportunity for each participant to customize the learning experience. You may choose to attend 5 of 9 concurrent sessions. Sessions are a variety of formats, including working groups as well as extended session.

À LA CARTE 1 CHAIR

Charles Bell
Director of Compliance
Kedrion Biopharma Inc.

8:15

1
Ensure Compliance for Speaker Programs

Eric Jen
Associate Director, Compliance
Heron Therapeutics, Inc.

 

À LA CARTE 2 CHAIR

Kelly J. Tope, Esq.,MBA
Director, Global Compliance: Transparency, Systems, and Data
Zimmer Biomet

8:15

6
Gain Best Practices for Creating a Valuable Assumptions Document

Donna L. Felker
Assistant General Counsel
Olympus Corporation of the Americas

9:00

2
Risk Prioritization — Using Data Analytics to Identify the Right ToV Oversights to Resolve, Mitigate and Accept In Open Payments

Mohammad Ovais
Founder & CEO
qordata

Elizabeth Bodine
Compliance Analyst
Merz North America

 

9:00

7
Examine Trends Over Four Full Years of Open Payments Data

Thomas Sullivan
Editor
Policy and Medicine;
Publisher
Life Science Compliance Update

9:45

Networking & Refreshment Break

 

9:45

Networking & Refreshment Break

10:15

3
Implementing New Markets in Global Programs

Antoinette Brock
Head, Global HCP Transparency
Reporting and Operations
Bristol-Myers Squibb

 

10:15

8
Understand the Risks Associated with HCP Interactions and Ensure Compliance

Mareike Hinck
Senior Finance Manager,
Compliance & Process Development
Carl Zeiss Meditec Inc.

11:00

4
Risk Assessment and Compliance Monitoring

Ishita Arora
Compliance Manager
Horizon Pharma

11:45

5
Capture Complete and Accurate Spend

Jennifer Parsons
Associate Director, US Transparency Operations, US Customer Excellence & Operations
Biogen

 

11:00

9
Optimizing your Data to Make Better Business Decisions

Ronan Daly
Global Transparency Lead,
Compliance Operations
Shire

Neeraj Gupta
Managing Partner
Cresen Solutions

11:45

10
Herding Cats — Working with Business Partners and Third-Parties

Rhonda Sobral O’Toole, Esq.
Director, Compliance Reporting and Systems
Ferring Pharmaceuticals, Inc.

12:30

Close of À La Carte / Networking Luncheon

1:30

Transparency of Financial Relationships Between Patient-Advocacy Organizations and the Life Sciences Industry

Matthew McCoy, Ph.D.
Assistant Professor, Department of Medical Ethics and Health Policy, Perelman School of Medicine
University of Pennsylvania

2:15

The Essentials of Change Management

Amie Phillips Pablo
Associate Director, Compliance Operations
Novo Nordisk

3:00

Close of Conference