The faculty
Darcy DiFede, RN, BSN, FAHA
Clinical Research Operations, Regulatory Compliance, cGMP, cGCP, HCTPs, & International/National Healthcare
Location : Miami, Florida
Speaks : English and Spanish
Darcy Lynne DiFede, BSN, RN, FAHA brings over two decades of experience in medical science, biotech, and clinical research. She specializes in regulatory compliance, clinical research operations, manufacturing, and international and domestic healthcare, serving as our Regulatory Advisor and co-author of the FDA Legal Foundations Of Regenerative Medicine
ABOUT ME
Darcy DiFede works in clinical research operations and regulatory compliance with deep experience across academic medical centers, biotech, and international healthcare development. She founded a biological consulting firm that catalyzed collaborations with clinicians and institutional partners, including initiatives to design and build hospitals abroad such as in Morocco.
Her leadership in oncology was demonstrated as Administrative Director of Clinical Research Operations at Miami Cancer Institute, Baptist Health South Florida, where she restructured the oncology clinical trials department and oversaw operations for Phase I to IV therapeutic studies, including management of the chemotherapy treatment unit. Previously, Darcy served as Director of Clinical Research at the University of Miami Miller School of Medicine’s Interdisciplinary Stem Cell Institute, where she led the clinical trials division and implemented programs across multiple disease areas. During this time, she oversaw numerous investigator-initiated clinical trials of novel cell-based therapies for cardiovascular disease, enrolling more than 200 patients, the largest single-center experience of its kind in the United States.
Darcy is also deeply committed to mentorship and professional development, having trained and supported physicians, medical students, nursing students, international nurses, and clinical research professionals throughout her career.
EXPERIENCE
Darcy completed her nursing education at the University of Miami School of Nursing and Health Studies. She is a Fellow of the American Heart Association (AHA) and a member of the American College of Cardiology (ACC).
She is currently a board member of the Healthspan Action Coalition, serving on the Patient Advocacy Advisory Board. She has been a past member of several boards, including the International Society for Cellular Therapy (ISCT) Cardiovascular Scientific Committee, and served as a sub-investigator on the NHLBI-funded Cardiovascular Cell Therapy Research Network (CCTRN) steering committee. She also served as Leadership Succession Chair for the Beta Tau Chapter of Sigma Theta Tau International Honor Society of Nursing.
Darcy has co-authored multiple clinical trials involving mesenchymal stem cells, published numerous peer-reviewed articles, and is an internationally recognized invited lecturer.
Hands-on training
Hands-on medical training courses.
Build real clinical skills the hands-on way. You learn by doing it. You work with live patients. And the clinicians who teach you are still in practice.
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Every course, by discipline.
The catalog
Every course is private. Every course is hands-on. It’s real training. You work on live consenting patients. And you do all of it under a practicing instructor.
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Important information
Read this before you book.
Six short notes on what the training is and is not. Open a heading to read it.
Education, not medical advice
Regen Med Academy provides education and training for licensed healthcare providers. Everything on this site is for educational purposes only. It is not medical advice, not a treatment recommendation, and not an offer to treat. Providers are responsible for practicing within the scope of their own license and their own state law.
Where a course can run
Courses are taught only in states where the modality is legal for the license you hold. State law in this field changes, sometimes more than once a year. Our reading of each state, with its sources and the date we checked, is on the rules by state page. It is a starting point, not legal advice. It is your responsibility to confirm the modality is legal in your state for your license. Do that before you book. The authority on your own scope is your licensing board, not us. State medical board contact details are published by the Federation of State Medical Boards.
Training on live patients
Procedures performed during training are performed on consenting patients, by licensed providers, under supervision. Participation is voluntary and outcomes vary.
Products and modalities
Some products and modalities discussed in these courses are not FDA approved or cleared for the uses described. Regen Med Academy does not manufacture, sell or endorse any product, and does not approve or clear any product. The FDA publishes guidance for patients and providers on regenerative medicine therapies.
What a certificate is, and is not
Regen Med Academy does not offer CMEs, credit hours or accreditation of any kind. What you receive is a Certificate of Completion. It records that you attended and performed the procedures under supervision. It is not a license, not a board certification, and it does not expand your scope of practice.
Coverage is yours to arrange
You are responsible for your own malpractice coverage. We will help you work out what to ask your carrier, and we recommend getting the answer in writing. Regen Med Academy does not provide, arrange or extend coverage to trainees, and nothing on this page is legal advice or an assurance of coverage.