2010 Webinar: Expanded Access

Webinar Archives - Members  Webinar Archives - Non-Members

Overview

Expanded Access: Ethical and Regulatory Issues for Investigational Drugs and Devices provided an overview of the complex policies that govern expanded access programs involving both investigational drugs and devices.

Presented by expert faculty representing both the regulatory and institutional perspectives, this webinar:

  • Broadened attendees' understanding of expanded access programs and how they differ from clinical research
  • Explored the ethical and regulatory implications of expanded access programs for IRBs, patients, healthcare providers and researchers
  • Taught how to interpret and apply investigational drug and investigational device regulations regarding expanded access
  • Advanced attendees' thinking about, and management of, these complex issues

Audience

  • HRPP Professionals
  • Instituional Officials
  • Investigators/Physicians
  • Research staff
  • IRB members and administrators

Faculty

George Gasparis, CIP
George Gasparis is the Assistant Vice President and Senior Assistant Dean for Research Ethics at Columbia University Medical Center. He also serves as the Executive Director, Human Subjects Protection Program for both Columbia University and Columbia University Medical Center. Prior to his arrival at Columbia University in June 2003, Mr. Gasparis was the Director for the Division of Assurances and Quality Improvement at the Office for Human Research Protections (OHRP). Prior to his tenure at OHRP, he was the Director, Office of Human Research at The George Washington University Medical Center (GWUMC) from 1991 –1996. In that capacity he served as the administrator for the GWU Medical Center IRB, Director of the Research Pharmacy, and also served on the behavioral IRB for the university. Mr. Gasparis also has had extensive experience with clinical trials when he was employed at the GWU Lipid Research Clinic (LRC) from 1981-1991. During his tenure as Data Manager at the LRC, he managed over 40 clinical trials, including NIH awards and studies for 10 different pharmaceutical companies. Mr. Gasparis is a graduate of GWU. He received his CIP in 2003. He was born in Northern Virginia and moved to New Jersey in August 2003.

Richard Klein
Richard Klein is the HIV/AIDS Program Director with the FDA Office of Special Health Issues, serving as the primary interface between the agency and the HIV/AIDS patient and advocacy communities. He works extensively with HIV and other patient communities and within the agency’s scientific offices to address issues and concerns of the affected community in a variety of areas, including drug access, product safety, and clinical trial design. Mr. Klein has worked at the FDA in various capacities for more than 30 years, gaining a well rounded understanding of the regulatory issues that affect patients. Immediately prior to becoming the HIV/AIDS Program Director, he was involved in Human Subject Protection policy development for the agency, working closely with other federal agencies and the Department of Health and Human Services to ensure consistent and meaningful policy for the protection of human subjects of biomedical research. He is a member of the FDA institutional review board, participating in the ethical review of research conducted by the agency.