Clinical Compliance 2011 - The GCP/ICH Obligations of Sponsors, Monitors, and Investigators - Barriers and Solutions

This GCP/ICH regulations training will focus on the regulatory requirements that Sponsors, Monitors, and Investigators must follow to be GCP compliant.

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.

Areas Covered in the Seminar:

- The historical background of why the GCP standards were developed.

- Who is responsible for what?

- 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?

NOTE : Use this Promocode (128600) to avail 10% discount, valid upto 29th November 2011.