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Topic:
Advance GCP - Theory to Practice
Date:
7th and 8th August 2009
Venue:
Mumbai
Course Description: The two day workshop aims to provide practical application of GCP for important clinical trial processes. This program is designed for professionals with at least two years of experience in the clinical research industry.
Learner Objectives:
• Review and update GCP knowledge
• Recognize the challenges of site selection
• Understand the issues involved in planning of clinical trial
• Analyze ethics committee approval process
• Assess acceptability of informed consent
• Discuss monitoring aspects of protocol compliance
• Comprehend identification and handling of safety issues
Faculty Objectives:
• To arouse curiosity about the topic.
• To explain concept of ‘Six Sigma’; its genesis and historical background.
• To explain relevance of ‘Six Sigma’ & its applications in Clinical Research.
• To sensitize the participants for a hands-on Workshop at a later date.
Who Should Attend: This course is recommended for experienced Clinical Quality Assurance Professionals, Clinical Research Associates, Project Managers, Investigators, and Study Coordinators.
Course Outline:
 Day 1:
| Time |
Topic |
| 09.30 am - 10.30 am |
GCP test and review |
| 10.30 am - 11.00 am |
Tea Break |
| 11.00 am - 01.00 pm |
Study Set up : Investigator selection |
| 01.00 pm - 02.00 pm |
Lunch |
| 02.00 pm - 03.30 pm |
Study Set up : Planning a trial |
| 03.30 pm - 04.00 pm |
Tea Break |
| 04.00 pm - 05.30 pm |
Monitoring 1 : Ethics committee approval |
Day 2:
| Time |
Topic |
| 09.30 am - 11.00 am |
Monitoring 2: Informed consent process |
| 11.00 am - 11.30 am |
Tea Break |
| 11.30 am - 01.00 pm |
Monitoring 3 : Protocol Compliance |
| 01.00 pm - 02.00 pm |
Lunch |
| 02.00 pm - 03.30 pm |
Safety reporting |
| 03.30 pm - 04.00 pm |
Tea Break |
| 04.00 pm - 04.30 pm |
Open Session |
Each topic had been handled as a case study / exercise / interactive discussion.
Conferences:
 Six Sigma in Clinical Research, Mumbai, Bengaluru
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