Safety Reporting in Industry-Sponsored Trials and Case Studies – Part 2

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:

In continuation with the fourth (4^th) course, Safety Reporting in Industry-Sponsored Trials and Case Studies Part 1, of this 6-part program, two case studies exploring clinical trial adverse event reporting for drugs and medical devices will be presented.

Topics:

1. Case Study #1
   • A rare serious adverse reaction is reported in an approved drug being studied for a new indication – what are your reporting requirements and what changes can be expected by the FDA?
2. Case Study #2
   • An investigational device is implanted in three subjects whom experienced different serious injuries – who is responsible for reporting, what needs to be reported and in what timeframe?

Speaker:

Julie Hoegi, M.D., is a pharmacovigilance physician with 19 years of pharmaceutical industry experience in clinical research and clinical/postmarket safety.  Successes include adverse event management compliance during global mergers and acquisitions, 12 country globalization of the Argus Safety System, and signal detection and management as well as successful completion of pharmacovigilance inspections conducted by FDA, Health Canada, Inspectorate of the Netherlands, and MHRA.  Dr. Hoegi is currently focused on oncology product development.Jhoegi@msn.com

Audience:

This course 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.

Learner Level: Beginner

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 fifth (5^th) course in a six (6) 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