Learning Documentation Lessons from FDA/EMA Inspections

Mar 14, 2014

The Association of Clinical Research Professionals (ACRP) is organizing an online teaching session about regulatory inspections, to be held on May 14, 2014.

The event will examine common findings from inspections by the Food and Drug Administration (FDA) and European Medicines Agency (EMA). The plan is to use a “lessons learned” approach to help identify and prevent common inspection findings related to essential document collection and retention.

According to a statement from the organizers, “This Webinar delves into essential document collection and retention by first identifying what essential documents are and why they are necessary. The presenter will then cover essential document requirements and responsibilities in clinical research, followed by essential document retention requirements.”

Also, the program will cover any differences between ICH/GCP, FDA, and the EU Clinical Trials Directive in the requirements and retention of essential documents.

The event is designed for experienced research nurses, investigators, research assistants, research associates, project managers and all other staff who are directly involved in performing clinical research who are familiar with the terminology. The presenter will be Judith van Heel, who formerly worked for Bristol Myers-Squibb and Novartis and CROs Kendle International and JCR).

The event will take place from 12 noon to 1.30 pm US Eastern Time. The cost of registration is $99 for members and $149 for non-members.