FDA Regulatory Control of the Drug Development Process and Investigator Responsibility in the Process
Friday, April 26, 2013 from 10:00 AM to 11:30 AM (PDT)
Palo Alto, CA
This training will review the clinical trial investigator's role in the drug development process and show how you can ensure that clinical studies are carried out in compliance with FDA's regulatory expectations.
Why Should You Attend:
There is an increasing frequency of real-time FDA Audits of trials and it seems that no one is well prepared. It is the obligation of the major players in the drug development process (the Investigator and the study Sponsor) to be sure studies are carried out correctly so that errors and mistakes are found and corrected by them (CAPA) and not by an FDA Investigator.
In this 90-minute webinar, you will 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. We will discuss how compliance with the Regs and Good Clinical Practice will ensure quality data, speed up the review process, and decreases the costs.
Areas Covered in the Seminar:
- The Investigators role in the clinical research process, the IC process..
- Know how the Regs define the many terms describing Adverse Events
- Why the investigator files the signed and dated protocol?
- What is the legal language of the FDA form 1572 or Device equivalent?
- Why is Financial Disclosure information important?
- What is the history of the drug / device regulations?
When & Where
At ComplianceOnline, we are focused on :
- Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
- Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
- Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
- Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.