PREP Course #27: Navigating the IBC Approval Process for Clinical Trials Involving Biological Agents

Description
  • Background: NIH Guidelines, Human Gene Transfer, Northwell Health Biosafety Program
  • Potential bottle necks when managing biological agents
  • Components of the risk assessment
  • Elements of a SOP for clinical trials involving biological agent
  • Policy and requirements of IBC review and biosafety precautions
  • The medical surveillance process

Objectives

As a result of attending this session, attendees will be able to:

  • Develop registrations and risk assessments involving biological agents for IBC review and approval
  • Identify what is required to participate in Northwell’s program of biological agent use in research
  • Understand the PI and study personnel roles and responsibilities in biological agent research.
  • Understand the organizations commitment to biosafety and biosecurity.

Speaker

Michelle Aparicio, Director, IACUC, and IBC
Stephen Frattini, DVM, Office of Research Compliance
Raymond Pica, Senior Research Assistant, Steinberg Lab

The Public Research Education Program (PREP) is a series of courses developed by various research support offices in conjunction with other health system offices. The courses offer CME credits and are designed to increase quality of research throughout the health system and streamline the process of conducting research.

PREP courses also aim to enhance and expand investigator capacity to conduct research. PREP courses are free and open to all Northwell Health employees, students, and volunteers. In addition, interested research collaborators and community partners are welcome to attend.

Light refreshments will be served at the courses held at the Goldman B Conference Room.

Click here to register for this event.

Don’t forget to check out select videos of PREP courses online.

For additional information, please visit: https://www.feinsteininstitute.org/professionals/resources-for-investigators/administrative-services/research-policy-training/training-professional-development/public-research-education-program-prep/
Cost
FREE
Location
350 Community Drive
Manhasset, NY 11030