Monitoring Module
Gain Essential Skills as a Study Sponsor & HOW TO ENSURE YOUR INVESTIGTOR ARE DOING WHAT THEY SHOULD OR SHOULDN’T
Date: 29th & 30th June 2009 (Monday & Tuesday)
Time: 8:30 am – 5:30pm
Venue: Crystal Crown, Petaling Jaya
Download Full workshop program
The MOPI Bioequivalence Workshop – Monitoring Module is a 2 days comprehensive, fast-paced learning program that covers all the essentials of Study Monitoring for Good Clinical Practice (GCP) compliance, as outlined in the ASEAN Guidelines for the Conduct of Bioavailability and Bioequivalence Studies.
The program focuses on PRACTICAL solutions with a number of exercises and case studies, helping you to understand the real work scenarios and make better decisions for your studies.
- Why GCP? Is it necessary?
- What are the regulatory requirements?
- Why Monitors? How does Monitoring impact on my study?
- What are the roles of DCA/NPCB and Ethics Committee?
- What are the roles of Sponsor in Monitoring?
- How to prevent fraud and scientific misconduct?
- How to conduct a site monitoring?
- Statistical Analysis for the Non-statistician
Who Should Attend?
The course is aimed for those involved in the monitoring and/or QA of Bioequivalence studies. Employees who work for Pharmaceutical firms, involved with the supervision or oversight of clinical trial practices and policies will find this course beneficial.
- Regulatory Affairs Manager / Executive
- Clinical Research Associate
- Study Monitors
- R&D Manager / Chemist
- Formulation Scientist
There are 3 easy ways to register:
Fax 603-7956 0018 or Call 603-7957 3070, 03-7957 1004 Or Email: mike@mopi.org.my.
Reaching out to you