|
Workshop – 1: Good Clinical Practice (GCP)
Day 1 (Thursday, 3 December 2009)
08.00 – 08.30 Registration
08.30 – 08.45 Welcome address by Dr. Yap Kok Wei,
CEO, GleneaglesCRC Group,
Group VP Research, ParkwayHealth, Singapore
08.45- 09.15 Overview of Drug Development & Clinical Research
Dr. Yap Kok Wei. CEO, GleneaglesCRC Group,
Group VP Research, ParkwayHealth, Singapore
09.15 – 09.45 Overview of ICH-GCP Guidelines
Ms. Azizah Mohamed, IRB Member
Parkway Independent Ethics Committee, Singapore
09.45 – 10.15 Exercise 1: ICH-GCP Guidelines
GCRC
10.15 – 10.45 Morning refreshments
10.45 – 11.15 Ethics in Clinical Research and Role of Ethics Committee
Ms. Azizah Mohamed, Senior manager
Hospital Administration of Mount Alvernia Hospital, Singapore
11.15 – 11.45 Informed Consent Process
Ms. Angeline Lim, Senior Clinical Research Manager
Gleneagles CRC Pte. Ltd
11.45 -.12.15 Role and Responsibilities of Investigator
Ms. Angeline Lim, Senior Clinical Research Manager
Gleneagles CRC Pte. Ltd
12.15 -.13.00 Networking luncheon
13.00 – 14.00 Exercise 2 : Informed Consent
GCRC
14.00 – 14.30 Good Documentation and Archiving
Ms. Fabiola C.R Hutabarat, Senior Clinical Research Associate
Gleneagles CRC Pte. Ltd
14.30 – 15.00 Handling and Accountability of Clinical Trial Material
Ms. Fabiola C.R Hutabarat, Senior Clinical Research Associate
Gleneagles CRC Pte. Ltd
15.00 – 16.00 Q & A
16.00 – 16.30 Tea and End of session
Day 2 (Friday, 4 December 2009)
08.15 – 08.30 Registration
08.30 – 09.15 Clinical Research in Indonesia
Dr. Lina Ratulangie, Medical Doctor
Taisho Pharmaceutical Indonesia (formerly BMS-Indonesia)
09.15 – 10.00 Regulatory Requirements of Clinical Trials in Indonesia
10.00 – 10.30 Role and Responsibilities of The Sponsor
Dr. Lina Ratulangie, Medical Doctor
Taisho Pharmaceutical Indonesia (formerly BMS-Indonesia)
10.30 – 11.00 Morning refreshments
11.00 – 11.30 Role and Responsibilities of the Study Site Coordinator
Ms. Angeline Lim, Senior Clinical Research Manager
Gleneagles CRC Pte. Ltd
11.30 – 12.00 Role and Responsibilities of the Site Study Monitor
Mr Rodmar Pulido, Country Manager
Gleneagles Clinical Research International Pte Ltd, Philippines
12.00 – 13.30 Networking luncheon
13.30 – 14.00 Safety Monitoring and Reporting
Mr Rodmar Pulido, Country Manager
Gleneagles Clinical Research International Pte Ltd, Philippines
14.00 – 14.30 Quality Assurance in Clinical Trials: Fraud and Misconduct
Mr Rodmar Pulido, Country Manager
Gleneagles Clinical Research International Pte Ltd, Philippines
14.30 – 15.00 Exercise 4: Case Studies on Fraud and Misconduct in Clinical Trials GCRC
15.00 – 15.30 Q & A
15.30 – 15.45 Closing Remarks by Dr. Yap Kok Wei,
CEO, GleneaglesCRC Group,
Group VP Research, ParkwayHealth, Singapore
15.45 – 16.30 Multiple choice question examination for certification
16.15 – 16.45 Participants Evaluation & Farewell Tea
End of session
|
