DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "US GCP Fundamentals for Pharmaceutical and Biologic Companies" conference to their offering.
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.
- 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 Should Attend:
- 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
For more information about this conference visit http://www.researchandmarkets.com/research/pshbvk/us_gcp