Day 1 - Wednesday, June 19, 2019

7:30
Registration Opens
8:30
Opening Remarks from the Co-Chairs
8:45

A New Standard for Legal and Compliance?

Taking Stock of Penalty Trends, Remediation and Declinations: What is Now Expected for Effective Global Compliance and Training in the Life Sciences Context
9:45

Is 2019 the Year of the Legal and Compliance Individual?

The Heightened Focus on Individual Liability: New, Special Considerations for Pharmaceutical and Medical Device Companies
10:45
Networking Break
11:00

TOWN HALL

FCPA Enforcement Update Interview / Q&A – Main and “Local” Justice — Coordination and Priorities for the Rest of 2019 and Beyond
12:00
Networking Luncheon
1:15

SUB-DISTRIBUTORS

Untold Lessons for Auditing Your Sub-Distributors – The Top 5 Pointers for Recordkeeping, Accounting and Indirect Sales Channel Management
2:30

Buying Subsidiaries and Foreign Start-Ups:

The Newest, Most Important M&A Due Diligence Practices to Deploy Across the R&D and Product Lifecycles
3:30
Networking Break
3:45

Case Study:

Life After an Enforcement Action: Bio-Rad’s Chief Compliance Officer Shares Their Experiences
4:30

Anti-Corruption and Economic Sanctions:

Leveraging Internal Screening and Healthcare Compliance Resources to Reduce DoJ, SEC and OFAC Penalty Risks
5:30
Conference Adjourns

Day 2 - Thursday, June 20, 2019

7:30
Registration Opens
8:30
Co-Chairs’ Opening Remarks
8:40
The Knowns and Unknowns of AI and Advanced Data Analytics: What Life Sciences Companies are Now Doing to Leverage Innovation and Maximize ROI
9:40

Case Study:

Case Study: Guidance for Successful Navigation through a Compliance Monitorship
10:40
Networking break
11:00

Interacting with HCPs:

Big Picture, Strategic Insights for Ethical Business Conduct, Anti-Corruption and Healthcare Compliance
12:00
Status and Impact of Recent, Upcoming Medtec and Medical Device Codes of Conduct (AdvaMed, MedTech, APACMed, China AdvaMed)
12:30
Networking Luncheon
1:45

Global Data Privacy Compliance:

Brazil and China’s New Data Privacy Standard, GDPR and What They Mean for Third Party Due Diligence, Audits and Cooperation with Authorities
2:45

Third Party Audit “War Stories”:

Industry Experts Reveal What They Wish They Knew Then That They Know about High Risk Markets
3:30
Networking Break
3:45

Hypothetical Exercise: Would You or Wouldn’t You?

Growing Your Business in Emerging Markets: Practical Solutions for G & E, Your Operations, Transactions, Clinical Trials and Local Reporting Obligations
4:45
The Grey Areas of Donations and Public-Private Partnerships in the Medical Device Context: Examples of How You Can Unintentionally Cross the FCPA Line
5:30
Conference Concludes

Day 1 - Wednesday, June 19, 2019

7:30
Registration Opens
8:30
Opening Remarks from the Co-Chairs

Nancy Grygiel
Vice President, Worldwide Compliance and Business Ethics
Amgen

Gary F. Giampetruzzi
Partner
Paul Hastings LLP

8:45

A New Standard for Legal and Compliance?

Taking Stock of Penalty Trends, Remediation and Declinations: What is Now Expected for Effective Global Compliance and Training in the Life Sciences Context

Lisa LeCointe-Cephas
Executive Director, Head of Global Investigations
Merck

Katherine DeKam
JD, MPA, Chief Compliance Officer
Acumed

  • What authorities now expect for compliance programs of life sciences companies
  • Have expectations increased amid recent DoJ policy shifts? What key developments tell us
  • Differences between DoJ declinations vs. SEC settlement
  • What recent cases reveal about heightened SEC expectations – New, emerging grounds for corruption enforcement in the life sciences arena
  • Which regions are receiving more attention by authorities
  • Key takeaways from remediation trends
  • Tailoring your employee training program to your organization:
    • online vs. in-person
    • special considerations for employees in the field
    • pitfalls to avoid for training in foreign languages
    • how much to spend
  • How to know if you are meeting DoJ expectations for employee training and what has fallen short: Key lessons from recent cases

9:45

Is 2019 the Year of the Legal and Compliance Individual?

The Heightened Focus on Individual Liability: New, Special Considerations for Pharmaceutical and Medical Device Companies

Anne Murray
Partner
Orrick, Herrington & Sutcliffe LLP

Jason Jones
Partner
King & Spalding

  • Recent enforcement actions against individual executives and key takeaways
  • Scope of legal and compliance professionals’ obligations to monitor suspicious activity and investigate potential red flags
  • What is expected from in-house counsel and compliance executives if your company is under investigation
  • Approaches to compliance and legal roles amid developments in the US and globally, and in response to internal corporate and industry pressures
  • Examination of high risk regions (China, Mexico, Brazil) and the heightened risks confronting local in-house legal and compliance employees

10:45
Networking Break
11:00

TOWN HALL

FCPA Enforcement Update Interview / Q&A – Main and “Local” Justice — Coordination and Priorities for the Rest of 2019 and Beyond

David Fuhr
Trial Attorney, Fraud Section (Criminal Division)
U.S. Department of Justice

Alixandra E. Smith
Deputy Chief, Business and Securities Fraud Section
U.S. Attorney’s Office | Eastern District of New York

Moderated by:

Gary F. Giampetruzzi
Partner
Paul Hastings LLP

  • Status report on the implementation of the DoJ’s Corporate Enforcement Policy
  • What constitutes sufficient voluntary self-disclosure of misconduct, what is considered reasonably prompt time and defining full cooperation
  • What is expected for timely and appropriate remediation?
  • Messaging apps – What the revised policy changes and what stays the same
  • DoJ insights on the evaluation of corporate compliance programs
  • Focus on individual vs. corporate enforcement

12:00
Networking Luncheon
1:15

SUB-DISTRIBUTORS

Untold Lessons for Auditing Your Sub-Distributors – The Top 5 Pointers for Recordkeeping, Accounting and Indirect Sales Channel Management

Robert I. Dodge
Assistant Director, FCPA Unit
U.S. Securities and Exchange Commission

Nancy Grygiel
Vice President, Worldwide Compliance and Business Ethics
Amgen

Arivee N. Vargas
Head of Global Anti-Corruption and Assurance Programs, Office of Business Integrity and Ethics
Vertex Pharmaceuticals, Inc

Moderated by:

Brian Kowalski

Brian Kowalski
Partner
Latham & Watkins

  • Increased enforcement of books and records provisions by the SEC
  • Latest SEC accounting provisions cases and their application to the sub-distributor context
  • How much third party distributor auditing is enough?
  • Internal recordkeeping – what is considered adequate internal accounting controls?
  • Life sciences-specific considerations for indirect sales channel management

2:30

Buying Subsidiaries and Foreign Start-Ups:

The Newest, Most Important M&A Due Diligence Practices to Deploy Across the R&D and Product Lifecycles

Irina Dragulev
Assistant General Counsel, M&A Function Lead/Training & Communications Function Lead, Compliance Division
Pfizer Inc.

Gary DiBianco
Partner
Skadden, Arps, Slate, Meagher & Flom

Jim McGovern
Partner
Hogan Lovells

  • Pre-acquisition and Post-acquisition considerations
  • How much due diligence should you do when acquiring a foreign company?
  • What are the primary factors to consider when designing your due diligence programs?
  • How to ensure smaller foreign companies have a good compliance program in place
  • Practical advice for absorbing another compliance program post-transaction – How do you integrate compliance seamlessly
  • What steps to take when you discover FCPA violations

3:30
Networking Break
3:45

Case Study:

Life After an Enforcement Action: Bio-Rad’s Chief Compliance Officer Shares Their Experiences

Matthew Werner
VP, Chief Compliance & Privacy Officer
Bio-Rad Laboratories

  • Taking stock of anti-corruption compliance successes and missteps
  • Implementing compliance upgrades and improved training programs
  • What it is like to move forward after joint DOJ and SEC enforcement
  • Role of whistleblower and how to avoid whistleblower retaliation
  • Strengthening corporate culture and how to ‘right the ship’ upon discovering an issue

4:30

Anti-Corruption and Economic Sanctions:

Leveraging Internal Screening and Healthcare Compliance Resources to Reduce DoJ, SEC and OFAC Penalty Risks

Ryan Rohlfsen
Partner
Ropes & Gray LLP

J. Patrick Rowan
Partner
McGuireWoods

  • When an FCPA investigation can trigger economic sanctions enforcement and vice versa
  • How economic sanctions now intersects with healthcare and FCPA compliance
  • Impact of recent, rapidly evolving sanctions on FCPA and healthcare compliance
  • Managing overlapping sanctions and FCPA risks posed by distributor and other third party relationships
  • List management: How to leverage OFAC and other lists for effective screening and re-screening of existing and new business partners

5:30
Conference Adjourns

Day 2 - Thursday, June 20, 2019

7:30
Registration Opens
8:30
Co-Chairs’ Opening Remarks
8:40
The Knowns and Unknowns of AI and Advanced Data Analytics: What Life Sciences Companies are Now Doing to Leverage Innovation and Maximize ROI

Elizabeth Jobes
Head of Corporate Compliance and Legal Counsel
Spark Therapeutics, Inc.

Kelly Clay
Global eDiscovery Counsel and Head of Information Governance Global Legal Operations
GSK

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

  • The lengths and limits of AI for strengthening global anti-corruption compliance programs
  • How companies use AI to mine real-world data outcomes and build better systems
  • Determining which technology to buy and how much to spend. How to know if your investment is the right one for your organization
  • Examples of how to use AI for real-time risk alerts and training
  • Crafting your business case to senior management: Securing buy-in and resources

9:40

Case Study:

Case Study: Guidance for Successful Navigation through a Compliance Monitorship

R. David Walk Jr.
Assistant U.S. Attorney, Health Care and Government Fraud Unit
United States Attorney’s Office District of New Jersey

Thomas Glavin
Chief Compliance Officer
Olympus Corporation of the Americas

Gregory Paw
Partner
Freeh, Sporkin & Sullivan
(former Director of the New Jersey Division of Criminal Justice and Deputy United States Attorney for the Eastern District of Pennsylvania)

Kathleen L. Matsoukas
Partner
Barnes & Thornburg

  • Turning a negative into a positive: Repairing the damage during the life of a DPA — and how to re-claim a good reputation
  • Remediation required after an enforcement action
  • First-hand experiences with a compliance monitor
  • Looking back: “What I wish I knew then that I know now?”
  • Metrics that have proven useful in the context of measuring compliance upgrades and cultural changes

10:40
Networking break
11:00

Interacting with HCPs:

Big Picture, Strategic Insights for Ethical Business Conduct, Anti-Corruption and Healthcare Compliance

Mark J. Wanda
Executive Director, Head of Anti-Bribery/Anti-Corruption Compliance
Astellas US LLC

Raul Heredia
Regional Counsel – Latin America
Celgene Corporation

David Ralston
Senior Associate General Counsel
Gilead Sciences

Moderator:

S. Joy Dowdle
Partner
Paul Hastings LLP

  • What the new DOJ enforcement policy means in practice for interactions with HCPs
  • How to confront the reality of bribery in key jurisdictions, including China, Brazil and India
  • What is the industry standard for HCP interactions?
  • What are companies doing in light of recent cases and enforcement priorities

12:00
Status and Impact of Recent, Upcoming Medtec and Medical Device Codes of Conduct (AdvaMed, MedTech, APACMed, China AdvaMed)

Nancy S. Travis
Vice President, International Compliance & Governance
Advanced Medical Technology Association (AdvaMed)

Ilana Shulman
Chief Compliance Officer
Hill-Rom

  • How are companies managing the changes?
  • Implementing the ban on direct sponsorship
    • what the new codes say about the ban
    • where and to what degree you can sponsor
  • How to know if your 3rd party is following the rules?

12:30
Networking Luncheon
1:45

Global Data Privacy Compliance:

Brazil and China’s New Data Privacy Standard, GDPR and What They Mean for Third Party Due Diligence, Audits and Cooperation with Authorities

Kathleen Hamann
Partner
Pierce Atwood LLP

Yuet Ming Tham
Global Co-Head: White Collar, Litigation & Investigations
Sidley Austin LLP

  • Balancing global data privacy laws with DoJ and SEC expectations
  • Data localization and cross-border data transfers requirements: How to cooperate with foreign government investigations or conduct internal investigations within data privacy boundaries
  • Implications of data privacy restrictions on due diligence of third party indirect sales
  • What to do when DOJ wants you to audit your third party, who invokes local data privacy laws

2:45

Third Party Audit “War Stories”:

Industry Experts Reveal What They Wish They Knew Then That They Know about High Risk Markets

Rodrigo Grion
Executive Director, Compliance
GE Healthcare

Andrey Valovoy
General Counsel Russia, CIS, Central and Eastern Europe
Eli Lilly and Company

Moderated by:

Mary Shirley
Senior Director, Ethics & Compliance, Compliance Operations
Fresenius Medical Care North America

  • Evaluating third party risks and how to prioritize them. Where do the real risks lie?
  • Best practices for due diligence and auditing your distributors and sub distributors
  • Striking the right balance with due diligence, monitoring and auditing: How much is “too much” and how much is “not enough”;
  • Best practices for drafting and enforcing compliance clauses
  • What to do when a third party delays or resists an audit? Lessons learned
  • How to decide whether to keep the due diligence and auditing processes decentralized or centralized; in house or outsource to external vendors.
  • Best practices for termination rights and how to avoid pitfalls

3:30
Networking Break
3:45

Hypothetical Exercise: Would You or Wouldn’t You?

Growing Your Business in Emerging Markets: Practical Solutions for G & E, Your Operations, Transactions, Clinical Trials and Local Reporting Obligations

Keir A. Strauss
SVP, Associate General Counsel, Business Legal
Syneos Health

Mary Engel
Assistant General Counsel, Global Legal Department
Iqvia

Rohan A. Virginkar
Partner
Foley & Lardner LLP

Through a review of common transactions that pose significant corruption risks — the use of distributors and promotional interactions with healthcare professionals — the expert speakers will impart best practices and practical tools for minimizing FCPA and anti-corruption risks in high risk regions. In addition, the panelists will highlight risks that are unique to each of these important markets and explain how best to tailor your compliance strategies to each jurisdictional context.

  • A review of common transactions that pose significant corruption risks
  • What risks are unique to each high risk market?
  • How to best tailor your compliance strategy to each jurisdictional context

4:45
The Grey Areas of Donations and Public-Private Partnerships in the Medical Device Context: Examples of How You Can Unintentionally Cross the FCPA Line

Megan Gordon
Partner
Clifford Chance

Jennifer Zerm

Jennifer Zerm
VP, Chief Compliance Officer
Fortive Corporation

  • When donations to a hospital can unknowingly cross a line. When is a donation in the public service?
  • Exploring public private partnerships when you are dealing with the government – Ensuring you don’t face FCPA violations
  • How to tailor anti-bribery policies to take into consideration donations and public private partnerships
  • Vetting third parties to catch red flags – what red flags to look out for?

5:30
Conference Concludes