Day 2 - ET (Eastern Time, GMT-05:00)
Join us for an insightful fireside chat where we will explore how Novartis successfully trained their 3rd parties over the course of their last two CIAs. Discover the meticulous approach taken to ensure compliance with the OIG and gain valuable insights into key topics such as vendor assessment, the creation of engaging eLearning content, and the use of a dedicated Vendor Training Portal. Learn about the importance of internal communication in delivering success and explore plans for post-CIA compliance. Don't miss this opportunity to benefit from Novartis' extensive experience and expertise.
- Catherine Shimsky - VP, ERC Advisory, Policy and Learning, Novartis
- Richard Hodgins - Head of Technology and Managed Services, Intuition
- Neil Falkingham - Senior Vice President, Chief Compliance Officer, GSK
- Moving past us-versus-them mindset: the future of collaboration, embed systems and ways of working for success
- What do Commercial teams want from Compliance and vice versa to be effective
- How can strategic relationships with internal stakeholders be optimized in different-sized pharmaceutical organizations?
- How can Compliance ensure the business owns its programs, accountable for enforcement, and how can they work together more strategically?
- Jill Fallows Macaluso - Corporate Vice President & Chief Compliance Officer, Novo Nordisk
- Gbubemi Nanna - Vice President, Area Commercial Lead - Mid West, Cardiometabolic Sales, Novo Nordisk
- Francisco Ribeiro - VP, Associate Compliance Officer, Oncology Global Therapeutics OEC, AbbVie
- Marci Juneau - Partner, Helio Health Group
- Practical perspectives on risk management in a dynamic enforcement environment
- Values-based vs. rules-based approaches to compliance in the global context
- Organizing global teams: what works and what doesn’t
- Establishing compliance standards across varied geographies
- Anisa Dhalla - Vice President and Chief Ethics and Compliance Officer, UCB
- Jennifer McGee - Former Senior Vice President, Global Chief Ethics and Compliance Officer, Otsuka Pharmaceutical Companies
- Leonardo Silva - Vice President, Chief Compliance & Privacy Officer, Ferring Pharmaceuticals
- Tim Stow - Global Head of Ethics & Compliance, Galderma
- Tara McCarthy - Co-Founder and Partner, Dovetail Consulting Group
- What are the next generation of enforcement cases?
- Where are companies focusing? Where are we seeing trends?
- Insiders’ insight: investigations and types of issues companies are struggling with
- Creative strategies being employed to increase market share: key risks and mitigation strategies
- How are you seeing your clients utilizing outside counsel and has the role of outside counsel changed?
- George Karavetsos - White Collar Defense, Compliance, and Investigations Practice Group Leader, Buchanan Ingersoll & Rooney
- Meenakshi Datta - Partner, Sidley Austin LLP
- Scott Liebman - Partner and Chair, FDA Regulatory & Compliance; Co-Chair, Life Sciences, Sheppard Mullin Richter & Hampton
- Kip Ebel - Partner/Principal, EY Americas - Forensics Consumer & Health Industry Group Leader, Ernst & Young
- How are organizations managing the expanding responsibilities and priorities in the era of AI?
- Balancing and integrating your core company mission alongside the need to keep your organization safe whilst embracing AI implementation
- Analyzing the impact of AI implementation on Compliance roles and departments
- Implications for your workforce and the effects on culture and staffing
- Keeping pace with fast-moving technological advances: leveraging your foundation of ethics in the absence of robust rules and regulations
- Franziska Janorschke - Global Head Data Privacy, Digital & AI Compliance; Ethics, Risk & Compliance, Novartis International AG
- Daryl Kreml - Former Chief Enterprise Risk and Compliance Officer, Sage Therapeutics
- Natasha Trifun - Head of Enterprise Compliance & Risk, AstraZeneca
- Andy Miller - Senior Vice President, Analytics and AI, Case IQ
- Key components of a successful communication program
- How to incorporate marketing-style communications and launch sophisticated campaigns
- What can we learn from brand marketing to amplify your message?
- Applying behavioral psychology tools to promote your message
- Alyssa Zeff - VP and Head, the bswift Engagement Agency
- Practical tools to measure the effectiveness of training
- Tips for avoiding information overloaded
- How do you know what individuals have retained: demonstrating Compliance learning in practice
- Metrics tracking when staff complete training and whether training is factored into performance management systems
- Sherri Borgal - Director, Ethics & Compliance at Alnylam, Alnylam
- Daniel O’Connor - Senior Vice President, NXLevel Compliance
- Practical tools and tips for handling difficult investigations and joint working with Legal/HR
- How to conduct them?
- Who conducts them?
- Should they always be done under privilege?
- How are sanctions determined?
- How are investigation outcomes shared with the organization?
- Tara Kennedy - Senior Director Ethics & Compliance, North America, Apellis Pharmaceuticals
- Audrey Perlow - Senior Director, North American Healthcare Compliance, Grifols
Practical considerations for meeting OIG, CMS and DOJ expectations for data access, knowledge and assessments.
Who: Internal resources to engage, train and help influence change
What: Practical considerations for gathering data from field interactions to system reports
Where: Key source systems and tools, configuration best practices, and control considerations
Why: Challenges with data quality, completeness, and integrity
How: Dos and Don’ts of Auditing and Analytics
- Cristina List - Director, Compliance Advisory Services, MedPro Systems
- Sharing practical takeaways from speaker program benchmarking
- Analyzing the key components of successful speaker programs
- Practicalities of meeting restrictions and regulations to ensure compliant speaker programs
- Best practice for designing policies to ensure the success and integrity of your speaker program
- Michael Young - Senior Director, Potomac River Partners
- Adam Oakley - Senior Director, Potomac River Partners
- Melanie Polloway - Executive Director, Daiichi Sankyo, Inc.
- Fresh perspective on vendor interactions with HCPs
- Policies and guidelines from HCP perspective on how they are allowed to engage with pharma, speaker bureau, food & beverage, speaking consulting
- How to work together to maximize engagement in a compliant way
- Tanya White - System Compliance Operations Officer, Yale New Haven Health
- Elizabeth Valentino - Senior Compliance & Conflicts of Interest Specialist, Yale New Haven Health
- John Kelly - Partner and Chair, Healthcare Department and Industry Practice, Barnes & Thornburg
- As data risks outside of privacy evolve, how does Compliance navigate an organization’s evolving data risk landscape?
- Other data risks to consider: data transfer, storage, data set management, data visibility, data platform considerations, data reporting, and data sharing across R&D, Medical, and Commercial functions
- Compliance’s role in data management and governance of risk
- Gina Nese - Vice President Associate General Counsel Compliance and Privacy Officer, Align Technology
- Jeff Hyre - Regional VP, Global Relay
- Ericka Watson - Principal & CEO, Data Strategy Advisors
- How do you set up privacy programs considering the varying privacy requirements and an ever-changing landscape?
- As privacy considerations grow for your business, where does it sit and how do you operationalize it? Compliance vs. Legal department vs. independent privacy officer?
- Joseph Philipose - Senior Vice President, Chief Ethics and Compliance Officer, Emergent BioSolutions
- Christie Dougherty - Associate Director, Ethics & Compliance, Global & US Privacy, Alnylam Pharmaceuticals
- Jennifer Couture - General Counsel, OncoVerity, Inc.
- Practical approaches and use cases to evaluating current and emerging risks associated with AI
- Who should to have a seat at the table to assess and approach AI governance and risk assessment
- Considerations for developing and refining Policies to reflect AI
- How to develop an approach to governing AI, enterprise models, and how an organization operationalizes AI governance
- Jeanille Gatta - Compliance Director, AstraZeneca
- Jim Dawson - Vice President, Compliance Solutions, qordata
- Melissa Fukushima - Deputy Chief Privacy Officer, Merck
- Expectations from the Compliance function in AI-enabled companies, and their implications
- Current AI initiatives in Compliance - benefits, challenges, and lessons learnt
- The path forward - exciting possibilities and key risks
- Top tips for success
- Christine Zettlemoyer - Senior Vice President, Global Head of Compliance, Risk, and Data Privacy Program, Genmab
- Christian Dingler - Executive Director, Risk Management and Program Effectiveness, Insmed
- Gaurav Sharma - Vice President, Product Management, RLDatix Life Sciences