San Francisco, California
London, United Kingdom
Good Clinical Practice (GCP) is a term used to describe a collection of various FDA regulations that govern the conduct of clinical trials. It includes regulations which apply to Sponsors and Contract Research Organizations (CROs) who run the trials, the clinical trial sites and Investigators who conduct the research, the Institutional Review Boards ("IRBs" or Ethics Committees) who oversee the conduct of the trials, and includes other aspects such as avoidance of financial conflict of interest on the part of clinical investigators. The FDA conducts inspections at all of these levels to determine if there has been compliance with GCP, and if not, the agency may take any of a variety of enforcement actions
This seminar provides an introduction to GCP, with emphasis on the regulations governing drug and biologic clinical trials. (Most of the information is also applicable to medical devices, but specific requirements for device trials are not discussed.) It also covers the essential elements of FDA inspections of Sponsors and CROs, clinical trial sites, and IRBs, provides guidance for how to effectively prepare for and manage these inspections, and how to communicate effectively with the FDA about inspection outcomes.
Since many companies operate clinical trials in a variety of world-wide venues, the course provides an introduction to key guidelines for GCP from the International Conference on Harmonization (ICH), which are used by multiple health regulatory authorities as definitive guidance for GCP compliance. The primary emphasis, however, is placed on FDA requirements.
Upon completing this course participants should:
- Understand the meaning of the term “Good Clinical Practice” (GCP)
- Know which FDA regulations constitute GCP
- Know the requirements the regulations place on Sponsors, CROs, clinical trial sites and IRBs
- Understand the basic elements of informed consent
- Understand the rules for avoidance of financial conflict of interest by clinical investigators
- Understand the applicability of Good Manufacturing Practice to the production of clinical trial materials
- Understand why inventory control and reconciliation is important to GCP compliance
- Understand the criticality of data integrity and the prevention and detection of fraud and misconduct in clinical trials
- Understand the basics of FDA inspection management, and how to find key guidance resources to prepare for and manage FDA GCP inspections
- Understand the role of ICH guidelines in GCP compliance
Who will Benefit:
This course is designed for people tasked with managing or overseeing clinical trial operations and quality assurance, or for hosting FDA inspections in the GCP (Bioresearch Monitoring, “Bi-Mo” area). It is basic in content, and is particularly well suited for those new to the concept of GCP or who have recently been placed in a position with oversight responsibility for working with CROs conducting clinic trials on behalf of their company as a Sponsor:
- Clinical Operations Staff
- Clinical QA Staff
- Clinical Research Associates
- CRO Employees involved in the above areas
- Regulatory Affairs professionals
- Clinical Auditors
- GMP Professionals who need to understand GCP requirements
- Clinical trial site coordinators
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.