2022 USA Medical Device IIS Conference

July 13 – 14, 2022
Virtual Event
Event details
July 13 – 14, 2022
12:00 am
Virtual Event

Event summary

The 7th Annual US Medical Device Investigator Initiated Study Conference will bring together industry leaders to address current challenges and highlight solutions for a successful IIS program. This virtual conference will provide practical insights on reviewing IIS proposals, building viable relationships with external thought leaders, aligning IIS with corporate strategy and fulfilling the regulatory expectations.

For more information or to register, please email Rebecca Lanz.

Featured agenda item

FDA and Fraud and Abuse: Navigating Key Regulatory & Compliance Issues for IIS 

Wednesday, July 13: 5:10 pm ET

Cooley partners Gina Cavalier and Sonia Nath will speak at this event.

Topics include
  • The importance of distinguishing IIS grants from fee-for-service research
  • Navigating informed consent and HIPAA authorizations
  • FDA’s approach to regulating clinical trials for devices: significant vs. non-significant risk devices, the role of IRBs and human subject protection requirements
  • FDA regulatory risks presented by IIS: ensure compliance with 21 C.F.R. Part 812, including restrictions on promotion and charges/costs recouped as part of study
  • Best practices for IIS contracting


 

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