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MRCT CoE

2014 APEC Multi-Regional Clinical Trial Regulatory Science Center Of Excellence Pilot Workshop

March 17-19, 2014 The Academia, Singapore General Hospital, Singapore
2014 APEC Multi-Regional Clinical Trial Regulatory Science Center Of Excellence Pilot Workshop : Time, Topics, Speaker

Time

Topics

Speaker

Monday, March 17
09:00-09:05 Welcome Remarks Raymond Chua (HSA)
09:05-10:00 Introduction Session Facilitated by
Justina Molzon
10:00-13:00 Session I - Protocol design: Pre-defined geographical regions and how to account for differences in epidemiology and medical practice (extrinsic factor) Masa Takeuchi
13:00 - 14:00 Lunch - Sponsored by Health Sciences Authority
14:00-17:30 Session II - Protocol design (statistical analysis plan): Statistical significance verses clinical trend analysis when evaluating clinical efficacy in sub-population data analyses Robert Li
Tuesday, March 18
09:00-12:30 Session III - Finding the Right Dose; Consideration of Dosing in Asian Patients Robert Meyer
12:30 - 13:30 Lunch Break
13:30-17:30 Session IV - Clinical data analysis: Safety signal detection, differentiating between clinically meaningful events and those not clinically meaningful due to confounding factors or an acceptable risk-benefit evaluation Aloka Chakravarty
Wednesday, March 19
09:00-12:30 Session V - Economy-Specific Patient Requirements To Satisfy Registration: Bridging Studies and Beyond Brain Harvey
12:30 - 13:30 Lunch Break
13:30-16:30 Presentation of Mock Application (APECSTATIN) by Industry & Discussion of Concepts Facilitated by
Justina Molzon
16:30-17:30 Onsite Survey & Feedback Session Facilitated by
Justina Molzon
17:30-18:00 Presentation of Certificates to Participants
18:00 Pilot Workshop Concludes