AdvaMed and Porzio Life Sciences have teamed up to offer a four-part virtual program to help you and your team mitigate the burden of compliance. These interactive programs 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. The dates for this event are still being finalized. Click here to be the first to receive an alret when the final dates are announced.
Session One: Introduction to Porzio's Compliance Framework
This session will introduce the four legs of the compliance framework: Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile.
Session Two: Compliance Challenge: Health Care Professional Engagements
- Culture: The importance of culture when determining how and why to engage HCPs
- Effective Compliance Program Development and Implementation: What are the rules of engagement?
- Government Expectations: Key risks and requirements
- Assessing Your Risk Profile: Implementing a compliant HCP engagement process that fits your organization
Session Three: Compliance Challenge: Grants, Donations and Other Funding
- Culture: Why provide funding?
- Effective Compliance Program Development and Implementation: Understanding the challenges with funding
- Government Expectations: Compliance issues with grants and donations
- Assessing Your Risk Profile: Facilitating compliant funding
Session Four: Compliance Challenge: Federal, State and International Transparency, Disclosures and Reporting
- Culture: Sunshine reporting - Creating a culture of compliance
- Effective Compliance Program Development and Implementation: The expansion of Sunshine Act reporting to include additional health care professionals
- Government Expectations: State law compliance obligations
- Assessing Your Risk Profile: OUS transparency and related considerations