The Association of Clinical Research Professionals

ACRP 2023 Regulatory Trends & Compliance – Replay

This package is a replay of 10 on-demand session recordings and presentation slides from the Regulatory Trends & Compliance Track at the ACRP 2023 Conference, April 29 – May 1, Dallas, Texas. Hear tips and strategies to mitigate risk and keep your studies in compliance.

Note: These 10 sessions will appear on your course dashboard individually as the titles seen below.


Member: $99 | Nonmember: $149


Participants can earn up to 11 ACRP contact hours. Upon purchase, the sessions will be accessible from your My Courses Dashboard. Replay sessions expire on May 31, 2026.

  • FDA’s CDER Update on Quality and Compliance

David Burrow from FDA’s Center for Drug Evaluation and Research discusses key opportunities to build quality into clinical research, and strategies to make the FDA inspection experience a positive one. David will describe the impact inspections can have on marketing applications, and how Quality by Design will help minimize the prevalence of errors that matter. When problems do occur, inspected entities should be able to respond appropriately. In this session, you will also take away practical approaches to working with the FDA during an inspection, responding to 483s after an inspection, and responding to subsequent regulatory correspondence. Speaker: David Burrow, PharmD, JD, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, FDA

  • 2023 U.S. Regulatory Update

This session will highlight key laws and regulations (or the absence of laws and regulations) that directly or indirectly affect the research industry. Speaker: David Vulcano, LCSW, MBA, CIP, RAC, Vice President, Research Compliance & Integrity, HCA

  • Remote Monitoring: Past, Present, and Future

Remote Monitoring is a hot topic. The core business challenge is the expense of remote monitoring vs onsite monitoring, and the core competency challenge is confidentiality during remote monitoring. This is important for the audience to learn and/or address in order to make remote monitoring go more smoothly. This will help the study team increase monitoring productivity and lessen the financial burden of onsite monitoring. Professionally, the CRA and the site must be able to communicate and work together to obtain the same results during the remote visit as occurs during an onsite visit. Speaker: Kristi Pinkston, BS, RN, MABC, Senior Clinical Research Associate, Merck

  • The Future of FDA BIMO Inspections: Are you Prepared?

In this session, we will discuss the FDA’s Bioresearch Monitoring Program (BIMO) inspections and how future inspections may look a little different than they did before. Learning Objectives: Be prepared for an FDA inspection; Learn some new technologies which may be employed during inspections; Learn how we are adapting to new technologies to ensure our CSOs are prepared. Speaker: Eric Pittman, Program Division Director, FDA, Office of Bioresearch Monitoring Operations, Office of Regulatory Affairs

  • FDA Inspections: Understand the Process and Manage the Consequences 2023

This interactive session is intended for experienced professionals who deal with complex issues, need to understand the latest developments, and can contribute their own experiences. We will cover important GCP topics to prepare for audits and regulatory inspections and for addressing inspectional/audit observations. Discussions will include how to create Corrective And Preventive Actions (CAPAs), utilizing root cause analysis (RCA) procedures to address FDA citations in warning letters, NIDPOEs and 483s. Speakers: Glenda Guest, CCRA, RQAP-GCP, TIACR, FACRP, ACRP-MDP, President, Assured of Quality Consulting & Training; Janet Holwell, CCRC, CCRA, TIACR, FACRP, Clinical Research Consultant/Trainer

  • Monitoring Medical Device Trials: A Sponsor’s Perspective

Are you a clinical site, CRC, CRA, or another member of the research trials team who would like to gain more exposure and knowledge of medical device trials? Are you interested in learning more about how pharma and device clinical trials are similar and different? Join this session to learn more about medical device trials, how the monitoring of trial data may be different, and what a typical day in the life of a device CRA looks like. Attendees will walk away with practical knowledge and monitoring tools, such as a Monitoring Visit Checklist. Speaker: Sherry Roberts, BSN, RN, CHPE, CCRC, Lead Clinical Trial Specialist, Stryker

  • Sponsor Oversight of Clinical Operations: What You Need to Know

All professionals involved in the Management of Clinical Research at the Sponsor, CRO, or Site level will benefit from this session. Oversight is a growing activity that is required of all Sponsors of Clinical Trials in compliance with ICH GCP Guidelines that enable governance and risk mitigation while supporting the study’s overall quality strategy and ongoing improvement. Speakers: Anne Blanchard, CCRA, CPM, FACRP, Clinical Operations Executive Consultant; Mary Lord, RN, MS, CCRA, CRA Manager, Site Management and Monitoring, Merck

  • EEK… What is Going on in Billing Compliance for Clinical Trials?

This session will help anyone who is a research professional to understand what the risks are in billing compliance. Inspect your program, measure risks, and assemble the team who can make billing compliance better. Speaker: Kelly Willenberg, DBA, RN, CHRC, CHC, CCRP, Manager, Kelly Willenberg & Associates

  • Collecting and Evaluating RWD/RWE from Expanded Access Programs

Expanded Access (EA), also known as “compassionate use”, is increasingly in the news, and sponsors are increasingly looking to mine “real world data” (RWD) from these treatment programs, which involve patients, not research participants. We will define these terms and describe opportunities and limitations for collecting data from EA. Listeners will become familiar with the ethical, data quality, and regulatory questions surrounding the collection and use of RWD from EA. This session’s content is relevant to any individual interested in learning more about real-world data generated both within and outside of EA, and how to evaluate RWD as a potential source of real-world evidence (RWE). Speakers: Alison Bateman-House, PhD, MPH, MA, Assistant Professor, NYU Langone Health; Hayley Belli, PhD, Assistant Professor, NYU Langone Grossman School of Medicine

  • Educating Patient Advocacy Groups

As more patient advocacy groups are undertaking their own research, such as natural history studies and patient registries, it is more important than ever to make sure patient advocates functioning in the researcher role, understand good clinical research practices. For patient advocates who may be new to clinical research, it is important that clinical research education is accessible and easy-to-understand. In this session, we will share techniques for developing an education program for the needs of these novice researchers, that guides them in good clinical research practices, while allowing the patient advocate to customize their research strategy to the unique needs of their research community. Speakers: Stephanie Christopher, MA, CCRC, FACRP, Director, Patient Advocacy, Pfizer; Janet Mauro, BA, CCRC, IAMRARE® Implementation Co-Lead, National Organization for Rare Disorders