KUALA LUMPUR, Nov 2 (Bernama) -- The launch of the Malaysian Phase I Clinical Trial Guidelines during the Clinical Research Malaysia’s (CRM) Industry Dialogue 2017 today marked an important milestone in the history of clinical research in Malaysia.
In a statement today, CRM said it was part of a much bigger initiative of the Phase I Realisation Project (P1RP) which aimed at building a complete and comprehensive early phase clinical research ecosystem in the country.
It said the writing committee had been tasked by the Ministry of Health (MOH) to develop a standard reference for the conduct of first-in-human (FIH) trials in the country.
The committee members included experts in the field of clinical trials from the MOH, Higher Education Ministry, industry experts and regulatory officers from National Pharmaceutical Regulatory Agency.
International experts on clinical trials were also invited as subject matter experts and be part of the guideline writing committee, the statement said, adding that feedback from industry players were also gathered during the development of the guidelines.
The launch was officiated by National Clinical Research Centre Director Dr Goh Pik Pin.
-- BERNAMA
No comments:
Post a Comment