GCPs are required to be followed during conduct of clinical trials; it is the responsibility of the sponsor to ensure that all aspects of the study comply with legal and regulatory requirements to ensure integrity and reliability of the data obtained. Requirements include but not are limited to, contract research organizations, clinical investagators, manufacturers of drug substance and drug product used in clinical studies and commercialized, packages, labelers and distributors, testing laboratories and warehouses.
In order to ensure compliance by employees and vendors you must have in a robust program for oversight of their activities, and a program for mitigating against risks that may arise related to key vendors. They must also have internal systems to ensure appropriate oversight and management of the program and data. This program will provide considerations for vendors, implementing a robust qualification & selection process, strategies for oversight and management of vendors, and a risk mitigation approach for key vendors. It will also provide considerations for internal oversight programs and tools for various phases of development.
Why You Should Attend:
This program will address the regulatory & legal requirements related to clinical trials and the sponsor responsilbilities for effective management of clinical trials. Learn toidentification & implement systems to effectively select & manage vendors and clinical sites, and monitoring programs.
Regulatory requirements for clinical trial management
Elements to consider In setting up and managing clinical trials
Formats and essential components of SOPs for CTM
SOP training and implementation
Systems to assist in CTM
Vendor selection oversight
- Quality Departments
- Regulatory Departments
- Compliance Departments
- Clincial Supervisors
- Clinical investigators, site management and contracting personnel
- Clinical operations
- Project managers
- Data management
- Medical writers
- Everyone who is required to understand clinical trial management