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:

An important factor for success in conducting clinical trials is the effective management of clinical trial products and supplies, especially in complex studies with detailed planning, extensive monitoring, and coordination between global enterprises.

Topics:

1. What is Supply Chain Management (SCM)?
   • “Amazon Effect”
   • Active management of supply chain activities
   • Pathways of pharmaceutical supply chain
   • Complexity of clinical SCM
   • Supply chain management: Healthcare and Biopharma
     • Precision medicine and complex science
     • Complex trials: customized clinical trial design, global trials, decentralized trials
     • Complex SCM: direct to patient/direct from patient, home health/home trial support
     • Innovative technology: interactive response technology, block chain, smart packaging, drones
     • SCM incompatibilities with clinical trials: geographical regulations, movement of product across state lines
     • Sponsors unaware of local or international regulations
2. COVID-19 clinical trials: Disruption to SCM
3. Career Outlook in Clinical SCM
   • SCM Roles & Job Responsibilities: information systems, warehousing, transportation, materials and procurement, sales, vendor management, customer service, quality, regulatory, operations, forecasting and planning, packaging, and labelling
   • Industry Growth
   • Education and work experience requirements
   • Salary

Speaker:

Lequina Myles, DRSc, MS, MBA, RAC, PMP, PMI-ACP is Director of Quality Control at MARKEN providing quality oversight for international and domestic life science, medical product, and clinical trial supply chain management and distribution. Her career started in the Quality Control Biochemistry Laboratories managing and supporting global projects, which increased organizational efficiency, productivity while improving client retention and strategic partnerships. Lequina holds a B.S. in Biochemistry from the University of California, Los Angeles, a Master of Business Administration (MBA) with an emphasis in Project Management from Mount Saint Mary's University, a Masters in Regulatory Science and Doctor of Regulatory Science (DRSc) at the University of Southern California. She is a certified Project Management Professional and holds a Regulatory Affairs Certification (RAC) in both drugs and devices. In addition to industry experience, Lequina is an Adjunct Faculty in the MBA Program at Mount Saint Mary's University and serves as a guest lecturer at the School of Pharmacy, USC. lmyles@usc.edu

Learner Level: Beginner/Intermediate/Advanced

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 nursing continuing professional development by the American Credentialing Center’s Commission on Accreditation. Attendees to this CNE activity will be awarded 1.0 contact hours by ENPDC. No conflict of interest has been found with the speaker for this CNE activity nor with the members of the planning committee.

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

Program Information: This is the second course in a five (5)-course program. To complete the entire program and earn a badge CLICK HERE.

Learner Disclosures:

Accreditation Status: Emory Nursing Professional Development Center (ENPDC) is accredited as a provider of nursing continuing professional development by the American Nurses Credentialing Center’s (ANCC) Commission on Accreditation.

Financial Relationships: ENPDC has evaluated everyone who has the ability to control content of this activity (planning committee members, subject matter experts, presenters) and found that no relevant financial relationships exist.

Awarding Contact Hours: To obtain contact hours participants must:

·       Review the entire activity

·       Pass the quiz

·       Complete the evaluation at the end

Certificates will be distributed at the end of the evaluation.

Enduring Materials Dates:

·       Start Date: 4/22/2024

·       Expiration Date: 4/22/2027