The Association of Clinical Research Professionals

Clinical Trial Agreement Negotiation – Everything Your Lawyers Want You to Know – Part II

Are you interested to learn more about clinical trial agreements and what clinical trial attorneys would love you to know?

Date: January 22, 2025
Time: 12:00 – 12:45 PM ET

Compliance Concerns

Building from the previous session on the infrastructure of clinical trial agreements, our speakers will focus on critical regulatory issues that can impact the trial’s legality. It covers: 

  • Medicare Billing (False Claims; Secondary Payor Rule)
  • Anti-Kickback Statute and the Personal Services Safe Harbor (Fair Market Value; Impact on Amendments; Services related to Intellectual Property)
  • Privacy

Now that you’ve established the framework for the clinical trial agreement, gain understanding in other areas that typically cause anxieties.

Upon completion of this continuing education program, participants should be able to:

  • Understand the essential elements of a clinical trial agreement.
  • Gain an understanding of differing sponsor and site objectives in contracting.
  • Offer alternative negotiated language to meet the needs of both parties.

Speakers:

Molly G. Huggins, JD, MHA
Partner
Huggins & Zuiker, LLP

Molly spent her formative years in Atlanta, Georgia. She moved to North Carolina to attend Davidson College and from there went on to obtain a Master of Health Administration at the Medical University of South Carolina. She worked for five years at a multi-hospital health care system, then returned to the Tar Heel state for her legal training and she earned a law degree from the University of North Carolina at Chapel Hill. Molly has a wide range of experience representing health care systems and an impressive command of the legal, regulatory, and business issues faced by health care providers. She is licensed in Georgia and North Carolina. She lives in Savannah with her husband and teenaged boys. In her free time, Molly enjoys running, travel, and college basketball.

Erin Shaughnessy Zuiker, JD, MPH
Partner
Huggins & Zuiker, LLP

Erin grew up in Cleveland, Ohio. After completing her undergraduate studies at John Carroll University, she served as a Peace Corps Volunteer in the Republic of Vanuatu, where she worked alongside the local healthcare providers and assisted in promoting better health outcomes for the rural community. Erin returned from the South Pacific and attended the University of North Carolina at Chapel Hill to study both public health and law. Erin is an experienced healthcare attorney with unique field experience in public health. Erin, her husband, and their three children live and work in North Carolina’s Research Triangle, a vibrant community of academic medical centers, biotech firms, CROs, and start-ups, all dedicated to medical science and innovation.

Note: Each webinar in the series requires separate enrollment; while attendees are encouraged to register for all three sessions, it is not required.

Approved for 1.0 ACRP Contact Hours

The WebEx service used for ACRP webinars includes a feature that allows audio and any documents and other materials exchanged or viewed during the session to be recorded. By joining this webinar, you automatically consent to such recordings. If you do not wish to participate in the live recording, we recommend that you register to receive the link to the webinar replay.