the quality management institute and acrp have partnered in a program of education for individual professionalism and the quality management of clinical research sites. in this session, you will learn how partnering with complion provides the top of the line technological tools and one-on-one advisory services you need to succeed. the quality management institute and acrp have partnered in a program of education for individual professionalism and the quality management of clinical research sites. the objective of this session will be to review site compliance from a cro perspective, while also discussing practical and effective corrective actions from both the monitor’s and sponsor’s view. this session will help you learn how to measure and improve the readability of your clinical research communications to a participant and public-facing audience. this presentation will focus on selecting the best vendors for a specific study, including vendor costs in the study budget, and how to successfully collaborate with the vendors from startup to close out. participants of this session will get a broad appreciation of the submission process and some best practices to support your team in the regulatory submission process. this session will provide a high-level walk through of quality risk management, the key components of a risk management program, and how to conduct a risk assessment at the system and protocol level. in this session the speaker will provide a basic overview of pediatric clinical research to include the specifics written in the ich e11 guideline and the rationale for the revision based on the fda’s input. we will discuss the challenges of implementing a quality management system and how to overcome setbacks. this session will provide a current and complete description of the two pathways, their advantages and challenges. the use of a project management tool, a work breakdown structure (wbs) to define clinical trial start-up tasks, timelines, and assignments is an effective method to improve project success. this session will provide information on the implications and consequences of investigator and staff misconduct in clinical research. this session will focus on an overview of the office of regulatory affairs “program alignment” initiative including new divisions, what the initiative will mean for your next (or first) inspection, and who to contact with concerns. a cyber-security incident could result in the compromise of critical information or systems, disruption of operations, and even harm to patients. a discussion of the exam format and valuable strategies for exam preparation will be discussed. in this presentation, dr. vaughn will review commissioner gottlieb’s statement, provide an overview of the six guidance documents, and discuss the implications for clinical development of new gene therapy products. the participant will obtain tools to develop successful clinical and regulatory strategies for new devices and indications.
in this interactive session participants will gain knowledge into the identification, assessment, evaluation, reduction, control and monitoring of risk that are essential to device risk management. therefore, the two organizations collaborated to launch the technology competency and adoption survey in early 2019. we will be sharing highlights from the survey results with a focus on discussing: • barriers to competency achievement and technology adoption • how individuals can enhance their individual competency • best practices for how organizations can foster improved adoption of clinical research technologies. this session will provide an overview of the reorganization of the fda’s center for devices and radiological health (cdrh). in this dynamic panel discussion, four industry experts will share their observations on the critical knowledge, skills and abilities essential for a great cra, how these can be developed and assessed and why it is important to consider a holistic view of cra performance from different perspectives. this session will look at these trends and use a “crystal ball” to tell us the expectations of clinical researchers in the future. leave with a strong understanding of the considerations and configurations that need to be made for a successful emr/ctms integration. the speaker will provide insights on the importance of maintaining a contemporary understanding of vulnerable subjects and adjusting perceptions in order to protect vulnerable subjects in clinical trials. review the use of a standard system and tools to compliment the risk-based monitoring strategy. learn the key communications between sponsors and sites that set the framework for the duration of a clinical research project. hear how these innovative workflows are paving the way for future research and playing an integral role in accelerating the translation of research to the bedside. the speaker will provide a detailed review of aes and requirements for assessment, documentation, recording, and reporting. speakers will provide tools, guidance, and some insider tips from the viewpoints of dedicated research sites and large, hospital-based research institutions on issues to consider during implementation. when conducting a clinical trial, the collection of important economic data in conjunction with medical and clinical outcomes is becoming more common. learn how to effectively gain support for moving clinical research from “just a small department” to part of the broader organizational culture. the speaker will lead an engaging and lively discussion of the regulatory year in review at this always-popular and provocative session. selecting the right trial for your clinical research site is key to the success of your accrual for the trial. this elearning course is an excellent starting point for anyone wanting to begin work in clinical research and a great refresher for those who have been in the role for some time. this elearning course uses a game to challenge the learner’s knowledge and application of these important efficacy guidelines. the quality management institute and acrp have partnered in a program of education for individual professionalism and the quality management of clinical research sites.
medicines development and regulation join us to review how clinical trial implementation is changing for research about the training course. topics include: clinical trial design and analysis, including new trends and for more information on clinical trial compliance, call us at 1-610-648-7550 or contact us. pharma and biotech courses , fda clinical investigator training course 2019, fda clinical investigator training course 2020, clinical trial training courses, clinical trial training courses, clinical trial management certification.
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