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Multi-Day Workshop: FDA Regulations

This workshop is designed as an essential resource for professionals engaged in the oversight of FDA-regulated drugs, biologics, and medical devices. By employing a multifaceted educational approach that includes pre-learning modules, hands-on exercises, and real-world case studies, the workshop aims to equip attendees with the skills necessary to navigate the complex landscape of FDA regulations for the conduct of research with human subjects effectively. The instructional content will address a range of critical aspects of FDA regulations, from legal frameworks and compliance protocols to specific challenges associated with emerging technologies. Learning Objectives Analyze the intricate relationship between FDA regulations and ethical considerations in research involving drugs, biologics, and medical devices, proposing solutions for compliance and ethical integrity. Evaluate FDA regulations in various research scenarios, making informed decisions to ensure compliance and address ethical dilemmas within the context of drugs, biologics, and medical devices. Construct strategies for implementing FDA regulations, integrating legal, ethical, and practical aspects to promote compliance and participant welfare across the spectrum of drugs, biologics, and medical devices.

Virtual Roundtable: Chat-IRB - Generative Artificial Intelligence (GenAI) for research ethics review

Join us for a discussion with the authors of “ Chat-IRB? How application-specific language models can enhance research ethics review .” During this roundtable, the authors will explore how IRBs can employ application-specific GenAI tools — such as Large Language Models (LLMs) — to transform, enhance, and augment their operations and ethics reviews. Members will have the opportunity to ask questions and have an open conversation about the potential of GenAI/LLMs, as well as their possible key challenges and ethical considerations in research ethics oversight.