This is a sponsored message.
If there’s one thing clinical researchers can count on when it comes to regulations and guidance from governing bodies, it’s change. In the closing three months of 2024 alone, new guidance documents were drafted or finalized on a number of topics, including:
- Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations
- Requests for Reconsideration at the Division Level Under the Generic Drug User Fee Amendments
- Postoperative Nausea and Vomiting: Developing Drugs for Prevention
- Protocol Deviations for Clinical Investigations of Drugs, Biological Products, and Devices
- General Principles for Model-Informed Drug Development
With a new administration in place as of January 20, more change is inevitable – all of which can impact the efficacy of, integrity of, and even processes to follow for your research.
The Health Care Compliance Association® (HCCA®), a nonprofit membership organization supporting healthcare compliance professionals, was founded, in part, to be your eyes and ears for compliance updates and regulatory changes. It’s our mission to stay up to date on laws, guidance, and best practices, and to relay the information through publications and educational conferences as efficiently as possible.
Two upcoming events from HCCA provide excellent opportunities to get the latest updates and information relating to research compliance:
The Research Compliance Conference is one such opportunity, with three days of educational sessions devoted to the challenges, strategies, and latest developments in healthcare research compliance. It’s a unique opportunity to not only stay up to date with research initiatives, but also to engage with healthcare research professionals from around the country.
The 2025 conference will take place June 2–4 at the Hilton Orlando Lake Buena Vista – Disney Springs® Area in Florida, and will feature sessions led by experienced research compliance professionals, including directors of research compliance at public and private healthcare institutions, chief compliance officers from major universities, auditing and monitoring leaders, attorneys, and government officials.
Specific session titles demonstrate the breadth and variety of content available:
- Research Year in Review
- Compliance Strategies for Decentralized Clinical Trials: A Former Regulator’s Perspective
- Navigating the Regulatory Environment in the New Administration
- Clinical Trial Agreement Basics for Non-Lawyers
- The Good, Bad, and Ugly of AI and Research Misconduct
For a look at the full selection of educational sessions and speakers, view the agenda.
We’d love to see you in Orlando! Registration options include the full conference experience (Monday–Wednesday), or the main conference (Tuesday and Wednesday only). Group discounts are available; bring your team for shared learning!
Another educational opportunity devoted to research compliance is HCCA’s Healthcare Research Compliance Academy, a uniquely hands-on, applied learning experience. The Academy format is highly interactive, featuring instruction from experienced faculty, small-group discussion, and problem-solving exercises designed to not only teach you key concepts, but how to put them into practice in your day-to-day work.
The Academy agenda covers:
- Human research protections
- U.S. Food and Drug Administration-regulated research
- Managing research conflicts of interest
- Scientific misconduct
- Clinical research billing
- Animal research regulation
- Research documentation
- Research risk assessments
- Auditing and monitoring
- Grants management
- Data and safety monitoring
- FCAP, UK Bribery Act, and hot topics/trends
- Internal investigations
In addition to the comprehensive content, the interactive nature of the Academy facilitates networking – attendees leave with a practical understanding of research compliance as well as strong, often career-long, professional connections.
Research compliance practitioners looking to enhance their credibility and demonstrate their knowledge level can also opt to sit for the Certified in Healthcare Research Compliance (CHRC)® exam, offered onsite on the last day of the Academy. Those who have the requisite work experience and continuing education are encouraged to submit the separate exam application and fee and take advantage of this valuable professional opportunity.
The Healthcare Research Compliance Academy is offered twice in 2025: March 24–25 in Chicago, Ill. and September 8–11 in Scottsdale, Ariz. Class sizes are limited. Take advantage of this unique learning experience and come away ready to improve your research compliance program effectiveness with increased knowledge and enhanced professional support.
About HCCA
Established in 1996, Health Care Compliance Association® (HCCA)® is a nonprofit membership association dedicated to supporting the healthcare compliance profession with valuable resources, education, and networking opportunities.
