Recorded at: Summit for Clinical Ops Executives (SCOPE)

Digital Course: Understanding and Implementation of the Affordable Care Act and Sunshine Act on Clinical Trial Management


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About this Product:

In this digital course, we will discuss the new "sunshine provisions" in the Patient Protection and Affordable Health Care Act ("PPACA") and its implications and effects on clinical trial operations. Key topics to be addressed:

  • Insurance coverage and strategies to improve clinical trial enrollment
  • What is the Sunshine Act and what are the company's legal requirements?
  • Opportunities in the Biosimilars FDA rules and changes in operations
  • What are first steps and strategies to become compliant with state and federal laws?
  • How can companies maintain flexibility in dealing with evolving legislation?
  • What business processes and systems are involved?
  • Implementation struggles: Centralization of all payments; FMV process and standardization and the effect
  • Change Management with Study teams: The balance of compliance and challenges of patient recruitment, site shortage


Product Details:
3 Presentation
87 Slides
89 Minutes
Individual: $345
Site License: $1380

Formats Available:
Digital Download
On Demand


Agenda at a Glance:


Topic 1: Physician Payment Sunshine Act Overview

Thomas Sullivan, President, Rockpointe Corporation

Topic 2: Implementation of PPSA

Marc Eigner, Partner, Polaris

Topic 3: Impact of Transparency Reporting On Clinical Operations – An Industry Perspective

Brenda Medina, Director, Global Head, Clinical Business Operations & Meeting Planning, Eisai

Speaker Biography:

Tom SullivanThomas Sullivan, President, Rockpointe Corporation

Thomas Sullivan is the President and founder of Rockpointe Corporation, a leading medical education company headquartered in Columbia, MD. Rockpointe and its ACCME accredited subsidiary, PCME, are recognized for the scientific content of its programs, compliance with CME guidelines and practices, and creative approaches to instructional design. Tom is a graduate of the University of Florida in Economics and a hard core Gator fan. He has 15 years of experience in medical education and program development working with clients such as the American Heart Association, American College of Cardiology, American College of Chest Physicians, American College of Physicians, The Endocrine Society, American Diabetes Association, National Multiple Sclerosis Society, American Society of Clinical Oncology, as well as most of the major pharmaceutical companies. Tom is a recognized authority in the changing medical education environment and economy. He has parlayed his passion for the political process to inform the medical education community and other stakeholders of emerging trends, threats and changing practices. Recently, Tom launched a website devoted to news and information about political events which effect CME providers and the pharmaceutical and device industries. Tom's leadership has helped to keep Rockpointe ahead of the curve in the changing regulatory environment.

Marc EignerMarc Eigner, Partner, Polaris

Marc heads Polaris' technology and aggregate spend practice, and is a co-founder of Polaris Solutions. Marc is considered one of the leading experts in Pharma compliance technology, including HCP/HCO spend automation and aggregate spend systems. Marc has spoken at many conferences on these topics. Marc has helped grow Polaris' technology practice from a small team to one of the largest Pharma compliance focused technology groups in the industry. Marc has personally supported over 55 life science companies with their processes and systems for supporting payments and grants to healthcare providers. Before joining Polaris, Marc worked in Accenture's technology practice. Early in his career, Marc worked for IBM. He has an MBA in IT Management, an MS in Computer and Systems Engineering, and a BS in Computer Engineering from Rensselaer Polytechnic Institute.

Brenda MedinaBrenda Medina, Director, Global Head, Clinical Business Operations & Meeting Planning, Eisai

Brenda Medina has 12 years of direct experience. Currently, she holds the position of Global Head of Clinical Business Operations responsible for the functions of Study Budget Management, R&D Aggregate Spend tracking and reporting, Investigators Fair Market Value Assessment &Benchmarking, Strategic Meeting Management, Clinical Insurance and Quickbase Implementation and Analysis all of these functions are focused on the Clinical/R&D business units of Eisai. She has been at Eisai six plus years and has fully developed the process and tools for study budget management process, including Investigator Benchmarking, Budget Negotiations, Reconciliation, and Aggregate Spend Reporting for Sunshine and State reporting. Previous to Eisai Brenda has a well balance mix of experience in Clinical Arena from Biotech and the Finance Arena from several auditing and private firms. Brenda's earned her degree in Accounting and Computer Information Systems from Dowling College and through her experience and education has been able to become a well-established Translator of the Clinical Development process for the Finance teams and a Financial Liaison to the Clinical Teams; a role and department (Business Operations) she has established at Eisai.


About the Conference:

Clinical trials are one of the most time-consuming and expensive components of the drug development process. Cambridge Healthtech Institute's Summit for Clinical Ops Executives (SCOPE), held February 4-7, 2013 in Miami, Florida, brings together key decision makers and industry thought leaders from more than 200 organizations for thoughtful, dynamic discussions on innovative solutions to optimize each phase of the clinical trial process. This year's program offered eight conferences and several pre-conference workshops addressing Forecasting, Site Selection, Recruitment, Data Collection, Post-Marketing Studies, Registries and other key issues in clinical trial operations.


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