Day One — Monday, August 12, 2019

12:30

Workshop Registration

1:30

CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS

A Industry Standards for Transparency Reporting for Medical Device, Dental Manufacturers and Distributors This workshop provides a detailed overview of the critical issues in transparency reporting for consideration by medical device, suppliers and dental manufacturers and distributors. I. Discuss Updates and Trends on Open Payments Reporting II. Global Transparency Requirements III. Loaner Devices There will be a 30-minute networking break at 3:00pm Conversation Contributors: Matt Wetzel Senior Counsel, Akin Gump Strauss Hauer & Feld LLP; former Vice President & Deputy General Counsel, AdvaMed Carol Seaman Vice President and Global Chief Ethics & Compliance Officer Cook Group Kelly Tope, Esq., MBA Global Director, Compliance Zimmer Biomet 5:00 Close of Workshop A

B Beginner’s Guide to Open Payments Reporting Expert leaders provide an essential overview of transparency reporting operations, serving as a primer on the fundamentals of aggregate spend and lay the foundation for the more in-depth conversations that will take place throughout the conference. I. Overview of Open Payments Federal Requirements II. State-By-State Breakdown — Specific Regulations to Know III. Effective Data Collection Processes and Trends There will be a 30-minute networking break at 3:00pm Conversation Contributors: Nicole Colapietro Manager, Transparency Reporting Group Olympus Corporation of the Americas Susan Hibbard Associate Director, Office of Ethics and Compliance-Transparency and Compliance Boehringer Ingelheim 5:00 Close of Workshop B

3:00

5:00

Close of Workshops and Day One

Please Join Us for a Networking
Wine and Cheese Reception

Day Two — Tuesday, August 13, 2019

7:00

Main Conference Registration and Continental Breakfast

8:00

Chairperson’s Welcome and Opening Remarks

Sharon Muscato
Director, Transparency & Compliance Operations
Alexion Pharmaceuticals, Inc.

9:00

PANEL DISCUSSION Collaborate on the Impact of Preparing for Sunshine Act Expansion to NPs and PAs on Data Collection, Analytics and Monitoring Processes

MODERATOR:

Brian Bohnenkamp
Partner
King & Spalding LLP

PANELISTS:

Nicole Colapietro
Manager, Transparency Reporting Group
Olympus Corporation of the Americas

Margaret Rossini
Director, Corporate Compliance Monitoring and Risk
Sandoz Inc.

Melissa Cox
Data Compliance Officer
Spectrum Pharmaceuticals

9:45

Networking and Refreshment Break

10:15

PANEL DISCUSSION Address the Recent Trends in State-By-State/ City-By-City Reporting and How to Keep on the Pulse of Change

MODERATOR:

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

PANELISTS:

Sharon Muscato
Director, Transparency & Compliance Operations
Alexion Pharmaceuticals, Inc.

April Pierce
Associate Director, Global Spend Transparency
Sage Therapeutics

Cheryl Chamallas
Director, Ethics and Compliance
Alnylam Pharmaceuticals

11:00

ENFORCEMENT PANEL Discuss Current Government Oversight and High Risk Areas to Closely Monitor

MODERATOR:

Donna White
Vice President, Contracts & Compliance
Chiesi

PANELISTS:

Corey R. Amundson
Director and Chief Counsel, Office of Professional Responsibility
U.S. Department of Justice

Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office District of New Jersey

Joseph Mack
Senior Compliance Counsel, U.S. Office of Compliance
Bayer U.S.

11:45

Overview of the DOJ’s 2019 Evaluation of Corporate Compliance Programs Guidance — How effective are your compliance program controls?

Diana Borges
Vice President of Compliance Solutions
MediSpend

12:30

Networking Luncheon

1:30

Reflect on HCP Engagement Trends, How Transparency has Evolved and How to Improve Global HCP Interactions

Kari Loeser
U.S. Healthcare Compliance Officer
Relypsa

Erik Gross
Consultant
NUI

2:10

Develop and Manage a Scalable Global Transparency Program

Michael O’Connor
Vice President of Compliance Technology
Porzio Life Sciences, LLP

Kiran Vuppala
Assistant Vice President, Compliance Technology
Porzio Life Sciences, LLC

2:50

Learn How to Apply A.I. and Enhance Tracking of HCP Spend

Wendy Sward
Senior Solution Consultant, Life Sciences
SAP Concur

Michael Pace
Senior Director, Enterprise Sales – Life Sciences Market, U.S.
SAP Concur

3:30

Networking and Refreshment Break

4:00

The True Value of An Integrated Transparency Program

Baris Goc
Director, Risk and Regulatory
PwC

Tim Canonico
Partner
PwC

4:40

The Art and Science of Deploying Key Risk Indicators (KRIs) in Compliance Monitoring

Mohammad Ovais
CEO
qordata

5:20

Transition to Working Group Sessions

5:30

Choose From Four Concurrent Working Groups (I-IV)

6:25

Close of Day Two

Please Join Us for a Networking
Wine and Cheese Reception

Day Three — Wednesday, August 14, 2019

7:30

Continental Breakfast

8:15

CHOOSE BETWEEN EACH PAIR OF CONCURRENT SESSIONS

CHAIR’S OPENING REMARKS Joel Norris Director, Global Transparency Amicus Therapeutics 8:15–9:15 A ADVANCED Deep-Dive into the Intricacies of State-By-State Reporting and Data Privacy Requirements Denise Jones U.S. Ethics & Compliance Transparency Partner UCB, Inc. Brian Sharkey Vice President Porzio Life Sciences, LLP		CHAIR’S OPENING REMARKS Bryan Stefanski Compliance Director Siemens Medical Solutions USA, Inc. 8:15–9:15 B INTERMEDIATE Learn Effective Approaches for Capturing and Reporting Transfers of Value Melissa Blaco Director, Compliance Reporting Regeneron Pharmaceuticals Michael Grandison Senior Manager, Transparency Regeneron Pharmaceuticals
9:15–10:15 C ADVANCED Address Best Practices for Monitoring and Executing Price Transparency Reporting Susan Hibbard Associate Director, Office of Ethics and Compliance-Transparency and Compliance Boehringer Ingelheim Mallory O'Connor Director Of Public Policy Mallinckrodt Pharmaceuticals		9:15–10:15 D INTERMEDIATE Review Data Collection Processes and Implement Key Metrics to Ensure Compliance Kelly Tope, Esq., MBA Global Director, Compliance Zimmer Biomet

10:15

Networking and Refreshment Break

10:45

CHOOSE BETWEEN EACH PAIR OF CONCURRENT SESSIONS

10:45–11:45 E ADVANCED Deep-Dive into Global Data Analytics Processes Margaret Rossini Director, Corporate Compliance Monitoring and Risk Sandoz Inc. Shruti Anand Karkun Senior Associate, Global Transparency Reporting Covance, Inc.		10:45–11:45 F INTERMEDIATE Understand Best Practices to Structure an Assumptions Document Emily Cunningham Associate Principal IQVIA Commercial Compliance Mark Scallon Senior Principal IQVIA Global Compliance
11:45–12:30 G ADVANCED Develop a Dedicated, Internal Task Group to Improve Cross-Functional Collaboration and Improve Business Efficiencies Kimi Gorman, CCEP, CFE Senior Director Ethics & Compliance Novo Nordisk		11:45–12:30 H CMS REVIEW Helpful Tips for Reporting and Preparing for a Potential CMS Audit Robert Forcier HCP Aggregate Spend Director Smith & Nephew

12:30

Networking Luncheon

1:30

PANEL SESSION Third-Party Monitoring and Oversight to Manage Key Risks

MODERATOR:

Emily Singh
Director
PwC

PANELISTS:

Jennifer Parsons
Director, US Transparency & Compliance Operations
Biogen

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

2:15

Best Practices for Streamlining Dispute Management

April Pierce
Associate Director, Global Spend Transparency
Sage Therapeutics

3:00

Close of Conference