As aggregate spend regulatory requirements evolve, several jurisdictions have implemented legislation calling for transparency on payments to practitioners. These new requirements are changing sales and marketing practices in the life sciences, specifically imposing a duty on companies to increase tracking mechanisms and implement better record retention efforts. With the emergence of transparency requirements at the federal level, companies struggling to meet the challenge of transparency reporting at the state level and are now challenged with nationwide reporting as well. Manually tracking and reporting at the national level is a titanic, unfeasible undertaking, and some companies have begun to implement aggregate spend tracking solutions. However since legislative requirements continue to evolve, each company’s aggregate spend solution will need to include scalability.

This presentation provides an overview of what companies must consider when implementing a scalable aggregate spend solution, covering the evolution of transparency requirements at the state and federal level and discussing the significance of tracking pending legislation. Our speakers also provide an overview of the current state and federal reporting requirements and the Federal Sunshine Requirements, and share best practices for capturing and recording data. The presentation also provides an overview of the system implementation process, and discusses the needs of business and regulatory intelligence.

This audio conference covers:

• The importance of building a scalable aggregate spend solution
• Key considerations when building a scalable aggregate spend solution
• The need to track pending legislation and how that impacts each company’s readiness
• Best practices for capturing and recording data
• An overview of the system implementation process

About the speakers:

John Patrick Oroho is a principal of Porzio, Bromberg & Newman, P.C., where his practice is concentrated in the area of federal and state regulatory compliance with respect to the Prescription Drug Marketing Act (PDMA), anti-kickback, false claims, patient inducement, and Medicare and Medicaid fraud and abuse. He is also the Executive Vice President of Porzio Pharmaceutical Services, LLC, and has been involved in designing and implementing internal and external sample accountability systems.

Mr. Oroho has extensive experience in ensuring that SFA systems are PDMA compliant. He has designed and implemented corporate compliance programs for pharmaceutical companies that focus on OIG, PDMA and state compliance. He previously served as Senior Vice President and General Counsel of the PDMA Alliance, Inc., a national trade association of pharmaceutical companies focused on pharmaceutical sales and marketing compliance, and continues to act as outside counsel to the PDMA Alliance.

Mr. Oroho provides counsel and advice to pharmaceutical and related service companies nationally. He has written and lectured extensively throughout the country in the areas of OIG, PDMA and state law compliance. He is a graduate of the United States Merchant Marine Academy, and received his JD from the University of Notre Dame School of Law.

Kiaema R. Reid is a Senior Regulatory Analyst for Porzio Pharmaceutical Services, LLC. Ms. Reid is a member of the core Porzio AggregateSpendID team and is responsible for the configuration and implementation of the system. Ms. Reid has extensive experience with compliance audits, providing guidance on marketing codes of conduct, the manual preparation of state compliance reports, lobbyist registration and disclosure, and pharmaceutical detailer licensure. She is heavily involved in the development of state reporting protocols and the preparation and filing of sales and marketing disclosure reports. Ms. Reid has a thorough understanding of the state and federal transparency laws affecting the sales and marketing practices of the life sciences industry.

She received a Bachelor of Arts from Fairleigh Dickinson University, a Certificate in Paralegal Studies from Fairleigh Dickinson University and is currently pursuing a Master of Science in Jurisprudence at Seton Hall Law.

Who should attend?

• Regulatory Affairs
• Legal Counsel
• Marketing
• Finance
• Sales/Business Development