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:

All parties to a clinical trial have a common purpose of conducting a successful trial but the parties also have competing perspectives. To protect each party from liability, contracts are created to typically include mutual indemnifications that exclude each party’s liability for consequential damages.

This course examines the complicated responsibilities, liabilities, purpose, intent, rights and indemnifications when numerous parties, such as drug manufacturer, study sponsor, CROs, study site, institutions, investigators, and various other entities comes together to run a successfully clinical trial.

Topics:

1. Common purpose / Competing perspectives
2. Involving parties
   • Types of studies
   • Working with potential changes over time
   • Who employs whom?
3. Benefits to transferring risk
4. The contract: A risk transfer tool
   • Risk mitigation
   • Clinical trial agreements
5. Identifying potential risk
6. What is indemnification?
   • Mutual or one way
   • Types of claims
7. Considerations for contractual indemnity
   • Example: Sponsor indemnification
8. Insurance terms

Speaker:

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 

Audience:

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. 

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 1.0 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 fifth course in a six session program. To complete the entire program and earn badge Click Here.