This course, created by AdvaMed and Porzio Life Sciences, has been designed for those who have recently taken on compliance responsibilities, are currently revamping an existing program or simply require a refresher. This one and a half day program will provide you with a thorough understanding of the compliance framework and practical approaches for addressing challenges and effectively managing compliance in a medical device company.
This course is recommended for in-house personnel with healthcare compliance responsibilities, those who may work in Legal, Compliance, Quality Assurance, Regulatory, Clinical Research, Medical Affairs and other related areas. Individuals who approve corporate, medical, promotional and investor communications, train company and third party staff on compliance topics, and monitor or audit compliance operations would greatly benefit from participation in this unique program.
Agenda topics include, among others:
- The foundation of your compliance program and the tools to support your company as it evolves and grows
- Identifying and mitigating your major compliance risk areas
- The most recent First Amendment Developments
- Breakout Groups Analysis Case Study
- Managing promotional, medical, & investor communications: what you can, should, and should not say to whom
- Healthcare compliance in the medtech industry
- Sunshine Act reporting so far and transparency developments at the state level
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