Second Annual Medical Device Regulatory, Reimbursement and Compliance Congress at Harvard
|Event Date/Time: Mar 28, 2007||End Date/Time: Mar 30, 2007|
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
Lawyers in private practice
Managed care officials
Insurance firm officials