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Agenda

Prioritize and Proactively Manage Emerging Areas of Risk

February 27-28, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, FEBRUARY 27, 2019

PRE-CONFERENCE WORKSHOP

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

Evolve Your Data Analytics Program to Mitigate Future Risk Areas

This session examines how organizations that have implemented data analytics programs are evolving their efforts to utilize data analytics in a more integrated and efficient manner.

Workshop Outline:

I. Identify Key Challenges to Advance Your Data Analytics Program

II. Key Considerations to Apply Data Analytics to Compliance Monitoring Activities

III. Deploy Data Analytics to Identify Risk-based Areas

Workshop Leaders:

Michael Driscoll
Director, Testing & Monitoring Services, North America, Health Care & Privacy
Johnson & Johnson

Mario Velichkov
Associate Director, Data Analytics and Risk Systems
Novartis Pharmaceuticals Corporation

Tony Brennan
Governance and Risk Management U.S. Compliance & Ethics
Bristol-Myers Squibb

12:00

Close of Workshop

There will be a 30-minute networking and refreshment break at 10:00am

MAIN CONFERENCE

12:00

Main Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Amy Pawloski
Compliance Officer
Endo Pharmaceuticals

1:10

PANEL Key Steps for Developing a Proactive Compliance Monitoring Strategy

MODERATOR:

Amy Pawloski
Compliance Officer
Endo Pharmaceuticals

PANELISTS:

Katie Winson
Senior Manager, U.S. Healthcare Compliance Monitoring
Celgene Corporation

Carrie Ann Ashcom
Vice President, Global Compliance Monitoring & Internal Controls
Zimmer Biomet

Katie Schottmiller
Independent Business Monitoring Director, North America
GSK

1:50

Automate Compliance Monitoring Activities to Expand Scope and Reduce Costs

Mark Scallon
Senior Principal
Polaris, IQVIA Global Compliance

Scot Steinheiser
Manager, Corporate Compliance
kaleo

2:20

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

Mohammad Ovais
CEO
qordata

2:50

Right-Size Your Compliance Team as New Areas of Risk Emerge

Natasha Calcraft
Associate Manager, Monitoring & Testing
Olympus Corporation of the Americas

Melissa Kaschak
Compliance Operations
Olympus Corporation of the Americas

3:20

Networking and Refreshment Break

3:50

Implement Advanced Monitoring Strategies and Leverage Data to Provide Business Value

Darryl Williams
Senior Director, Analytics
MediSpend

4:20

PANEL Next Generation Tools and Processes for Advanced Monitoring Activities

MODERATOR:

Rob Zelinsky
Vice President, Customer Engagement
Cresen Solutions

PANELISTS:

Yelena Maksina
Associate Director, Data Analytics & Transparency
Merck

Michael Driscoll
Director, Testing & Monitoring Services, North America, Health Care & Privacy
Johnson & Johnson

Isabelle Fulton
Global Compliance, Associate Director, Global Monitoring
Teva Pharmaceuticals

5:00

Understand Current Trends and Challenges in Compliance Monitoring for Speaker Programs

Shawn Reardon
President
Independent Commercial Compliance

5:30

Designing a Proactive Monitoring Program as New Risks Emerge

Jennifer Romanski, Esq.
Principal
Porzio, Bromberg & Newman, PC;
Vice President
Porzio Life Sciences, LLC

6:10

The Future of CIAs — Mitigate Risk in Interactions with Patient Assistance Programs and Specialty Pharmacies

Anthony Greco
Director, Pharmaceutical & Life Sciences Advisory Services
PwC

Stephen Panarese
Manager, Health Industries Advisory
PwC

6:40

Close of Day One

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

DAY TWO THURSDAY, FEBRUARY 28, 2019

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

Amy Pawloski
Compliance Officer
Endo Pharmaceuticals

8:10

KEYNOTE PANEL DOJ Enforcement Panel — Recent Trends and Areas of Enforcement

MODERATOR:

Heather McCollum, JD MHA, CCEP-1
Director, Compliance
Shionogi Inc.

PANELISTS:

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

Evan Panich
Assistant United States Attorney
U.S. Attorney’s Office, District of Massachusetts

8:50

PANEL Effective Strategies to Manage Anti-Bribery and Anti-Corruption Risk with Third-Party Vendors

MODERATOR:

Chris Matteson
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

PANELISTS:

Poonam Maharjan
Associate Director, Office of Business Integrity and Ethics
Vertex Pharmaceuticals

Sanjay Sharma
Director, Global Healthcare Compliance Monitoring, Audit
Amgen

Lynn Marran
Senior Manager, U.S Testing Operations
Johnson & Johnson

Katie Gitas
Senior Director, Compliance
Teva Pharmaceuticals

9:50

Networking and Refreshment Break

10:20

Forge Cross-Functional Business Partnerships to Expand Compliance Monitoring Reach

Joe Calarco
Chief Compliance Officer
NEOS Therapeutics

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

11:15

CHOOSE ONE OF TWO CONCURRENT SESSIONS (A or B)

A Technology-Enabled Compliance Monitoring — Implementing AI

This session examines what next steps need to be taken to incorporate AI into compliance monitoring efforts.

Vahan Minassian
Director, U.S. Promotional Monitoring Lead
Pfizer Inc

Noah Mallon
Senior CMA Specialist
Pfizer Inc

 
B Monitoring and Auditing for Pre-Launch Activities

Launches can be a very exciting time for a pharmaceutical or device company. However, the activities that are conducted during the pre-launch phase can come under increased scrutiny. This session explores key considerations for monitoring and auditing activities conducted during this critical juncture.

Katie Winson
Senior Manager, U.S. Healthcare Compliance Monitoring
Celgene Corporation

Kathryn Pryze
Compliance Senior Manager, Monitoring
Endo Pharmaceuticals

12:00

NETWORKING LUNCHEON & INTERACTIVE TABLE TALK SESSION

Real-World Compliance Monitoring Challenges
Participants will address three real-world compliance monitoring challenges in small breakout groups and cross-share learnings and potential solutions.

1:00

Effective Strategies to Examine Data Sets Across Multiple Systems

Eren A. Efe
Senior Manager, Compliance Auditing & Monitoring
Becton Dickinson

Joseph Lake
Lead, Compliance and Ethics, Monitoring & Analytics
Bristol-Myers Squibb

1:30

PANEL Expanding Compliance Monitoring into Global Regions

MODERATOR:

Kate Watt
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

PANELISTS:

Eren A. Efe
Senior Manager, Compliance Auditing & Monitoring
Becton Dickinson

Sanjay Sharma
Director, Global Healthcare Compliance Monitoring Audit
Amgen

Gustavo H. Franca
Head of Monitoring, International, Global Compliance and Risk Management
Takeda

2:15

PANEL Reset Compliance Monitoring Activities as Speaker Programs Evolve

MODERATOR:

Christina Woods
Manager
PwC Pharmaceutical and Life Sciences
Risk Consulting

PANELISTS:

Kathryn Pryze
Compliance Senior Manager, Monitoring
Endo Pharmaceuticals

Shelley Fisher
Senior Manager, Compliance Operations
Jazz Pharmaceuticals

Schanel McIntire Mize
Manager, Independent Business Monitoring
GSK

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE WEDNESDAY, FEBRUARY 27, 2019

PRE-CONFERENCE WORKSHOP

7:30

Workshop Registration and Continental Breakfast

8:30

Workshop Leaders’ Welcome and Opening Remarks

Evolve Your Data Analytics Program to Mitigate Future Risk Areas

This session examines how organizations that have implemented data analytics programs are evolving their efforts to utilize data analytics in a more integrated and efficient manner.

Workshop Outline:

I. Identify Key Challenges to Advance Your Data Analytics Program

II. Key Considerations to Apply Data Analytics to Compliance Monitoring Activities

III. Deploy Data Analytics to Identify Risk-based Areas

Workshop Leaders:

Michael Driscoll
Director, Testing & Monitoring Services, North America, Health Care & Privacy
Johnson & Johnson

Mario Velichkov
Associate Director, Data Analytics and Risk Systems
Novartis Pharmaceuticals Corporation

Tony Brennan
Governance and Risk Management U.S. Compliance & Ethics
Bristol-Myers Squibb

12:00

Close of Workshop

There will be a 30-minute networking and refreshment break at 10:00am

MAIN CONFERENCE

12:00

Main Conference Registration

1:00

Chairperson’s Welcome and Opening Remarks

Amy Pawloski
Compliance Officer
Endo Pharmaceuticals

1:10

PANEL Key Steps for Developing a Proactive Compliance Monitoring Strategy

MODERATOR:

Amy Pawloski
Compliance Officer
Endo Pharmaceuticals

PANELISTS:

Katie Winson
Senior Manager, U.S. Healthcare Compliance Monitoring
Celgene Corporation

Carrie Ann Ashcom
Vice President, Global Compliance Monitoring & Internal Controls
Zimmer Biomet

Katie Schottmiller
Independent Business Monitoring Director, North America
GSK

1:50

Automate Compliance Monitoring Activities to Expand Scope and Reduce Costs

Mark Scallon
Senior Principal
Polaris, IQVIA Global Compliance

Scot Steinheiser
Manager, Corporate Compliance
kaleo

2:20

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

Mohammad Ovais
CEO
qordata

2:50

Right-Size Your Compliance Team as New Areas of Risk Emerge

Natasha Calcraft
Associate Manager, Monitoring & Testing
Olympus Corporation of the Americas

Melissa Kaschak
Compliance Operations
Olympus Corporation of the Americas

3:20

Networking and Refreshment Break

3:50

Implement Advanced Monitoring Strategies and Leverage Data to Provide Business Value

Darryl Williams
Senior Director, Analytics
MediSpend

4:20

PANEL Next Generation Tools and Processes for Advanced Monitoring Activities

MODERATOR:

Rob Zelinsky
Vice President, Customer Engagement
Cresen Solutions

PANELISTS:

Yelena Maksina
Associate Director, Data Analytics & Transparency
Merck

Michael Driscoll
Director, Testing & Monitoring Services, North America, Health Care & Privacy
Johnson & Johnson

Isabelle Fulton
Global Compliance, Associate Director, Global Monitoring
Teva Pharmaceuticals

5:00

Understand Current Trends and Challenges in Compliance Monitoring for Speaker Programs

Shawn Reardon
President
Independent Commercial Compliance

5:30

Designing a Proactive Monitoring Program as New Risks Emerge

Jennifer Romanski, Esq.
Principal
Porzio, Bromberg & Newman, PC;
Vice President
Porzio Life Sciences, LLC

6:10

The Future of CIAs — Mitigate Risk in Interactions with Patient Assistance Programs and Specialty Pharmacies

Anthony Greco
Director, Pharmaceutical & Life Sciences Advisory Services
PwC

Stephen Panarese
Manager, Health Industries Advisory
PwC

6:40

Close of Day One

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

DAY TWO THURSDAY, FEBRUARY 28, 2019

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

Amy Pawloski
Compliance Officer
Endo Pharmaceuticals

8:10

KEYNOTE PANEL DOJ Enforcement Panel — Recent Trends and Areas of Enforcement

MODERATOR:

Heather McCollum, JD MHA, CCEP-1
Director, Compliance
Shionogi Inc.

PANELISTS:

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

Evan Panich
Assistant United States Attorney
U.S. Attorney’s Office, District of Massachusetts

8:50

PANEL Effective Strategies to Manage Anti-Bribery and Anti-Corruption Risk with Third-Party Vendors

MODERATOR:

Chris Matteson
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

PANELISTS:

Poonam Maharjan
Associate Director, Office of Business Integrity and Ethics
Vertex Pharmaceuticals

Sanjay Sharma
Director, Global Healthcare Compliance Monitoring, Audit
Amgen

Lynn Marran
Senior Manager, U.S Testing Operations
Johnson & Johnson

Katie Gitas
Senior Director, Compliance
Teva Pharmaceuticals

9:50

Networking and Refreshment Break

10:20

Forge Cross-Functional Business Partnerships to Expand Compliance Monitoring Reach

Joe Calarco
Chief Compliance Officer
NEOS Therapeutics

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

11:15

CHOOSE ONE OF TWO CONCURRENT SESSIONS (A or B)

A Technology-Enabled Compliance Monitoring — Implementing AI

This session examines what next steps need to be taken to incorporate AI into compliance monitoring efforts.

Vahan Minassian
Director, U.S. Promotional Monitoring Lead
Pfizer Inc

Noah Mallon
Senior CMA Specialist
Pfizer Inc

 
B Monitoring and Auditing for Pre-Launch Activities

Launches can be a very exciting time for a pharmaceutical or device company. However, the activities that are conducted during the pre-launch phase can come under increased scrutiny. This session explores key considerations for monitoring and auditing activities conducted during this critical juncture.

Katie Winson
Senior Manager, U.S. Healthcare Compliance Monitoring
Celgene Corporation

Kathryn Pryze
Compliance Senior Manager, Monitoring
Endo Pharmaceuticals

12:00

NETWORKING LUNCHEON & INTERACTIVE TABLE TALK SESSION

Real-World Compliance Monitoring Challenges
Participants will address three real-world compliance monitoring challenges in small breakout groups and cross-share learnings and potential solutions.

1:00

Effective Strategies to Examine Data Sets Across Multiple Systems

Eren A. Efe
Senior Manager, Compliance Auditing & Monitoring
Becton Dickinson

Joseph Lake
Lead, Compliance and Ethics, Monitoring & Analytics
Bristol-Myers Squibb

1:30

PANEL Expanding Compliance Monitoring into Global Regions

MODERATOR:

Kate Watt
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

PANELISTS:

Eren A. Efe
Senior Manager, Compliance Auditing & Monitoring
Becton Dickinson

Sanjay Sharma
Director, Global Healthcare Compliance Monitoring Audit
Amgen

Gustavo H. Franca
Head of Monitoring, International, Global Compliance and Risk Management
Takeda

2:15

PANEL Reset Compliance Monitoring Activities as Speaker Programs Evolve

MODERATOR:

Christina Woods
Manager
PwC Pharmaceutical and Life Sciences
Risk Consulting

PANELISTS:

Kathryn Pryze
Compliance Senior Manager, Monitoring
Endo Pharmaceuticals

Shelley Fisher
Senior Manager, Compliance Operations
Jazz Pharmaceuticals

Schanel McIntire Mize
Manager, Independent Business Monitoring
GSK

3:00

Close of Conference