Legal Considerations of Compassionate Use
Full course description
The Georgia Clinical & Translational Science Alliance- Georgia CTSA and Southern California Clinical and Translational Science Institute -SC-CTSI have collaborated to provide free, high quality educational programs for clinical research professionals at novice to expert levels of experience. At the completion of each course or program, participants earn contact hours recognized by a certificate and/or badge.
Over the last two decades, the FDA has permitted industry sponsors to broaden access to investigational products while they are still undergoing clinical trials for patients with serious or immediate life-threatening diseases with no comparable or satisfactory therapeutic alternatives eligible.
This course examines the FDA’s expanded access program, also referred to as compassionate use, and its regulations and requirements. Key factors in obtaining expanded access, including treating physician and manufacturer requirements, institutional review, and patient qualifications will also be discussed.
- What is the 21st Century Cures Act?
- What is Expanded Access?
- Investigational Products Access Pathways
- Manufacturer Investigational New Drug Application (IND)
- Investigator Initiated-Sponsor IND
- Individual Patient Request (Emergency or Non-Emergency) – 21CFR312.310
- Key Steps in obtaining Expanding Access
- Manufacturer’s Expanded Access Policies
- Expanded Access Request Preparation and Planning
- Manufacturer’s Review
- Additional considerations
- Adverse Events
- FDA, and Manufacturer’s Concerns
Kellie Ann Moore, Esq., is a practical business savvy attorney with over 18 years of experience providing legal counsel to pharmaceutical, biologic and medical device organizations for compliant conduct in conformance with FDA and international regulations. Kellie thrives on helping organizations strategically (and contractually) drive their FDA-regulated products and R&D services forward. By mapping contractual relationships and identifying regulatory risk mitigation strategies proactively, Kellie utilizes her unique role as an FDA-Regulatory lawyer to expedite product lifecycle events and the achievement of corporate goals. After Graduating from University of Southern California in 1992, Kellie began her regulatory career developing Biologics at AMGEN. Later, she earned her Juris Doctor Degree from Loyola Law School. Better known to USC’s students as “Professor Moore,” Kellie has been teaching MPTX 516, “Medical Products and the Law” for the USC Regulatory Science Program since 2001. Kellie currently performs legal, regulatory and contract consulting services for a range of pharmaceutical and medical device clients. BioMedLegal@gmail.com
Learner Level: Intermediate
This symposium is designed for Clinical Research Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with at least 3 years of clinical research experience. Individuals should be experienced with research study coordination, IRB submission process, budgeting, research compliance, recruiting, enrolling, financial management, data collection and analysis.
Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 1.5 Continuing Nursing Education contact hours from ENPDC.
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Program Information: This is the fourth course in a six session program. To complete the entire program and earn badge Click Here.