New York/New Jersey Chapter: The Ins and Outs of FDA Sponsor-Monitor Inspections

RAC Credits
Thursday, 18 October 2018 (5:30 PM) - Thursday, 18 October 2018 (8:30 PM) (Eastern Time (US & Canada))
100 Interpace Pkwy
Parsippany, NewJersey, USA, 07054-1149

Thursday, 18 October 2018
5:30-8:30 pm EDT
Ferring Pharmaceuticals
100 Interpace Parkway
Parisippany, NJ 07054
+1 973 796 1600

The Food and Drug Administration’s (FDA) bioresearch monitoring program (BIMO) includes on-site inspections and data audits designed to monitor the conduct and reporting of FDA regulated research. The objectives of the BIMO program are to protect the rights, safety and welfare of human research subjects and to assure the quality, reliability and integrity of the data collected and reported to FDA as part of the drug and medical device approval processes. It is imperative for regulatory professionals to understand the BIMO inspection process and to understand best practices for preparing and hosting these types of inspections.

Come join others from your local regulatory community for an evening of networking, along with a presentation and interactive question and answer session. Topics to be covered will include:

  • History and purpose of BIMO inspections
  • Objectives of FDA sponsor-monitor inspections
  • FDA inspections statistics
  • Common findings from FDA inspections
  • Tips for hosting an FDA inspection
  • Case studies

The engagement activity, hosted by Ferring Pharmaceuticals, is brought to you by the RAPS New York/New Jersey chapter and is intended to promote professional development and networking opportunities in the local regulatory community. Light refreshments will be available to all attendees and RAC holders may claim two RAC recertification credits

Featured speaker:
Michael A. Trapani, MS, MBA, group leader, senior consultant, Biologics Consulting

Registration Information:
Prior to 11 October:
RAPS Member:  $35
Nonmember:  $50

On or After 11 October:
RAPS Member:  $45
Nonmember: $60