You will not want to miss "The Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress." This Congress, which will take place on the campus of Harvard University, will bring together present and former U.S. and international regulators, senior officials in medical device firms, lawyers, consultants and trade association officials. The regulators will talk about 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 from large, medium and small companies to participate. You need to be there
to contribute your ideas and learn from others.
To ensure a meaningful experience, there will be plenty of time for questions, answers and networking.
Course Learning Objectives
- To provide an overview of FDA's new regulatory initiatives for 2007.
- To provide an overview of CMS's new regulatory initiatives for 2007.
- To explain which countries have implemented fraud and abuse laws and the action taken against medical device firms for failing to comply with these laws.
- To describe how private payers make reimbursement decisions affecting medical devices and the clinical data they require.
- To explain how to respond to 438 observations to avoid getting a warning letter.
- To provide an overview of the challenges to international harmonization of regulatory requirements for medical devices.
- To explain innovative techniques firms have used to comply with the requirements of the quality system regulation.
- 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 results of a survey on how medical device firms have organized the reimbursement function within their organizations.
- To provide the results of a survey on the barriers that medical device firms are experiencing in adopting effective compliance programs.
- To describe the programs that the Advanced Medical Technology Association is offering to promote compliance with the fraud and abuse laws.
- To describe what constitutes fair market assessments for health care professionals.
- To describe recent enforcement actions taken against drug and device firms for off-label promotion.
- To explain the regulatory requirements for marketing medical devices in
Asia, Europe and South America.
Who Should Attend
From Medical Device Firms:
- Quality and regulatory officials
- Quality engineers
- Marketing officials
- Financial officials
- Reimbursement officials
- Compliance officers
- Legal counsel
- Lawyers in private practice
- Government officials
- Managed care officials
- Provider groups
- Insurance firm officials