Description :
This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements during clinical trials for both drugs and medical devices.
To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.
GCP requirements including documentation requirements (a set of SOPs) with key elements to be contained in the SOP will be discussed.
In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety.
Areas Covered in the Session :
Laws and Regulations
Definitions
Clinical Trials and Requirements
Regulatory Requirements for INDs and IDEs.
Duties and Responsibilities for Clinical Investigators (CI), Institutional Review Boards (IRBs), Sponsors and Monitors, and Contract Research Organizations (CROs)
ICH-GCP Guidelines
ISO 14155
List of SOPs and Adequate Documentation
Key Elements in the SOPs
Common GCP Deficiencies in EU and US
Enforcement Actions
Lessons Learned
Who Will Benefit:
Clinical Affairs
Regulatory Affairs
Quality Assurance
Research & Development
Consultants
Contractors/Subcontractors
Senior Management
Anyone Interested in the Topic
This webinar is intended to help you adequately implement Good Clinical Practices (GCP) including documentation requirements during clinical trials for both drugs and medical devices.
To adequately implement GCPs, there are a set of standard operating procedures (SOPs) to be established and maintained at any given facility, to the extent applicable, as a sponsor, clinical investigators, monitors, and CROs, etc.
GCP requirements including documentation requirements (a set of SOPs) with key elements to be contained in the SOP will be discussed.
In this 60-min webinar, you will have unparalleled opportunities to bring great value and benefits to your organization and to greatly improve your GCPs with increased awareness of the needs - sustainable compliance and patient safety.
Areas Covered in the Session :
Laws and Regulations
Definitions
Clinical Trials and Requirements
Regulatory Requirements for INDs and IDEs.
Duties and Responsibilities for Clinical Investigators (CI), Institutional Review Boards (IRBs), Sponsors and Monitors, and Contract Research Organizations (CROs)
ICH-GCP Guidelines
ISO 14155
List of SOPs and Adequate Documentation
Key Elements in the SOPs
Common GCP Deficiencies in EU and US
Enforcement Actions
Lessons Learned
Who Will Benefit:
Clinical Affairs
Regulatory Affairs
Quality Assurance
Research & Development
Consultants
Contractors/Subcontractors
Senior Management
Anyone Interested in the Topic
