18th Advanced Forum on
FCPA & ANTI-CORRUPTION FOR THE LIFE SCIENCES

DISTINGUISHED 2023 CO-CHAIRS
NEW, PRACTICAL SESSIONS
Assessing the Effectiveness of Your Compliance Program: Real-World Takeaways Amid the Latest DOJ Enforcement Posture
Ephemeral Messaging: DOJ’s Expectations and Navigating WeChat Communication Pitfalls

Employee Compensation and Clawbacks: Best Practices Amid Increased DOJ Oversight


Russia Sanctions and the FCPA: Managing the Impact on Your Supply Chain and Compliance Risk Management
More Internationally-Focused Discussions:
Revisiting Your Evolving Risk Profile in China and the Region: The Top 5 Most Vexing Questions and Best Practices for Navigating Grey Areas
LEARN AND BENCHMARK WITH SENIOR IN-HOUSE EXECUTIVES FROM:
Abbott
Aimmune
Anthrex
Bio-Rad Laboratories, Inc.
Dr. Reddy's Laboratories
Eli Lilly and Company
EMD Serono
Fortive Corporation
Illumina
IQVIA


Johnson & Johnson
Lonza
Medtronic
Merck & Co
Novartis
PHC Holdings Corporation
Regeneron
Sanofi
Stryker
Thermo Fisher Scientific
Zimmer Biomet
ç Managing Unique, Heightened Challenges in Brazil: Industry-Specific Hurdles to Market Entry and Due Diligence Post-Election
ç Africa: Market Growth Drivers, Entry Challenges, and What it Takes to Strengthen and Monitor Compliance
FOR THE LIFE SCIENCES INDUSTRY
GOVERNMENT
Derek Ettinger
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division U.S. Department of Justice
DISTINGUISHED IN-HOUSE EXPERTS
Arunabha Bhoumik
Executive Director, Assistant General Counsel, Head, General Litigation and Government Investigations
Regeneron Pharmaceuticals, Inc.
Mara Senn Executive Global Compliance Leader GE Healthcare



Senior Corporate Counsel, Litigation and Government Investigations Bristol Myers Squibb
Ricardo Caiado Partner
Campos Mello Advogados in cooperation with DLA Piper (Brazil)
Joy Dowdle Partner
Paul Hastings
Tarek J. Helou Partner
Wilson Sonsini Goodrich & Rosati
Brockton B. Bosson
Partner
Cahill Gordon & Reindel
Irene Chiu
Senior Vice President, General Counsel MicroPort Orthopedics
Kevin Espinoza Chief Integrity Officer




Kaleo
Marc Hennes Head of Legal Investigations



Novartis
Marilyn Batonga Partner Baker & McKenzie LLP



Liana Cunha Compliance Director, Latin America Thermo Fisher Scientific

Naana Frimpong Partner
DLA Piper
Scott Hollander
Assistant General CounselCompliance, Investigations and Litigation
Dr. Reddy's Laboratories
Jennifer Bragg Partner

Skadden, Arps, Slate, Meagher & Flom LLP
Jill Dailey
Chief Compliance Officer Incyte Pharmaceuticals
Gary Giampetruzzi Partner

Paul Hastings
Jay Holtmeier Partner WilmerHale



Darshak S. Dholakia Partner Dechert LLP

Markus Green

Vice President and Assistant General Counsel, Government Relations
Pfizer
FOR THE LIFE SCIENCES INDUSTRY
Kathryn Jenne
Senior Counsel, Global Healthcare Compliance
Abbott
Susan Lipsitz
Vice President, Associate General Counsel, and Chief Compliance Officer
IQVIA
David Ralston
Senior Vice President Deputy General Counsel
Taysha Gene Therapies
Yuet Ming Tham
Global Co-Head, White Collar, Litigation & Investigations

Sidley Austin LLP
(Hong Kong/Singapore)
James M. Koukios
Partner
Morrison & Foerster LLP
Lilian Lustre
Head of Ethics and Business Integrity, LATAM
David H. Resnicoff Partner





Riley Safer Holmes & Cancila LLP
Maria Villanueva Sessions
Brian Kowalski Partner

Latham & Watkins LLP
Sanofi Thaddeus McBride Partner
Bass Berry & Sims PLC
Ryan Rohlfsen Partner

Ropes & Gray LLP
Vice President, Compliance Officer, and Head of HR
Ra Medical Systems
Janice Wang


Senior Anti-Corruption Counsel
Gilead Sciences
Daryl Kreml
Chief Compliance Officer
Sage Therapeutics
Mark Mendelsohn Partner


Paul, Weiss, Rifkind, Wharton & Garrison LLP
J. Patrick Rowan Partner

McGuireWoods
Ashley Watson
General Counsel, Medical Devices
Johnson & Johnson
Fabiana Lacerca-Allen
Senior Vice President, Chief Compliance Officer
Aimmune
Member, Board of Directors Shield Therapeutics plc
Ja Moon Vice-President, Healthcare Legal and Compliance

Alector
Jennifer Saperstein Partner











Covington & Burling LLP
Matt Werner
Senior Vice President, Chief Compliance & Privacy Officer Bio-Rad Laboratories, Inc.
Channing Landreth
Associate Vice President, Managing Counsel
LabCorp
Kristine Mueller
Director, Global Compliance Operations
Arthrex Rebecca Orttel
Terri Segura
Vice President, Global Compliance Investigations
Zimmer Biomet
Jennifer Zerm
Chief Compliance Officer Fortive Corporation
Angelique Lee
Vice President, Chief Compliance & Ethics Officer
Jazz Pharmaceuticals
Vice President, Ethics and Compliance Medtronic

Dan Spicehandler
Vice President, ComplianceCommercial Divisions
Stryker
ANTI-CORRUPTION FOR THE LIFE SCIENCES INDUSTRY
MAIN CONFERENCE DAY 1
WEDNESDAY, MAY 10, 2023
8:45
Opening Remarks from the Co-Chairs
Mara Senn
Executive Global Compliance Leader
GE Healthcare
9:00 FIRESIDE CHAT
Adam Yoffie
Senior Corporate Counsel, Litigation and Government Investigations


Bristol Myers Squibb
DOJ Enforcement Updates in the Life Sciences Context: Key Updates on Individual Accountability, Measuring Past Misconduct, Cooperation Credit and Self Disclosure

• Update on recent enforcement trends-and priorities for the remainder of 2023 (and beyond)
• How DOJ weighs past misconduct and self-disclosure in the wake of the revised Corporate Enforcement Policy
• How credit for voluntary self-disclosures is distinctly important for life sciences companies
• Key metrics DOJ will use to assess a company’s program and commitment to fostering a culture of compliance
Derek Ettinger
Assistant Chief, FCPA Unit, Fraud Section, Criminal Division
U.S. Department of Justice
Tarek J. Helou Partner
Wilson Sonsini Goodrich & Rosati

FOR THE LIFE SCIENCES INDUSTRY
9:45
EPHEMERAL MESSAGING
Life Sciences and the Continuing Compliance Challenges of Ephemeral Messaging: DOJ’s Increasing Oversight and How to Resolve the Most Complex Dilemmas
How are life sciences companies reviewing ephemeral business communications policies and procedures, as well as emerging privacy, security, and employment law scrutiny?
Don’t miss this critically important session as we discuss:
• The new expectations for retaining business records and correspondence
• Data privacy issues that can affect compliance with DOJ data retention policies
• How the life sciences industry is updating messaging app policies, procedures, and monitoring
• When to restrict use of messaging apps to company-owned
• The three biggest ephemeral messaging dilemmas for life sciences:
» Mitigating WeChat messaging and document sharing and retention risks when operating in China
» Reviewing data privacy policies and regulations: Ensuring that all business communications can be reviewed in high-risk jurisdictions like China, Latin America, and India
» Implementing internal investigations practices for data localization, collection, and review

10:45 Extended Networking Break

Jay Holtmeier Partner WilmerHale


Rebecca Orttel
Vice President, Ethics and Compliance MedtronicRyan Rohlfsen Partner Ropes & Gray LLP
Matt Werner Senior Vice President, Chief Compliance & Privacy Officer Bio-Rad Laboratories, Inc.

FOR THE LIFE SCIENCES INDUSTRY
11:15 CRO AND SPONSOR FOCUS GROUP
Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs
• Ensuring partners in global clinical trials are developing processes to determine the legitimacy of and need for clinical trials
• What CROs are doing to prevent improper payments, and reduce bribery risks when interacting with government officials, and seeking clinical trial and marketing approvals
• Sponsor obligations to assess and monitor CRO anti-corruption compliance: How much due diligence and oversight can be done while remaining at arm’s length during the clinical trial?
• How to go about bridging the legal/technical divide when launching a trial
• Bridging the commercial/medical affairs divide
» Executing health economics and outcomes studies that can evaluate the impact of a drug’s use on variables such as medical costs and patient quality of life
• Knowing where the money is going: Effective monitoring and auditing plans for foreign clinical trials
» Mitigating bribery risks when engaging local doctors

• Explore different types of data and stage-gate approaches that can be used to assist with decisionmaking for allocating resources
• Establishing effective due diligence processes and oversight over all third parties involved in your clinical research plans
12:00 COMPLIANCE PROGRAM BENCHMARKING
Susan Lipsitz Vice President, Associate General Counsel, and Chief Compliance Officer IQVIA



Life Science-Specific Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Pressure-Testing Your Program Amid the Latest DOJ Guidance and Enforcement Posture
Amid the newly revised DOD Corporate Enforcement Policy, it is critical that life sciences companies ensure that their compliance programs are fully developed, implemented and pressure-tested to confirm that they are functioning effectively and detecting issues when they arise.
• DOJ’s focus on the development of a compliance culture: Perspectives on designing and operationalizing a compliance culture that passes DOJ muster
• Assessing your compliance controls in an era of remote and hybrid work
• Where does FCPA compliance intersect with data privacy compliance requirements?
• How to evaluate your training and controls by means other than audits
• Ensuring that your program is aligned on paper and in practice
Arunabha Bhoumik Executive Director, Assistant General Counsel, Head, General Litigation and Government Investigations RegeneronPharmaceuticals, Inc.
Jill Dailey Chief Compliance Officer Incyte Pharmaceuticals Joy Dowdle Partner
FOR
THE LIFE SCIENCES INDUSTRY
1:00 Networking Luncheon

2:15 APAC MARKET-HYPOTHETICALS AND AUDIENCE POLLING
China and The Region's Fast-Changing Life Sciences Business Landscape: The Top 5 Most Vexing Questions and Practical Tips for Navigating Grey Areas
The life sciences market in Asia Pacific remains strategically important with its predicted growth and market size. However, the business environment in markets such as China, Japan and Korea will continue to shift due to geopolitical tensions, macroeconomic and policy changes. To help build or maintain a successful life sciences business in the region, what compliance questions should multinationals be aware of about the realities of operating in Asia, and navigating known and unknown risk factors?
• We examine the structural rapid transformation taking place in the healthcare systems of China and in the rest of Asia, and critical compliance implications for life science companies such as pricing, reimbursement and market access issues
• A view from the ground – we discuss the latest legal developments and the most critical or common compliance risks faced by multinational Life Sciences companies operating in Asia
• Navigating WeChat and WhatsApp communication landmines: Document sharing, data retention
• Data protection and blocking statutes in China: Balancing these laws with DOJ and SEC expectations for FCPA compliance



• What go-to-market considerations are most important in crafting a winning strategy in response to rapid health reforms taking place in Asia?
• How multinationals are evolving their programs in response to global trade tensions relating to China
Ashley Watson
General Counsel, Medical Devices Johnson & Johnson
David Ralston
Senior Vice President Deputy General Counsel
Taysha Gene Therapies
Yuet Ming Tham
Global Co-Head, White Collar, Litigation & Investigations

Sidley Austin LLP (Hong Kong/Singapore)
Janice Wang
Senior Anti-Corruption Counsel Gilead Sciences
Irene Chiu
Senior Vice President, General Counsel MicroPort Orthopedics

FOR THE LIFE SCIENCES INDUSTRY
3:15
Employee Compensation and Clawbacks: Compliance Program Best Practices Amid Increased DOJ Oversight
DOJ will be evaluating companies’ compliance programs to see whether they use positive and negative compensation incentives to create a compliance culture. How should life sciences companies be structuring their employee compensation packages accordingly and better position themselves in the event of a DOJ inquiry or investigation?
• Compensation arrangements for positions that pose higher risks of compliance issues:
» Senior executives
» Sales professionals who interact with HCPs

» Sales professionals who frequently interact with HCPs who are government officials
• Implementing compensation structures that reward and incentivize compliant behavior
» Considering compliance-promoting behavior during employee performance reviews
• Incorporating compensation structures that penalize compliance failures: Clawbacks
• Integrating compliance efforts into company functions
» Compensation committees
» Employee performance evaluations
4:15 Networking Break
Scott Hollander
Assistant General Counsel - Compliance, Investigations and Litigation
Dr. Reddy's Laboratories
Brockton B. Bosson Partner

Cahill Gordon & Reindel LLP




Thaddeus McBride
Partner
Bass Berry & Sims PLC
Mark Mendelsohn
Partner
Paul, Weiss, Rifkind, Wharton & Garrison LLP
Kristine Mueller
Director, Global Compliance Operations
Arthrex
FOR THE LIFE SCIENCES INDUSTRY
4:30 BRAZIL-HYPOTHETICALS AND AUDIENCE POLLING
New Compliance Challenges for the Life Sciences Industry in Brazil: Market Entry Due Diligence for Public/Private
Amid the election in Brazil and a shifting compliance and enforcement landscape, don't miss this in-depth, practical session on new, emerging issues, including:

• How to effectively tailor your compliance program, while ensuring appropriate baseline standards globally
• How to run a profitable business without falling a foul of local legislation
• Evolving enforcement priorities on anti-bribery, penalty trends and key takeaways from local and international cases
• Data localization and cross-border data transfers: How to cooperate with foreign government investigations or conduct internal investigations within data privacy boundaries
• How multinationals are evolving their compliance programs in response to local political tensions
Campos Mello Advogados in cooperation with DLA Piper (Brazil)
Lilian Lustre
Head of Ethics and Business Integrity, LATAM Sanofi



Liana Cunha
Compliance Director, Latin America
Thermo Fisher Scientific
5:30 Close of Day One
MAIN CONFERENCE DAY 2
THURSDAY, MAY 11, 2023
8:45
Opening Remarks from the Co-Chairs
Mara Senn Executive Global Compliance Leader GE Healthcare

9:00 IN-HOUSE COUNSEL THINK TANK
Tune in to an in-house counsel think tank where senior legal executives will address:
• Assessing which anti-corruption issues create the most risk when building your compliance program
• Deciding which metrics are rights to measure the effectiveness of your compliance initiatives
• Perspectives on designing and operating an anti-corruption compliance culture
• Matching resources with the most applicable risk
• Assessing anti-corruption compliance controls in an era of remote work
9:30
Adam Yoffie Senior Corporate Counsel, Litigation and Government Investigations

Bristol Myers Squibb
Channing Landreth Associate Vice President, Managing Counsel LabCorp
Ja Moon Vice-President, Healthcare Legal and Compliance Alector
Jennifer Saperstein Partner Covington & Burling LLP




Engaging with Foreign Governments and Providers: Special Considerations for Gaining Access to Government Formularies and the Sale of Drugs and Medical Supplies, Devices and Vaccine Procurement
• HCPs as government officials and how to mitigate risk when they may be wearing two hats
• The importance of including key contractual provisions, including audit rights, subcontractor notification requirements, annual compliance certifications, and mechanisms for billing for pass through costs
• Use of third-party intermediaries and the special risks they present in helping gain access to foreign markets
• The impact of political contributions and/or lobbying outside the United States
James M. Koukios Partner Morrison & Foerster LLP


Brian Kowalski Partner
Latham & Watkins LLP
Maria Villanueva Sessions
Vice President, Compliance Officer, and Head of HR Ra Medical Systems
FOR THE LIFE SCIENCES INDUSTRY
10:30 Networking Break
10:45 RUSSIA-HYPOTHETICALS AND AUDIENCE POLLING
Russia Sanctions and the Unique Challenges for Global Life Science Companies
The far-reaching economic sanctions and export controls imposed on Russia over its invasion of Ukraine creates unique challenges for global life science companies, including complying with specific licenses authorizing business, risks associated with restricted parties, complex export control requirements and the heightened corruption risks associated with maintaining supply chains and operations.
During this session, benefit from practical insights on how to navigate converging risks and leverage compliance resources for effective risk management. The discussion will focus on the most critical considerations for life sciences companies.
11:30 CHIEF COMPLIANCE OFFICER FOCUS GROUP


Chief Compliance Officer Perspectives: "Big Picture" Insights on Key Priorities and The Most Pressing Compliance Pain Points

Take a deep dive into the topics and areas that keep senior-level compliance executives up at night. Explore what is on their legal radar and why it should be on yours. Discuss how to institute a culture of compliance from the top down and more practical takeaways for strengthening your compliance program.
Paul Hasting
Aimmune
Member, Board of Directors, Shield Therapeutics plc
Jennifer Zerm Chief Compliance Officer Fortive Corporation


FOR THE LIFE SCIENCES INDUSTRY
Networking Luncheon
1:30 AFRICA-HYPOTHETICALS AND AUDIENCE POLLING
Africa: Market Growth Drivers, Entry Challenges, and What it Takes to Strengthen and Monitor Compliance
• Shaping sales teams: Ensure a high degree of flexibility to ensure responsiveness to the needs of local markets and associated compliance challenges
• Forging local partnerships in private and public sectors: The importance of including key contractual provisions and audit rights and mechanisms for billing for pass through costs
• Addressing supply chain challenges: Route-to-market as a strategic lever
2:30
Maintaining Effective and Compliant HCP Relations in Practice: How Life Sciences Companies are Dovetailing Operationally Efficient Processes with Required Checks and Balances
• Operationalizing compliant HCP engagement strategies: Creating top-down approved policies, SOPs, and work instructions for transparency for different country and different state reporting
» On-going risk monitoring
Integration with enterprise risk management (ERP) systems
How often to conduct risk assessments: How much is too much?
The intersection of legal and compliance: Understanding the risks of the federal Anti-Kickback Statute for HCP engagements and transparency
» The omni-channel public/private HCP experience: Virtual calls, mobile app meetings and their associated compliance risks as well as the value of engaging HCPs on the virtual stage
Defining the difference between public and private HCP engagement
Assessing what is “fair market value” for HCP services for in-person and virtual settings
How to connect internal and external meetings where HCPs are involved and how
Practical solutions for boosting the internal and external customer experience
Transparent reporting mechanisms
• Examples of key violations and investigations involving interactions with HCPs-and lessons learned
Marc Hennes Head of Legal Investigations Novartis

Jennifer Bragg Partner, Life Sciences and Health Care; Litigation Skadden, Arps, Slate, Meagher & Flom LLP



Dan Spicehandler Vice President, Compliance - Commercial Divisions Stryker


FOR THE LIFE SCIENCES INDUSTRY
3:15 Networking Break



3:30 HYPOTHETICAL SCENARIOS AND AUDIENCE POLLING
The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Policies
Don’t miss this practical, interactive session that will delve into the most vexing “on the ground” dilemmas. Through use of hypothetical scenarios, the expert speakers will impart best practices for effective compliance decision-making amid a host of grey areas.
Topics will include:
• When donations can cross the FCPA line
• Responding to scrutiny over improper influence of healthcare providers through travel, gifts, entertainment – particularly in sponsorship of educational meetings and conferences
• When it is appropriate to retain a foreign healthcare provider for advisory services and compensate for their time
• Best practices for mitigating FCPA risk while staying on top of local legal requirements
• What level of due diligence is now required before outreach to an HCP?
• How companies are operationalizing controls around HCP conflicts of interest
4:15 Conference Concludes
David H. Resnicoff Partner

Riley Safer Holmes & Cancila LLP
Kathryn Jenne
Senior Counsel, Global Healthcare Compliance
Abbott
Kevin Espinoza Chief Integrity Officer

Kaleo
Mara Senn Executive Global Compliance Leader GE Healthcare


FOR THE LIFE SCIENCES INDUSTRY
VENUE INFORMATION Bed
Martinique New York Broadway

Address: 49 W 32nd St, New York, NY 10001
Reservations: 1-212-736-3800
American Conference Institute is pleased to offer our delegates a limited number of hotel rooms at a negotiated rate. To take advantage of these rates, please contact the hotel directly and quote “FCPA & Anti-Corruption for the Life Sciences Industry”.
Please note that the guest room block cut-off date is April 24th, 2023. After that date OR when the room block fills, guestroom availability and rate can no longer be guaranteed.
CONTINUING LEGAL EDUCATION CREDITS
Accreditation will be sought in those jurisdictions requested by the registrants which have continuing education requirements. This course is identified as nontransitional for the purposes of CLE accreditation.
ACI certifies this activity has been approved for CLE credit by the State Bar of California.
ACI certifies this activity has been approved for CLE credit by the New York State Continuing Legal Education Board.
ACI has a dedicated team which processes requests for state approval. Please note that event accreditation varies by state and ACI will make every effort to process your request.
Questions about CLE credits for your state? Visit our online CLE Help Center at www.americanconference.com/accreditation/cle/

CONTINUING PROFESSIONAL EDUCATION CREDITS

American Conference Institute is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of Continuing Professional Education (CPE) on the National Registry of CPE Sponsors. State Boards of Accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be submitted to the National Registry of CPE Sponsors through its website: www.nasbaregistry.org

Course Objective:
• Life Sciences and the Continuing Compliance Challenges of Ephemeral Messaging: DOJ’s Increasing Oversight and How to Resolve the Most Complex Dilemmas
• Clinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs
• Life Science-Specific Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Pressure-Testing Your Program Amid the Latest DOJ Guidance and Enforcement Posture
• China and The Region's Fast-Changing Life Sciences Business Landscape: The Top 5 Most Vexing Questions and Practical Tips for Navigating Grey Areas
• Employee Compensation and Clawbacks: Compliance Program Best Practices Amid Increased DOJ Oversight
• New Compliance Challenges for the Life Sciences Industry in Brazil: Market Entry Due Diligence for Public/Private Ventures
• Engaging with Foreign Governments and Providers: Special Considerations for Gaining Access to Government Formularies and the Sale of Drugs and Medical Supplies, Devices and Vaccine Procurement
• Russia Sanctions and the Unique Challenges for Global Life Science Companies
• Africa: Market Growth Drivers, Entry Challenges, and What it Takes to Strengthen and Monitor Compliance
• Maintaining Effective and Compliant HCP Relations in Practice: How Life Sciences Companies are Dovetailing Operationally Efficient Processes with Required Checks and Balances
• The Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen Policies
Field of Study: Business Law
Prerequisite: None
Level of knowledge: Basic Advanced Preparation: None
WHO SHOULD ATTEND:
In-House Investigations & Compliance Counsel, General Counsel, Chief Legal Officer, VP/Director –Anti-Corruption, Compliance & Ethics, Partners from Law, Investigations and Accounting Firms
TEACHING METHOD: Group Live and Group Internet Based
DELIVERY METHOD: Group Live and Group Internet Based Participants will earn up to 12.0 CPE credits for the main conferences.
Group Internet Based Participants, please note: To be awarded full credits, you must actively participate in activities (such as polling) and submit the verification codes presented in the chat. For more information and to submit your CPE request visit: https://www.americanconference.com/accreditation-instructions-for-virtual-attendance/#CPE.
Refunds and Cancellations: Requests for credit memos or refunds must be received in writing by April 30, 2023 and will be subject to a cancellation fee. No refunds will be granted after April 30, 2023. For more information regarding refund, complaint, and/or program cancellation policies please contact our offices at 1-888-224-2480.
FOR THE LIFE SCIENCES INDUSTRY

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