The Quality Colloquim - The Leading Forum on Health Care Quality Enhancement and Medical Error Reduction

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Congress Overview

You will not want to miss "The Medical Device Regulatory and Compliance Congress: Benchmarking Your Firm's Practices in Risk Management, Quality Systems, Fraud and Abuse and Reimbursement." This Congress, which will take place on the campus of Harvard University, will bring together present and former regulators, senior officials in medical device firms, lawyers, consultants and trade association officials. The regulators will talk about the today's requirements and what will be required in the future. They will explain the criteria for instituting regulatory action and the consequences of being subject to that action. Then representatives of medical device firms, lawyers and consultants will provide concrete examples of innovative ways to comply with the requirements. An essential feature of the Congress will be the ability to compare what your firm is doing with others in the industry. To ensure a meaningful experience, there will be plenty of time for questions and answers and networking. You will have the opportunity to talk with the regulators and your colleagues in other companies who are struggling with the same issues that you are. We expect representatives of large, medium and small companies to participate. You need to be there-to contribute your ideas and to learn from others.

Course Learning Objectives

  • To provide an overview of FDA's new regulatory initiatives for 2006.
  • To provide an overview of CMS new regulatory initiatives for 2006.
  • To explain what the best practices are for using metrics to measure and improve the quality of medical devices.
  • To describe the current process for obtaining reimbursement for medical devices and discuss the benefits versus challenges of various models that may be implemented in the future.
  • To explain the need to balance the public's right to know with the government's obligation to protect patients.
  • To describe how medical device firms are creating systems to ensure regulatory compliance.
  • To explain the consequences when medical device firms violate the Federal Food, Drug, and Cosmetic Act and the laws pertaining to fraud and abuse.
  • To set forth how medical device firms are integrating the principles of risk management within their quality systems.
  • To describe best practices for complying with the AdvaMed Code of Conduct.

Who Should Attend

From Medical Device Firms:

  • Presidents
  • Quality and regulatory officials
  • Quality engineers
  • Marketing officials
  • Financial officials
  • Officials who are in charge of obtaining reimbursement
  • Compliance officers
  • Legal counsel
Others:
  • Lawyers in private practice
  • Government officials
  • Consultants
  • Press
  • Managed care
  • Provider groups
  • Officials in insurance firms


Overview | Agenda/Faculty Presentations | Promotional Opportunities | Continuing Education
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