Become an expert on quality and risk-management strategies and procedures. This interactive eLearning course answers the fundamental questions: What is RBM and how is it different from the standard monitoring approach?
As we head towards the end of the second decade of the twenty-first century a great deal has changed about the way research is done at the site level particularly as it relates to the many disruptive technology driven changes that have evolved. Or has it? After 13 years managing sites and taking the investigator view followed by 13 years in the CRO industry taking the sponsor view, the author will look at what has changed in over a quarter of century and the future holds for clinical research sites. In particular he will look at the site landscape through the lens of four, supposedly major, disruptive changes.
Physician-Sponsored IDE (PS-IDE) offers an ability for the physicians to design the study to treat patients with the unapproved medical devices without the industry support or oversight. The unapproved devices may be born out of physician’s innovation (new devices) or innovative practice such as using the commercially available devices for unapproved indication (i.e., off-label use) or customizing/modifying the approved devices (altered device is considered a new device). Although there is a lot of freedom for the physician to design and conduct his or her own PS-IDE study, it is important to understand the regulatory requirements in every aspect of the trial that you will be personally responsible for. The study site will also have a unique challenge as it must incorporate sponsor obligations into their practices.
We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life-cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection “game plan” brings confidence to any inspection team.
Regulatory submissions are a result of teamwork, often occurring over many years. Each person involved in the testing, organization, or clinical studies is integral to the success of the submission. This session will take a step by step approach to walk attendees though what is required in the 510(k) and PMA submission process; and how you can best support the process. In order to commercialize, additional FDA establishment registration and device listings are required; these registration/listings help the FDA plan facility inspections. 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.
