By : Compliance Online
Date : 2011
Location : United States US / Palo Alto
This GCP compliance in Clinical Trials training aims to provide an overview of the parameters critical in ensuring GCP compliance and in doing this, will translate GCP in a more practical, applied sense.
GCP, Clinical Trials, Clinical Practice
Applying GCP in a real life situation is often subjective, requires experience and training. A Clinical Trial, like any other project is divided in stages with tasks running in parallel or in sequence and affecting one another in a cause and effect relationship. Over the years, findings of inspectors and experiences of monitors have identified clusters of deficiencies in complying with GCP principles, key areas that emanate straight from the GCP guidelines.
This presentation will shed light on what one needs to pay attention to, in order to run a clinical trial in a GCP compliant manner, securing both results and quality. By defining the key parameters and providing lists of common deficiencies, an understanding of how to progress through each stage of a project and what to watch out for will be gained. As a result, working knowledge of GCP will increase.
Areas Covered in the Seminar:
- Importance of Good Clinical Practice.
- Key areas of deficiencies in Clinical trials.
- Common findings in audits and inspections.
- Definition of ranking of findings: minor-major-critical.
- Definition of Adverse and Serious adverse events.
- ICH guidelines on the Informed consent process.
- Management of investigational drug.
- Investigator site file and essential documents.
- Source data.
- Site and people management.
Leonidas Lambrinidis, BSc Biochemistry, MSc Biochemical Engineering, MBA. 10 years in clinical research. Held various positions in the industry from CRA to Associate director of project management. Worked both in the Pharmaceutical industry and CROs. Experience in sponsor, FDA and EMA inspections. Conducted both internal and external trainings.
Organizer : Compliance OnlineComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria