China Anti-Corruption 2.0: How New Legislation on Commercial Bribery Elevates Risks for MMs and Increases Standard for Compliance Controls – Special Focus on Third Party Risks and Pitfalls with the Media

Jun 26, 2017 9:00am - 12:30pm

Speakers

Walter Siegel
Senior Vice President & General Counsel
Henry Schein, Inc. (Melville, NY)

Bingna Guo
Partner
O'Melveny & Myers LLP (Beijing, China)

Day 1 - Tuesday, June 27, 2017

7:45
Registration Begins and Continental Breakfast
8:30
Conference Co-Chairs’ Opening Remarks
8:40
Think Tank on Where We Stand and What We Know about FCPA Enforcement in the Life Sciences Industry: Six Months into the Trump Administration
10:15
Refreshment Break
10:35
When Relationship Building with HCPs “Crosses the Line” and Might Turn into an FCPA Violation – The Top 5 Risks and Pitfalls
11:30
How to Effectively Manage Auditing and Due Diligence of High Risk Third Parties: A Special Focus on Global Vendors and Distributors
12:30
Networking Lunch
1:45
A Practical Debate on the Value of ISO 37001 and Other Compliance Certifications: Weighing the Pros and Cons in the Life Sciences Context
2:45
Special Focus on Section 13 of the FCPA: Why “Gatekeepers” of the Internal Controls Provisions are under Increased Scrutiny and What to Watch Out for
3:30
Refreshment Break
3:50
How Companies can Turn the Page and Move On After a Scandal: A Focus on Corporate Culture and Restoration of Confidence
4:45
Compliance LAB When “Giving-for-Free” Becomes a Bribe: Samples, Disposable Medical Items, Certain Capital Goods
5:30
Conference Adjourns

Day 2 - Wednesday, June 28, 2017

8:00
Continental Breakfast
8:30
Conference Co-Chairs’ Opening Remarks
8:35
Strategic Insights When Conducting Due Diligence and Integrating Compliance Programs: Spotlight on M&A and JV
9:30
Countdown to the General Data Protection Regulation (GDPR) and Other Privacy Legislation: How it Will Affect Compliance, Investigations and Third Party Screening, and How Life Sciences Companies Should Prepare
10:30
Refreshment Break
10:50
Sponsorship and Congresses: 5 Big Mistakes to Avoid
11:45
Compliance LAB Teetering on the Edge of Legality and Ethics: How to Minimize the Most Common Risks with Physician-Owned Distributors (PODs)
12:45
Networking Lunch
2:00
Prosecutor Alumni Panel: What’s Next? How Has the Risk Map Changed? – How Life Sciences Companies Should Determine Where and How Much to Invest in Anti-Corruption Compliance
3:15
Refreshment Break
3:35
The Anatomy of a Corruption Investigation in China: What Recent Cases Reveal about the Greatest Risks
4:30
Leveraging Technology Innovations to Enhance your Corporate Compliance Program and Initiatives… and Make your Employees Actually Want to Participate
5:15
Conference Concludes

Day 1 - Tuesday, June 27, 2017

7:45
Registration Begins and Continental Breakfast
8:30
Conference Co-Chairs’ Opening Remarks

Beth Janeway Hallyburton
Assistant General Counsel and Head, US Government Investigations
GlaxoSmithKline (Durham, NC)

Daniel J. Moynihan
Global Compliance Officer - Life Science
MilliporeSigma, A business of Merck KGaA (Boston, MA)

8:40
Think Tank on Where We Stand and What We Know about FCPA Enforcement in the Life Sciences Industry: Six Months into the Trump Administration

James P. Loonam
Deputy Chief, Business and Securities Fraud Section
United States Attorney’s Office, E.D.N.Y.

Mark Filip P.C.
Partner
Kirkland & Ellis LLP (Chicago, IL)

Sandra Moser
Principal Deputy Chief
U.S. Department of Justice, Criminal Division, Fraud Section

  • How to assess the increased intersection of the various laws and statutes used by the DOJ and SEC to launch anti-corruption compliance investigations
  • To what extent will your anti-bribery and anti-corruption compliance efforts today will be measured against higher minimum standards inthe future
  • What to make of the extension of the DOJ’s Pilot Program on voluntary self-disclosure and the potential legislative changes to Dodd-Frank and the Affordable Care Act (”Obamacare”)
  • 2016 in numbers: 27 corporate enforcement resolutions by DOJ and SEC and, separately, 27 individuals charged with FCPA violations – a growing trend?
  • What to make of the “sophistication” of FCPA enforcement tools applied across the life sciences industry (as compared to enforcement in “other” industries)
  • The continuously growing importance of the Yates Memo
  • Multijurisdictional enforcement by way of a real-life example: Embraer
  • What practical lessons can be learned from Teva’s $519 million settlement
  • How to assess enforcement priorities of the DOJ and SEC (disgorgement vs. criminal charges vs. monitor imposition)
  • How companies can devise an appropriate compliance action plan based on their risk exposure
  • How to tap into the most useful (official) resources at companies’ disposal and how to put them to best use

10:15
Refreshment Break
10:35
When Relationship Building with HCPs “Crosses the Line” and Might Turn into an FCPA Violation – The Top 5 Risks and Pitfalls

Avi Spira
Vice President & Chief Compliance Officer
Cantel Medical Corp. (Little Falls, NJ)

Joseph V. Moreno
Partner
Cadwalader, Wickersham & Taft LLP (Washington, DC)

James A. Garrett
Chief Risk and Compliance Officer and Leader, Global Risk & Integrity
NuVasive, Inc. (San Diego, CA)

  • Anti-corruption considerations dealing with health care professionals who straddle the public and private sectors
  • Navigating the line between hospitality and bribes
  • Crafting appropriate guidelines for HCP interactions with physicians, pharmacists, hospitals and others
  • Examples of key violations and investigations involving interactions
  • Mitigating the risks associated with government-employed HCPs

11:30
How to Effectively Manage Auditing and Due Diligence of High Risk Third Parties: A Special Focus on Global Vendors and Distributors

Barry McCoy
Executive Director, Lead of Anti- Corruption Program
Merck & Co., Inc. (Philadelphia, PA)

Sara M. Lord
Partner
Arnall Golden Gregory LLP (Washington, DC)

Michael Bernstein
Vice President – Global Compliance & Risk Management
CSM (Philadelphia, PA)

  • Examining new ways in which life sciences outfits are “getting into trouble” in their business relations with a third party: How to approach the question whether to engage a high-risk third party
  • How to make sure you’re taking account of components of an effective due diligence and audit program
  • The importance of focusing on third party employees in positions most exposed to compliance risks (e.g., finance, IT and data, cyber security, business development, sales, clinical research)
  • What does the US government consider to be sufficient internal controls?
    • How to use technology to detect cross-reference relationships that may indicate wrongdoing
    • How to put automated gift controls in place
    • How to make sure that subsidiaries are on board
    • How to conduct employee training on a regular basis
    • How to master auditing and monitoring of distribution networks

12:30
Networking Lunch
1:45
A Practical Debate on the Value of ISO 37001 and Other Compliance Certifications: Weighing the Pros and Cons in the Life Sciences Context

Keir Strauss
Assistant General Counsel & Global Privacy Officer
INC Research (Durham, NC)

S. Joy Dowdle
Partner
Paul Hastings LLP (Houston, TX)

  • Understanding the value and (international) recognition of ISO 37001, and assessing the prospects for standardizing and harmonizing compliance programs
  • How to determine whether to get certified and best practices on going about doing so: Is it “worth it?”
  • Is ISO 37001 more relevant to some life sciences industries (e.g., drug manufacturers) over others?
  • Is the new standard considered “sufficient” by regulators in the US and in non-US jurisdictions that may have unique requirements (e.g., Mexico, Brazil, France, Russia, China)?
  • How to assess the potential competitive advantages of adhering to a higher compliance and integrity standard via certification
  • Will certified third parties need to continue to be audited by life sciences companies?

2:45
Special Focus on Section 13 of the FCPA: Why “Gatekeepers” of the Internal Controls Provisions are under Increased Scrutiny and What to Watch Out for

Chris Allen
Vice President, Head Counsel, US Litigation and Investigations
Shire (Boston, MA)

Ryan Rohlfsen
Partner
Ropes & Gray LLP (Chicago, IL)

Daniel J. Moynihan
Global Compliance Officer - Life Science
MilliporeSigma, A business of Merck KGaA (Boston, MA)

  • Assessing adherence to internal controls requirements over recent months
  • What lessons to draw from recent high-profile cases
  • How compliance officers (“gatekeepers”) can overcome the challenges associated with adherence to guidelines and address the tension between the compliance department and the business, sales and marketing teams
  • Best practices on maintaining an adequate system of internal controls and how to decide who to involve (compliance, legal, accounting/finance, etc.)

3:30
Refreshment Break
3:50
How Companies can Turn the Page and Move On After a Scandal: A Focus on Corporate Culture and Restoration of Confidence

Michael C. Pacella
Vice President, Global Anti-Corruption & Investigations Counsel
Zimmer Biomet (Washington, DC)

Andrew Levine
Partner
Debevoise & Plimpton LLP (New York, NY)

  • How to speak openly about your case: Transparency and lessons learned as key elements to rebuild the trust and motivation of employees
  • How to strengthen your ethics and compliance culture based on “zero tolerance”
  • Reinforcing the credibility of the whistleblower channel as the best tool for detection and prevention of violations
  • Best practices to foster employee discipline rewards
  • Employment decisions: Which employees to terminate, which to rehabilitate and how
  • Tone at the top – How leadership can ensure and spread a strong ethical culture: Leading by example
  • Ongoing training and education: The need for repeated discussion around ethics and compliance so that they remain top of mind for employees in their day-to-day
  • Business partner best practices: When to make disclosures to customers and what to disclose
  • Living with a compliance monitor: Selection, review and work plan

4:45
Compliance LAB When “Giving-for-Free” Becomes a Bribe: Samples, Disposable Medical Items, Certain Capital Goods

Peter Schutzel
Division Counsel, Anti-Corruption & Global Healthcare Compliance
Abbott (Chicago, IL)

Steve Nickelsburg
Partner
Clifford Chance US LLP (Washington, DC)

Beth Janeway Hallyburton
Assistant General Counsel and Head, US Government Investigations
GlaxoSmithKline (Durham, NC)

  • How to assess from an anti-corruption perspective the particular risks regarding abuse of samples and no charge products
  • What purpose does the provision of samples, disposable medical items, and certain capital goods serve?
  • When medical device manufacturers’ “free-of-charge” lending of products to hospitals constitutes a legitimate business (development and/or marketing) reason
  • How the provision of samples not intended for sale can further research purposes and result in medical insights and progress
  • How corporations are devising novel practices to give free-of-charge products, and how enforcement authorities are targeting the same

5:30
Conference Adjourns

Day 2 - Wednesday, June 28, 2017

8:00
Continental Breakfast
8:30
Conference Co-Chairs’ Opening Remarks
8:35
Strategic Insights When Conducting Due Diligence and Integrating Compliance Programs: Spotlight on M&A and JV

Warren Feldman
Partner
Skadden, Arps, Slate, Meagher, & Flom LLP (New York, NY)

Markus Hartmann
Vice President & North American General Counsel
Sandoz (Princeton, NJ)

Irina Dragulev
Assistant General Counsel
Pfizer Inc. (New York, NY)

This expert panel will exemplify best-in-class practices to have in place a robust, integrated compliance program following an M&A or JV transaction involving your company. The following scenarios will be addressed:

 

  • Being bought (acquired) vs. buying (acquiring): How does the role of the CCO differ?
  • Pre- and post-acquisition risks and pitfalls
  • JV majority vs. minority positions
  • Practical advice on integrating compliance programs of companies with different risk profiles
  • How to anticipate and preemptively address successor liability
  • Solving common due diligence risks and pitfalls in M&A and JV transactions
  • What role outside counsel should play in the integration

9:30
Countdown to the General Data Protection Regulation (GDPR) and Other Privacy Legislation: How it Will Affect Compliance, Investigations and Third Party Screening, and How Life Sciences Companies Should Prepare

Mihai G. Popa
Country Head of Law, Patents and Compliance
Patents and Compliance

  • Don’t wait! What measures the life sciences industry ought to take prior to GDPR’s coming into effect in May 2018, and how to assess the benefits of being proactive
  • How are companies thinking about the law and what do they expect of their vendors during this “readiness” period
  • How companies are addressing compliance with GDPR and trying to be compliant while also anticipating the needs of customers
  • How the harmonization of EU member states’ data protection regulations will affect multinationals’ compliance efforts
  • What are the changes in privacy policies and notices, record-keeping requirements, data storage, etc.
  • How to identify trends across the customer base

10:30
Refreshment Break
10:50
Sponsorship and Congresses: 5 Big Mistakes to Avoid

S. Joy Dowdle
Partner
Paul Hastings LLP (Houston, TX)

Michael Dusseau
Vice President, Compliance Operations
Allergan plc (Parsippany, NJ)

Aaron Tidman
Anti-Corruption Counsel
Gilead Sciences Inc. (San Francisco, CA)

  • How to disentangle the wide range of global laws, association codes of ethics, and tools for guidance around sponsorships and congresses for health care professionals
  • Compliance best practices for hosting events as well as sponsoring healthcare professionals to attend events
  • What constitutes an appropriate location and venue for an event hosting healthcare professionals?
  • How to assess whether you can support an event, financially or otherwise, organized by a third-party
  • What leisure activities or entertainment is included in the context of the event?
  • IFPMA’s note for guidance on sponsorship of events and meetings, and integration into your formal screening processes

11:45
Compliance LAB Teetering on the Edge of Legality and Ethics: How to Minimize the Most Common Risks with Physician-Owned Distributors (PODs)

Sheva J. Sanders
Partner
Stinson Leonard Street LLP

  • A contemporary assessment of PODs as they are addressed by the Sunshine Act, Stark Law and Anti-Kickback Statute
  • How doctors and corporations are discovering novel ways to “cut corners” and “hook” clients to products in which they have a financial stake
  • Special focus on implant procedures and how entities (physicians, medical device manufacturers, health care providers, hospitals, etc.) expose themselves to the risk of violating anti-corruption compliance

12:45
Networking Lunch
2:00
Prosecutor Alumni Panel: What’s Next? How Has the Risk Map Changed? – How Life Sciences Companies Should Determine Where and How Much to Invest in Anti-Corruption Compliance

Matthew S. Axelrod
Partner
Linklaters LLP (Washington, DC)

Jason A. Jones
Partner
King & Spalding LLP (Washington, DC)

Nathaniel B. Edmonds
Partner
Paul Hastings LLP (Washington, DC)

  • How to devise practical learnings from the latest FCPA enforcement in the life sciences industry
  • How to learn from compliance risks identified from recent FCPA and anti-corruption resolutions in the US and internationally
  • How to assess the impact of the FCPA Pilot Program on life science compliance programs
  • What insights can be drawn from interactions with the DOJ’s Compliance Consultant
  • Top compliance recommendations from former prosecutors

3:15
Refreshment Break
3:35
The Anatomy of a Corruption Investigation in China: What Recent Cases Reveal about the Greatest Risks

K. Lesli Ligorner
Partner
Morgan, Lewis & Bockius

Nathan Bush
Partner
DLA Piper (Singapore)

This panel of experts will shed light on the particulars of being under investigation by Chinese authorities. The discussion will revolve around China’s anti-bribery and anti-corruption enforcement climate, how the government investigates a company and how – if your compliance team approaches it the wrong way – an investigation can result in significant damage, both commercial and reputational in nature.

4:30
Leveraging Technology Innovations to Enhance your Corporate Compliance Program and Initiatives… and Make your Employees Actually Want to Participate

Zachary N. Coseglia
Assistant General Counsel
Pfizer Inc. (New York, NY)

Kimberly A. Parker
Partner
Wilmer Cutler Pickering Hale and Dorr LLP (Washington, DC)

This highly practical panel will present a selection of cases where companies have effectively leveraged technology to improve their compliance function. Don’t miss this opportunity to hear top-tier compliance practitioners share their insights on how technological innovations resulted in:

 

  • More compliance program effectiveness
  • Increased data accuracy and usability
  • Better compliance training for employees and third parties
  • Improved employee buy-in across various corporate departments

5:15
Conference Concludes

China Anti-Corruption 2.0: How New Legislation on Commercial Bribery Elevates Risks for MMs and Increases Standard for Compliance Controls – Special Focus on Third Party Risks and Pitfalls with the Media

Jun 26, 2017 9:00am - 12:30pm

$600

Speakers

Walter Siegel
Senior Vice President & General Counsel
Henry Schein, Inc. (Melville, NY)

Bingna Guo
Partner
O'Melveny & Myers LLP (Beijing, China)

What is it about?

China’s anti-corruption enforcement landscape continues to evolve rapidly. It is therefore indispensable for corporate compliance executives – especially those in the life sciences industry – to comprehend what constitutes effective compliance controls lest they fall afoul of anti-bribery legislation and find themselves slapped with a hefty fine based on nebulous accusations or, at worst, incarceration. This workshop offers the timeliest and most pertinent know-how in order to successfully run a life sciences business in this high risk market, highlighting third party and media-related risks.

 

  • Exploring novelties with legislative and judicial developments of China’s anti-corruption law
  • How to assess developments and pitfalls regarding compliance with Chinese commercial bribery law
  • How to tailor an effective compliance program in light of China’s anticorruption campaign and authorities’ expectations
  • How to conduct effective due diligence on third party intermediaries when doing business in China
  • How to manage some unique risks posed by travel agents, business consultants, marketing and media intermediaries in China
  • How to deal with media in China for crisis management and relevant compliance issues
  • How to identify third party risks through ongoing engagement and reporting
  • How to manage parallel investigation proceedings involving FCPA investigation and Chinese authorities’ investigation

A Practical Guide to Resolving Complex Event Sponsorship, Charitable Donations, Gifts, Travel & Entertainment, and Hospitality Challenges: How to Support Your Business Development, Sales and Marketing Heft within the Confines of Compliance

Jun 26, 2017 1:30pm - 5:00pm

$600

Speakers

Michael C. Pacella
Vice President, Global Anti-Corruption & Investigations Counsel
Zimmer Biomet (Washington, DC)

Michelle J. Shapiro
Partner
Dentons (New York, NY)

What is it about?

  • Sponsorship, donation, travel arrangement, conferences, advisory boards and other entertainment offerings under the microscope: What unique risks they present to life sciences companies and how to set up controls to flag them early
  • How to arrange events and activities that are transparent and open
  • How to manage the risks of inviting government officials to events and offering travel
  • What evidence is sufficient to prove the commercial purpose vs. public interests of sponsorship and donations
  • How to make your marketing and sales managers aware of potential bribery and corruption issues