Essential documentation serves to demonstrate the compliance of the investigators, Sponsors, monitors/CROs, and IRBs with the current regulatory requirements and ICH GCP standards. Techniques on how to develop best practices and meet all applicable regulatory requirements will be discussed.
This course will cover various types of essential documentation, subject specific and non-subject specific, for clinical trials involving drugs, biologics and medical devices trials. The course will help define what should be maintained at a research site and Sponsors to promote adequate and accurate documentation in compliance with current regulatory requirements.
Content and preparation of regulatory submissions, including an Investigational New Drug Application (IND), an Investigational Device Exemption (IDE), a New Drug Application (NDA), a Biologic License Application (BLA), a Pre-Market Approval Application (PMA), and a 510K PreMarket Notification are described.
Why You Should Attend:
Intended for those interested in regulatory affairs or in the clinical evaluation, development, manufacture, testing and/or commercialization of biomedical products.
Provided is an in-depth review of relevant FDA regulations and guidelines and links these to the scientific and logistical activities involved in taking a these products from clinical research point to the market. Current regulatory requirements and guidelines for records/reports handling, storage and retention will be discussed.
- Define clinical research essential documentation
- Review the GCP requirements for essential documents
- Determine essential subject and non-subject specific documentation requirements per trial
- Discuss essential documentation for drugs, biologics and devices
- Describe the significance of document management in clinical research
- Learn how to set up, maintain and manage a document system that meets regulatory standards
- Understand the role of auditors, and learn how to archive documentation and prepare for a quality assurance (QA) audit or regulatory inspection
- Prepare for regulatory inspection: Proactive and reactive use of essential documentation
- Regulatory Affairs Professionals
- Medical Affairs
- Project Managers
- Clinical Research Associates (CRAs) involved in Planning, Monitoring, Execution of trials and Responsible for Clinical Trial Reporting
- Grant Managers
- Principal Investigators