Click here to go to the previous page
How Industry Can Partner with FDA in Defining a Risk-based Monitoring Program
Program Code:
301
Date:
Wednesday, June 27, 2012
Time:
8:00 AM to 9:30 AM
EST
CHAIR
:
Jan Pierre,
Dynport Vaccine Company LLC CSC, United States
Ms. Pierre is currently Clinical Quality Principal Leader with Dynport Vaccine Company (DVC). Prior to DVC, Ms. Pierre served as Sr. Regulatory and Quality Scientist with HHS/OS/ASPR/BARDA. She has held senior QA leadership positions with both CROs and site management as well as a FDA regulator.
|
PRESENTER
(S):
Charles Preston, Beardsworth Consulting Group Inc
Ex-FDA, Pharma, CRO, SMO & consulting firm GCP compliance specialist, now independent consultant. Specializing in significant FDA compliance concerns, cost effective auditing, identification of systemic GCP issues, evaluation of CQA operations, and focused GCP Training.
|
Jan Pierre,
Dynport Vaccine Company LLC CSC, United States
Ms. Pierre is currently Clinical Quality Principal Leader with Dynport Vaccine Company (DVC). Prior to DVC, Ms. Pierre served as Sr. Regulatory and Quality Scientist with HHS/OS/ASPR/BARDA. She has held senior QA leadership positions with both CROs and site management as well as a FDA regulator.
|
Description
FDA encourages more effective monitoring of clinical trials through their August 2011 draft guidance. Risk-based monitoring strategies and approaches will be discussed from the FDA, sponsor and site perspectives, and a focus on expected key changes in FDA's bioresearch monitoring (BIMO) inspection program will be provided.
Learning Objectives:
Identify infrastructure, ethical, scientific, and practical risks in running quality clinical trials
Discuss suitable controls to monitor and mitigate inherent risks
Describe elements of a risk monitoring checklist to be incorporated in an effective clinical monitoring plan.