Registration and Continental Breakfast (provided)

Welcome / Introduction

Research Compliance 101 - high level overview of key research compliance issues -Human research protections, scientific misconduct, conflicts of interest, research billing, effort reporting, and more -Integration of research compliance into the corporate compliance program

Break

Health Care Compliance 101 -An overview of general compliance topics focusing on the elements of an effective compliance program -The infrastructure of a research compliance program - The Board’s role in compliance

Lunch (provided)

Human Research Protections -Overview of Federal Regulations governing investigators, institutions, IRBs - Discussion of frequent trouble spots identified in Determination Letters and Warnings, and how they can be managed - Interactive dissection of hypothetical scenarios and practical approaches managing thorny issues

Break

FDA-Regulated Research -Guidelines for determining whether research is regulated by FDA and, if so, by which component -Institutional and investigator responsibilities in FDA-regulated research: FDA and industry expectations for compliance -FDA inspections: What to expect and how to respond

Break

Conflicts of Interest - Identifying a potential conflict of interest that may introduce bias into the design, conduct, or reporting of research - Determining when action needs to be taken, and what actions are necessary and appropriate for reduction, management, or elimination of the potential or actual conflict -Action that can be taken to decrease the possibility of conflict of interest situations arising in the conduct of research