Kum Cheun (KC) is Head of Asia Pacific Regulatory & Development Policy for Novartis, leads in the development of regulatory and development policy, and regulatory intelligence for Asia Pacific. He is Co-Chair of Singapore Association of Pharmaceutical Industries (SAPI) Regulatory Affairs Committee, Chair of EFPIA ASEAN Regulatory Network.
KC is actively involved in ASEAN Pharmaceutical Harmonisation and was Co-Chair of the ASEAN Pharmaceutical Research Industry Association (APRIA). He is an active member of EFPIA International Regulatory Expert Group (IREG), EFPIA regional regulatory networks (India, Korea-Taiwan), Steering Committee of DIA Singapore, Steering Committee of Asia Partnership Conference of Pharmaceutical Associations (APAC), member of APAC RA-EWG and APAC E-Labelling WG, member of Asia Partnership Conference of Regenerative Conference (APACRM) and DUKE-NUS Centre of Regulatory Excellence (CoRE) Visiting Expert.
KC was former Drug Registration Branch’s Deputy Head responsible for the ‘Quality Evaluation and Submissions Section’ of the Centre for Drug Administration at the Singapore Health Sciences Authority (HSA). In HSA he was involved in the development of HSA’s product registration guidance and introducing the Variation Guideline and BA/BE Guideline. KC participated actively in the ASEAN Harmonization of Pharmaceutical Products technical development and was Co-Lead in developing the ASEAN Process Validation Guideline.
