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Agenda

Innovative Models for Assurance and Advisory Practices

October 2-4, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

IN-DEPTH WORKSHOP
WEDNESDAY, OCTOBER 2, 2019

12:30

Workshop Registration

1:30

Chairperson’s Welcome and Opening Remarks

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

Building a Third-Party Risk Assessment Framework

With the rise of third-party use in the life sciences industry today, it is critical for organizations to conduct risk-driven, third-party audits to ensure responsibilities and processes are aligned for compliance to contractual terms. Join this interactive discussion to walk through the third-party management lifecycle and risk management frameworks and learn best practices to integrate into your company’s governance process.

I. Design a Third-Party Risk Assessment Framework

II. Identify Risks in Third-Party Relationships

III. Prepare for Contract Compliance Challenges and Red Flags

IV. Considerations and Best Practices for Monitoring and Auditing

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

WORKSHOP LEADERS:

Roberta Rima
Associate Director of Internal Audit
Gilead

Pierre Helfer
Vice President, Head of Internal Audit & Risk Management
Indivior Inc.

Nate Ruey
Partner, Risk Advisory Services
RSM US LLP

Adam Marshall
Director, Risk Advisory Services
RSM LLP

5:00

Close of Workshop

DAY ONE THURSDAY, OCTOBER 3, 2019

7:15

Networking Breakfast

8:15

Chairperson’s Day One Kick-Off

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

Trends, Frameworks and Innovations
Driving Advancements in IA

8:30

CHIEF AUDIT EXECUTIVE ASSESSMENT Internal Audit Today and Future Trends Amidst a Changing Risk Environment

As the role of internal audit continues to evolve, it is crucial to adapt and identify trends that allow growth in the life sciences sector. Join experts to explore top of mind items for Chief Audit Executives (CAEs) today and the opportunities for innovation in the future.

MODERATOR:

Harold Silverman
Managing Director of CAE Services
The Institute of Internal Auditors (IIA)

PANELISTS:

Philippe Attias
Chief Audit Executive, Vice President of Internal Audit
Vertex Pharmaceuticals

Marie Hendrixson
Vice President, Internal Audit
Teleflex

Ryan Lenz
Vice President, Head of Europe, Middle East, Africa and Asia Audit and Assurance
GlaxoSmithKline (Invited)

Pierre Helfer
Vice President, Head of Internal Audit & Risk Management
Indivior Inc.

9:30

LUMINARY SHOWCASE Leading Audit Frameworks, Business Controls and Governance Based on Company Size and Scope

Hear audit examples showcasing the necessary resources and operational processes involved in assurance from industry experts. Compare strategies of cross functional collaboration, prioritizing meeting requirements and next-generation models among different size IA departments.

I. Small

II. Mid-Sized

III. Large

IV. Closing Audience Q&A

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

Rahul Khara, Pharm. D
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

10:15

Networking and Refreshment Break

10:45

Intellectual Property Protections — Prepare for Insider and Outsider Threats

Philippe Attias
Chief Audit Executive, Vice President of Internal Audit
Vertex Pharmaceuticals

11:30

Reinvent Audit and Risk Processes —
Optimizing Digital Risk Management Platforms

Michael Briganti
Director, International Business Controls Function Lead
Bristol-Myers Squibb

Manish Singh
Executive Vice President, Sales & Client Success
Oversight Systems

12:15

Networking Luncheon

CHIEF AUDIT EXECUTIVE NETWORKING LUNCHEON Invitation-Only*

This exclusive, closed-door networking luncheon is designed for Chief Audit Executives to engage in advanced dialogue to share challenges and forward-thinking solutions for the role of the Internal Auditor today.

*CBI reserves the right to qualify participants for this session.

1:30

Navigate FCPA, Anti-Bribery and Corruption and Fraud Audits

Vincent Hom
Partner, Forensic & Integrity Services
Ernst & Young LLP

2:15

Optimize Cloud Governance and Enterprise Risk Management —
Executing IT Audit

Vicky Cheng
Life Sciences Managing Director
Crowe LLP

3:00

Networking and Refreshment Break

Stay on the Pulse of Regulatory and
Enforcement Actions

3:30

Examine Enforcement Trends and Fraud Investigations

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

Amanda Strachan
Chief, Health Care Fraud Unit
U.S. Attorney’s Office for the District of Massachusetts

Emerging Third-Party Risks and
Oversight Strategies

4:15

Forward-Thinking Strategies for Evaluating and Managing Third-Party Risks

Roberta Rima
Associate Director of Internal Audit
Gilead

5:00

Close of Day One

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

DAY TWO FRIDAY, OCTOBER 4, 2019

8:15

Continental Breakfast

8:45

Chairperson’s Review of Day One

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

9:00

Inaugural Benchmarking Survey Results Revealed —
Powered by the Institute of Internal Auditors

Harold Silverman
Managing Director of CAE Services
The Institute of Internal Auditors (IIA)

Spotlight on Cross-Border Risks in a
Complex Global Market

9:45

KEYNOTE ADDRESS A Journey to the Dark Side of International Business —
Steps to Protect Your Organization

Richard Bistrong
CEO, Front-Line Anti-Bribery LLC;
former FCPA Violator and FBI/UK Cooperator

10:45

Networking and Refreshment Break

11:15

CHOOSE BETWEEN TWO TAILORED CONTENT STREAMS (A-B)

A Third-Party Oversight Standards for Outsourcing Excellence

11:15

The Third-Party Challenge — Oversight and Auditing of CROs, CMOs and other Vendors

Seth B. Whitelaw
Editor
Policy & Medicine Compliance Update

12:00

Networking Luncheon

1:00

Compliant Patient Assistance and Support Programs

Peter Agnoletto, CPA
Senior Director,
US Ethics and Business Integrity
Sanofi US

Sheila Faella, CCEP
Senior Manager, North America Testing & Monitoring Services
Johnson & Johnson

1:45

Practice Alignment and Governance Frameworks for Finance and Accounting Activities

Michelle Hayes, CPA, CIA, CISA, PMP
Director, Financial Controls and Compliance
GlaxoSmithKline (GSK)

Wetonia Evans CPA, CIA, CFE
Director, Business Risk and Compliance
GlaxoSmithKline (GSK)

B Forward-Thinking
IA Strategies for Integrated Assurance

11:15

Data Governance, CA Privacy Protection Act and GDPR Applications

Holly Kramen
Chief Compliance Officer and Privacy Officer
PolarityTE, Inc.

12:00

Networking Luncheon

1:00

Demystify Managed Markets Activities for Streamlined Audits

Rahul Khara, PharmD
Senior Director,
Compliance and Commercial Counsel
Acceleron Pharma Inc.

1:45

PANEL DISCUSSION Enhance Controls to Mitigate Compliance Risks Associated with Sales and Marketing Efforts

PANELISTS:

Franco Kakiko
Director, Internal Audit
Daiichi Sankyo Inc.

Alexis Stroud
Director, Ethics & Compliance, Auditing, Monitoring and Risk Assessment
Boehringer Ingelheim

Holly Kramen
Chief Compliance Officer and Privacy Officer
PolarityTE, Inc.

2:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

IN-DEPTH WORKSHOP
WEDNESDAY, OCTOBER 2, 2019

12:30

Workshop Registration

1:30

Chairperson’s Welcome and Opening Remarks

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

Building a Third-Party Risk Assessment Framework

With the rise of third-party use in the life sciences industry today, it is critical for organizations to conduct risk-driven, third-party audits to ensure responsibilities and processes are aligned for compliance to contractual terms. Join this interactive discussion to walk through the third-party management lifecycle and risk management frameworks and learn best practices to integrate into your company’s governance process.

I. Design a Third-Party Risk Assessment Framework

II. Identify Risks in Third-Party Relationships

III. Prepare for Contract Compliance Challenges and Red Flags

IV. Considerations and Best Practices for Monitoring and Auditing

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

WORKSHOP LEADERS:

Roberta Rima
Associate Director of Internal Audit
Gilead

Pierre Helfer
Vice President, Head of Internal Audit & Risk Management
Indivior Inc.

Nate Ruey
Partner, Risk Advisory Services
RSM US LLP

Adam Marshall
Director, Risk Advisory Services
RSM LLP

5:00

Close of Workshop

DAY ONE THURSDAY, OCTOBER 3, 2019

7:15

Networking Breakfast

8:15

Chairperson’s Day One Kick-Off

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

Trends, Frameworks and Innovations
Driving Advancements in IA

8:30

CHIEF AUDIT EXECUTIVE ASSESSMENT Internal Audit Today and Future Trends Amidst a Changing Risk Environment

As the role of internal audit continues to evolve, it is crucial to adapt and identify trends that allow growth in the life sciences sector. Join experts to explore top of mind items for Chief Audit Executives (CAEs) today and the opportunities for innovation in the future.

MODERATOR:

Harold Silverman
Managing Director of CAE Services
The Institute of Internal Auditors (IIA)

PANELISTS:

Philippe Attias
Chief Audit Executive, Vice President of Internal Audit
Vertex Pharmaceuticals

Marie Hendrixson
Vice President, Internal Audit
Teleflex

Ryan Lenz
Vice President, Head of Europe, Middle East, Africa and Asia Audit and Assurance
GlaxoSmithKline (Invited)

Pierre Helfer
Vice President, Head of Internal Audit & Risk Management
Indivior Inc.

9:30

LUMINARY SHOWCASE Leading Audit Frameworks, Business Controls and Governance Based on Company Size and Scope

Hear audit examples showcasing the necessary resources and operational processes involved in assurance from industry experts. Compare strategies of cross functional collaboration, prioritizing meeting requirements and next-generation models among different size IA departments.

I. Small

II. Mid-Sized

III. Large

IV. Closing Audience Q&A

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

Rahul Khara, Pharm. D
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

10:15

Networking and Refreshment Break

10:45

Intellectual Property Protections — Prepare for Insider and Outsider Threats

Philippe Attias
Chief Audit Executive, Vice President of Internal Audit
Vertex Pharmaceuticals

11:30

Reinvent Audit and Risk Processes —
Optimizing Digital Risk Management Platforms

Michael Briganti
Director, International Business Controls Function Lead
Bristol-Myers Squibb

Manish Singh
Executive Vice President, Sales & Client Success
Oversight Systems

12:15

Networking Luncheon

CHIEF AUDIT EXECUTIVE NETWORKING LUNCHEON Invitation-Only*

This exclusive, closed-door networking luncheon is designed for Chief Audit Executives to engage in advanced dialogue to share challenges and forward-thinking solutions for the role of the Internal Auditor today.

*CBI reserves the right to qualify participants for this session.

1:30

Navigate FCPA, Anti-Bribery and Corruption and Fraud Audits

Vincent Hom
Partner, Forensic & Integrity Services
Ernst & Young LLP

2:15

Optimize Cloud Governance and Enterprise Risk Management —
Executing IT Audit

Vicky Cheng
Life Sciences Managing Director
Crowe LLP

3:00

Networking and Refreshment Break

Stay on the Pulse of Regulatory and
Enforcement Actions

3:30

Examine Enforcement Trends and Fraud Investigations

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

Amanda Strachan
Chief, Health Care Fraud Unit
U.S. Attorney’s Office for the District of Massachusetts

Emerging Third-Party Risks and
Oversight Strategies

4:15

Forward-Thinking Strategies for Evaluating and Managing Third-Party Risks

Roberta Rima
Associate Director of Internal Audit
Gilead

5:00

Close of Day One

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

DAY TWO FRIDAY, OCTOBER 4, 2019

8:15

Continental Breakfast

8:45

Chairperson’s Review of Day One

Chris Palermo
Chief Audit Executive and Vice President, Internal Audit
Endo Pharmaceuticals

9:00

Inaugural Benchmarking Survey Results Revealed —
Powered by the Institute of Internal Auditors

Harold Silverman
Managing Director of CAE Services
The Institute of Internal Auditors (IIA)

Spotlight on Cross-Border Risks in a
Complex Global Market

9:45

KEYNOTE ADDRESS A Journey to the Dark Side of International Business —
Steps to Protect Your Organization

Richard Bistrong
CEO, Front-Line Anti-Bribery LLC;
former FCPA Violator and FBI/UK Cooperator

10:45

Networking and Refreshment Break

11:15

CHOOSE BETWEEN TWO TAILORED CONTENT STREAMS (A-B)

A Third-Party Oversight Standards for Outsourcing Excellence

11:15

The Third-Party Challenge — Oversight and Auditing of CROs, CMOs and other Vendors

Seth B. Whitelaw
Editor
Policy & Medicine Compliance Update

12:00

Networking Luncheon

1:00

Compliant Patient Assistance and Support Programs

Peter Agnoletto, CPA
Senior Director,
US Ethics and Business Integrity
Sanofi US

Sheila Faella, CCEP
Senior Manager, North America Testing & Monitoring Services
Johnson & Johnson

1:45

Practice Alignment and Governance Frameworks for Finance and Accounting Activities

Michelle Hayes, CPA, CIA, CISA, PMP
Director, Financial Controls and Compliance
GlaxoSmithKline (GSK)

Wetonia Evans CPA, CIA, CFE
Director, Business Risk and Compliance
GlaxoSmithKline (GSK)

B Forward-Thinking
IA Strategies for Integrated Assurance

11:15

Data Governance, CA Privacy Protection Act and GDPR Applications

Holly Kramen
Chief Compliance Officer and Privacy Officer
PolarityTE, Inc.

12:00

Networking Luncheon

1:00

Demystify Managed Markets Activities for Streamlined Audits

Rahul Khara, PharmD
Senior Director,
Compliance and Commercial Counsel
Acceleron Pharma Inc.

1:45

PANEL DISCUSSION Enhance Controls to Mitigate Compliance Risks Associated with Sales and Marketing Efforts

PANELISTS:

Franco Kakiko
Director, Internal Audit
Daiichi Sankyo Inc.

Alexis Stroud
Director, Ethics & Compliance, Auditing, Monitoring and Risk Assessment
Boehringer Ingelheim

Holly Kramen
Chief Compliance Officer and Privacy Officer
PolarityTE, Inc.

2:30

Close of Conference