| 7:30 |
Registration and Continental Breakfast
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| 8:15 |
Geoffrey M. Levitt
Senior Vice President & Associate General Counsel Regulatory, Environmental and Global Supply
Pfizer (New York, NY) Michael Parini
Executive Vice President and Chief Legal Officer
Vertex Pharmaceuticals (Boston, MA)
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| 8:30 |
Karen S. Lovitch
Leader, Health Law Practice
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C. (Washington, D.C.)
- Knowing when it is time to start thinking about a compliance program infrastructure
- Formulating a work plan for creating a compliance program infrastructure
- selecting a chief compliance officer
- creating a compliance committee
- establishing a reporting structure
- defining Board of Directors oversight and responsibility
- allocating resources
- Developing and implementing an “effective” compliance program
- identifying key risk areas based on product portfolio, sales model, payor x, co-promotion activity, distribution model and other considerations
- creating training programs
- implementing policies and procedures
- establishing an auditing and monitoring program
- creating a disclosure program
- designing an investigation protocol and corrective action process
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| 9:30 |
Kari K. Loeser
Senior Corporate Counsel & Senior Director
Jazz Pharmaceuticals (Palo Alto, CA) Peter Brensilver
Vice President, Assistant General Counsel, and Chief Compliance Counsel for Pfizer Essential Health
Pfizer (New York, NY)
- Identifying the seven key elements of a compliance program under the Federal Sentencing Guidelines
- establish standards and procedures to prevent and detect criminal conduct and promote an organizational culture of compliance
- appointment of a compliance officer
- criminal activity and leadership positions
- training
- auditing
- provide incentives for good conduct, punish non-compliant conduct
- appropriate response to criminal conduct
- Learning to use these elements to design a flexible and global program that can adapt to corporate growth
- tailoring objective elements to fit subjective corporate needs
- learning to think of compliance in global terms – i.e., integral and comprehensive as well as potentially international
- Collaborating with existing departments and corporate functions to establish compliance structure and get necessary “buy-in”
- importance of top brass taking ownership of compliance program
- Examining compliance program implementation vis-a-vis existing company structure
- which person/department is the best choice to start a compliance program?
- Legal?
- HR?
- Appointment of a compliance officer in small to mid to sized company
- understanding why this may be the most critical component of a compliance program
- review of compliance officer provisions in recent CIAs
- reporting structure for compliance
- to whom should the compliance officer report?
- Board of Directors? Legal?
- and to whom should the CO never report?
- Where should the compliance department ultimately be placed?
- can compliance objectives/duties be shared among various departments?
- separation of departmental duties and implementation of safe guards
- Dotted line reporting responsibilities
- compliance liaisons
- Why compliance should be separate from legal?
|
| 10:30 |
Morning Coffee Break
|
| 10:45 |
- Overview of the federal False Claims Act and state federal anti-kickback laws as they apply to the life sciences industries
- How actions brought under these laws against life sciences companies have used “real world” applications of the Codes and Guidance to prove violations?
- Exploring the evolution of enforcement actions from sales and marketing violations to medical affairs deviations
- Reviewing circumstance in which corporate executives and employees have been indicted in addition to the company
- Exploring settlements and Corporate Integrity Agreements (CIAs)
- understanding the terms of CIAs and what compliance lessons can be gleaned from them
- Predictions for future enforcement trends
- pricing and reimbursement?
- Implementing best practices through compliance protocols to avoid situations giving rise to violations
|
| 11:45 |
Jenny Alonso
General Counsel and Compliance Officer
Prometheus Laboratories Inc. (San Diego, CA)
- Overview of existing state aggregate spend laws, i.e., Physician Payment Sunshine laws and the importance of developing compliance protocols to fit their requirements
- Identifying required disclosures under these laws
- Review of carve outs and exceptions
- Learning from previous reporting cycles
- Mitigating exposure to government enforcement and liability stemming from transparency
- Developing compliance protocols that account for Sunshine and state requirements
- Proactively using Sunshine data for internal auditing and monitoring and internal investigations
|
| 12:45 |
Networking Lunch
|
| 2:00 |
Seth Mailhot
Partner
Michael Best & Friedrich LLP (Washington, DC)
- Identifying essential elements of cGMP and quality systems compliance and incorporating them into your global compliance program
- What departments should be involved to coordinate in the development of a proactive and effective quality system?
- what is the role of compliance in this implementation?
- Examining the FDA’s approach to quality systems in light of new agency enforcement initiatives
- what does the agency expect?
- what must you now do to demonstrate compliance during an inspection?
|
| 2:45 |
Micheline Awad
Director, Regulatory Affairs – Advertising & Promotion
Neurocrine Biosciences, Inc. (San Diego, CA) Paul M. Kirsch
Vice President, Regulatory Affairs
Iroko Pharmaceuticals, LLC (Philadelphia, PA) Karen Weaver
Chief Counsel - Regulatory
Becton Dickinson & Co. (Franklin Lakes, NJ)
- Overview of the Office of Prescription Drug Promotion (OPDP), Advertising and Promotional Labeling Branch (APLB) & Office of Compliance – duties, responsibilities, and enforcement authority
- Identifying the role of the FTC in the advertising and promotion of drugs
- Exploring advertising requirements for prescription versus non-prescription products
- Overview of the promotional materials submission and review process
- Dissecting the FDA’s draft guidances on promoting a drug or a medical device on Internet/Social Media platforms
- Devising response strategies to third-party misinformation about a drug or a medical device posted on a Social Media platform
- Considerations for how to respond to third-parties and what type of information to include in a response
- Examining mobile apps for the life sciences industry
- Analyzing the factors that may lead you to not use social media to promote a product
- How does a drug or device company’s Internet or social media presence impact its responsibility to monitor adverse events?
- Reviewing examples of social media practices: ways to navigate social media platforms
|
| 3:45 |
Afternoon Refreshment Break
|
| 4:00 |
Geoffrey M. Levitt
Senior Vice President & Associate General Counsel Regulatory, Environmental and Global Supply
Pfizer (New York, NY) Saul Perloff
Partner
Norton Rose Fulbright US LL (San Antonio, TX)
- Defining off-label promotion in light of recent First Amendment case law
- Exploring the role of the label in advertising and the perils of off-label promotion
- Labeling, promotional labeling and advertising: how it works
- FDA compliance and non-compliance: what you can and cannot say
- Employing FDA guidance on use of the internet and social media
- Science and Medical Developments: What happens to labeling when new science is published or an interpreter reinterprets a critical study?
- What must you do?
- What can you say?
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| 5:00 |
- Applying HIPAA and HITECH protocols to pharmaceutical, biotechnology and device companies
- HIPAA Privacy Rule compliance
- identifying the essential elements of HIPAA privacy compliance and incorporating them into your global compliance plan
- HIPPA Security Rule compliance
- essential elements, required
- documentation and risk analysis
- Examining business associate requirements
|
| 5:45 |
Conference Adjourns to Day Two
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