Name
C190a - Good Clinical Practice and Inspection Readiness (Part 1)
Date & Time
Sunday, May 1, 2022, 11:00 AM - 2:00 PM
Description

This interactive program is designed for regulatory professionals who deal with complex issues, need to understand the latest developments, and can contribute their own front-line experiences. We will cover important GCP topics and preparation for audits and regulatory inspections. Bring your own GCP questions and dilemmas.

Learning Objectives
  1. Explain ICH GCP R2 update and GCP training for NIH awardees involved in NIH-funded clinical trials.
  2. Describe GCP for medical device studies and how to incorporate ISO 14155.
  3. Explain how to be ready for audits and inspections in clinical trials.
Speakers
Michelle Brignac - Manager of Clinical Research Operations - St. Jude Children's Research Hospital (Speaker)
Linda Coleman - Director, Human Research Protection Program - Yale University (Speaker, Leader)
Janet Holwell - Clinical Research Consultant/Trainer - Holwell Clinical Research Consulting (Speaker)
Laura Odwazny - Senior Attorney - US Department of Health and Human Services (Speaker)
Michelle Brignac Linda Coleman Janet Holwell Laura Odwazny
Track
C - Regulatory Compliance
Location Name
Back Bay C