Medical Device Feasibility Clinical Trials – A Medical Case Study

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.

Description:

This course provides an overview of a feasibility trial for a novel active implantable device.The case study will demonstrate a private company’s approach to feasibility trials, accomplishments, and lessons learned.

Topics:

1. Medical overview of the trial device
2. Feasibility study design and key objectives
3. Study stages
4. Site selection and activation
5. Investigator and study staff training
6. Screening and enrollment
7. Monitoring
8. Study closeout

Speaker:

Lusin Markaryan, MS, is the Vice President of Regulatory Affairs at SetPoint Medical, a privately held clinical stage bioelectronic medicine company dedicated to treating patients with chronic autoimmune diseases. She obtained FDA approval for the company’s first-in-human clinical trial and is currently preparing the IDE submission for the pivotal study. Prior to SetPoint, Lusin was the Director of Regulatory Affairs at Medtronic Diabetes where she authored and obtained approval on an original PMA for MiniMed® 530G insulin pump and Enlite® sensor, a breakthrough first-generation artificial pancreas system. Lusin has over 18 years of regulatory experience in medical devices and pharmaceuticals and worked in regulatory and clinical roles at Boston Scientific Neuromodulation and Cedars Sinai IRB. She is a graduate of the Regulatory Science program and RAC-certified by the Regulatory Affairs Professional Society (RAPS). 

Learner Level: Beginner

Audience:

This symposium is designed for Clinical Research Assistant/Associates or Clinical Research Coordinators in academia, clinics, hospitals, industry, or CRO with 1- 2 years of clinical research experience.Individuals may be new to clinical research with limited knowledge of clinical trial conduct, good clinical practices, regulations and common terminology associated with clinical research.

Contact Hours:

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 0.75 Continuing Nursing Education contact hours from ENPDC.

Need Help with Registration? Please contact us at ene@emory.edu or 404-727-9208.

Program Information: This is the fourth course in a seven session program. To complete the entire program and earn badge Click Here.