2022 Agenda
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- Day 2
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Pre-Conference Workshops
Day 1 - Wednesday, May 10, 2023
Day 2 - Thursday, May 11, 2023
Day 1 - Wednesday, May 10, 2023
8:45 |
Opening Remarks from the Co-Chairs |
9:00 |
FIRESIDE CHATDOJ and SEC Enforcement Updates in the Life Sciences Context: Key Updates on Individual Accountability, Measuring Past Misconduct, and Self Disclosure
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9:45 |
Life Sciences and the Continuing Compliance Challenges of Ephemeral Messaging: DOJ’s Increasing Oversight and How to Resolve the Most Complex DilemmasConsidering increased DOJ oversight, how are life sciences companies reviewing ephemeral business communications policies and procedures as well as emerging privacy, security, and employment law scrutiny?
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10:45 |
Extended Networking Break |
11:15 |
SPONSOR/CRO BEST PRACTICES ROUNDTABLEClinical Trials: The Latest on Managing Unique, Evolving Bribery Risk Factors for Sponsors and CROs
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12:00 |
Life Science Sector Considerations for Measuring the Effectiveness of Compliance Programs: Real-World Takeaways for Updating Your Program Amid the Latest DOJ Guidance and Enforcement PostureAmid increased DOJ enforcement postures and industry standards, it is critical that life sciences companies rededicate themselves to ensuring that their compliance programs are fully developed, implemented and pressure-tested to confirm that they are functioning effectively and working to surface issues when they arise.
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1:00 |
Networking Luncheon |
2:15 |
HYPOTEHTICALS AND POLLINGNavigating China’s Life Sciences Business Landscape and Your Risk Profile: The Top 5 Most Vexing Questions and Best Practices for Navigating Grey AreasThe life sciences market in China remains strategically important with its predicted growth and market size. However, the business environment within China will likely continue to change and shift due to geopolitical tensions, macroeconomic and policy changes. To help build or maintain a successful life sciences business in China, what compliance questions should multinationals be addressing about the realities of operating in China, and navigating known and unknown risk factors?
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3:15 |
Life Science Employee Compensation and Clawbacks: Compliance Program Best Practices Amid Increased DOJ OversightDOJ will be evaluating companies’ compliance programs to see whether they use positive and negative compensation incentives to create a compliance culture. How should life science companies be structuring their employee compensation packages to improve compliance culture and better position themselves in potential criminal investigations?
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4:15 |
Networking Break |
4:30 |
HYPOTEHTICALS AND POLLINGThe Grey Areas of G&E, Donations, Sponsorship and Hospitality in High-Risk Markets: What Companies are Now Doing to Strengthen PoliciesDon’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:
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5:30 |
Close of Day One |
Day 2 - Thursday, May 11, 2023
8:45 |
Opening Remarks from the Co-Chairs |
9:00 |
CHIEF LEGAL OFFICER INTERVIEWENTERING AND OPERATING IN HIGH-RISK MARKETS |
9:30 |
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
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10:30 |
Networking Break |
10:45 |
New Challenges for Brazil and the Life Sciences Industry: Market Entry Due Diligence for Public/Private VenturesBrazil’s increasingly global ties in the life sciences sector provide growth opportunities for domestic and international firms. But as a contentious Brazilian presidential election comes to an end, what will happen in the Brazilian health sector? This session will outline key market change predictions and pitfalls to consider before launching a Latin American life sciences endeavor.
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11:30 |
In-House Counsel and Chief Compliance Officer Panel: Perspectives on What to Look for from Outside Counsel |
12:15 |
Lunch |
1:30 |
Effective and Compliant HCP Relations in Practice: How Life Sciences Companies are Weighing Operationally Efficient Processes Against Required Checks and BalancesOperationalizing compliant HCP engagement strategies: Creating top-down approved policies, SOP’s, and work instructions for transparency for different country and different state reporting
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2:30 |
New Considerations for Your Self-Disclosure Calculus Amid DOJ Cooperation Credit EnhancementsUsing the DOJ’s voluntary self-disclosure protocol to report potential compliance violations offers life science companies potential cooperation credits. However, when companies are evaluating whether to self-report violations of the FCPA, what points should they carefully consider around the potential benefits of voluntary disclosure and how do these outweigh the risks?
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3:00 |
Break |
3:15 |
The Africa Opportunity: Market Growth Drivers, Entry Challenges, and What it Takes to Win
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4:00 |
Conference Concludes |
Workshop A — Third-Party Distributor, Sub-Distributor, Subsidiary and Reseller Monitoring in Practice: A Deep Dive Into Assessing Industry Specific Risks Affecting Your Supply Chain
What is it about?
The tools required for effective third-party management for life sciences continue to change. Added to this is the reality that certain jurisdictions present unique, heightened risks and obstacles to tailoring your program to each specific context. This workshop will allow candid discussion and life-science-specific benchmarking around third-part risks and evolving compliance and geopolitical realities.
- The latest triggers for life sciences investigations, prosecutions, and penalties for third party misconduct
- How life sciences companies are changing their best practices for a risk-based program tailored to a specific country/region
- Contractual agreements with distributors and sub-distributors: Tailoring and monitoring
- Due diligence around compliance training of distributors and sub-distributors
- Controls around inflated margins: How to design appropriate discounts for distributors and sub-distributors
- Strengthening your due diligence with tier one and tier two distributors and resellers and contractual risk flagging process and procedures
- How to vet distributor past history around prior accusations, improper affiliations, and the strength of their own compliance programs
- Linking third-party risk management to enterprise risk management (ERP) tools and controls
- Data: How often do you need to refresh third-party analytics?
- Risk assessments: How much is too much?
- On-the-ground obstacles to monitoring third-party conduct, including distribution and sub-distribution networks
- Knowing how far down the supply chain to go: How to know when to stop
- Designing a questionnaire for third parties: What type of information to include
- Concrete examples of addressing resistance to follow-up questions after an initial questionnaire
Workshop B — Leveraging Life-Sciences Predictive Analytics, AI and Machine Learning Amid DOJ Expectations: Concrete Examples of How to Achieve Effective Data-Driven Compliance and Monitoring
What is it about?
Now that the DOJ is taking a more proactive approach of identifying companies that have gaps in their compliance programs, establishing a culture of compliance that incorporates data-driven insights has never been greater. Incorporating data analytics into your compliance program has instantly changed from a “nice to have” to a “must have” element of your program. This deep dive into data analytics for life sciences will provide you with practical knowledge around implementing your own data analytics dashboard that compliance can use to help ensure the right questions are being asked of your data to gather the right information to get to the right answers.- Leveraging data analytics for interactions with HCPs: Collating and measuring the right data points to glean what kind of content, communication channels, and forms of communication HCPs will be most receptive towards
- Customer relationship management data
- Clinical trials data
- Promotional and marketing activities data
- Data that identifies the right mix of face-to-face/virtual engagements to meet each HCP’s individual needs