11th Investigator Initiated Trials

Industry-Leading Conference has the Key Topics, Industry Case Studies, Interactive Sessions and hosts the Investigator Initiated Sponsored Research Association (IISRA) Fall Meeting

Highlights include:

FDA Perspective on Different Paradigms for Submitting Investigator Initiated Research
Patricia Holobaugh, MS, Branch Chief, Division of Inspections and Surveillance, CBER

Case Study: IIS Studies from the Perspective of a US Affiliate under Global SOPs
David L. Cooper, MD, MBA, Director of Medical Affairs, Novo Nordisk Inc.

ITT Takes a Village - Innovative IT for IIT Review and Conduct
Michael O. Montgomery, MD, Director, Worldwide Medical Affairs Immunology Research at Johnson & Johnson-Centocor Ortho Biotech

Pre-Conference Workshop
Investigator Initiated Research – Oversight and Responsibilities at an Academic Institution
Harvey M. Arbit, PharmD, MBA, RAC, CCRP, Director, IND/IDE Assistance Program, Office of Clinical Research, University of Minnesota, Academic Health Center
Laura S. Williams, Principal Grant and Contract Administrator, Business and Industry Grants and Contracts, Sponsored Projects Administration

Get an Update from the Investigator Initiated Sponsored Research Association (IISRA)
Karen Bartels, RN, OCN, MBA, PMP, Clinical Project Manager, Oncology, AstraZeneca Pharmaceuticals