Serious Adverse Event and Medical Device Reporting(Presented Live and via WebEx.)
Speaker: Pamela Horowitz, MSN, ACNP
Program Agenda:
- 5:30 PM – 5:50 PM - Arrival, networking, light snacks
- 5:50 PM – 6:00 PM - Announcements and Speaker Introduction
- 6:00 PM – 6:45 PM - Educational Presentation
- 6:45 PM – 7:00 PM - Question/Answers
Registration Cost: Chapter Members: Free
Non-members: $5.00 plus processing fee
Program Description: This presentation provides the FDA definitions and requirements for Serious Adverse Event and Medical Device reporting.
Upon completion of this Webinar, attendees should be able to:
- Demonstrate understanding of FDA definitions for Adverse Events (AEs), Serious Adverse Events (SAEs), and Device related Adverse Events.
- Demonstrate knowledge of FDA reporting requirements for SAEs.
- Demonstrate knowledge of FDA requirements for Medical Device Reporting (MDR).
Target Audience: Executives, Risk Management/Quality/Safety Professionals, Investigators, site managers and others engaged in clinical research
Sponsor: Medelis is providing the webcast ability, meeting room and light refreshments. They do not have influence on presentation content.
Questions: acrp.greaternashville@gmail.com Contact hours: 1.0 Contact hours have been approved through ACRP. Membership is not required for online registration of contact hours.
To receive contact hours: Purchase the contact hours, sign in at the registration desk, and attend the program. Log on to the ACRP website then “ACRP Learning Portal” to complete the evaluation no later than 30 days following the event and obtain the online certificate.
Contact Hour Cost:
- $0 Chapter Members
- $15 ACRP Members
- $30 Non-Members
Refund Policy: The cost of registration and contact hours will not be refunded.
Level: Core