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.
Description: This course focuses on the importance of subject recruitment in clinical trials, including exploring the current landscape in clinical trials, and recruitment strategies in clinical trials of recently approved drugs.
Topics:
· What shapes patient differences?
· Factors influencing participant selection in clinical trials
· Target Patient Populations
· Consideration of genetics, physiological differences, co-morbidities, geography, and multi-factors in studies for new products
· Study Populations in Clinical Research
· Challenges: Bringing New Drug to Market
· Regulations
o Good laboratory practices: 21 CFR 58
o Good manufacturing practices:21 CFR 210-211
o Good clinical practices: 21 CFR 11, 50, 54, 56, 312, 314, 320, 812, 814
o Goal: Obtaining approved labeling
· ACE inhibitors, carbamazepine, isosorbide dinitrate/hydralazine, and rasburicase
· Variability in drug response across patient groups
· Necessity of clinical trial data to include all populations
· Overview of the Complexity of the Issue
· How biological traits impact study results
· External factors influencing health outcomes
· Trust in the clinical trial process
· COVID-19: Highlighting differences in health risks across groups
· Moderna, Inc. - efforts to broaden trial participation
Speaker:
Eunjoo Pacifici, PharmD, PhD, is the Chair and Associate Professor of Regulatory and Quality Sciences and Associate Director of the International Center for Regulatory Science. Dr. Pacifici received a BS in Biochemistry from the University of California Los Angeles followed by a PharmD and PhD in Toxicology from the University of Southern California. She conducted her graduate research in the laboratory of Dr. Alex Sevanian in the Institute for Toxicology where she studied the mechanism of oxidative damage and repair in endothelial cell membrane. Before returning to USC as faculty, Dr. Pacifici worked at Amgen and gained experience in conducting clinical research with a special focus on the Asia Pacific and Latin America regions. She initially worked in the clinical development group managing U.S. investigational sites and central laboratories and then went on to work in the Asia Pacific / Latin America group interfacing with local clinical and regulatory staff in Japan, the People’s Republic of China, Taiwan, and Mexico. She represented regional clinical and regulatory views on therapeutic product development teams and led satellite task forces in order to align local efforts with U.S. activities. Her additional professional experiences include community pharmacy practice in various settings and clinical pharmacy practice at the Hospital of the Good Samaritan in Los Angeles. Her current focus is on developing the next generation of regulatory scientists and pharmacy professionals with the knowledge, tools, and skills to expedite the development of innovative, safe, and effective biomedical products. epacific@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 continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. Attendees to this CNE activity will be awarded 0.5 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 first 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