Handouts

CEU Application | Overall Conference Evaluation | Agenda 

Research Year in Review with Updates from June 1, 2022

F. Lisa Murtha, Partner, Moses & SInger LLP

  • This session will present relevant new laws, regulations, and guidance from federal and state government agencies on the conduct of research
  • We will review new OIG Workplan and its research initiatives as well as key enforcement initiatives and settlements related to research
  • We will discuss novel approaches to addressing these new government initiatives within research compliance programs

Presentation
Evaluation

Follow the Money: How Not to Get a Visit from DOJ (and Their Friends) When Conducting Research

Genevieve deLemos, Partner, deLemos & Wever, PLLC
Andrea Wever, Partner, deLemos & Wever, PLLC

  • Provide brief overview of regulatory and statutory environment governing research funding, FCA, AKS, potential financial fraud implications
  • Review and discuss recent enforcement activity in clinical trials and grants & contracts, including up to date settlement/incarceration information
  • Describe methods for strengthening your research compliance program to avoid unfriendly interactions with government agencies and enforcement bodies

Presentation
Evaluation

NIH Data Sharing and Management Policy: The Final Countdown to January 25, 2023

Kristin West, Director, Research Ethics & Compliance, Council on Governmental Relations (COGR)

  • Overview of policy and associated notices and FAQs
  • Protecting privacy in open science
  • Budget, budget, who’s got the budget - handling costs

Presentation
Evaluation

Sponsor Clinical Quality Assurance Audits of Investigator Sites: Readiness, Response, and CAPAs

Shanley Curran, RM CQA Fellow, Boston Scientific

  • Understand authority, purpose, and framework for sponsor CQA audit programs (including Investigator-Sponsors)
  • Discuss site audit readiness throughout study conduct and for the audit
  • Discuss audit process, sponsor observations, site responses, quality CAPAs

Presentation
Evaluation

CMS Open Payments Expansion: Impacts to Research Conflicts of Interest

Catharine Fortney, VP, Chief Compliance and Privacy Officer, Cone Health
Sandra Shumaker, Director Hospital Compliance, Denver Health and Hospital Authority

  • Understand what has changed under the CMS Open Payments expansion
  • Explore how the HHS OIG identifies and investigates high-risk industry-provider relationships
  • Discuss practical tips on incorporating CMS Open Payments review into research COI processes

Presentation
Evaluation

Boost Compliance with Clinical Trial Billing Education

Kelly Willenberg, CEO, Kelly Willenberg and Associates

  • Analyze needs of stakeholders related to research billing
  • Evaluate workflow and utilize tools already in place to streamline the process
  • Understand the technical process to simplify daily workflow

Presentation
Evaluation

 

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