The GCP-ICH Obligations of Sponsors, Monitors, and Investigators - barriers and solution
Overview:
The principal objective in a new drug development program is to assess the benefit / risk ratio.
Learn what the risk information is that must be collected, documented and reported accurately. Learn also how the International Conference on Harmonization (ICH) has been the most outspoken as to what GCP is including a formal listing of the "Principles of GCP" and a definition that is clear. Covered also will be what the practices are that ensure subject safety and credible data, which are the hallmarks of GCP.
You will see why the single most important function of the Principal Investigator and the study conduct team is the awareness, assessment, and management of Adverse Events occurring during the conduct of clinical research with drugs or devices utilizing human subjects. See why AE’s are one of the key ways the Clinical Investigator has of monitoring the safety of subjects or patients in her/his charge.
Learn how well-controlled and well-conducted clinical trials that follow the Code of Federal Regulations and the Principles of GCP are important to both sponsors and CRO’s / investigator sites. See how compliance with the Regs and Good Clinical Practice will ensure quality data, speed up the review process, and decreases the costs to sponsors. This Webinar addresses the obligations of sponsors, monitors, and investigators who conduct and verify clinical research that is governed by US FDA regulations and ICH guidelines.
Why Should You Attend: All CRO’s, Sites, and Sponsors of Clinical Research involved in the drug and device development process have an interest in being prepared for the audit process. Attending this Webinar is a good step toward learning the ICH processes and why the Sponsor’s / CRO’s Monitors are so important.
Areas Covered in the Session:
- The historical background of why the GCP standards were developed
- The concept of and the purpose of ”GCP”
- The thirteen ICH Principles of “GCP”
- The ICH definition of “GCP” and how it is applied
- The Regulatory requirements to follow to be GCP compliant
- Who, in the clinical research team is responsible that GCP is followed?
- How to be sure CPU / Site staff know their role in maintaining GCP
Who Will Benefit:
This Webinar will provide invaluable assistance to all personnel in the Pharmaceutical, Biotechnology, and CRO industry Conducting Clinical Trials including: Sponsor Senior Management, Project Managers, CRA Managers, as well as QA/Compliance persons.
- Principal Investigators and sub investigators
- Clinical Research Scientists (PKs, Biostatisticians, ...)
- Safety Nurses
- Clinical Research Associates (CRAs) and Cordinators (CRCs)
- Recruiting staff
- QA / QC auditors and staff
- Clinical Research Data managers