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P1RP – Development of Phase 1 Clinical Trial Guideline
May 20, 2016 @ 3:00 pm - May 21, 2016 @ 5:30 pm
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About P1RP
This workshop is an important milestone towards the Phase 1 Realization Project, also known as the P1RP. The development of the Phase 1 guideline marks an important step in the P1RP blueprint which has four other pillars to it; People Development, Capability Development, Preparation of Sites and Risk Management.
Malaysia is fast becoming the preferred destination for industry sponsored clinical trials; from 143 trials in 2010 to 201 trials in 2015, a 41% increase. However, of the 201 clinical trials conducted in 2015, only one Phase 1 study was conducted, with the majority of the rest of the studies being in Phase III.
Phase 1 Clinical Trial Guideline Committee are represented by the various MOH hospitals, public/private institutions and regulatory body that are able to advise and give invaluable input to the development of Malaysia’s first Phase 1 Clinical Trial Guideline.
