Full program description
This 6-course program explores the regulatory, scientific and logistical considerations in clinical trials involving emerging technologies, cutting edge devices, immunotherapies, gene therapies, and stem cell therapies.
Rapid advances in science over the past decade have provided new technologies to innovate, manufacture and assess novel medical products, and to the discovery of life changing cures.Regulators have a key role in providing guidance to industry to ensure safe and effective use of these new scientific advances. In this program, scientific achievements will be highlighted along with their real-world impact. Consideration will be given to regulatory and logistical operations, and successes and consequences of failure.
At the end of this program, Conducting Clinical Trials in the Era of Emerging Technologies and Treatments, participants will understand basic terminologies associated with gene therapies, stem cell therapies, and immunotherapies, and the intricate process of harvesting, manufacturing and administrating cells for these therapies.Additionally, participants will gain knowledge of unique technologies including a fetal micropacemaker and the concept of decentralized clinical trials.
- Course 1: Regulatory Considerations
- Course 2: Gene Therapy Trials and Tribulations
- Course 3: Clinical Trials for Stem Cell Therapies
- Course 4: Clinical Trial Enabling Technologies – Decentralized Clinical Trials
- Course 5: Immunotherapy Trials
- Course 6: Cutting Edge Technologies and Humanitarian Devices
Learner Level: Advanced
This symposium is designed for Clinical Research Coordinators, Project Managers, Monitors, Regulatory, Medical and Clinical Affairs Professionals or junior faculty with 3+ years of experience seeking to further develop clinical research conduct skills and principles.Clinical research professionals should have responsibilities that include clinical trial start up planning, mentoring and complex issues involving site management, study management, and sponsor/ CRO challenges.
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