Session Details

Advanced Practice Professionals* (APP) Track Session 2 - Responsibilities of the Investigator and the Lab in the Investigation, Communication and Reporting of Adverse Events
Saturday, September 14, 2019 01:45 PM - 03:15 PM
Ballroom A
Chair:

Valkal Bhatt, PharmD, BCOP, BCPS, Memorial Sloan Kettering Cancer Center, USA

Speakers:

Responding to drug related serious adverse events; the manufacturer’s obligation to the Sponsor and the PI
Julia Thebiay, IMPACT, Mayo Clinic Rochester, USA
Learning objectives:
•      Understand the critical role proper communication plays between sponsor and manufacturer
•      Understand the use and implementation of ‘root cause analysis’ to identify possible contributors to lack of product integrity
•      Reporting events to the FDA: use of the IND annual report to communicate manufacturing failures, process changes and other manufacturing issues to the FDA

Proper reporting of drug related serious adverse events; regulatory obligations of the PI and Sponsor
Ashwani Khurana, PhD, Mayo Clinic, USA
Learning objectives:
•      Educating the Sponsor-Investigator to understand the attribution, reporting process and responsibilities for federally regulated studies
•      Understand proper communication requirements between the Sponsor and the FDA regarding adverse events
•      Understand how the protocol can affect timelines, classification and reporting of SAE to the FDA